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Organizational communication of regulatory intelligence: a survey of the medical device industry
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Content
ORGANIZATIONAL COMMUNICATION OF REGULATORY INTELLIGENCE:
A SURVEY OF THE MEDICAL DEVICE INDUSTRY
by
Martha Kamrow
A Dissertation Presented to the
FACULTY OF THE USC SCHOOL OF PHARMACY
UNIVERSITY OF SOUTHERN CALIFORNIA
In Partial Fulfillment of the
Requirements for the Degree
DOCTOR OF REGULATORY SCIENCE
December 2020
Copyright 2020 Martha Kamrow
ii
Dedication
This dissertation is dedicated to the memory of my husband, Mark Kamrow, who
passed during my research. He was there to always offer support and encouragement
through my multiple and seemingly endless academic endeavors.
An enormous amount of gratitude to my mother and late father who were
supportive and understanding while instilling a love of learning in me from a very early
age. They both always had confidence in me and offered encouragement and support in
all my endeavors.
iii
Acknowledgements
A huge thank you to my advisor, Dr. Frances Richmond, for her countless hours
of reading, guidance, encouragement, support and most of all patience throughout the
entire process. I wish to also thank my committee members who were more than
generous with their expertise and precious time. Thank you, Dr. Susan Bain, Dr. George
Tolomiczenko, and Dr. Terry Church, for agreeing to serve on my committee.
iv
TABLE OF CONTENTS
Dedication .................................................................................................................... ii
Acknowledgements .................................................................................................... iii
List of Tables .............................................................................................................. vii
List of Figures .......................................................................................................... viii
Abstract ....................................................................................................................... ix
Chapter 1. Overview ..................................................................................................... 1
1.1 Introduction ............................................................................................ 1
1.2 Statement of the Problem ....................................................................... 4
1.3 Purpose of the Study............................................................................... 5
1.4 Importance of the Study ......................................................................... 6
1.5 Limitation, Delimitations, Assumptions................................................. 6
1.6 Organization of Thesis ........................................................................... 7
Chapter 2. Literature Review ....................................................................................... 9
2.1 Introduction ............................................................................................ 9
2.2 The Role of the Regulatory Professional ................................................ 9
2.3 Medical Device Company Structure .................................................... 12
2.4 Emerging Markets ................................................................................ 18
2.4.1 Economic power ..................................................................... 18
2.4.2 Expenditures on Health Care .................................................. 20
2.4.3 Expenditures on Health Care .................................................. 22
2.5 The Role of “Regulatory Intelligence” ................................................. 23
2.6 Creating a Regulatory Intelligence Subgroup ...................................... 26
2.7 Communication of Changing Global Regulations within Medical
Device Companies ................................................................................ 27
Chapter 3. Methodology ............................................................................................. 36
3.1 Overview .............................................................................................. 36
3.2 Survey Development ............................................................................ 36
3.3 Focus Group Survey Validation and Participant Selection .................. 37
3.4 Administration, Data Collection and Analysis ..................................... 38
Chapter 4. Results ....................................................................................................... 40
4.1 Analysis of Survey Results ................................................................... 40
4.1.1 General Information about Survey Respondents .................... 41
4.1.2 Regulatory Intelligence Process .............................................. 47
4.1.3 Regional International Regulatory Offices ............................. 55
v
4.1.4 Regulatory Intelligence Communication ................................ 78
Chapter 5. Discussion ................................................................................................. 90
5.1 Overview .............................................................................................. 90
5.2 Methodological Considerations ............................................................ 90
5.2.1 Delimitations ........................................................................... 92
5.2.2 Limitations .............................................................................. 94
5.3 Considerations of the Results ............................................................... 96
5.3.1 Characteristics of Communication: Sources and Receivers .... 96
5.3.2 Characteristics of Communication: Exchanges ...................... 99
5.3.2.1 Types of Messaging .................................................... 99
5.3.2.2 Relative Roles of Regional and Headquarter Offices
................................................................................ 102
5.3.2.3 Nature of Interactions .............................................. 103
5.3.3 Signal Quality and Fidelity ................................................... 106
5.3.3.1 Location of international offices .............................. 106
5.3.3.2 Considerations of verbal/nonverbal communication
................................................................................ 109
5.3.3.3 Capability and Experience of RI professionals ........ 111
5.3.4 Other sources of challenge .................................................... 112
5.3.4.1 Organizational and reporting structures ................. 113
5.3.4.2 Resource concerns ................................................... 114
5.3.4.3 Cooperation or Collaboration? ............................... 114
5.4 Conclusions and Future Direction ...................................................... 115
References ................................................................................................................ 118
Appendix A .............................................................................................................. 130
Text responses to the question: “In your opinion, what is the best country to
work with regarding gathering Regulatory Intelligence and why?” ... 130
Appendix B ............................................................................................................... 132
Text responses to the question: “In your opinion, what is the most challenging
country to work with regarding gathering Regulatory Intelligence and
why?” ................................................................................................. 132
Appendix C ............................................................................................................... 134
Text responses to the question: “In your opinion what are the biggest
communication issues between international regional and headquarter
offices?” ............................................................................................. 134
Appendix D .............................................................................................................. 136
Text responses to the question: “To what do you attribute your success of
gathering data?” .................................................................................. 136
vi
Appendix E ............................................................................................................... 138
Survey ........................................................................................................... 138
vii
List of Tables
Table 1: Focus group participant profiles ..................................................................... 38
Table 2: Analysis of those eliminated from the data analysis ...................................... 40
Table 3: Employees in company .................................................................................. 42
Table 4: Office location of survey respondents - Other response included ................. 43
Table 5: Product specializations of represented companies – other responses
included ..................................................................................................... 44
Table 6: Handling of Regulatory Intelligence by level of process maturity ................ 49
Table 7: Handling of Regulatory Intelligence by medical device company size ......... 52
Table 8: Frequency of gathering Regulatory Intelligence ............................................ 54
Table 9: International regional offices by medical device company size .................... 56
Table 10: Location of international regional offices ...................................................... 57
Table 11: Impediments to communication with international regional offices .............. 59
Table 12: Location where Regulatory Intelligence activities are performed ................. 61
Table 13: MD vs Non-MD: Distribution of responsibilities between headquarter
and international regional offices .............................................................. 63
Table 14: Cross-Tabulation of impediments to communication with
international regional offices with the most challenging regional
office for the selections of ‘always’ and ‘most of the time’. ..................... 65
Table 15: Regulatory Intelligence frequency of communication ................................... 68
Table 16: Best country to obtain Regulatory Intelligence .............................................. 72
Table 17: Most challenging country to obtain RI ........................................................... 74
Table 18: Most troublesome causes when collecting Regulatory Intelligence .............. 76
Table 19: Most troublesome communication issues between offices ............................ 78
Table 20: Areas of comment regarding successful elements for gathering RI
data ............................................................................................................ 81
Table 21: Methods of communication currently used ranked ........................................ 83
Table 22: Preferred Regulatory Intelligence communication flow ................................ 84
Table 23: Regulatory Intelligence communication flow ................................................ 86
Table 24: Understanding the language used in Regulatory Intelligence ........................ 88
Table 25: Clarification for misunderstood language ...................................................... 89
viii
List of Figures
Figure 1: Example of International Structure Stages – International Division ..............14
Figure 2: Fresenius organizational structure (Fresenius 2016) ......................................16
Figure 3: Actual and projected top 10 economies ranked based on GDP and
PPP terms ...................................................................................................19
Figure 4: Population of older persons, estimated for 2014 and projected for
2050............................................................................................................21
Figure 5: Answer to the “What are the biggest challenges you face?”, taken
from Global Medical Device Industry Outlook for 2014 ..........................22
Figure 6: Shannon Weaver communication model – Linear Communication ...............28
Figure 7: Schramm-type communication model ............................................................30
Figure 8: Example of Hub and Spoke communication model .......................................31
Figure 9: Job levels of respondents ................................................................................41
Figure 10: Company characterization with respect to international activities .................45
Figure 11: Organizational home of Regulatory Intelligence ............................................46
Figure 12: Organizational placement of Regulatory Intelligence by medical
device company size ..................................................................................47
Figure 13: Regulatory Intelligence maturity level ...........................................................48
Figure 14: Regulatory Intelligence process ......................................................................50
Figure 15: Handling of Regulatory Intelligence ..............................................................51
Figure 16: International regional offices ..........................................................................55
Figure 17: Distribution of responsibilities between headquarter and branch
offices .........................................................................................................62
Figure 18: Most challenging international regional office ...............................................64
Figure 19: Participation when gathering Regulatory Intelligence ...................................66
Figure 20: Level of Regulatory Intelligence participation ...............................................69
Figure 21: Sharing of Regulatory Intelligence .................................................................70
Figure 22: Obtaining Regulatory Intelligence difficulties ...............................................71
Figure 23: Satisfaction with currently used communication method ...............................79
Figure 24: Issues when communicating timely Regulatory Intelligence .........................87
ix
Abstract
Regulatory Intelligence (RI) is a job function whose professionals gather, process
and distribute publicly available data to be analyzed for use by medical product companies.
Different groups in the company need diverse types of competitive and facilitative
information to identify regulatory authority product acceptances, post-market event reports
and recalls, or the release of new regulations or guidance documents in multiple
constituencies. These tasks are complicated by the push for stronger sales of products in
emerging markets where medical device regulations can be rapidly changing, confusing
and even contradictory. Therefore, understanding how, when and to whom to communicate
the new or changing regulatory information within a company affects global market
strategy and product success. This research study used survey methods to examine how
medical device companies structure their regulatory intelligence operations and
communicate that information to other parts of the company, using a hub-and-spoke model
of regulatory information acquisition and communication complemented by reference to
Schramm’s communication model with bidirectional interactions. Results suggest that two-
way conversations or discussion, similar to Schramm’s bidirectional communication
model, are the preferred method of communicating regulatory intelligence but are not the
methods typically used most frequently. Difficulties in communicating, characterized in the
models as “noise”, was found to stem from a number of factors, notably language
differences or the capabilities of those within the RI function.
1
Chapter 1. Overview
1.1 Introduction
Advancements in medical technologies over the past 50 years have produced a
variety of medical devices that offer tremendous benefits to patients. These same products
can also have substantial risks. Governments recognize those risks and work to control
them through national and local laws and regulations designed to assure that patients in
their jurisdictions are protected from ineffective and unsafe products. When each country
develops laws and regulations independently, they can put into place different regulatory
requirements that can make it more difficult for companies to plan product development
and marketing strategies. Until recently, the challenges introduced by region-specific
regulations were quite modest, because most medical device companies sold their products
in only a few major developed markets such as the United States, Europe and Japan.
However, companies are now attempting to market their products globally, and face
challenges greater than those that were typical even a decade ago. Dramatic shifts have
occurred in the international marketplace as many more countries, some with considerable
market potential, have attempted to provide their citizens with better access to medical
technology. Many of these targeted markets have their own different methods of regulating
medical devices that must be managed by the Regulatory Affairs departments of the
company.
Regulatory Affairs departments in medical device companies have evolved
considerably in response to the challenges of internationalization. Historically, in larger
medical device companies, most regulatory departments in the United States were a
relatively small part of the organizational structure. Their principal task was to assure that
their companies met the regulatory requirements imposed by the U.S. Food and Drug
2
Administration during the review and registration processes for their products. Over time
these modest operations, often staffed by a single person, grew. This growth was due not
only to the expansion of regulatory requirements in the US but the subsequently introduced
device requirements in Europe and Japan. The European and Japanese regulatory systems
were set up differently than those in the US and demanded additional sets of submission
information, labeling, and ongoing regulatory reporting. In larger companies, the centrally
located, singular Regulatory Affairs office was replaced with distributed regulatory
operations with local offices in many countries. As more markets were added to the mix of
constituencies, more regulations had to be satisfied, making regulatory operations and
communications complicated and difficult to manage. For companies to enter such markets
effectively, individuals “on the ground”, either as contractors, distributors, employees or
advisors, are often the first to recognize when regulations were changing or are being
implemented in unpredictable ways.
The Regulatory Affairs department of a company today is faced with the task of
communicating effectively with regulators in global markets, where they face barriers
associated with language and culture as well as regulatory hurdles. Knowing how to
manage product commercialization in emerging markets whose regulations are changing
rapidly can be difficult even for local businesses with a working knowledge of the local
regulatory landscape. It is more difficult for foreign businesses that attempt to gain market
entry. Foreign companies are not always welcomed enthusiastically and can be seen as
competition for local companies whose operations are considered important and sometimes
given precedence to boost local economic development or national pride by the
government of that country. Strong “intelligence” about regulatory changes and patterns of
3
oversight is therefore essential in today’s medical device environment to develop and
execute a strategy for staged market introductions into different countries. Thus, members
of the Regulatory Affairs department have become essential members of the teams
responsible for global strategic planning. The effectiveness of those individuals depends
on their ability to bring together a diversity of regulatory and local knowledge about
regulatory requirements in different countries. Regulatory Affairs serves as a valuable
resource for “regulatory intelligence”, obtained by gathering information to help product
development teams by identifying requirements for pre-market submissions, timelines for
product progression, and constraints related to regulatory oversight and life-cycle
management.
Several definitions of Regulatory Intelligence (RI) exist, but experts typically
regard it as a
…process-based, ongoing and reliant upon experiential and publicly
available data. RI is based on a reasoned approach to sorting and analyzing
information gleaned from a variety of sources that could impact the
acceptability of a product to a regulator (Reilly-O’Dell: 1).
Common types of information can include information about competitive companies or
products, such as recent product approvals, adverse event reports or recalls, information
about regulatory changes or actions taken by government agencies, such as the release of
guidance documents or statistics. Early identification of regulatory requirements will set
the stage for tailored data collection needed to develop or update market-entry plans and
regulatory strategies. These activities have a strong potential to shorten regulatory approval
timelines, decrease development costs, prevent compliance-related delays, and increase the
product’s marketing potential. Surprisingly not much attention has been paid to the
methods used to gather and disseminate regulatory intelligence. Previously the gathering,
4
processing, and communicating of RI might be described as ad hoc. Today, many
companies are developing positions or even stand-alone departments specifically for
regulatory intelligence activities. However, such entities are relatively new. It is unclear to
what extent companies are specializing these activities and how they maintain
communication links with both regulatory authorities and local informants in regional
affiliates of local offices.
1.2 Statement of the Problem
The value that internationally focused RI can bring to a company is becoming
apparent as companies face the challenge of interpreting publicly available information into
actionable, meaningful intelligence that can influence reducing timelines and budgets for
product development. What is less apparent is how this should be done. We know that the
potential roles played by the RI group can vary from relatively simple tasks such as
distributing RI news from established sources to more complicated activities such as
conducting research requests and analysis, preparing and submitting draft guidance
comments to trade associations or health authorities, providing intelligence highlights to
key stakeholders, or developing impact analyses for a targeted group of key
stakeholders/experts. RI experts have access to huge amounts of data that can enhance
strategic decisions, but those same data sources present analytical challenges. Data are
provided in numerous separate public databases that are not cross-referenced. Finding
associations between different types of information can prove to be difficult and
increasingly relies on the use of targeted software tools. The RI group may also have
access to people and documentary resources in different countries that could at least in
theory provide much needed translations of documents and oral communications given by
5
local authorities that are often in a language not understood by the RI professional in the
US headquartered office. What we do not know is how these various sources of
information and people are managed by large and small device companies. Almost nothing
has been written on the current practices of device companies in structuring RI personnel or
groups. Further we know little about where and how information is gathered and
communicated throughout the organization, especially when that information comes from
other countries in which the organization has affiliates.
1.3 Purpose of the Study
This study evaluated how RI information is communicated throughout an
organization. The information was gathered from global regulatory professionals who have
experience working with RI in a global environment. Using survey methods, I investigated
how RI personnel are integrated into the organizational structure and how regulatory
intelligence is communicated internally within medical device organizations. In the first
stage of the research, literature relating to the evolving regulatory landscape of emerging
markets was reviewed to demonstrate that the most desirable markets are going through
change. It further discussed how this change affects the way in which relevant information
is reported internally within the organization. In a second stage, I developed a novel survey
tool designed to probe the experience and views of regulatory affairs professionals with RI
responsibilities or needs. This survey was critically examined by a focus group that
included regulatory intelligence experts. The feedback from the focus group was used to
fine-tune the survey. The survey was administered to regulatory professionals who were
responsible for gathering and reporting regulatory change within a medical device
organization.
6
1.4 Importance of the Study
This study contributes to the very limited body of research concerned with the
communication of RI-related medical device information from multiple markets. In order
to communicate the changing regulatory landscape from the local to the central office,
there must be a communication process. By understanding industry practices to
communicate regulatory change, companies can evaluate their own activities and gain
insight into ways that they could plan RI activities more effectively.
To date, the limited information on RI communication within companies comes
from studies of the pharmaceutical industry. In that sector, harmonization of regulatory
requirements has advanced more quickly at the international level than it has for the
medical device sector. Thus, little to no information is available on this subject with
respect to medical device companies whose regulatory practices may be less mature and
more variable internationally. The exploratory research conducted here provides insight
into the approaches that medical device companies take to ensure that regulatory
intelligence communication is managed effectively. It provides insight into what may be
seen as potential standard or even best practices. This can then set the benchmark for
medical device companies to evaluate their current processes and systems.
1.5 Limitation, Delimitations, Assumptions
In this study, our focus is delimited to evaluating methods of communication with
the BRIC emerging markets which include Brazil, Russia, India and China as well as more
mature, robust markets such as the US, European Union and Japan that continue to evolve.
It is further delimited to regulatory communication and interactions related only to those
governmental agencies responsible for registration and oversight of medical product safety,
7
and that have direct impact on product shipments to the emerging markets. It evaluated the
views and experience of regulatory professionals. The survey is directed only at regulatory
professionals who have worked or are currently working within the medical device industry
and focuses on the views of regulatory professionals that have experience working in
regulatory intelligence.
The study was limited by the ability to access sufficient numbers of appropriate
survey subjects or obtain the appropriate information from that pool of RI professionals,
already known to be relatively small. The numbers of respondents were limited because the
potential respondents may not be willing or able to participate this study. Thus, the sample
of willing participants may affect the validity of some detailed answers that could only be
provided by a subset of respondents.
The depth of the results is constrained given the logistical challenge of
administering a survey whose length is short enough to be completed by busy professionals
with time constraints. Investigator bias may have crept into the survey questions. This
limits the ability to conduct a thorough analysis. To minimize these limitations, attention
was paid to selecting an appropriate survey design that was critiqued by a focus group of
regulatory experts. This critique helped to assure that unclear or biased questions were
identified and modified.
1.6 Organization of Thesis
In the following work Chapter 1 provides an overview of the problem and an
introduction to the research. Chapter 2 reviews the current state of knowledge in this field
by studying the available literature relating to communicating regulatory intelligence in
medical device companies. Chapter 3 outlines the methods used to drive the development
8
of the survey tool. Chapter 4 analyzes the results of the survey deployment, and Chapter 5
discusses the results and their implications.
9
Chapter 2. Literature Review
2.1 Introduction
The medical device company of today is a very different organization from that
even two decades ago. The rapid development of emerging markets has pivoted the
business focus of medical device companies from mature western markets with little
growth potential to countries in Asia, South America and Africa where wealth is growing
and healthcare expenditures fuel demand for drugs and medical devices (Besbarres 2015,
Simon 2016). However, emerging markets pose different market-entry risks related to
unstable economic conditions and underdeveloped regulatory environments. Good
decision-making to coordinate these multiple changeable environments depends upon
strong communication channels with local offices that can inform headquarters about
regulatory and commercial requirements. Those same communication channels are critical
to supporting the development of the country-specific submissions needed for market
registration and reimbursement. However, the communications between headquarters and
local offices in emerging countries can be difficult to manage and these challenges can
create misunderstandings and undesirable actions that can slow market entry. What do
companies do to ensure that such communication is managed effectively and what might
they see as standard or even best practices when gathering regulatory intelligence or
managing local governmental interactions?
2.2 The Role of the Regulatory Professional
The challenge to bring medical devices into new markets has changed the way that
regulatory departments function and regulatory professionals perform their duties. In the
past, many individuals working in a regulatory department spent their time collating and
10
formatting documents for submission to regulators in a single constituency. However, that
role has evolved rapidly to the point where regulatory professionals are expected to be
global experts who understand the evolution and differences in requirements for a range of
countries with diverse language and documentation needs, different local cultures and
different regulatory rules and procedures. These changes can be appreciated by examining
the typical modes of operation for a regulatory professional over the last 30 years.
In the 1990s, the medical device industry typically sold product in the key markets
of US, Europe, Canada and Japan. Entry into these countries was typically staged
according to the expected level of difficulty and delay in the submission process of each
country. Typically, the Regulatory Affairs department was simply informed about the
marketing strategy and instructed to submit the applicable documentation to regulators as
soon as possible. The structure and content of most submissions were relatively simple, and
the depth of knowledge required to create those submissions was modest. Creating the
medical device application for a new product in the US often took the most effort. Because
the global leader at that time was typically considered to be the US, many medical device
manufacturers would focus on gaining market registration in the US or Europe first, then
use the applicable portions of the filing to submit subsequent submissions to other countries
such as Canada, Australia and Japan (Lamph 2012). Entry into many emerging countries
was simpler because they had no medical device regulations or had regulations whose
requirements were modest and often not well enforced. Some market entries were
simplified because the country might be willing to use the market clearance of one of the
mature regulatory agencies in lieu of a separate submission. In addition, many of these
markets were very small because the economies of the developing countries could afford
11
only modest therapeutic interventions, and not expensive medical devices (Saini, Kaushik
et al. 2010). Thus, companies had little motivation to enter these markets.
However, many changes have made the role of the regulatory professional more
complex. Two types of challenges are particularly important as part of this evolution.
First, the regulatory environment in the principal countries that composed the established
markets have added many more requirements and standards (Weeks 2014). Second, many
countries have become stronger economically and have recognized a need for a more
robust regulatory system. Thus, several countries with growing markets have begun to
develop and enforce medical device regulations of their own. For example, China has seen
an enormous growth in its medical device regulations and their rules are not well-
harmonized with practices or standards in the West (Schorre 2014). Some countries have
also insisted on unique requirements for new types of product testing or specialized
regulatory audits of facilities or manufacturing processes (Cheng 2003). To function in this
new global environment, regulatory professionals must not only develop a much deeper
understanding of regulatory rules, information-sharing practices, approval systems and
enforcement trends in a range of constituencies. They must also be able to communicate
that information horizontally and vertically within the organizational structure, so that it
can be used to make better strategic decisions based on the specific approval timelines and
risks in different countries. Such information is essential to stage market entries
internationally by selecting which emerging markets are more desirable for early entry.
These more challenging predictions rely on effective communication in and beyond a
larger and often regionally disseminated Regulatory Affairs department.
12
The amount of information that a Regulatory Affairs professional must manage now
is extensive (Sunil, Sanju et al. 2016). It can be arduous to keep track of requirements
country-by-country. It becomes even more difficult if the Regulatory department is divided
into functional units that manage different product franchises and have local operations in
different geographic constituencies. Medical device companies, like pharmaceutical
companies, have regulatory intelligence frameworks that
...are often fragmented, except [for] few centralised functions, with diverse
products and markets and respective product and market representatives.
Cross-functional teams located in different regions often slow down the
information exchange process and further change assessment and
implementation (Raj 2018: 2).
To do its job, regulatory professionals must rely more heavily on local offices in
distant countries to gain market advantage or to build relationships with regulators.
Because new requirements in those countries may involve satisfying new standards and
design procedures earlier in the product development path, the local team must become
more involved in decision-making and critical path analysis for early-stage activities
related to new product introduction. Unless a systematic process is in place and managed
by disciplined and organized personnel, working in Regulatory Affairs can become chaotic;
more time can be spent firefighting than developing submissions for market entry.
2.3 Medical Device Company Structure
As medical products are marketed globally, companies face the challenge of how to
manage the complexities of regulatory and marketing requirements inherent in a distributed
system of countries and districts. The structural challenges of large organizations have been
recognized as a fertile field for study for more than 50 years, when multinational
enterprises became central to the economic health of many industrial subsectors. The
13
evolution in structure of multinational companies was studied in the seminal 1960s’
research of Stopford and Wells (1972), who developed a model of organizational
development based on the study of 187 companies on Fortune’s list of 500 largest US
manufacturing enterprises. Stopford and Wells traced the organizational changes needed to
become a more globally active enterprise. Their “International Structure Stages” model
attempts to describe the organizational evolution of companies as they expand abroad
(Figure 1). During this process the company grows, diversifies its products and expands
into new markets. It then must put into place systems to deal with the complexity of the
environment. The purpose of the structure that emerges is to gather necessary functions
under the same umbrella to coordinate and control them (Eskola, Jultman et al. 2006).
14
Figure 1: Example of International Structure Stages – International Division
Permission granted from (Stopford and Wells 1972)
The types of organizational structure identified by Stopford and Wells are useful in
identifying broad general principles and nomenclature related to organizational hierarchies
in large companies. However, these early researchers would be challenged to capture the
wide variety of organizational structures that are found today in large multinational medical
product companies. Companies today are experimenting with different models of
organization to find ways that foster interactions more flexibly and consider the importance
of subsidiaries and partnerships (Judge and Li 2012). As a result, some of the emerging
organizational structures allow subsidiaries to take on some of the strategic roles previously
controlled by the headquarters of the traditional company (Markgraf 2017). The medical
products companies of today also have job functions that differ from those that were
present when Stopford and Wells conducted their research. Their research was focused on
15
companies outside of the medical products area, so that functions such as regulatory
operations, clinical trial quality assurance or design control management, as examples of
the many specializations now needed, would not be typically seen in many of the
previously well-studied companies, such as GE Healthcare and Phillips Healthcare, 50
years ago.
To illustrate the complexity and variability of organizational structures, it is
instructive to look at two different medical-products companies, Fresenius and Medtronic.
Fresenius Societas Europaea (SE) and Company Kommanditgesellschaft Auf Aktien
(KGaA translated to German means limited partnership on shares; business entity) is a
multinational holding company that dates to the 15th century when it began as a pharmacy
in Frankfurt Germany. Its current structure is vertically integrated around a singular
product sector, kidney disease and treatment. Under this umbrella, a highly decentralized
structure knits together several different types of business segments and subsidiaries
ranging from kidney dialysis centers to pharmaceutical manufacturing operations in over
100 countries. The Fresenius Group includes four independently operated business
segments (Figure 2). Fresenius Medical Care focuses on chronic kidney failure, Fresenius
Helios is based in Europe and is a private hospital operator, Fresenius Kabi supplies drugs,
clinical nutrition products, medical devices and services to help critically and chronically ill
patients and Fresenius Vamed plans, develops and manages healthcare facilities. Each of
these units is a complex organization in itself, with separate corporate and regional
headquarters. For example, Fresenius Kabi, a pharmaceutical production group
headquartered in Germany, has locations in Africa, Asia Pacific, Europe, Latin America,
Middle East and North America (Fresenius SE & Co. KGaA 2017).
16
Figure 2: Fresenius organizational structure (Fresenius 2016)
In a structure like Fresenius, the crossflows of experts, specialized technologies and
access to products needed for key activities between the units with different but related
functions can be powerful weapons for market advantage but can also be confusing to
coordinate. The infrastructure for each of the divisions may be structured similarly but
often may have additional specializations relevant to the particular needs of the division’s
business. For example, the customer support center, Fresenius Helios, which manages
kidney dialysis centers, may have quite different needs than a manufacturing center that
develops new dialysis machines such as Fresenuis Kabi. Each division can be anticipated
to have its own regulatory group that reports up through the management chain of specific
individualized businesses in one or another constituency. However, at some level these
17
subordinate regulatory teams presumably must report up through a function-specific
structure of Global Regulatory Affairs.
Medtronic Public Limited Company (PLC) is another organization whose
substantial growth has required its organizational structure to evolve. In 2014, Medtronic
employed more than 85,000 people and earned total revenues of $20.3B through its
operations in over 150 countries. Medtronic’s corporate organizational structure consists of
four operating entities: Cardiac and Vascular Group, Restorative Therapies Group,
Minimally Invasive Therapies Group and Diabetes Group (Medtronic 2017). To some
extent, these units operate autonomously. However, not all decisions and structural needs
appear to be made at the divisional level, as suggested by the restructuring that occurred
after the important acquisition of Covidien in 2014. According to Omar Ishrak,
Medtronic’s chief executive, “… the combined company’s operations will be re-organized
into four geographical segments: Asia Pacific, the Americas, EMEA (Europe) and Greater
China” (Kennedy 2014). In this structure, the company headquarters would maintain
control over the strategic development and financial management of the firm, but product
divisions under that central body would have autonomy to deal with the management of a
variety of different product lines that were being sold in a particular geographical area.
Medtronic’s executive headquarters and US division would remain in the US but the Asia-
Pacific region office would reside in Singapore, its Europe-Middle East-Africa division in
Switzerland, and its China division in China (Kennedy 2014).
The goal of these examples is not to explore in detail the many types of structures
that can be developed to manage a large multinational company, but rather to illustrate the
structural complexity of the organizations today regardless of specific form. To date, no
18
obvious evidence suggests that one structure is “better” than another for effective
communication and business capability. In any of these structures, there will necessarily be
communication challenges both within regulatory affairs subgroups and between those
subgroups and other parts of the company. However, the challenges may vary somewhat
according to the organizational structure in ways that have not yet been well explored in the
medical device industry.
2.4 Emerging Markets
Perhaps the single most important development to increase complexity of company
organization and regulatory communication has been the drive to enter new markets in
emerging economies. This trend has put additional pressure on regulatory groups to
manage device registrations in multiple regions. Stresses are magnified when the
marketing requirements of many of those countries are still evolving their submission,
quality and distribution requirements (Schorre 2017). It becomes complex to decide when
and how to enter these markets, because attention must be paid to a number of attributes of
each market, including their economic strength and propensity to spend money on health
care products.
2.4.1 Economic power
Economic analysts often group emerging economies into subsets that share certain
growth trajectories, geographic locations or economic characteristics. Perhaps the most
rapidly changing countries in this collection are brought together under the acronym,
BRIC, which includes Brazil, Russia, India and China. However, other groupings
including for example, MIKT (Mexico, Indonesia, South Korea, Turkey), MINT (Mexico,
19
Indonesia, Nigeria, Turkey) and CIVETS (Colombia, Indonesia, Vietnam, Egypt, Turkey,
South Africa) also exist (Besbarres 2015).
At least two characteristics are important when deciding to introduce a medical
product into a country with a specific economic profile. First is the growth of that
country’s economic power, often measured by such indices as Gross Domestic Product
(GDP) or Purchasing Power Parity (PPP) (Hawksworth 2017). Because an economy
changes with time, geopolitics and trade conditions, the list of the most desirable markets
also varies. Analyses of different countries will produce growth projections such as that
shown in Figure 3.
Figure 3: Actual and projected top 10 economies ranked based on GDP and PPP
terms
Permission granted from (Hawksworth 2017)
In 2011, Price Waterhouse Cooper reported that the US has the largest GDP.
However, the margin of that differential with respect to other economies is shrinking. In
their most recent report in 2016, the US is listed as second to China. China is predicted to
be ranked first through 2050 when the US is predicted to be placed third behind India. The
20
other BRIC countries are projected to become dominant players. For example, the ranking
of Brazil was projected to fall slightly, from 7 in 2016, to 8 in 2030 and 5 in 2050
(Hawksworth 2017). However, different forecasters may predict somewhat variable
rankings of these emerging economies. The Economist Intelligence Unit, for example,
predicted that Indonesia will be positioned between India and Japan, in fourth position (The
Economist Intelligence Unit Limited 2015) rather than eighth as estimated by Price
Waterhouse Cooper.
Predictions can change rapidly in the face of changing political or economic
environments. Emerging economies can be fragile, so the predictions of growth are often
misleading and complicate strategies to sell into these countries. For example, the
publication from Freedonia Focus Reports – World Collection on World Medical Devices
May 2016 suggest that the BRIC countries are not as desirable as they seemed in past
years. Noteworthy markets in this report recognized the US, EU and China as the markets
in which continuing market share is expected to dominate (The Freedonia Group 2016).
2.4.2 Expenditures on Health Care
A second important attribute of a desirable country in which to sell medical
products relates to the likelihood that it will purchase medical products for its citizens.
Usually this is correlated more generally with the efforts of that country to provide better
healthcare for its population. As an example, China’s goal to achieve universal healthcare
by 2020 leads medical device manufacturers to view China as one of the most desirable
future markets for medical devices (American Chamber of Commerce in Shanghai 2011).
Most of these medical devices will be procured through government-subsidized insurance
21
plans, adding a further level of potential optimism about the likelihood that needed devices
can be procured.
Sales of many types of medical devices are linked to the treatment of older patients.
Countries with a growing population of elderly individuals and good healthcare insurance
coverage will be preferential target markets (Holtzman 2012). The projected distribution of
older people in different regions in the world can be seen in Figure 4. It predicts that
numbers of individuals in older cohorts will grow rapidly across Asia, Latin and Caribbean
America and Africa. As the population continues to age into the future, the demand to
diagnose, treat and prevent age-related illnesses will also increase. These needs will likely
drive the medical device industry through 2050 (United Nations 2014).
Figure 4: Population of older persons, estimated for 2014 and projected for 2050
Permission granted from (United Nations 2014).
22
2.4.3 Expenditures on Health Care
The decision to sell a medical product in an emerging market has regulatory risks
related to the unique laws, regulations and compliance in different countries. Thus, market
success can depend on more than economic and demographic factors. Companies that are
planning to enter those markets must develop more sophisticated regulatory strategies. It is
imperative to learn how to navigate the evolving laws and regulations in an emerging
market (Boets 2008). Many medical device companies are acutely aware of this growing
challenge. When the Emergo Group surveyed over 3,500 Medical Device professionals,
with the question, “What are the biggest challenges you face?”, “changing regulatory
environment” was the most common answer (43%), as shown in Figure 5 (Schorre 2014).
Figure 5: Answer to the “What are the biggest challenges you face?”, taken from
Global Medical Device Industry Outlook for 2014
Reproduced from (Schorre 2014).
23
2.5 The Role of “Regulatory Intelligence”
In any country, laws, regulations, guidance documents, standards and policies
change with time. A medical device company must be able to gather regulatory intelligence
on these changes and incorporate the changes into their strategic plans. In some cases, the
company may make efforts to influence change if the environment is in some way hostile
to their products.
Timely and accurate predictions of regulatory expectations can save time and
money (Reilly-O'Dell 2014). Less time is needed in meetings with regulators to clarify
expectations, correct misleading information or answer questions. Less time and money is
wasted by pursuing non-productive paths; a clear understanding of regulatory requirements
will enable the collection of tailored data and timely revisions to regulatory strategy when
environments change. Well-informed strategy may shorten regulatory approval times,
decrease development costs and prevent compliance-related delays. Thus, most companies
today are recognizing the importance of a new subgroup of regulatory employees
considered to be experts in “regulatory intelligence” (Reilly-O'Dell 2014).
Regulatory Intelligence (RI) is a relatively new subfield of regulatory science.
According to the European Intelligence Network Group,
Regulatory intelligence is the act of processing targeted information and
data from multiple sources, analyzing the data in its relevant context and
generating a meaningful output – e.g. outlining risks and opportunities – to
the regulatory strategy. The process is driven by business needs and linked
to decisions and actions (Hynes 2014: 2)
Little in the way of formal scholarly work exists yet in the domain of regulatory
intelligence but much has been written about “competitive intelligence” of which
regulatory intelligence is a part. Defined by Prescott (1999), “competitive intelligence is
24
defined as the process of developing actionable foresight regarding competitive dynamics
and non-market factors that can be used to enhance competitive advantage”.
Like competitive intelligence, good regulatory intelligence should drive “the
continuous planning dialogue at the top of the organization” (Ettorre 1995). It is a
processed-based, on-going activity that uses a systematic approach to analyze information
that could affect the acceptability of a product to a regulator (Reilly-O'Dell 2014). Diverse
experiential and publicly available data sources can be used to conduct such an analysis. It
may come from governmental sources such as product approvals, adverse event reports,
recalls, guidance documents, and recent actions taken by government agencies. It may
come from the analytic and scholarly reports of domain experts. Sources include
information obtained directly from the government, trade association briefings, advice from
consultants and information available via websites, blogs, forums and social networks. As a
result, large amounts of data are available to support strategic planning, but accessing and
curating those data can be challenging, because the data are often found in various public
databases and information channels that are not cross-referenced (Brown-Tuttle 2014).
Good judgment is needed to decide what information is most important to collect, from
which channels it can be accessed most easily, and when enough data has been found
(Brown-Tuttle 2014). Thus, companies are placing higher value on the role that RI can play
in giving actionable, meaningful intelligence that can increase regulatory efficiency and
effectiveness.
The individual working in Regulatory Intelligence is like an investigative reporter.
He or she may be found writing summaries of new legislation or guidance. He or she may
also review news articles, verbal communications, or public and subscription databases to
25
identify relevant information. Services may take the form of distributing and archiving RI
materials, conducting research requests and analysis, preparing and submitting draft
guidance comments to trade associations, regulators or health authorities, and providing
intelligence highlights and impact analyses to key stakeholders (Brown-Tuttle 2014). The
range of information on regulatory requirements available to businesses is both wide and
deep. Many third-party vendors offer databases that can help to navigate these information
sources. For example, the companies Tarius and Cortellis are typical vendors whose
resources include curated laws, guidance documents, Federal Register notices, compliance
information, warning letters, establishment inspection reports and inspection observations
that can be easily found and even analyzed or annotated. The third-party resources may
also include explanatory documents that guide a user through registration processes in
different countries and summarize new or projected activities of various regulatory
agencies (Reed Technology and Information Services Inc. 2017, Tarius 2017). Because RI
professionals have limited time to gather, read and summarize new information, these types
of databases can provide needed information quickly from one central resource (Brown-
Tuttle 2014).
Globalization has had a significant impact on the way that regulatory intelligence is
managed. When personnel worked in a single head office and had responsibilities for only
a few countries, it was possible to use a less formal approach to gather, process and
communicate RI. When multiple sites are added and personnel are collecting information
more broadly in different countries, informal approaches have the risk of failing to reach all
the appropriate people within the organization. Regional local affiliates may be positioned
to collect information that is not accessible to headquarters and vice versa, information
26
gathered or used at headquarters may not be accessible to the regional affiliates. Two-way
communication can be vital to assure that different groups have meaningful, regulatory
updates from multiple regions to stay in touch with global regulatory trends (Kahaner
1996).
2.6 Creating a Regulatory Intelligence Subgroup
The RI professional is expected to provide a wide range of services. He or she is
expected to contribute meaningfully to decisions about regulatory strategy and to develop
integrative answers to broad or globally based research questions. The form that RI
services take will vary according to company size. Small companies may have one person
performing RI duties part-time, with constraints on the time that can be devoted to the
intelligence activities. This individual must be creative and flexible because the company
may not have the financial resources to subscribe to regulatory intelligence databases. He
or she may therefore depend on publicly available blogs and information sources,
colleagues and consultants. Larger companies can often afford to commission a dedicated
team, in which the workload can be divided by therapeutic area or global region amongst
RI analysts. The larger companies often have multiple RI tools or databases available to
perform, communicate and manage RI activities more efficiently. On certain projects,
resources can be sufficient to provide a deep analysis of regulatory topics key for their
product development (Brown-Tuttle 2014).
The development of formalized RI groups in medical device companies, however,
is at an early stage, so literature related to them is limited. Most often discussed are the
tools and techniques available to gather information for RI activities. From that point on,
however, literature is scanty. It is not clear from the literature and research to date how the
27
gathered information is communicated within the company. The central focus of this
research is to gain a better understanding of how regulatory intelligence is communicated
currently in medical device companies, because without such communication, RI data
collection is of little use. As a foundation to this investigation, it is important to examine
some of the theoretical constructs related to communication.
2.7 Communication of Changing Global Regulations within Medical Device
Companies
In order to study communication systematically, it is useful to ground the research
using a framework or model to guide the development of a survey that incorporates as
many elements as possible. Communication models and frameworks are abstracted forms
of representation that create a common vocabulary and simplified set of elements that
describe the process of communication. They have been studied extensively over the last
70 years, since the seminal work of Shannon, beginning in the 1940s (Whetmore 1982).
Shannon’s goal was to formulate a theory to guide the efforts of engineers who were
searching for a way of transmitting electrical signals from one location to another (Shannon
1948). Toward that end, he published a basic model of one-way communication, shown in
Figure 6, to guide research in Bell Laboratories, where investigators were attempting to
optimize telephone line capacity with minimum distortion. With Weaver, he co-authored a
1963 treatise titled “The Mathematical Theory of Communication”. This book served as a
widely accepted basis for research in the communication and social science fields
(Mortensen 1972).
28
Figure 6: Shannon Weaver communication model – Linear Communication
Permission granted from (Shannon 1948).
The framework developed by Shannon and Weaver is relatively intuitive and can be
used to describe not only telephonic communication but all other forms of communication
as well. Regardless of medium, a message begins at an information source. It is relayed
through a transmitter and then sent via a signal towards the receiver. On its path to the
receiver, the message must go through noise that may interfere with the signal. After it
arrives at the receiver, the receiver must convey the message to its destination (Mortensen
1972).
At each stage of the model are concerns about whether the message is
communicated effectively. The “coding” of the message, i.e., the way that it is represented
when it leaves the source, is crucial. It is not only technology-dependent but also culture-
dependent. The values, beliefs, religion, culture and general understanding of society can
affect the effectiveness of even a standardized message (Reuben and Steward 2006).
When that message is delivered in person, contextual cues, gestures, and body language
will affect the way that a message is received, especially in high-context cultures where
nonverbal communication is an essential part of the messaging (Andersen 1999). If the
29
communication is electronic some of these elements are not often available, although the
increasing use of videoconferencing promises to challenge this assumption.
Concerns about the way that a message is received are also important. The simple
Shannon-Weaver Communication model assumes a singular receiver, but messages may
also be directed at groups or may be transmitted to others by forwarding messages that are
sent in text or electronic forms (Wells 2011). The level of knowledge of the receiver(s) and
the familiarity of the subject being communicated will influence the audience’s reaction to
the communication. Where the communication takes place, in a public versus a private
forum for example, can also affect the way that the message is transmitted and received
(Jablin and Putnam 2004). Shannon and Weaver's model thus provides insight into the
reasons why the simplest of communications can be misunderstood. When signals are
transmitted simultaneously to many individuals using different media formats,
communication becomes even more complex and more likely to be distorted or
miscommunicated.
One of the criticisms of Shannon-Weaver model is its simplicity. The model lends
itself to one-on-one communication rather than one-to-many communication. Non-linear
communication models have therefore been developed that may better represent the
complex problems often typical of mass communication today. If a communicative act is
viewed as an interaction rather than a broadcast, it is apparent that participants send and
receive information simultaneously; they are at both the transmitting and receiving end of
the model. Communication usually requires active participation, so that communication
models should at least account for reciprocal aspects of communication, with feedback
loops as seen in Figure 7.
30
Schramm was one of the first to alter the Shannon-Weaver model of
communication. He added “decoding” and “encoding” as activities that both the sender and
receiver utilize and added situations for the bilateral exchange of messages (Schramm
1954). He also added an interpreter to represent a stage in which the message is subjected
to intermediary activities before it is decoded and understood. Schram posits that
communication is more effective when the receiver can ask clarifying questions, when the
nature and sources of coding and noise are understood by the information source and
destination, the initial message can be improved and may decrease the need for feedback.
Figure 7: Schramm-type communication model
Reproduced from (Schramm 1954).
To take extended communication models further, a useful approach is the “hub and
spoke” model of communication, in which a strong central hub projects to a series of
31
receivers by means of radially arranged connecting spokes (Nayar 2016). This model has
been commonly used to model some forms of activities, such as supply chain relationships,
as well as communications. Airlines, for example, have become sophisticated in using
central hubs; aircraft fly on spokes between destinations and the hub, with very few direct
flights between other destinations, to increase efficiency (Delve 2014). This model has also
been popular to model some forms of communication planning, such as that required for
computing connections, in which information flows to and from a central server to a
number of distant computers (Bartlett, Ghoshal et al. 2008). This model could be used to
depict communication from a regulator to its receivers as shown in Figure 8. Where the hub
in the center of the diagram would be the regulator and the individual spokes would be
those receiving the information from the regulator.
Figure 8: Example of Hub and Spoke communication model
Permission granted from (Matrikonopc.com 2017).
The hub and spoke model appears also to be reminiscent of the structure of some
global medical device companies discussed earlier. To date, little formalized academic
32
research has focused specifically on the way that communication occurs between these
“hubs” (i.e., central offices or headquarters) and “spokes” (i.e., branch or local operations).
We can, however, form ideas about how those communications must be structured from the
theoretical models of communication explained above. Because communication is used to
accomplish various goals, each of the models seems appropriate for different types of
interactions. For example, the simpler model of Shannon may be sufficient for information
that flows in one direction, such as information to notify a local operation that the
centralized headquarter office has been notified of a new marketing approval. However,
Schramm’s communication model with its bidirectional interactions between two parties
probably represents more fully the nature of the interchange that would be expected to
occur as part of regulatory activities. A bidirectional interchange typically occurs between
the regulatory agency and company before the market approval of a product, when
questions were asked and answered. The complex, multiple levels of communication
between several sources, however, must elaborate this model. For example, the
development of a regulation involves multidirectional communication not only between
hubs and spokes but also across spokes and between various players in the hub or spoke
itself.
Those involved with regulatory intelligence are particularly affected by the nature
of the organizational channels and exchanges that take place. Rapid, free exchange of
information helps organizations to respond to rapidly changing markets, build employee
morale and take advantage of knowledge workers. However, many challenges can be faced
when trying to assure open communication in which messages are transmitted without
33
distortion or misinterpretation. Thus, attention must be paid to how such communication
occurs.
In addition, information channels can be described in different ways. For example,
they can be differentiated as formal or informal. Formal or structured communication
channels are typically used to transmit information that requires modest feedback. In these
cases, messages may follow an organization’s chain of command or organizational chart.
For example, a message that is sent by a company executive may flow downward through
managers to supervisors and finally to the lower-level employees. Organizations also have
formal communication channels through intranet connections, newsletters and official
messages. In these cases, the flow does not necessarily follow the organizational hierarchy
but rather is disseminated simultaneously to a wide audience. However, what does seem to
typify these types of formal communication channels are their one-way structures (Quain
2019).
At the same time, communication is typically occurring between employees along
multiple informal channels. These are much harder to model. Water-cooler conversations,
email exchanges and happy hours can complicate how messages are sent and received even
when they flow through formal channels (Quain 2019). Further, communication can flow
in four directions: downward, upward, laterally and diagonally. Communication flows can
also be categorized as either internal or external to an organization. Internal communication
takes place via electronic and print media, face-to-face meetings or strategically placed
signage (such as notice boards and plasma/LCD screens). External communication is
communication that takes place between an employee and an external group such as a
34
supplier or a regulator. These channels and sources contribute to a complicated system that
only becomes more problematic as companies work globally rather than in a single site.
As the foregoing discussion suggests, the challenges of global communications are
particularly acute in the regulatory intelligence groups of multinational companies that
manufacture medical products. Individual countries have their own standards, policies and
ways of organizing regulatory filings that must be understood by the timely exchange of
regulatory intelligence. However, capturing this knowledge is only the first step in a
cascade of communications between different sites and headquarters, as well as different
regulatory agencies. Much has been written about the types of formal interactions that
occur between companies and regulators to gain marketing approval. However, what is not
clear is how companies manage to disseminate the knowledge that they obtain through a
regulatory intelligence activity to others in the company who might need this information.
The overarching goal of the present research is to explore how companies are
attempting to manage the communication of regulatory intelligence about global regulatory
requirements and preferred practices within the company itself. The model of hub and
spokes will be used to investigate several related questions regarding the organization’s
structure of communication channels between different sites, the nature and level of
formality of the communication means and the hurdles encountered when trying to
communicate a message from sender to receiver when those individuals have different
cultural sets, technological capabilities and vulnerabilities to message distortions. The
nature of the interactions will be characterized with reference to the vocabulary and
concepts developed by Shramm. Of particular interest are those structures and methods that
35
seems to work better than others in order to see if best practices emerge from a survey of
multiple companies with potentially different communication strategies.
36
Chapter 3. Methodology
3.1 Overview
A new survey instrument was developed to examine how companies communicate
regulatory intelligence throughout a medical device organization. To improve the validity
of the survey, a focus group of subject matter experts was assembled to critique the survey
questions. The survey was disseminated to industry professionals in multinational
companies who are experienced in Regulatory Intelligence. The resulting data were
collected, analyzed and reported in Chapter 4 of this dissertation.
3.2 Survey Development
A survey of 42 questions was constructed that was able to be completed in less than
30 minutes. In this survey, demographic questions first identify characteristics of
respondents and their organizations. The survey explores the structure of headquarters-
regional site organization and its formal reporting structures. It then solicits the
perspectives of respondents regarding the role and relative importance of formal and
informal communication channels in the collection and communication of RI information.
It also explores the challenges that respondents experience when communicating changes
in regulation to his/her organization.
The electronic survey platform, Qualtrics (qualtrics.com), was used to structure the
survey. The Qualtrics platform enables questions to be developed in a variety of formats,
including yes/no, multiple choice, matrix and ranked preference formats, as well as free-
text entries. Questions that solicit open-ended responses were structured to supplement or
clarify responses in the multiple-choice answers. Qualtrics software allows responses from
the panels to be collected in a way that protects the anonymity of respondents.
37
3.3 Focus Group Survey Validation and Participant Selection
A selected group of industry professionals and academics experienced in various
aspects of regulatory communication and/or survey development were asked to review and
comment on the working draft of the survey. Their comments regarding the content and
format of the survey instrument were used to modify the draft survey into a final document
ready to be disseminated to industry professionals.
Focus group members were asked to consider the purpose of the research when
commenting on the survey instrument and to provide input on the overall organization of
the survey and the relevance and clarity of each question. In addition, they were asked to
comment on the survey from a user perspective and to identify any gaps in topics. Video
conferencing was provided to facilitate the interactive experience of remote participants.
This also allowed the proceedings to be recorded for later reference. The group was
provided an electronic copy of the survey prior to the meeting and a paper copy, for those
attending in person, at the time of the focus group.
The focus group began with a presentation regarding the purpose of the research
and the survey. In the discussion that followed, an initial theme was the appropriateness of
the search for survey respondents and distribution method for the survey. Each of the
proposed questions was reviewed and discussed. Written feedback from the focus group
was also collected at the end of the two-hour session. The survey questions were then
modified according to the advice received from the focus group participants (Appendix E).
Table 1 provides the profiles of the focus group participants.
38
Table 1: Focus group participant profiles
Institution Job Title
Medical Device Company
(2) Executive, Regulatory Affairs
(1) Principal Engineer
USC Professors
(1) Research Advisor
(2) Assistant Professor, Department of
Regulatory and Quality Sciences
Total Number of Participants (6) Six
A mailing list of potential participants was developed by approaching professionals
with RI experience in multinational medical device companies. Inclusion criteria required
that respondents be professionals with more than seven months of experience in regulatory
departments self-identify as involved in RI, and have experience communicating or
receiving communication about regulatory changes in emerging or multiple countries.
These participants were contacted via e-mail to brief them about the purpose of the study
and to solicit their participation in an anonymized survey within a specified time frame.
3.4 Administration, Data Collection and Analysis
The web-based survey was sent initially to a small number of Regulatory Science
faculty who examined the survey to assure that it displayed questions and captures answers
appropriately. Email addresses of the appropriate candidates were compiled into a
consolidated survey panel. The survey was sent electronically to the identified respondent
panel, with a personal note to assure the respondents that the results would only be used in
a grouped way that protects their individual identities and the identities of their employers.
No remuneration was given to encourage survey participation. However, a report on the
39
findings of the survey was promised to the survey participants when the study is complete.
Busy professionals can find it difficult to prioritize the survey with their current workload.
Thus, I gave two reminders if the survey was not returned within a timely manner.
Responses to the survey were collected and stored electronically. The survey data
was analyzed using basic descriptive statistics including the use of weighting factors, where
the question structure is amenable to that approach. To do this, a graded weighting was
assigned to values that for example, ranged from important to not important. Each assigned
factor was multiplied by the number of respondents making that choice and the resulting
numbers were summed, then divided by the total number of participating respondents.
40
Chapter 4. Results
4.1 Analysis of Survey Results
The surveyed respondents were identified by using multiple sources to obtain
contacts from industry organizations, referrals from other participants and interested parties
as well as networking at conferences and academic events. The intent was to access the
widest possible group of industry experts from a diversity of medical device organizations
and thus to provide a broad perspective on experiences with RI communication between
sites. Links to the 42-question survey were distributed by email on May 10, 2019 and left
open until July 31, 2019. A total of 50 of 111 recipients responded in some degree, yielding
a 45% response rate. One respondent did not meet the criteria of having more than seven
months experience in Regulatory Intelligence and was excluded from participation in the
survey. Three respondents indicated that they were not involved in Regulatory Intelligence
activities and were also omitted from the data analysis (Table 2).
Table 2: Analysis of those eliminated from the data analysis
How many years of experience in total do you have in Regulatory Intelligence (RI)? (n=49)
Highlighted cells indicate respondents who did not meet inclusion/exclusion criteria.
Regulatory Intelligence Experience
0 – 6 months 2%, 1/49
7 months – 1 year 4%, 2/49
1+ years 88%, 43/49
I am not involved in Regulatory Intelligence activities 6%, 3/49
41
4.1.1 General Information about Survey Respondents
Demographic data was aggregated from industry professionals who had greater than
seven months experience in Regulatory Intelligence, were involved in Regulatory
Intelligence activities and were able to complete the survey (Table 2). The respondents
identified their current professional level as Senior Manager/Manager (29%, 13/45), Senior
Director/Director (22%, 10/45), VP/Executive (18%, 8/45), Specialist/Associate (13%,
6/45), Consultant/Third-party (13%, 6/45) and other (4%, 2/45). Those in the other
category identified themselves as Senior Product Compliance Engineers (Figure 9).
Figure 9: Job levels of respondents
What is your current level in the company? (n=45)
8
10
13
6
6
2
0 2 4 6 8 10 12 14
VP/Exec
Sr Dir/Dir
Sr Mgr/Mgr
Specialist/Assoc
Consult/3rd‐Party
Other
42
Nearly half (44%, 20/45) worked with large (15,001+ employees) companies, about
a quarter (24%. 11/45) with mid-sized companies (2,001 – 15,000 employees), 13% (6/45)
with small companies (101 - 2,000 employees) and 18% (8/45) with micro-sized companies
(1 – 100 employees) (Table 3).
Table 3: Employees in company
How many employees in your company? (n=45)
Size of Company
Micro (1 – 100) 18%, 8/45
Small (101 - 2,000) 13%, 6/45
Medium (2,001 – 15,000) 24%, 11/45
Large (15,001+) 44%, 20/45
A small majority (58%, 26/45) of the survey respondents were located at the
headquarter office and 16% (7/45) at international regional offices. A quarter (27%,12/45)
selected the “other” category, and provided clarifications shown in Table 4. Most of these
might be considered as international regional offices of some form.
43
Table 4: Office location of survey respondents - Other response included
In which type of office are you based? Other responses included. (n=45)
Type of office
Headquarter 58%, 26/45
International Regional 16%, 7/45
Other (listed below) 27%, 12/45
Remote/Home Office 5
Regional/Branch Site 2
Manufacturing Site 1
One of many plants 1
Plant located away from corporate
headquarters
1
Satellite device development and
manufacturing operation
1
R&D Office 1
When asked how to best describe their companies, most survey respondents
selected medical device/IVD (64%, 29/45). A few chose other options such as:
consultant/third party (11%, 5/45); other (11%, 5/45); pharmaceuticals (9%, 4/45); and
biotech (4%, 2/45). The nature of product specialization in the “other” category is detailed
in Table 5. The other categories included specific product specializations that aligned with
one or more selections that were provided.
44
Table 5: Product specializations of represented companies – other responses
included
How is your company best described? (n=45)
Product specializations
Medical Device/IVDs 64%, 29/45
Pharmaceuticals 9%, 4/45
Consultant/3
rd
-Party 11%, 5/45
Biotech 4%, 2/45
Other (listed below) 11%, 5/45
Pharmaceuticals/Medical Device/Biologics 1
Third party medical device service and asset
management
1
Medical device, diagnostics,
pharmaceuticals, consumer
1
Pharmaceuticals, medical device, consumer 1
Contract manufacturing 1
Many of the survey respondents (64%, 29/45) work in companies with a global
focus, 20% (9/45) in companies with primary activities in well-established markets and a
few emerging markets, 7% (3/45) in well-established markets only, 4% (2/45) in only a few
markets and 4% (2/45) in one country. No respondents were affiliated with companies only
in emerging markets or startup companies (Figure 10).
45
Figure 10: Company characterization with respect to international activities
In your opinion, how would you characterize your company? (n=45)
The Regulatory Intelligence function was identified to be placed most commonly in
regulatory affairs (62%, 37/59). Fewer respondents, 19% (11/59), placed the function in
quality assurance or engineering, 7% (4/59) in government affairs, and 2% (1/59) in
medical or legal affairs. A few respondents (5%, 3/59) used a consultant or third party for
Regulatory Intelligence and 3% (2/59) did not have a Regulatory Intelligence function
(Figure 11). There was no “other” category identified.
29
9
3
2
2
0 5 10 15 20 25 30 35
Global Focus
Well‐established & few emerging…
Well‐established markets only
In only a few markets
In one country
In emerging markets
No countries, start up
46
Figure 11: Organizational home of Regulatory Intelligence
Where is the Regulatory Intelligence function typically centered in your organization?
(Select all that apply) (n=59)
The placement of the Regulatory Intelligence function was further analyzed to
determine where the function was placed specific to the size of medical device company
(Figure 12). In large medical device companies, three-fourths (74%, 14/36) place the RI
function in Regulatory Affairs. Similar percentages are found in medium (67%, 6/9), small
(75%, 3/4) and micro (75%, 3/4) sized companies. In large companies RI is also located in
QA/Engineering (11%, 2/19) or government affairs (11%, 2/19). In about one-third of
medium sized companies RI is also located in QA/Engineering (33%, 3/9) (Figure 12).
47
Figure 12: Organizational placement of Regulatory Intelligence by medical device
company size
4.1.2 Regulatory Intelligence Process
Substantial variation was apparent in the stage of reported maturity of regulatory
intelligence across different companies. Relatively few had well developed, mature
systems (10%, 4/42) characterized as having optimized and well-trusted processes that
meet expectations with little oversight. An additional small number (12%, 5/42)
characterized their systems as quantitatively managed with processes that were measured
and controlled. Amongst the others that constituted the majority, a third (33%, 14/42) had a
mature system in which processes were established and followed, a quarter (24%, 10/42)
had processes that were partially implemented, and 21% (9/42) had processes seen to be
unpredictable, poorly controlled and reactive (Figure 13). Three respondents failed to
answer this question.
48
Figure 13: Regulatory Intelligence maturity level
In your opinion, what level of maturity, described below, best describes Regulatory
Intelligence in your company? (n=42)
The RI process maturity of the reported programs was cross tabulated with the
formality of processes. Less than half of the respondents selected that the regulatory
intelligence function was a formalized stand-alone function (40%, 17/42). Within that
grouping 41% (7/17) had identified that the maturity of the process is defined, and the
processes are followed; more than a third of the others characterized the maturity as more
advanced that this, either quantitatively managed or optimized, (24%, 4/17 and 18%, 3/17
respectively). Forty-three percent (18/42) of the respondents indicated that the regulatory
intelligence is an informal activity (Table 6). For those cases in which it was an informal
activity, that activity was mostly characterized as unpredictable or managed or with defined
processes (44%, 8/18; 22%, 4/18 and 28%; 5/18 respectively).
9
10
14
5
4
02468 10 12 14 16
Initial ‐ process unpredictable
Managed ‐ process not implemented
Defined ‐ processes are followed
Quantitatively mgd ‐ processes
controlled
Optimized ‐ processes are well trusted
49
Table 6: Handling of Regulatory Intelligence by level of process maturity
(n=42)
Shaded numbers represent the most common choice.
Formalized
stand-alone
function
(n=17)
Formalized
function
(n=7)
Informal
activity
(n=18)
Third
party
(n=0)
Other
(n=0)
Initial - process
unpredictable
6%, 1/17 0%, 0/7 44%, 8/18 0%, 0/0 0%, 0/0
Managed -
process not
implemented
12%, 2/17 6%, 4/7 22%, 4/18 0%, 0/0 0%, 0/0
Defined -
processes are
followed
41%, 7/17 3%, 2/7 28%, 5/18 0%, 0/0 0%, 0/0
Quantitatively
Mgd - processes
are controlled
24%, 4/17 1%, 1/7 0%, 0/18 0%, 0/0 0%, 0/0
Optimized -
processes are
well trusted
18%, 3/17 0%, 0/7 6%, 1/18 0%, 0/0 0%, 0/0
Total
40%, 17/42 17%, 7/42 43%, 18/42 0%, 0/42 0%, 0/42
When asked to describe their RI systems in more detail, 33% (14/43) had an
established Regulatory Intelligence department with a formally embedded process; 37%
(16/43) had a Regulatory Intelligence function that relied on unstructured processes; 2%
(1/43) had explored the idea of Regulatory Intelligence processes but had insufficient
resources; and 7% (3/43) did not have a Regulatory Intelligence process but had identified
resources to put one in place. A fifth of respondents (21%, 9/43) reported that they did not
50
have a Regulatory Intelligence process and collected information as needed (Figure 14).
Two respondents did not answer this question.
Figure 14: Regulatory Intelligence process
How would you best describe your current Regulatory Intelligence (RI) process? (n=43)
Many survey respondents indicated that Regulatory Intelligence is a formalized
stand-alone function managed by an internal team (42%, 18/43); a similar number
identified their system as an informal activity done by several internal people (42%, 18/43).
Fewer had a formalized Regulatory Intelligence function conducted primarily by one
internal person (16%, 7/43). None of the respondents identified that their RI function was
conducted by an outsourced third party or another method (Figure 15). Two respondents
skipped this question.
9
3
1
16
14
0 5 10 15 20
Don't have RI process, RI is collected as
needed
Don’t have RI process, have identified
resources
Have explored RI processs but no resource
Have an unstructured RI process
Established RI department, formally
embedded
51
Figure 15: Handling of Regulatory Intelligence
Which statement best describes the way that Regulatory Intelligence is handled in your
company? (n=43)
How Regulatory Intelligence is managed was further analyzed by company size. Three-
fourths (74%, 14/19) of large medical device companies have a formalized, stand-alone
Regulatory Intelligence function. Over half of medium (64%, 7/11), small (60%, 3/5) and
micro (63%, 5/8) sized medical device companies manage Regulatory Intelligence as an
informal activity (Table 7).
18
7
18
0 5 10 15 20
Formalized stand‐alone function
Formalized function
Informal activity
Third party
Other
52
Table 7: Handling of Regulatory Intelligence by medical device company size
Shaded numbers represent the most common choice.
Large
(n=19)
Medium
(n=11)
Small
(n=5)
Micro
(n=8)
Formalized
stand-alone
function
74%, 14/19 18%, 2/11 20%, 1/5 13%, 1/8
Formalized
function
11%, 2/19 18%, 2/11 20%, 1/5 25%, 2/8
Informal
activity
16%, 3/19 64%, 7/11 60%, 3/5 63%, 5/8
Third party
0%, 0/19 0%, 0/11 0%, 0/5 0%, 0/0
Other
0%, 0/19 0%, 0/11 0%, 1/5 0%, 0/0
When asked how often Regulatory Intelligence is gathered from a list of different
RI sources, the most common frequencies were either on a daily/weekly or an ad hoc basis.
The most common sources that were consulted on a daily or weekly basis were regulations
and guidance documents (49%, 20/41) and websites, blogs and forums (46%, 19/41); the
regular use of these avenues for information was typical for nearly half of the respondents.
In contrast, only about a third of respondents (32%, 13/41) conducted daily or weekly
examinations related to post market and compliance issues, and even fewer examined
scholarly reports or trade association briefings (29%, 12/41), their own company’s product
approvals (29%, 12/41), or briefings from colleagues who have met with a
regulators/government agencies (27%, 11/41). Least often consulted was information from
third party vendors or consultants (22%, 9/41) or product approvals from competitors
(15%, 6/40). Two “other” sources of information were identified by respondents, one of
53
whom specified the information as coming from purchased subscription services for
Regulatory Intelligence. The second respondent did not specify the source. About one-fifth
to one-third of the respondents consulted the same sources listed above on a less frequent,
monthly or quarterly basis (Table 8). Only a few respondents identified that they consulted
these sources semiannually or annually. However, it was relatively more common for
respondents to identify that information from many of the listed sources was consulted on
an ad hoc basis; between 20% and 45% of respondents identified an ad hoc approach for
each category, with product approvals of competitors (45%, 18/40) and consultants or
third-party databases (42%, 17/41) selected most frequently. Only a few respondents
identified that they never consulted the listed sources (Table 8).
54
Table 8: Frequency of gathering Regulatory Intelligence
How often does your company gather RI from the following sources? (n=41)
Shaded numbers represent the most common choice.
Daily/
weekly
Monthly/
Quarterly
Semi-
Annually/
Annually
Ad hoc Never
Product Approvals,
your company
29%, 12/41 20%, 8/41 15%, 6/41 29%, 12/41 7%, 3/41
Product Approvals,
competitors
15%, 6/40 30%, 12/40 0%, 0/40 45%, 18/40 10%, 4/40
Post Market,
Compliance Issues
32%, 13/41 34%, 14/41 10%, 4/41 22%, 9/41 2%, 1/41
Regulations/
Guidance
49%, 20/41 24%, 10/41 7%, 3/41 20%, 8/41 0%, 0/41
Information from
Third Party, Vendor
Database, Advice
from Consultants
22%, 9/41 20%, 8/41 10%, 4/41 42%, 17/41 7%, 3/41
Scholarly Reports,
Trade Association
Briefings
29%, 12/41 20%, 8/41 17%, 7/41 24%, 10/41 10%, 4/41
Websites, Blogs,
Forums
46%, 19/41 17%, 7/41 5%, 2/41 32%, 13/41 0%, 0/41
Briefing from a
meeting w/
regulators/govt
27%, 11/41 22%, 9/41 10%, 4/41 39%, 16/41 2%, 1/41
Other
5%, 2/41 0%, 0/41 2%, 1/41 7%, 3/41 7%, 3/41
Other
0%, 0/41 0%, 0/41 2%, 1/41 2%, 1/41 10%, 4/41
55
4.1.3 Regional International Regulatory Offices
About a quarter of respondents (26%, 11/43) worked for companies with no
regional international offices. Most of the remaining respondents worked in companies
with over ten international regional offices (44%, 19/43). Only a small number had
between four and ten international regional offices (9%, 4/43) or one to three international
regional offices (19%, 8/43) (Figure 16). The eleven respondents who did not work with
any international regional offices along with one respondent who did not know if
international regional offices existed in their company were excluded from the data
analysis for the remaining questions.
Figure 16: International regional offices
Do you have International Regional Offices, if yes how many? (n=43)
The number of international regional offices was further analyzed to include
company size. Of large medical device companies, 84% (15/19) have more than ten
11
8
4
19
1
0 5 10 15 20
No
1 ‐ 3
4 ‐ 10
10+
Do not know
56
international regional offices. Over one-third (36%, 4/11) of medium sized companies have
more than ten international regional offices, but most have fewer. Sixty percent (3/5) of
small companies had one to three international regional offices and the others had none. All
but one of the micro sized companies had no international regional offices (Table 9).
Table 9: International regional offices by medical device company size
Company Size
Large
(n=19)
Medium
(n=11)
Small
(n=5)
Micro
(n=8)
No 5%, 1/19 9%, 1/11 17%, 2/5 88%, 7/8
1-3 11%, 2/19 27%, 3/11 60%, 3/5 0%, 0/8
4-10 0%, 0/19 27%, 3/11 0%, 0/5 13%, 1/8
10+ 84%, 15/19 36%, 4/11 0%, 0/5 0%, 0/8
Do not know 5%, 1/19 0%, 0/11 0%, 0/5 0%, 0/8
The international offices had a diverse geographic distribution: 20% (23/115) in
Europe (including Russia, Eastern block); 18% (21/115) in Americas (e.g. Canada, USA,
South America); 19% (19/115) in South East Asia and Pacific (e.g. Australia, South Korea,
Vietnam); 16% (18/115) in China (Including Hong Kong, Taiwan, Mongolia); 11%
(13/115) in the Middle East (e.g. Afghanistan, Egypt, Iran, Pakistan); 10% (11/115) in
India (including Indian subcontinent); and 9% (10/115) in Africa (Table 10).
57
Table 10: Location of international regional offices
Where are your regional offices located? (n=115)
Geography
Americas 18%, 21/115
South East Asia and Pacific 17%, 19/115
China 16%, 18/115
Middle East 11%, 13/115
Europe 20%, 23/115
India 10%, 11/115
Africa 9%, 10/115
Respondents were asked to rate (always to never) the factors that impede
Regulatory Intelligence communication with their most challenging international regional
offices. The factors that were assigned the highest, “always”, ratings were environment (ie,
political, economic) (22%, 5/23) and culture (ie, language, beliefs, religion) (13%, 3/23).
This is also reflected in the lowest weighted scores of 3.0 that were calculated by giving the
selections a weighting factor as described in methods, Thus the selection of “always” had
the highest weighting factor of 1 and “never” the weighting factor of 6. Less frequently
selected as “always” impeding communication were the locations where communication
take place (ie, private/public, live/virtual location) (4%, 1/23); voice patterns (ie, inflection,
accent, word pronunciation) (4%, 1/23). Two individuals that selected the “other” category
specified “lack of transparency” and “relationship between company versus distributor
affiliates”.
58
Conversely, the factors that were identified to “never” impede Regulatory
Intelligence communications are: location where communication takes place (ie,
private/public, live/virtual location) (26%, 6/23: 4.3); non-verbal communication (ie,
gestures, facial expressions) (26%, 6/23: 4.2); voice pattern (ie, inflection, accent, word
pronunciation) (4%, 1/23: 3.9); environment (ie, political, economic) (4%, 1/23: 3.0); and
culture (ie, language, beliefs, religion) (4%, 1/23: 3.0). Communication location (4.3) and
non-verbal communication (4.2) had the highest weighted mean scores and therefore
appear to be the least challenging factors to impede RI communication (Table 11).
59
Table 11: Impediments to communication with international regional offices
Please consider the international regional office that you consider to be the most
challenging from an RI communications point of view. How important are the following
factors that you have found to impeded RI communication? (n=23)
Shaded numbers represent the most common choice per frequency.
Always
Most of
the time
About half
the time
Sometimes Never
Mean,
SD
1 2 3 5 6
Non-verbal
communication
0%, 0/23 26%, 6/23 13%, 3/23 35%, 8/23 26%, 6/23
4.2,
2.06
Communication
location
4%, 1/23 13%, 3/23 17%, 4/23 39%, 9/23 26%, 6/23
4.3,
2.24
Culture 13%, 3/23 39%, 9/24 17%, 4/23 26%, 6/23 4%, 1/23
3.0,
1.18
Voice pattern 4%, 1/23 17%, 4/23 22%, 5/23 52%, 12/23 4%, 1/23
3.9,
1.74
Environment 22%, 5/23 26%, 6/23 17%, 4/23 30%, 7/23 4%, 1/23
3.0,
1.34
Other 9%, 2/23 9%, 2/23 4%, 1/23 0%, 0/23 0%, 0/23
1.8,
0.84
The survey respondents were asked how activities are split between headquarters
and international regional offices. Most of the responses revealed that tasks were shared
between headquarters only or split between headquarters and international regional offices.
Most notably the activities commonly held at headquarter office only were managing an RI
database (63%, 18/28), communicating RI to executives (54%, 15/28) and analyzing data
(46%, 12/28).
60
Most often the activities were split between headquarters and international regional
offices included: developing comments on draft guidance (57%, 16/28); assessing the
impact of regulatory analysis (57%, 16/28); or gathering intelligence (57%, 16/28). About
half also split activities including conduct of research requests (54%, 15/28);
communication regulatory intelligence to other regional offices (50%, 14/28); or analysis
of data (46%, 13/28). More than one third communicated Regulatory Intelligence to
executives (39%, 11/28). Even fewer split activities related to the management of a
database housing regulatory intelligence (18%, 5/28). One respondent selected “other” as a
category without specifying the nature of that additional task.
The international regional offices were seldom tasked with Regulatory Intelligence
responsibilities alone. Less than 10% of respondents identified they performed certain
tasks alone such as: gathering Regulatory Intelligence (7%, 2/28); analyzing data (7%,
2/28); conducting research requests (7%, 2/28); communicating Regulatory Intelligence to
executives (7%, 2/28); developing comments on draft guidance (7%, 2/28); communicating
RI to other regional offices (4%, 1/28); managing a database that houses regulatory
intelligence (4%, 1/28) and assessing the impact of regulatory analysis (4%, 1/28). There
was no “other” category selected by respondents.
A few respondents noted activities that were not performed at all in their
organization. These included: managing a database that houses regulatory intelligence
(14%, 4/28); conducting research requests (7%, 2/28); developing comments on draft
guidance (4%, 1/28) and communicating regulatory intelligence to other regional offices
(4%, 1/28). No respondent reported that the company failed to communicate Regulatory
Intelligence to executives (0%, 0/28); conduct research requests (0%, 0/28); assess the
61
impact of regulatory analysis (0%, 0/28); analyze data (0%, 0/28) or gather intelligence
(0%, 0/28) (Table 12).
Table 12: Location where Regulatory Intelligence activities are performed
At what location do the following activities typically occur? (n=28)
Shaded numbers represent the most common choice per activity.
Commonly
Headquarters
Office Only
Split between
Headquarters
&
International
Regional
Office
Commonly
International
Regional
Office Only Not at All Other
Gathering
intelligence
36%, 10/28 57%, 16/28 7%, 2/28 0%, 0/28 0%, 0/28
Analyzing data 46%, 13/28 46%, 13/28 7%, 2/28 0%, 0/28 0%, 0/28
Assessing
impact
39%, 11/28 57%, 16/28 3%, 1/28 0%, 0/28 0%, 0/28
Managing an RI
database
63%, 18/28 18%, 5/28 4%, 1/28 14%, 4/28 0%, 0/28
Conducting
research
requests
32%, 9/28 54%, 15/28 7%, 2/28 7%, 2/28 0%, 0/28
Communicating
RI to execs
54%, 15/28 39%, 11/28 7%, 2/28 0%, 0/28 0%, 0/28
Developing
comments on
draft guidance
32%, 9/28 57%, 16/28 7%, 2/28 4%, 1/28 0%, 0/28
Communicating
RI to other
regional offices
43%, 12/28 50%, 14/28 4%, 1/28 4%, 1/28 0%, 0/28
Other 0%, 0/28 4%, 1/28 0%, 0/28 0%, 0/28 0%, 0/28
62
Over half of the respondents indicated that the Regulatory Intelligence
responsibilities primarily lie in the headquarter office with some input from the
international regional office (52%, 12/23). Another third identified that Regulatory
Intelligence responsibilities are distributed more equally between these offices (39%, 9/23).
Much less frequently were arrangements in which Regulatory Intelligence responsibilities
took place primarily at international regional offices with some input from the headquarter
office (9%, 2/23). In no case did respondents identify that the responsibilities occurred only
in the international offices (Figure 17).
Figure 17: Distribution of responsibilities between headquarter and branch offices
How are RI responsibilities distributed between the headquarter and international regional
offices? (n=23)
The distribution of responsibilities was analyzed further against company focus and
size of the company as shown in Table 13. Half (50%, 8/16) of the respondents in medical
12
9
2
02468 10 12 14
Only HQ
Primarily HQ with some Intl Regional
Equally HQ and Intl Regional
Primarily Intl Regional with HQ input
Only Intl Regional
63
device or IVD companies identified that RI responsibilities are primarily conducted in
headquarters with some help from the international regional offices and most of the others
(44%, 7/16) divided the responsibilities equally between headquarters and regional offices.
A similar distribution was identified in the five non-medical device companies (60%, 3/5
and 2/5 respectively). In companies of different sizes there appeared to be a trend in which
RI activities were centered primarily in headquarters in small and micro sized companies,
but were distributed more equally across regional offices in large and medium-sized
companies, but numbers are small in some of these subcategories for definitive conclusions
(Table 13).
Table 13: MD vs Non-MD: Distribution of responsibilities between headquarter
and international regional offices
Company Focus Size of Company
Medical
Device/IVD
(n=16)
Non-Medical
Device/IVD
(n=5)
Large
(n=13)
Medium
(n=6)
Small
(n=3)
Micro
(n=1)
Only HQ 0%, 0/16 0%, 0/5 0%, 0/13 0%, 0/6 0%, 0/3 0%, 0/1
Primarily HQ
with some
Intl Regional
50%, 8/16 60%, 3/5 39%, 5/13 50%, 3/6 100%, 3/3 100%, 1/1
Equally HQ
and Intl
Regional
44%, 7/16 40%, 2/5 46%, 6/13 50%, 3/6 0%, 0/3 0%, 0/1
Primarily Intl
Regional
with HQ
input
6%, 1/16 0%, 0/5 15%, 2/13 0%, 0/6 0%, 0/3 0%, 0/1
Only Intl
Regional
0%, 0/16 0%, 0/5 0%, 0/13 0%, 0/6 0%, 0/3 0%, 0/1
64
Over half of the 22 respondents stated that their most challenging international
regional office was China (Including Hong Kong, Taiwan, Mongolia) (64%, 14/22). Less
frequently selected were: the Middle East (e.g. Afghanistan, Egypt, Iran, Pakistan) (14%,
3/22); South East Asia and Pacific (e.g. Australia, South Korea, Vietnam) (9%, 2/22);
Europe (including Russia, Eastern block) (5%, 1/22), Americas (e.g. Canada, USA, South
America (5%, 1/22); India (including Indian subcontinent) (5%, 1/22). No respondent
selected Africa (Figure 18).
Figure 18: Most challenging international regional office
Where is the most challenging regional office? (n=22)
The most challenging international regional offices were also analyzed further against the
impediments to communication as shown in Table 14. The respondents that selected
environment as “always” an impeding factor for communication with the regional offices
also selected China (100%, 5/5) as the most challenging regional office. Those that selected
14
3
2
1
1
1
02468 10 12 14 16
China
Middle East
South East Asia and Pacific
India
Europe
Americas
Africa
65
culture as an impediment “most of the time” identified China (67%, 6/9), Middle East
(22%, 2/9) and South East Asia and Pacific (11%, 1/9) as challenging international regional
offices.
Table 14: Cross-Tabulation of impediments to communication with international
regional offices with the most challenging regional office for the
selections of ‘always’ and ‘most of the time’.
Always Countries
Most of
the time
Countries
1
2
Non-verbal
communication
0%, 0/23 26%, 6/23
China (4)
Americas (1)
South East Asia & Pacific (1)
Communication
location
4%, 1/23 Americas (1) 13%, 3/23
China (2)
Europe (1)
Culture 13%, 3/23
China (2)
Americas (1)
39%, 9/24
China
(67%, 6/9)
Middle East
(22%, 2/9)
South East Asia & Pacific
(11%, 1/9)
Voice pattern 4%, 1/23 Americas (1) 17%, 4/23 China (4)
Environment 22%, 5/23
China
(100%, 5/5)
26%, 6/23
China (3)
Americas (1)
Middle East (1)
Europe (1)
Other 9%, 2/23 China (2) 9%, 2/23
China (1)
Europe (1)
66
When the respondents were asked to identify the extent of RI contributions across
different offices, similar numbers reported that most (46%, 11/24) or only a few (42%,
10/24) of the internatonal regional offices contribute RI data. Many fewer indicated that RI
is gathered from a headquarter office with minimal or no international regional office
participation (13%, 3/24) (Figure 19).
Figure 19: Participation when gathering Regulatory Intelligence
When gathering Regulatory Intelligence…. (n=24)
Respondents were asked how often Regulatory Intelligence was reported by the
most active international regional office. The most frequent information collected on a
daily/weekly basis was that concerning product approvals (29%, 7/24). About a quarter
collected regulations, guidance documents, market access information (25%, 6/24) and
information from websites, blogs, forums, social networks and/or Google® (25%, 6/24) on
a weekly basis. The information that was communicated most commonly on a
monthly/quarterly basis was regulations or guidance documents (38%, 9/24); post market
or compliance information (33%, 8/24); information from third party vendor databases
11
10
3
02468 10 12
Most Intl Regional Offices contribute
RI
Only few Intl Regional Offices
contribute RI
RI gathered from HQ with limited Intl
Regional Office participation
67
(29%, 7/24); advice from consultants and scholarly reports and trade association briefings
(29%, 7/24); and product approvals (25%, 6/24). A few respondents identified that these
activities were carried out semi-annually or annually.
However, an ad hoc approach was the predominant way by which many types of RI
information was supplied: scholarly reports and trade association briefings (38%, 9/24);
post market or compliance information (33%, 8/24); regulations, guidance documents or
market access information (33%, 8/24); information from third party vendor databases or
advice from consultants (33%, 8/24); websites, blogs, forums, social networks or Google®
(33%, 8/24); and product approvals (25%, 6/24). Two respondents selected “other” but did
not specify the nature of those activities.
A few respondents identified that certain types of information was never
communicated from international regional offices: information from a third party vendor
databases or advice from consultants (17%, 4/24); websites, blogs, forums, social networks
and/or Google® (13%, 3/24); briefings from a colleague/or consultant that has met with
government agencies (13%, 3/24); scholarly reports and trade association briefings (8%,
2/24) and post market or compliance issues (4%, 1/24) (Table 15).
68
Table 15: Regulatory Intelligence frequency of communication
What is the typical frequency in which RI is communicated from your most active regional
office? (n=24)
Shaded numbers represent the most common choice per information selection.
Daily/weekly
Monthly/
Quarterly
Semi-
Annually/
Annually
Ad hoc Never
1 2 3 4 5
Product Approvals
29%, 7/24 25%, 6/24 8%, 2/24 25%, 6/24 13%, 4/24
Post Market,
Compliance
Information
21%, 5/24 33%, 8/24 8%, 2/24 33%, 8/24 4%, 1/24
Regulations,
Guidance
Documents
25%, 6/24 38%, 9/24 4%, 1/24 33%, 8/24 0%, 0/24
Information from
Third Party Vendor
Database, Advice
from Consultants
13%, 3/24 29%, 7/24 8%, 2/24 33%, 8/24 17%, 4/24
Scholarly Reports,
Trade Association
Briefings
21%, 5/24 30%, 7/24 4%, 1/24 38%, 9/24 8%, 2/24
Websites, Blogs,
Forums, Social
Networks
25%, 6/24 21%, 6/24 8%, 2/24 33%, 8/24 13%, 3/24
Briefing from a
colleague/or
consultant that has
met with
government
agencies
21%, 5/24 29%, 7/24 8%, 2/24 27%, 7/24 13%, 3/24
Other
0%, 0/24 0%, 0/24 0%, 0/24 8%, 2/24 0%, 0/24
69
When asked whether international regional offices share RI differently or in the
same way as one another, more than three-quarters of respondents identified that they
participate differently (79%, 19/24), whereas one-fifth identified they participated in the
same way (21%, 5/24) (Figure 20).
Figure 20: Level of Regulatory Intelligence participation
In your opinion, do all International Regional Offices have the same or different levels of
participation with regard to Regulatory Intelligence development or sharing? (n=24)
When asked about the extent to which international regional offices share
Regulatory Intelligence with one another without going through the headquarter office,
respondents most commonly identified that this happened occasionally (38%, 9/24).
However, a quarter of respondents (25%, 6/24) reported that it happened commonly and
only a few reported that it did not happen (17%, 4/24). Five respondents did not know if
international regional offices shared Regulatory Intelligence with one another (Figure 21).
5
19
0 5 10 15 20
Participate in the same way
Participate differently
70
Figure 21: Sharing of Regulatory Intelligence
Do International Regional offices share RI with one another without going through the
Headquarter office? (n=24)
Survey respondents were asked if it was difficult to obtain Regulatory Intelligence
from international regional offices. Most commonly they identified that it was sometimes
difficult (sometimes yes, sometimes no, 42%, 10/24); sometimes yes (25%, 6/24). A
minority had more difficulty and selected “definitely yes” (21%, 5/24). Only one
respondent selected “sometimes no” (4%, 1/24) or “definitely no” (4%, 1/24). One
respondent did not know (Figure 22).
6
9
4
5
02468 10
Yes, commonly
Yes, occasionally
No
Do not know
71
Figure 22: Obtaining Regulatory Intelligence difficulties
Do you find it difficult to obtain regulatory intelligence from international regional office?
(n=24)
When asked what, in their opinion, was the best country with which to work to
gather Regulatory Intelligence and why, respondents typically selected USA, Europe,
Canada, and Brazil. The responses were grouped into eight categories as shown in Table
15. The fully documented set of replies are available in Appendix A. Respondents typically
pointed to transparency, timeliness and ease of access of regulatory updates and
information. The majority identified transparency (38%, 8/21) in USA, Europe and Canada
as the reason why Regulatory Intelligence is easy to gather from those specific countries
(Table 16).
5
6
10
1
1
1
02468 10 12
Definitely yes
Sometimes yes
Sometimes yes, sometimes no
Sometimes no
Definitely no
Do not know
72
Table 16: Best country to obtain Regulatory Intelligence
In your opinion, what is the best country to work with regarding gathering Regulatory
Intelligence and why? (n=21)
Shaded numbers represent the most common choice.
Best Country
Why Category
USA
Europe
Canada
USA / Canada
Brazil
Total
Transparency
“information is typically known well in advance with
adequate transition times and individuals present in
this market follow the processes closely to report and
assess the intelligence.”
4 2 0 2 0
38%,
8/21
None provided
0 2 1 0 0
14%,
3/21
RI location
“US because the regulatory intelligence group is
located there”
3 0 0 0 0
14%,
3/21
Regulator communication
“United States due to direct email notifications from
FDA. Other regions (e.g. EU and Canada) are helped
by a subscription to Notified Body/MDSAP authority.”
1 0 1 0 0
10%,
2/21
Aware of changes
“USA and Canada, they are more focused on
regulations and are able to communicate changes in
a timely manner. The regulation also does not
change frequently or there is a long implementation
time for the new/changed regs.”
0 0 0 1 1
10%,
2/21
Policy making
“US because of significant emphasis on policy
making and impact it has on our industry”
1 0 0 0 0
5%,
1/21
Able to help
“Canada - always polite and willing to help”
0 0 1 0 0
5%,
1/21
Experience
“US, experience.”
1 0 0 0 0
5%,
1/21
Total
48%,
10/21
19%,
4/21
14%,
3/21
14%,
3/21
5%,
1/21
73
The most challenging country from which to obtain Regulatory Intelligence was
most commonly suggested to be China. The responses gathered were grouped into five
categories as shown in Table 17. The most common reason was split between the
awareness of changes (14%, 3/22) and implementation timeline (14%, 3/22). Other reasons
for difficulty gathering Regulatory Intelligence include language barriers, transparency and
concerns about differences in interpretation of guidelines. The full responses are available
in Appendix B.
74
Table 17: Most challenging country to obtain RI
In your opinion, what is your most challenging country from which to obtain Regulatory
Intelligence and why? (n=22)
Shaded numbers represent the most common choice.
Challenging Country
Why Category
China
Middle East
None provided
Africa
Africa, Middle
East
Asia
Canada, Brazil
Japan, Korea,
Middle East
Philippines
Russia
Unaware of
Changes
“Changes a lot
and only in
Chinese.
Translations are
spotty.”
14%,
3/22
0%,
0/22
0%,
0/22
5%,
1/22
0%,
0/22
5%,
1/22
5%,
1/22
0%,
0/22
5%,
1/22
0%,
0/22
Language
“Primary barrier is
language and
ability of country
reps to adequately
translate the
technical
language and
requirements.”
9%,
2/22
0%,
0/22
5%,
1/22
0%,
0/22
0%,
0/22
0%,
0/22
0%,
0/22
5%,
1/22
0%,
0/22
5%,
1/22
Transparency
“Regulation still
forming in some
areas or not well
formed for existing
regs.”
9%,
2/22
9%,
2/22
5%,
1/22
0%,
0/22
0%,
0/22
0%,
0/22
0%,
0/22
0%,
0/22
0%,
0/22
0%,
0/22
Implementation
timeline
“They "publish the
regulation, then
determine how to
implement the
regulation…”
14%,
3/22
0%,
0/22
0%,
0/22
0%,
0/22
0%,
0/22
0%,
0/22
0%,
0/22
0%,
0/22
0%,
0/22
0%,
0/22
None provided
5%,
1/22
0%,
0/22
0%,
0/22
0%,
0/22
5%,
1/22
0%,
0/22
0%,
0/22
0%,
0/22
0%,
0/22
0%,
0/22
75
When the survey respondents were asked what causes the most trouble when
working with the most challenging international regional office, most selections (Table 18)
were considered to pose problems with a frequency of at least sometimes. The use of a
weighting function with “always” weighted as 1 and “never” as 5 gave additional insight
into the degree to which various factors were found to be challenging. These generally
correlated with the frequency with which a selection was seen to be “always” challenging:
translation of Regulatory Intelligence is difficult to understand (22%, 5/23; 2.7);
interpretation of Regulatory Intelligence is difficult to understand (17%, 4/23; 2.7); the
time zone of the person reporting the RI is different than mine (13%, 3/23; 3.4) and
inadequate electronic tools for the purpose (4%, 1/23; 3.7).
76
Table 18: Most troublesome causes when collecting Regulatory Intelligence
Still thinking about the most challenging international regional office from a Regulatory
Intelligence (RI) communications point of view, what causes the most trouble? (n=23)
Shaded numbers represent the most common choice.
Always
Most of
the time
About half
the time
Sometimes Never
1 2 3 4 5 Mean, SD
Inadequate
electronic
tools
4%, 1/23 22%, 5/23 4%, 1/23 35%, 8/23 35%, 8/23 3.7, 1.29
Translation of
RI is difficult
to understand
22%, 5/23 26%, 6/23 13%, 3/23 39%, 9/23 0%, 0/23 2.7, 1.22
Interpretation
of RI is
difficult to
understand
17%, 4/23 30%, 7/23 17%, 4/23 35%, 8/23 0%, 0/23 2.7, 1.15
Time zone RI
is different
than mine
13%, 4/23 9%, 2/23 9%, 2/23 52%, 12/23 17%, 4/23 3.4, 1.35
Other
0%, 0/23 0%, 0/23 0%, 0/23 0%, 0/23 0%, 0/23 0.0, 0.00
When asked about the biggest communication issue between international regional
and headquarters offices and why, respondents offered 23 comments that were categorized
into ten topic areas, shown in Table 18. These were judged to include: placement of
Regulatory Intelligence within the organization (13%, 3/23), lack of resources (13%, 3/23);
segregation of teams (13%, 3/23); relevance/timeliness of reporting (9%, 2/23); language
barriers (9%, 2/23); level of experience (4%, 1/23); and US centric thinking (4%, 1/23);. A
77
sample comment from each category is presented in Table 19. The detailed comments are
available in Appendix C.
78
Table 19: Most troublesome communication issues between offices
In your opinion what are the biggest communication issues between international regional
and headquarter offices? (n=23)
Communication issue between region and
headquarters
Total
NA
17%, 4/23
Placement in organizational structure
“…reporting lines can be confusing for staff in regional offices. For
example, if there is no direct reporting line to the headquarters the
nature of the job might prevent frequent and efficient
communication…”
13%, 3/23
Resources
“No dedicated resource and process to consistently collect,
evaluate and communicate RI from multiple sources.”
13%, 3/23
Segregation
“Often regional offices act in Silos or there is a bet of me versus
them mentality which could cause much rework.”
13%, 3/23
Relevance/Timeliness
“…the information is overwhelming and difficult to know if or when
its applicable. In other places, it feels like the information is late
and therefore causes disruptions. Many times, the information
can also be at such a high level that it requires consultation…”
9%, 2/23
Language
“Language barriers”
9%, 2/23
Time zone / Culture
“Time zones and cultural differences, not understanding what is
important to the other office.”
9%, 2/23
Timeliness
“…in order for the business to react to meaningful RI the change
needs to be communicated with enough time to analyze and
study the impact.”
9%, 2/23
Experience
“Empathy and understanding of the perspective and experience
each group brings and what expertise is required.”
4%,1/23
US centric thinking
“Understanding of criticality to the local office by corporate (US
centric thinking).”
4%, 1/23
4.1.4 Regulatory Intelligence Communication
Respondents were asked about their level of satisfaction with the communication
methods that they were using to exchange Regulatory Intelligence. Half of the survey
79
respondents were “somewhat satisfied” with communication methods currently used (50%,
16/32). Fewer were “somewhat dissatisfied” (22%, 7/32) or “neither satisfied or
dissatisfied” (16%, 5/32). Only a few selected more extreme levels of satisfaction, either
“extremely dissatisfied” (9%, 3/32) or “extremely satisfied” (3%, 1/32) (Figure 23).
Figure 23: Satisfaction with currently used communication method
How satisfied are you with the methods of communication that are currently used? (n=32)
When asked about factors contributing to the success of gathering data, the
respondents provided a wide variety of comments, that were grouped into eight categories
as shown in Table 20, and then documented fully in Appendix D. These categories
included: experience of the personnel; use of vendor databases or other resources; ability to
share information; availability of resources; level of prioritization; the presence of clear
owners; and the degree of collaboration. Some identified their experience (34%, 10/29)
where the individuals that are involved in Regulatory Intelligence have a passion and are
1
16
5
7
3
0 5 10 15 20
Extremely satisfied
Somewhat satisfied
Neither satisfied nor dissatisfied
Somewhat dissatisfied
Extremely dissatisfied
80
dedicated and “know when to reach out to internal and external subject matter experts to
gauge importance and to help interpret RI before disseminating.” The use of third-party RI
databases and Regulatory Intelligence (21%, 6/29) resources were identified to benefit the
success of data gathering. The ability to share information with the rest of the organization
was as viewed as a contributing factor to the success of developing Regulatory Intelligence
information (17%, 5/29) (Table 20).
81
Table 20: Areas of comment regarding successful elements for gathering RI data
To what do you attribute your success of gathering data? (n=29)
Communication issue Total
Experience
“Luck and experience of the individuals who have background in regulatory
intelligence”
34%, 10/29
Vendor database/RI resources
“Purchase subscription services for RI”
21%, 6/29
Sharing information
“Having the regions being able to report RI data. Although this is also an
issue as we find out about RA late and sometimes not at all”
17%, 5/29
NA 7%, 2/29
Resources
“Dedicated resource to process, store, evaluate and communicate data”
7%, 2/29
Business priority
“Priority that is placed on the intelligence and wide network.”
3%, 1/29
Clear owners
“Actionable steps with clear owners”
3%, 1/29
Collaboration
“Getting Buy In from multiple departments and collaboration”
3%, 1/29
Timely communication 3%, 1/29
Respondents were asked how information is shared with individuals or groups,
either in one-way or two-way communication exchanges, by ranking different choices from
the most to least used. Many respondents identified that the most common methods were
through unidirectional communication either from one person to another (22%, 6/27) or
from one person to a group (26%, 7/27). However, group to group discussions were also
chosen (22%, 6/27), as was that of “one person to another in a two-way conversation or
interaction” (19%, 5/27). Much less frequently chosen were methods involving either one
person to a group in a two-way conversation (7%, 2/27) or a group to group
82
communication without expectation of interaction (4%, 1/27). Nonetheless, responses
varied across the spectrum from most common to never used for most of the offered
choices. For this reason, most weighted scores were intermediate in value, close to 3,
between a potential score range between one (most used) to 6 (never used), for the
selections involving communication from one person to other individuals or groups, and
somewhat lower, closer to 4, for interactions initiated by groups rather than individuals
(Table 21).
83
Table 21: Methods of communication currently used ranked
When thinking about receiving RI communications how would you order the method of
communications currently used? (1 = most common; 6 = least common) (n=27).
Shading shows the most common choice.
1 2 3 4 5 6
Mean,
SD
One person to another
unidirectionally without
expectation of interaction
22%,
6/27
11%,
3/27
11%,
3/27
22%,
6/27
7%,
2/27
26%,
7/27
2.9,
1.58
One person to another in a
two-way conversation or
interaction
19%,
5/27
33%,
9/27
11%,
3/27
22%,
6/27
11%,
3/27
4%,
1/27
2.9,
1.46
One person to a group in a
two-way conversation
7%,
2/27
33%,
9/27
30%,
8/27
19%,
5/27
7%,
2/27
4%,
1/27
3.0,
1.22
One person to group
unidirectionally without
expectation of interaction
26%,
7/27
4%,
2/27
19%,
5/27
22%,
6/27
30%,
8/27
0%,
0/27
3.2,
1.57
Group to group without
expectation of interaction
4%,
1/27
11%,
3/27
11%,
4/27
11%,
4/27
41%,
11/27
22%,
6/27
4.3,
1.42
Group to group discussion
22%,
6/27
7%,
2/27
19%,
5/27
34%,
1/27
4%,
1/27
44%,
12/27
3.9,
2.11
The same respondents were asked about their preferences related to communication
flow. The most common first-choice selection was a bimodally distributed between one
person to another unidirectionally with no interaction (24%, 7/29) and group to group
discussion (24%, 7/29). The first-choice preference for these options was only slightly
higher than that for options to gain information in a two-way conversation either from a
single individual (21%, 6/29) or to a group in a two-way conversation (21%, 6/29). These
preferences are reflected in the weighted preference scores that had values of 2.4 to 2.7 for
84
those choices in which information was discussed in a two-way manner compared to the
weighted values 4.0 to 4.7 for those choices in which the information was shared
unidirectionally. The respondents also chose one person to another unidirectionally with no
interaction (38%, 11/29) as the least preferred method of communication (Table 22).
Table 22: Preferred Regulatory Intelligence communication flow
When thinking about RI communications, how would you prefer to manage
communications to ensure efficient RI communication flow? (1 = most common; 6 = least
common) (n=29)
Shaded numbers represent the most common choice per frequency.
1 2 3 4 5 6
Mean,
SD
One person to another
unidirectionally with no
interaction
24%,
7/29
7%,
2/29
0%,
0/29
21%,
6/29
10%,
3/29
38%,
11/29
4.0,
2.05
One person to another in a
two-way conversation or
interaction
21%,
6/29
24%,
7/29
35%,
10/29
7%,
2/29
10%,
3/29
3%,
1/29
2.7,
1.36
One person to a group in a
two-way conversation
21%,
6/29
38%,
11/29
31%,
9/29
7%,
2/29
0%,
0/29
3%,
1/29
2.4,
1.12
One person to group
unidirectionally without
interaction
7%,
2/29
3%,
1/29
7%,
2/29
31%,
9/29
45%,
13/29
7%,
2/29
4.2,
1.24
Group to group without
interaction
3%,
1/29
3%,
1/29
3%,
1/29
28%,
8/29
31%,
9/29
31%,
9/29
4.7,
1.25
Group to group discussion
24%,
7/29
24%,
7/29
24%,
8/29
7%,
2/29
3%,
1/29
17%,
5/29
2.9,
1.72
85
When asked further about preferences regarding the formality of the
communication, respondents differed according to the nature of the information that was
communicated. The majority of survey respondents would prefer a formal or structured
communication when receiving post market, compliance information (76%, 25/33);
regulations, guidance, market access requirements (74%, 26/34); information from third
party vendor database/advice from consultants (64%, 21/33); product approvals (56%,
18/32); or regulators/government agency briefings from a colleague (55%, 17/31).
Somewhat less commonly preferred in such a format were scholarly reports, trade
association briefings (45%, 14/31) and information gathered from websites/blogs (40%,
12/30). For such materials, a more informal method of communication appeared to be
preferred by the majority of the respondents. However, for all choices, respondents were
substantially split on their preferences (Table 23).
86
Table 23: Regulatory Intelligence communication flow
To describe communication flow within your company from the Regulatory Intelligence
sources listed below the most useful information may be received in either formal or
informal manner. Please identify how most information is conveyed.
Shaded numbers represent the most common choice.
Formal or
structured
Informal or
unstructured
Product Approvals
56%, 18/32 44%, 14/32
Post Market,
Compliance
Information
76%, 25/33 24%, 8/33
Regulations, Guidance,
Market Access
requirements
74%, 26/34 27%, 9/34
Information from Third
Party Vendor
database/Advice from
Consultants
64%, 21/33 37%, 12/33
Scholarly Reports,
Trade Association
Briefings
45%, 14/31 55%, 17/31
Websites, Blogs,
Forums, Social
Networks, Google
40%, 12/30 60%, 18/30
Regulators/government
agency briefings from
a colleague
55%, 17/31 45%, 14/31
Other
0%, 0 3%, 1/31
87
Respondents were asked to select major issues that impeded timely communication
of Regulatory Intelligence. More than one-third identified that the RI information needed
clarification (32%, 20/63). Some identified a failure to assure timely reports of RI (19%,
12/63) and others that RI is too incomplete to be actionable (18%, 11/63) or must be
translated (16%, 10/63). Also identified less frequently were difficulties when RI is not
submitted at all (11%, 7/63). A few additional challenges were identified as “other” (5%,
3/63). (Figure 24).
Figure 24: Issues when communicating timely Regulatory Intelligence
What is the major issue that causes trouble communicating timely RI? (n=63)
Other Frequency
Lack of regulatory maturity within company
1
Introduction of new terminology, inaccurate translation and lack of
experience with the new RI to determine a go-forward plan
1
Interpretation changes; no process within our company, information
included only informally
1
3
11
20
10
7
12
0 5 10 15 20 25
Other
RI is incomplete, not actionable
RI needs clarification
RI needs translation
RI is not submitted
RI is not reported quickly
88
Most respondents (72%; 23/32) did not find that the language used when
communicating Regulatory Intelligence was troublesome to understand. However, a
significant minority (28%; 9/32) did regard the language used when communicating
Regulatory Intelligence as troublesome (Table 24).
Table 24: Understanding the language used in Regulatory Intelligence
Do you find that language of conveyed or received information troublesome to understand?
(n=32)
Yes No
Language of conveyed or received information troublesome to
understand?
28%, 9/32 72%, 23/32
Those who identified that language was difficult to understand were asked to
explain how they would clarify that unclear information by selecting multiple choices from
a list of alternatives. More than one-third of the answers suggested that the respondent
would seek clarification from a subject matter expert (37%, 7/19) or from the person
initiating the communication (32%, 6/19). Fewer would seek clarification from a
consultant/third party (21%, 4/19) or from other staff at an international regional office
(11%, 2/19). No respondents would seek clarification from staff at headquarter office or
would fail to seek clarification at all (Table 25).
89
Table 25: Clarification for misunderstood language
If you found the information troublesome to understand, how do you seek clarification?
(n=19)
Overall
From a subject matter expert 37%, 7/19
From the person initiating the communication 32%, 6/19
From a Consultant/Third Party 21%, 4/19
From staff at International Regional Office 11%, 2/19
From staff at Headquarter Office 0%, 0/19
I don’t seek clarification 0%, 0/19
Other (Please specify) 0%, 0/19
90
Chapter 5. Discussion
5.1 Overview
Regulatory Intelligence (RI) is becoming a key industry function as the world
shrinks. The communication of RI can help medical device companies enter target markets
more rapidly and effectively, an accomplishment clearly important to gain greater market
share. The results of this research provide insights into how medical device companies
currently manage the process of communicating regulatory intelligence. These insights are
a window into current or even best practices and can help to provide “lessons learned” for
other medical device companies.
5.2 Methodological Considerations
The choice of research method affects the depth and breadth of the results and the
validity with which those results can be viewed (Hammarberg, Kirkman et al. 2016). In
this research, an online survey was used because it facilitated dissemination to different
geographies in a manner that makes it relatively easy for respondents to share their
valuable experiences and thoughts. A different approach that could have been used would
have been to conduct interviews with individual respondents. However, such an approach
seemed to have several disadvantages compared to survey methods. For the researcher,
interviews are time-consuming and typically yield qualitative data that requires
transcription and extensive content analysis (Wyatt 2000) to avoid bias and anecdotalism
(Holbrook, Green et al. 2003, Duffy, Smith et al. 2005, Silverman 2011). For the
respondent, interviews often take more time than a survey. Further, recent research
suggests that respondents dislike telephone interviews because they have been sensitized by
91
the numerous telemarketing calls to which they have been recently subjected (Draugalis,
Coons et al. 2008).
In comparison, web-based surveys are faster (Taylor 2000, Yun and Trumbo 2000),
cheaper (Fisher, Margolis et al. 1996, Miller, Daly et al. 1996, Couper 2000) and more
convenient, especially for those who are comfortable with web-based interfaces (Fox 2001,
Nie, Sunshine Hillygus et al. 2002). A well-constructed survey can reduce the concern that
the interviewer will unintentionally impose his/her viewpoint (Buchanan and Bryman
2007). Further, data analysis may be more robust statistically. Error rates can be reduced if
the respondents use conventional survey formats and if their answers can be coded and
stored without data re-entry by a researcher. Further, encryption can be used to protect the
confidentiality of particularly sensitive responses (Hayslett and Wildemuth 2004).
Compared to paper-based surveys often used in the past, web-based surveys are returned
more quickly and can be easily prompted by electronic reminders, which have been shown
to be more effective than paper-based requests (Hayslett and Wildemuth 2004).
In order to gain an acceptable survey response rate, there must be an effective
pathway to reach a representative audience. It was clear that finding regulatory
professionals with acceptable RI experience was a significant challenge that required not
only my professional network, but also referrals from others and the use of professional
groups such as RAPS (Regulatory Affairs Professionals Society) to ensure that appropriate
survey respondents were selected and were willing to complete a survey focusing on
communicating RI within an organization. I therefore attempted to assure that the survey
respondents came from companies of different sizes, worked for companies that marketed
more than one type of medical product, and had more than seven months of experience
92
with Regulatory Intelligence activities, often gained by employment at more than one
company. This heterogeneity is important to assure some degree of generalization to the
overall study population.
Ultimately, this web-based survey yielded a 45% (50/111) response rate of
respondents that met the initial criteria. In the research by Watt et al. (2002), the overall
response rate for a series of selected online surveys was estimated to average 32.6%.
Inspection of the responses suggested that the survey was reaching saturation, and that the
response rate was sufficient to provide at least a beginning picture of current trends and
views.
5.2.1 Delimitations
Ensuring external validity, the ability with which the results of a study can be
generalized across other situations, people, situations and times, is often a challenge
associated with electronic surveys (Bhattacherjee 2012). The current study is delimited in
time; it assesses industry views as they exist in 2019. However, the regulatory environment
and its relevant literature are changing constantly. The views of communicating RI within a
medical device company therefore may change as the regulatory environment undergoes
further evolution. Further, the study has a circumscribed scope, delimited to a relatively
small subset of regulatory affairs professionals who have had experience working with RI.
These individuals are in a job function that will allow them to understand and provide
meaningful responses to questions about the structure of communications specifically
related to RI between international regional offices and headquarters within an
organization. Within these boundaries, smaller numbers of surveys were also sent to
individuals currently or previously working in other medical product industries such as
93
biotechnologies, pharmaceuticals or third-party consultants. This expanded approach
resulted in more viewpoints but had the potential to blur the results if differences existed
across different subsectors of the medical products industry. To explore whether such
differences existed, I carried out different cross-tabulations based on industry type. The
sixteen non-medical device/IVD respondents who participated in the survey probably
constituted an insufficient sample size to make any definitive statements, but their views
did not vary greatly from those in the sampled medical device companies. The initial
thought was that the non-medical device results would bring additional insight to the
survey while conveying a broader representation of views and minimize bias (Rea and
Parker 2014). The survey results from the non-medical device/IVD participants collected
here could be used as a guide for future research that might expand the findings of this
study to other constituencies.
Although it is well-known that securing the participation of individuals in busy and
relatively rare job functions can be difficult (Council 2013), it was encouraging that a good
cross-section of middle managers, senior managers and directors dominated the mix,
because the individuals in these positions are more likely to be experienced with
communication strategies between headquarters and international regional offices.
However, the study does not explore views from other job functions within the company
that would also utilize RI. To broaden the study scope, this research might be expanded to
include other stakeholders who would provide valuable insights, particularly with regard to
effectiveness and satisfaction, that may have been excluded here.
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5.2.2 Limitations
Survey methods by their nature have methodological limitations. The structure and
length of the survey can challenge the internal validity of the study (Marshall and Rossman
2014). Question syntax, word length and frequency, and sentence length all can affect the
readability of survey questions and could have an impact on the survey results (Sahlqvist,
Song et al. 2011, Lenzner 2014). The survey respondents might also answer questions from
different points of view if questions were to be worded inappropriately. To lessen this
threat, a focus group was utilized to critique the appropriateness of the survey questions
(Nassar-McMillan, Wyer et al. 2010, Elser 2016). The survey was improved when the
focus group found questions that were confusing and suggested alternative approaches to
ensure that the questions were more understandable and relevant.
Survey development in this study was also challenged by the modest literature
written about how RI is communicated within medical device companies. Further, the scant
literature that did exist often came from non-peer reviewed sources, such as magazines,
blogs, the web and reports. It can be risky to rely on this type of literature as the theoretical
foundation on which to base a survey. The strongest voices are presumably those who have
taken the time and effort to express their ideas in trade journal and internet blogs
(McAuley, Pham et al. 2000, Moher, Cook et al. 2000). Nevertheless, for a study like this,
the “grey” literature is now believed to be an important sociological source and should be
included when meeting certain criteria (Balshem, Stevens et al. 2013). The small amount
of available literature illustrates the need for additional more systematic research to add to
the current body of knowledge on communication of RI.
The types of questions typically associated with survey methods can pose
limitations. Simple survey questions answered by “yes/no” or Likert scale choices can
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introduce ambiguity, and a neutral choice such as “neither agree nor disagree” can be
selected as a way of hiding the fact that the respondent does not know the answer (Garland
1991, Hartley 2014). Investigator bias can also be introduced unwittingly into the questions
(Lavrakas 2008). Thus, open-ended questions were used to give respondents some
opportunity to share their experiences and opinions in more detail. Nevertheless, surveys
do tend to fall short when seeking a very deep understanding of views and experiences, so
future studies might use the responses described here as a base for other types of
investigations, where deeper insight is warranted. This may be particularly important when
a group of respondents fail to answer a question, because that failure can signal ambiguity
that the respondents did not know the answer, were concerned about sharing an answer, or
were confused by the question.
One of the potential survey weaknesses can be related to the level of participation
or persistence of respondents. Busy professionals may be unwilling to give their time if the
topic does not seem interesting, or may hurry through the survey, thus giving incomplete or
superficial responses (Creswell and Creswell 2017) if they lack the time and inclination to
take the survey (Bhattacherjee 2012). The group that does respond may include only those
who are particularly interested in the topic, so may introduce some bias (Braithwaite,
Emery et al. 2003, Draugalis, Coons et al. 2008). In this study, respondents were drawn
from a specialized group of individuals with a set of experiences not common to regulatory
professionals more generally, so a purposeful sample appeared to be the most appropriate
sampling design (Hulley 2007). This sample was then expanded by using a “snowballing”
approach to access others in this hard-to-reach population (Atkinson and Flint 2001).
However, snowball methods, in which individuals recommend others with like interests or
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backgrounds, have been criticized because the new additions may share similar views,
diminishing the likelihood that the sample will be drawn randomly from the target
population (Atkinson and Flint 2001, Sadler, Lee et al. 2010).
Finally, an area of great concern is obtaining an acceptable response rate when
dealing with an electronic survey (Sheehan 2001). Validity of the study can be challenged
if the respondent group is too small. Short surveys are known to result in higher response
rates; a lengthy survey can cause even motivated respondents to leave the survey
prematurely (Bhattacherjee 2012, Kost and deRosa 2018). The survey for this study
consisted of 42 questions and took respondents on average less than 20 minutes to
complete. To encourage a higher response rate, the survey was held open for more than
eleven weeks and participants who did not complete were sent reminder emails.
Nevertheless, security constraints imposed by companies on their electronic
communications blocked many surveys from the e-mail inbox of potential recipients. Some
respondents identified that they later found the email with the attached survey tool in a
“spam” folder, but others may have missed the email because they did not check for it
there. Thus, it is not possible to know whether many potential respondents were
unresponsive because the survey did not arrive as intended.
5.3 Considerations of the Results
5.3.1 Characteristics of Communication: Sources and Receivers
Regulatory Intelligence is a form of communication that can be characterized as an
exchange between two or more parties. A beginning aspect important to understanding this
exchange is knowing the nature of both the sources and the receivers. The term,
“regulatory intelligence”, would seem to suggest that the source and receiver would be
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regulatory professionals who might act on the information and implies that the regulatory
department might be the logical home for this function. It should not come as a surprise,
then, that this is typical for most companies. Nonetheless, nearly one-third of companies
sampled here appear to situate this function in other departments, most often in the quality
assurance department. This finding is provocative because it suggests that the interest in RI
stems not only from understanding how to submit and maintain registration dossiers, but,
perhaps more importantly to many companies, how to ensure ongoing quality compliance
in overseas jurisdictions.
Issues of quality management have always been an important concern for medical
device companies. This focus is apparent, for example, from recent FDA initiatives such as
its “case for quality” program. As FDA states on its website, “Top-quality medical devices
help the FDA better protect and promote public health. And one of the top priorities for
FDA's medical devices center is a focus on quality (FDA 2020)”. Thus, for some
companies where the submission volume or regulatory agency interactions are low or
absent, the primary relationships with regulatory agencies may be driven by regulatory
inspections and other aspects of quality oversight. The close relationship between quality
and regulatory functions is often reflected by their consolidation into a singular
“Regulatory Affairs and Quality” function, especially in smaller companies (Armitage
2019). Placing RI outside of a regulatory department may also make sense for companies
that are manufacturing products offshore and then relabeling them for the US and other
markets. This increasingly common practice is an effective way of minimizing operational,
management, and infrastructure costs (MarketWatch.com 2019) but makes the oversight of
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compliance more difficult, so regional, as well as, US approaches to manufacturing
inspections are more important to understand (Hammond 2019).
The affiliation of the sources and receivers is important because it seems to affect
the level of formality in the way that RI information is handled. The majority of
respondents from larger medical device companies (79%) reported formalized, stand-alone
RI functions with either defined, quantitatively managed or optimized processes. This
percentage is higher than might have been expected from an informal survey conducted
recently through the professional association, TOPRA, where 39% (16/41)respondents (38
from companies with over 1000 employees) reported RI to be a stand-alone function
(Hynes and Todd 2011). For smaller companies, RI activities appeared to have less
formalized processes. It seems reasonable that larger companies engaged in commerce
through a larger number of global offices might need a more formal organization to deal
with the broader set of RI sources from which information is being derived. As the
organizational structure of a company grows and becomes more distributed, the
communication style becomes more complex. Large companies develop a strong emphasis
on hierarchy and rely on more formal communications which generally follow a well-
defined organizational pattern (Mintzenberg 1979). In contrast, micro- and small
companies have a much simpler organizational structure. With only a few employees, tasks
tend to be distributed in an informal manner and few experts with narrow specializations
are affordable (Edwards 2014).
As might also be expected, larger companies typically have a more global focus and
a larger number of international regional offices, as has been noted elsewhere (MedPAC
2017). Nevertheless, exceptions do exist. One respondent, for example, identified that its
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micro-sized company had four to ten international regional offices. This could be a
company that has one medical device that is marketed globally or alternatively, could be a
subsidiary business belonging to a multi-national corporation whose subsidiaries operate
relatively independently as described in Chapter 2.
5.3.2 Characteristics of Communication: Exchanges
5.3.2.1 Types of Messaging
Not only is communication strategy dictated by the individuals who play the roles
of source and receiver, but also by the nature of the messages that they exchange. The
results from this survey illustrate the complexity of the types of RI messaging to and from
international regional offices. The most frequent regulatory information communicated
from the most active offices - as often as daily or weekly - were regulations and guidance
from regulatory agencies. Such regular updates would be important for the direct
operations of the regulatory teams because global regulations are constantly evolving. A
continual scan of the regulatory requirements and advice is vital to monitor that landscape.
Emergo’s Global Medical Device Industry Outlook for 2019 has provided additional
evidence regarding the importance of regulatory information to medical device companies.
They noted that most firms identified “the changing regulatory environment” as a large
challenge and the proportion of companies with this response was somewhat greater in
2019 than just a year before (72% 2019 versus 68% 2018) (Eisenhart 2019). Respondents
here also reported that websites, blogs and forums were monitored daily or weekly. Such
sources are a rich trove of information related to experience of other regulatory experts in
the field and can provide a first look and interpretation of regulations and guidance
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documents. Their use has been suggested to play a larger role in the future (Hynes and
Todd 2011), but already seems to be incorporated into the activities of most companies.
At the other end of the spectrum, scholarly reports or trade association briefings
were most frequently exchanged on an ad hoc basis. This type of information is not usually
available in a predictable pattern. Trade association briefings often become available
shortly after a trade association meeting is held (ABPM 2016). Scholarly reports also come
out at irregular times. Nonetheless it can be vital to circulate information from these
sources because they often provide unique guidance on specific questions that arise during
product development not yet available from the regulators. For example, trade association
briefings and scholarly reports can contain information about past experiences with certain
subtypes of devices that can influence marketing strategy. Further, they often identify
problems or trends well in advance of peer-reviewed papers, which can take months or
years to develop and publish (Bjork and Solomon 2013).
Newsletters are also a common source for intelligence as well as a common
mechanism for communicating that information within the company itself. In 2009, the
Regulatory Intelligence Networking group (RING) looked at the different practices that
companies took with respect to RI newsletters. About 70% of the companies read a
newsletter distributed at least monthly; half of these newsletters were considered global
because they covered multiple regions. The main recipients of RI newsletters were
regulatory affairs, clinical development, pharmacovigilance and government affairs. The
newsletters contained both public and non-public information such as trade association,
conference or workshop briefings (Hynes and Todd 2011).
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Newsletters are a one-way method of communication that do not allow for any
feedback or method of clarification. In 2010, a second RING survey explored other ways
that companies were trying to increase the operational efficiency of their intelligence
gathering activities. They found an increasing use of social media, using tools with a
variety of forms, including blogs, microblogs, wikis, social and professional networking
platforms as well as news aggregators and tagging such as RSS (Real Simple Syndication)
(Hynes and Todd 2011). However, the extent to which these methods are useful and
credible may depend on strategies to convince colleagues of their value. These strategies
could stress examples of positive impact where RI was captured and shown to be beneficial
by using such a tool.
The RING studies do stimulate thinking about future tools for gathering and
communicating RI. Although the use of social media may be an attractive tool to some,
others may find that they do not have the time to survey many networking platforms to
glean RI information (Hall, Huddle et al. 2019). Thus, the use of third-party analysts and
regulatory intelligence databases are seen by some in this study as options that might
increase efficiency. However, such services can be costly (Hall, Huddle et al. 2019).
Another study that has researched trends in the biopharmaceutical industry noted the use of
“Smart” tools that included artificial intelligence and language processing functionality to
find and filter what is important on regulatory authority websites and publications. Such
tools may shape the future of RI gathering (Gens and Brolund 2019). However, such
sophisticated tools seem a long way from current RI practices, in which only a minority of
companies even have a structured RI process. It seems useful if future tools to gather and
disseminate RI could support a communication feedback loop as suggested by Schramm’s
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communication model. However, any alternative communication tools must take into
consideration the challenges of implementing a new process into a job function that is
already seems unstructured and presumably resource starved in many companies. My
research showed that 37% of medical device companies, mostly smaller, had an
unstructured RI process. These types of organizations would presumably struggle to
institute a new RI process, particularly one that relied on costly tools.
5.3.2.2 Relative Roles of Regional and Headquarter Offices
The relationship between regional and headquarters offices are difficult to
characterize because of the complexity of the information that they share. It seemed clear
at the outset of the study that a unidirectional model such as that proposed by Shannon and
Weaver (1948) would be insufficient to account for the nature of the communications that
typify RI. Results here confirm that the exchanges are most commonly bidirectional and fit
more appropriately into the bidirectional model of Schramm (1954). However, that does
not mean that the exchanges are symmetrical. Further, responsibilities assigned to
headquarters and international regional offices were found to differ across the surveyed
companies. Respondents from smaller companies typically identified that most activities
occurred at headquarters with assistance from the international regional offices, a structure
consistent with a hub-and spoke model (Nayar 2016). However, most larger companies
appeared to have a different structure in which roles were more decentralized and
contributions were balanced more equally (Vantrappen and Wirtz 2017). As pointed out by
Vantrappen and Wirtz, the decision to “veer toward” decentralization is important when
immediate information is important to assure responsiveness. However, decentralized
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systems can be duplicative and disorganized and thus may require more formalized
structures to ensure efficiency and stability.
Some roles carried out by headquarters and regional offices did vary from one
another in certain ways that did not seem to depend on company size. Typically,
headquarters took responsibility for managing an RI database, analyzing data and
communicating to executives who were usually co-located at the headquarter office. Such
an arrangement appears to ensure a centralized management system in which pertinent
information from different sources is gathered close to the individuals who need it for
strategic decision-making (Kahaner 1996). Headquarters and regional offices shared more
equally the responsibilities to gather the intelligence. In mature, distributed systems, the
international regional offices play a vital role in serving as the “eyes and ears” of the
organization; they observe and report any relevant changes and activities that could impact
the regulatory interests of the company globally (Kahaner 1996). The activities performed
at the headquarters and international regional offices align with the tasks to be carried out
at the respective locations. Having the individuals most familiar with the concern or topic
under scrutiny helps to assure that the information that is gathered is used in a way that
maximizes its impact (Kahaner 1996).
5.3.2.3 Nature of Interactions
Results suggested that many types of RI, such as product approvals, post market
compliance issues, regulations or guidance information for market access, are
communicated most commonly in a formal or structured format. These types of
information can use structured communication channels because they do not require
feedback. However, other types of RI such as trade association briefings and information
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taken from blogs or websites were often reported to be shared more informally. The fact
that multiple types of information are exchanged may help to explain the complicated
modes of communication, split quite evenly in this study between one extreme, in which
one person is communicating to another unidirectionally, to the other, where groups at
different sites discuss a particular piece of RI. In some cases, it might be most effective to
communicate a change to just one person who will then follow up by doing more research
or sharing that information more broadly. In other cases, an important new change that will
challenge both the regional operation and headquarters might require that groups work
together to develop a shared strategy.
An interesting finding was that respondents preferred methods of exchange
different from those used most frequently. Two-way conversations or discussions were
mostly preferred to exchanges without such interaction. These results would seem to
validate the usefulness of a Schramm type of communication model in which an
opportunity for feedback allows the receiver to ask clarifying questions and gain a better
understanding of the communication. However, communication preferences were not
homogeneous across respondents, considering that a quarter of individuals preferred a
unidirectional mode of interaction. The differences might stem from at least two sources.
First, the nature of the respondent’s job function may affect the preference. For example, a
respondent whose responsibility is to create a database of needed information might prefer
a one-to-one method, but another respondent with responsibilities for strategic planning
might prefer a broader set of more nuanced inputs, where discussion and clarifications may
be more important. Second, the preferences of respondents may be affected by their
different personality types (Marston 1928). For example, some respondents with analytic-
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type personalities might prefer approaches that lend themselves to efficiency and
achievement of goals, so that one-to-one communication might be preferred. In contrast, an
intuitive/thinking personality might prefer exchanges of opinions, ideas, concepts, and
methodological approaches (Meyers Briggs 2020) and those with “amiable” personalities
might find more affiliative, team-to-team interactions to be more appealing (Marston
1928).
Variations in communication preferences are not only the province of regulatory
professionals. It is well-known more generally that different personality types prefer
different types of interaction. In 2013 Oseland conducted an on-line survey of North
American and European personnel supplying architectural, workplace consulting and
design services. He attempted to determine how people prefer to communicate, where they
prefer to meet, how they use social media, how they view differences in meeting space
design and how they spend time in and out of the office. He further related these
preferences to the personality profiles of the respondents. This allowed him to examine
relationships between personality and workspace factors. Most commonly, the respondents
preferred face-to-face meetings rather than social media to share information and make
decisions although some respondents preferred social media for socializing outside of work
(Oseland 2013). When commenting on the use of social media Oseland also states:
Introverts may suffer from increasing anxiety in face-to-face situations and
studies have shown that they prefer to communicate through email and
social network sites to overcome this apprehension. However, it was also
found that extroverts use social networking sites more than introverts do.
This is possibly because extroverts generally seek more interaction
regardless of whether it is on-line or face-to-face (Oseland 2013: 3).
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5.3.3 Signal Quality and Fidelity
In most communication models, much attention is paid to “noise”, defined as
unwanted signals that interfere with the communication, measurement or processing of an
information-bearing signal (Vaseghi 2000). Results here suggest that different sources of
noise can affect communications with international regional offices. Perhaps the most
important of these sources, at least through the eyes of the respondents in this study, appear
to be related to the location of the international regional office, the language differences
and the capabilities of the individuals responsible for the RI function.
5.3.3.1 Location of international offices
Results here suggest that the location of the international regional office affects the
nature of communications and the difficulties faced with those communications. Most
companies with international regional offices had those offices in both well-established
markets with mature regulatory systems, such as Europe, and in emerging markets with
evolving regulatory systems, such as China. These distributions are not surprising, given
that the largest markets outside of North America are in Europe and China (Hawksworth
2017). The finding that many larger companies had more than ten offices outside of the US
suggests that companies appreciate the importance of having operations in many distant
sites. However, these regional offices are in countries with very different marketing
environments. European markets are relatively stable whereas the emerging markets are
growing dramatically. For example, in 2016, the medical device market in China increased
by 20.1 % from 2015 (MarketingToChina.com 2019) about 73% of this growth was driven
by hospital procurements that depend on technology-intensive or imported medical devices
(MarketingToChina.com 2019). Demand is fueled also by the aging of the Chinese
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population and the increased wealth that allows for a better quality of medical treatments
(MarketingToChina.com 2019). Chinese as well as other emerging markets identified as E7
economies, (China, India, Indonesia, Brazil, Russia, Mexico and Turkey) are predicted to
double in size over the next 25 years, greatly outpacing the modest market growth
predicted for G7 countries (US, UK, France, Germany, Japan, Canada and Italy)
(Hawksworth 2017).
The variations in different countries appear to complicate the work done by RI
professionals. Regional offices in E7 countries are unstable politically and economically
(FFP 2019). Even countries that are characterized typically as “stable” see political and
economic disruptions that are often unexpected. As this dissertation is written, for
example, political challenges related to COVID-19 management illustrate how reliant
companies, and by extension their RI functions, have become on political and economic
stability. In the medical device arena, particular problems associated with international
travel restrictions, shortages of medical products and closures of clinical sites in which
trials are conducted during the COVID-19 emergency have amply shown how important RI
can be to assure the company understands and responds effectively in the face of
governmental and regulatory policy changes (Taylor 2020).
The shift in product distribution to emerging markets puts pressure on the
management of RI communications, because these offices appear to be more difficult to
manage. As predicted by the literature (Yip and McKern 2014, MarketingToChina.com
2019, Zhang and Chen 2019), the rapidly changing regulatory systems and staffing
requirements in China seemed to make its regional offices the most challenging to manage.
Some of these challenges appear to stem from the rapidly changing polices/regulations
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typical of a country that has a very short history of regulatory formality. Over the last few
years, an unusually large number of new documents were issued by the Chinese authorities
(Emergo Group 2019), most of which were not translated into English in a timely manner.
Even when translated, these documents appeared to be difficult to understand. For example,
one survey respondent stated:
We are attempting to enter the China market. Perhaps because of language
difficulties, or perhaps due to government influence, we have found it very
difficult to nail down device/drug regulatory requirements. They ask is for
"everything", including proprietary information such as algorithm
specifications, which I will not provide. It is difficult to establish what is
actually required for device/drug licensing, and what a consulting
organization (Or, government agency) would "like to have".
In addition, entry into emerging markets can pose a new and precarious challenge
for some companies. Medical device companies that do not have global resources to
distribute products directly often use a local distributor in that country (Parker 1997).
Numerous international distributors are interested in Western manufactured medical
devices; however, not all distributors are necessarily qualified to understand and
communicate RI effectively. Further, their position as a sales office as well can introduce
conflicts of interest (PacificBridgeMedical.com 2020). This challenge was expressed by
one distributor as follows:
We only have distributor affiliates (in China) rather than internal. And
gathering data from distributor can be difficult if they are not aligned with
the process.
In comparison, the best countries from which to obtain RI were typically identified
to be those with well-established regulatory systems, where documents in English
increased the transparency of requirements and staggered implementation dates for new
regulations generally provided a sufficient cushion to make any required changes. The
preferences are consistent with basic communication theory that would designate the
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language of documents from regulatory agencies as the “coding” of the message. Such
coding is well understood to affect the effectiveness of the communication (Reuben and
Steward 2006). Further, in the Schramm model of communication an “interpreter” step is
added to the Shannon-Weaver communication model (discussed in Chapter 2), to represent
the decoding of messages before they can be understood. Schram states that when the
information source understands the nature of coding and noise, the initial message can be
improved. Such improvements can decrease the need for feedback (Schramm 1954).
5.3.3.2 Considerations of verbal/nonverbal communication
The challenges posed by language appeared to be an important reason why
emerging economies were seen to be more difficult from the perspective of RI
management. Perhaps because much of the regulatory documentation is new and
untranslated, some information may not be easy or possible to access, contributing to a lack
of transparency. However, language concerns extend beyond the written documents.
Companies must also gauge how cultural and language barriers may affect their
interactions with regulatory authorities. China is a case in point. There, for example,
unique requirements exist for product testing at an NMPA-authorized laboratory in China
(Liu 2019). Language difficulties can pose significant challenges in communicating with
these laboratories, because staff in the laboratories are rarely fluent in English.
Additionally, the standards used by those laboratories are written in Chinese. As a result, it
can be difficult for US manufacturers to prepare for and pass the testing requirements
smoothly and predictably (Liu 2019) unless it has a robust and effective Mandarin-
speaking RI function in China.
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Another factor that has often been stressed in analyses of cross-cultural
communication has been the importance of body language and gestures, especially in “high
context” cultures like those common in Asia. Albert Mehrabian, a pioneer researcher in the
study of body language in the 1960s, investigated with Susan Ferris how feelings of a
speaker are perceived through verbal and nonverbal expression (Mehrabian and Ferris
1967). In this study, participants were presented with the word ‘maybe’ spoken with a
positive, neutral and negative tone. The subjects were provided photographs of models
depicting expressions of like, neutrality and dislike. While looking at the photographs and
listening to the recording, the subjects were asked to imagine the person looking at and
talking to another person. They were then asked to rate on a Likert scale the attitude of the
person speaking. As a result of this experiment, Mehrabian and Ferris found that the
expression in the photograph had a stronger effect on their perception of the underlying
mood than the vocal tone (Mehrabian and Ferris 1967). Further, he observed that
individuals relied most commonly on the nonverbal cues when presented with
inconsistencies between the meaning conveyed by the spoken word and that expressed by
nonverbal cues (n.a. 2020). He concluded that only about seven percent of the impact of a
message came from of the words that were spoken. In comparison, about 38 percent came
from vocal cues, such as tone of voice, inflection, and other sounds, and 55 percent came
from non-verbal cues (Mehrabian 1971).
The work of Mehrabian and others (Argyle 1970, McMahan 1976) suggest the
importance of non-verbal cues to assure clear communication. Surprisingly, however, the
respondents in this study did not seem to feel that non-verbal cues such as hand gestures or
facial expression affected communication as much as most other factors when
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communicating RI information. In today’s world, international teams interact in ways that
could never even have been imagined 50 years ago. In Mehrabian’s studies, subjects were
expected to make judgements based upon a voice and a photograph. Today, technology
has allowed us to communicate in a way completely different from that studied by
Mehrabian. In the modern workplace, virtual teams commonly use teleconferences and
emails that restrict the degree to which team members can see each other (Chillcoat and
DeWine 1985). Virtual teams inherently demonstrate less body language so members must
learn without visual cues and must rely on written, social/cultural and spoken cues. It will
be interesting to know whether the recent introduction of videoconferences as a preferred
communication method, particularly encouraged to facilitate “work-from-home” during the
coivd-19 pandemic, will increase reliance on facial expressions and nonverbal cues.
5.3.3.3 Capability and Experience of RI professionals
The importance of effective communication was highlighted by the frequency with
which respondents commented on the need for experience and information-sharing in order
to manage RI effectively. “Experience” is a complex attribute that can have many
dimensions, including not only the time that one has spent either gathering or reporting RI
but also the growing abilities to assess the usefulness of diverse information sources and to
build a network of RI subject matter experts. The importance of building network was well
captured by one survey respondent:
I do independent RI in multiple regions of the world to stay on top of the
changing regulatory landscape. My independent research and the RI I get from
the company often complement each other. I have been building my RI contacts
over the last 10 to 15 years and am confident in the source material.
Survey respondents identified several ways in which they shared RI information.
One respondent identified that having strong RI resources to ensure continuous contact
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with people in government and industry was key to staying current with changes. Another
survey respondent noted that “…ensuring each person has access to timely information and
has the ability to share among the organization is a successful way to set up an organization
for successful RI gathering.”
Acquiring information is not simply a matter of talking to people. Effective
information gathering can be assisted by developing fluency with purchased subscription or
vendor databases that compile a variety of information types regarding regulatory policies
and changes across multiple regions. Such databases were recognized as an important asset
by the respondents because they serve as a “one-stop-shop” for RI data. However,
experience is needed to use the tools and to know which is best suited for a specific
purpose. Regulatory agency websites are especially important, but they often can be
difficult to use. Thus, the experience of RI specialists is vital to navigating these systems
and may handicap smaller companies with relatively inexperienced teams. Recognizing
this challenge, some regulators have attempted to develop initiatives to increase their
transparency and clarity. For example, in June 2009, the FDA launched a Transparency
Initiative which resulted in an April 22, 2014 report recommending ways to enhance the
transparency and public accessibility of the agency's compliance and enforcement data.
Also on December 2011, FDA issued a report focused on improving the transparency and
efficiency of the Agency's guidance development processes (FDA 2017).
5.3.4 Other sources of challenge
Three additional areas seen as troublesome were more logistical and were
associated with the internal operations of some companies. These included the
organizational and reporting structures of RI, resource restrictions, and segregation of RI
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activities from other parts of the company or offices. For companies interested in
improving their RI capabilities, these areas would seem to be particularly important to
consider.
5.3.4.1 Organizational and reporting structures
One key to effective communication is having clear reporting lines within the
organizational structure. One survey participant stated:
…if there is no direct reporting line to the headquarters the nature of the
job might prevent frequent and efficient communication. It is essential that
policy function be a centralized function which will ensure proper
communication channels ensuring agreed upon standards including
effective and frequent communication.
For small companies it may be possible to inform all employees across the company
by calling a single meeting or distributing a single document. However, large companies
with multiple medical devices at different stages of development rely on RI to support
many kinds of activities such as guiding strategy for future products as well as assuring that
current products comply with regulations in multiple jurisdictions. Therefore, the RI will
need to be communicated in various ways to ensure that all applicable stakeholders are
informed. As departments evolve and reporting lines increase, it becomes more important
to define communication strategies more explicitly (Huddle and Messmer 2019). Further,
some form of quality assessment, such as surveys or internal audits of affected parties,
might be helpful in mapping the effectiveness of communications with stakeholders. In a
large organization, it might even be useful to create a specialized job function to ensure that
RI activities and communications are accomplishing key objectives (Hall, Huddle et al.
2019). Such an approach is easier in a resource rich environment where multiple regional
114
offices are central to operations; it may not be feasible or even necessary in smaller
companies.
5.3.4.2 Resource concerns
Effective RI communication depends on adequate assigned resources. In this
survey, respondents identified certain concerns, such as problems with the timeliness of
communications with sufficient clarity and depth, that could be alleviated by adding more
staffing or better communication tools. It is likely that some of these issues are rooted in
RI teams that have insufficient or inexperienced personnel or lack access to proprietary
tools to provide “actionable” intelligence. Actionable intelligence must be provided quickly
enough and in sufficient detail to inform the strategic decisions of a company (n.a. 2020).
However, it is common for RI professionals to be given other responsibilities and work
activities (Hall, Huddle et al. 2019), and these can take priority over RI communication.
Because the amount of time-critical RI information has been predicted to increase (Hall,
Huddle et al. 2019), failure to invest in these activities may prove to be false economy.
5.3.4.3 Cooperation or Collaboration?
The third issue identified by some respondents was an “us versus them” mentality
that seemed to develop between different offices. Bouquet and colleagues (Bouquet,
Birkinshaw et al. 2016) characterized some of these problems as arising from the
“Headquarters Knows Best” syndrome in which regional offices felt that they were “at the
end of a long rope”. In those organizations, headquarters often seemed to treat the
regionally based employees differently, by restricting opportunities for promotion,
assuming that regional innovations are only relevant locally, and failing to place regional
representatives on top teams. Further, few opportunities often existed to contact or work
115
with other regional offices. Such segregation may contribute to a loss of motivation
amongst the employees; dysfunctional communication linkages may then become limited
and unproductive (Tett 2015). Bouquet and his associates suggested certain remedies that
they learned from companies participating in their study. Some examples that seem
relevant to RI operations included cross-company brainstorming sessions or innovation
fora to showcase initiatives being taken across the broader company. In addition, visits to
regional offices and plants by C-suite executives, having senior executives spend time in
the regional offices or treating the regional offices as “hubs” with specific mandates were
observed to increase buy-in and motivation. Finally, it might help if companies could be
assisted to understand that RI communication will become more difficult as the size of the
organization grows so that RI structure can be modified to increase effectiveness.
5.4 Conclusions and Future Direction
Strong regulatory intelligence is essential in today’s medical device environment to
develop and execute a strategy for staged market introductions into different countries.
Global strategic planning relies on RI to bring together and interpret publicly available
information as a basis for that planning. Thus, good RI can reduce costs for product
development and timelines for market entry. Results of this study suggest that most
companies appreciate the need for RI as a strategic compass, but that much could be done
to improve its effectiveness and efficiency. Further, it is increasingly difficult to stay
current with the rapid globalization of the medical device landscape that introduces diverse
challenges related to language, political climate and rapidly changing and sometime
unclear regulations.
116
Amongst the areas in which companies could focus to improve RI management
include the placement of RI within an organization, providing sufficient resources and
ensuring that effective channels exist for RI communication. The approaches that are used
will vary with the sizer and type of organization. However, one common feature is likely
to be the evolving technological landscape. For example, new opportunities may exist to
replace traditional systems such as newsletters with more targeted approaches, such as
social media channels that facilitate two-way interactions. Further, some of the newer,
two-way methods of communication, including videoconferencing tools such as Skype,
Zoom or Microsoft Teams (Boogaard 2018, Carter 2019) can help to ensure
communication is sent and received appropriately. This also allows to improve
communication by eliminating some elements of “noise.”
Knowing how to manage product commercialization in emerging markets whose
regulations are changing rapidly is a difficult task even for local businesses with a working
knowledge of the local regulatory landscape. If the organization is unable to staff the RI
function with experienced professionals, a third-party service might be considered for that
function, particularly when investigating global markets where they may not already have a
presence. A significant challenge in emerging markets is the need for timely translation
and interpretive services. This requirement is central to collecting actionable intelligence if
it is to be used effectively to inform business strategy. Solving these problems, however,
should not be the only the responsibility of industry. Transparency initiatives in regulatory
Agencies should be an important goal not only of the agencies themselves, but also of
global organizations such as WHO (World Health Organization), APEC (Asia-Pacific
Economic Cooperation) and IMDRF (International Medical Device Regulators Forum) as
117
part of harmonization efforts in support of world trade. Further, professional organizations
might be tasked with doing more to assist with translation of materials that are needed by
all of their members, rather than expecting each company to hire expensive translators on
their own.
The survey represents industry views on how Regulatory Intelligence is being
communicated in a time of great change. Not only are communication strategies evolving
with the access to novel communication platforms and professional services, but new
approaches are being forced upon us by a global pandemic. It would be useful to repeat
this survey in a few years to see how these changes will affect RI communication as well as
intracompany communication more widely.
118
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International Journal of Emerging Markets, 9(1), pp. 2-10.
Yun, G. and Trumbo, C. (2000) Comparative response to a survey executed by post, e-
mail, and web form, Journal of Computer-Mediated Communication, 6(1), pp. 1-26.
Zhang, J. and Chen, A. (2019) NMPA medical device registration requirements in China,
12 December 2019. Available at: https://www.emergobyul.com/resources/nmpa-medical-
device-registration-requirements-china (Accessed: 10 March 2020).
130
Appendix A
Text responses to the question: “In your opinion, what is the best country to work with
regarding gathering Regulatory Intelligence and why?”
Best
country
Why category Survey response
USA Policy making US because of significant emphasis on policy making and
impact it has on our industry
Brazil Aware of
changes
Brazil - just have a close relationship with them and they are
very open and engaging with regulatory updates and
changes.
USA Transparency The US. Easy to access and well distributed.
Europe Transparency Europe, most transparent and in English
USA RI location US, more people doing that job and FDA publication
USA/
Canada
Transparency North America, easier to access information
USA RI location US because the regulatory intelligence group is located there
USA Transparency US, The US publishes the guidance documents and makes
them available in a timely manner in English. They come out
as Draft and then after a period of time they get published
with an implementation date making it easier to meet the
requirement.
Canada None provided Canada
USA/
Canada
Aware of
changes
USA and Canada, they are more focused on regulations and
are able to communicate changes in a timely manner. The
regulation also does not change frequently or there is a long
implementation time for the new/changed regs.
USA Transparency US - transparent and available data
USA Transparency United States - information is typically known well in advance
with adequate transition times and individuals present in this
market follow the processes closely to report and assess the
intelligence.
USA Experience US, experience
Europe None provided EU
USA Regulator
communication
United States due to direct email notifications from FDA.
Other regions (eg EU and Canada) are helped by a
subscription to Notified Body/MDSAP authority.
USA RI location US. A lot of companies have a focus on US regulations.
Canada Regulator
communication
Canada - it's very prescribed by Health Canada
Canada Able to help Canada - always polite and willing to help
Europe Transparency Europe. The regulations are clear, and their development is
transparent.
Europe None provided All of Europe
USA/
Canada
Transparency This would be a split between the US and Canada. HC has
become more transparent and inclusive in the past few
years, inviting more industry participation in process
development. The US has generally been the leader in
131
Best
country
Why category Survey response
regulatory information sharing and soliciting industry input.
FDA has, however, generally continued its historic nature in
ignoring that which it doesn't want to hear.
132
Appendix B
Text responses to the question: “In your opinion, what is the most challenging country to
work with regarding gathering Regulatory Intelligence and why?”
Most
challenging
country
Why category Survey response
Africa Unaware of
changes
Africa - information is not so readily available and there are so
many countries to deal with
Africa /
Middle East
None provided Many countries in Africa and the Middle East
Asia Unaware of
changes
Asia due to the fact that must of the information is more
restricted.
Canada /
Brazil
None provided Canada, Brazil
China Language China. Changes a lot and only in Chinese. Translations are
spotty.
China Implementation
timeline
China. They implement regulations with a very tight time frame
and usually only officially in Mandarin. The tight time frame
and language barrier cause confusion and possible delays.
China Unaware of
changes
China, they institute changes very quickly and without
translating the regulation to other languages. It is also the most
difficult to interpret due to language translations and when we
are aware of the changes.
China Transparency China - lack of transparency and interpretation differences
China Unaware of
changes
China - culturally it seems that much is held internal to the
country and individuals there, additionally the environment is
highly dynamic and there is typically little specificity in what is
required based on the changes and the transition times are
short or undefined.
China None provided China
China Unaware of
changes
China. We only have distributor affiliates rather than internal.
And gathering data from distributor can be difficult if they are
not aligned with the process.
China Transparency China - closed off to information until last minute
China Language We are attempting to enter the China market. Perhaps
because of language difficulties, or perhaps due to government
influence, we have found it very difficult to nail down
device/drug regulatory requirements. The ask is for
"everything", including proprietary information such as
algorithm specifications, which I will not provide. It is difficult to
establish what is actually required for device/drug licensing,
and what a consulting organization (Or, government agency)
would "like to have".
China Implementation
timeline
China - the "publish the regulation, then determine how to
implement the regulation" approach makes it difficult to plan
compliance activities during product development. Many
times, requires rework once implementation measures are
communicated
China Implementation
timeline
China. It is hard to get a clear answer on implementation with
adequate time to comply.
133
Most
challenging
country
Why category Survey response
Japan,
Korea,
Middle East
Language Japan, Korea, and most of Middle East. Primary barrier is
language and ability of country reps to adequately translate the
technical language and requirements
Middle East Transparency Middle East- some unstable economies; poor visibility or lack
of transparency
Middle East Transparency Middle East - regulation still forming in some areas or not well
formed for existing regs
None
provided
Transparency Countries that are not transparent or accountable"
None
provided
Language Any country that does not maintain a website in English
Philippines Unaware of
changes
Philippines - never really seem to know what's going on there
and find out about changes long after they happen.
Russia Language Russia, complexity of regulations and lack of English
translation.
134
Appendix C
Text responses to the question: “In your opinion what are the biggest communication issues
between international regional and headquarter offices?”
Category grouping Survey response
Segregation Having been at a global company in the past, the biggest
communication issues revolved around those in regional and
headquarter offices feeling segregated with respect to responsibilities,
collaboration, and formal organizational hierarchy. These factors
contribute to the tendency for some regional offices to not want to
share information or not want to contact the headquarter office unless
there were serious challenges that warranted raising them to the
headquarter office. Alternatively, headquarter office activities may be
too high level to include following all relevant regulatory intelligence
that may affect the other offices. We often shared regulatory
intelligence updates as part of quarterly management review meetings
to the headquarter group, but that does not seem like the most efficient
method as these updates may occur very frequency and the work
needed to address such updates should be evaluated immediately
rather than potentially losing several months of time.
Placement in Org
structure
Typically, regulatory intelligence groups are small, and staff is involved
in many activities besides intelligence. Additionally, reporting lines can
be confusing for staff in regional offices. For example, if there is no
direct reporting line to the headquarters the nature of the job might
prevent frequent and efficient communication. It is essential that policy
function be a centralized function which will ensure proper
communication channels ensuring agreed upon standards Including
effective and frequent communication.
Segregation Headquarters is not engaged unless it's becomes a serious issue that
impacts profit.
Relevance/Timeliness In general, I think that there can be a "relevance" and "timeliness" piece
that can cause issues. In some cases, the information is overwhelming
and difficult to know if or when its applicable. In other places, it feels
like the information is late and therefore causes disruptions. Many
times, the information can also be at such a high level that it requires
consultation, but the SMEs, while SMEs from the regulatory side, may
not have experience to translate it into the QA or QMS side of the
business.
Language Language barriers
NA Not applicable. We do not have regional versus headquarter offices.
Relevance/Timeliness Lack of understanding importance of the information
US centric thinking Understanding of criticality to the local office by corporate (US centric
thinking)
135
Category grouping Survey response
Segregation Often regional offices act in Silos or there is a bet of me versus them
mentality which could cause much rework. Need to have a common
group or a mediator that can do the primary decision making.
Resources Lack of resources
Placement in Org
structure
The biggest communication issue is the political set-up of the company.
Upper management has to agree to the RI before it is sent, and this
causes delays and dilutes the information and removes the source of
the information so an adequate dialog cannot take place if the
information is not understood.
NA Not applicable
Timeliness Timeliness, in order for the business to react to meaningful RI the
change needs to be communicated with enough time to analyze and
study the impact.
Time zone / Culture Time zones and cultural differences, not understanding what is
important to the other office.
NA Not applicable for me
Resources No dedicated resource and process to consistently collect, evaluate
and communicate RI from multiple sources.
Resources Time and enough personnel to search, read and interpret a piece of RI
Experience empathy and understanding of the perspective and experience each
group brings and what expertise is required
Placement in Org
structure
Man on the mountain mentality from headquarters
Time zone / Culture time zone differences
Timeliness Timely information
Language Language, time zones (Sometimes this seems to be intentional - It
really isn't all that difficult), locals spin RI to their advantage instead of
taking a global view, management misinterpretation of RI, necessitating
"managing up" for a while.
NA Nothing specific comes to mind.
136
Appendix D
Text responses to the question: “To what do you attribute your success of gathering data?”
Success
grouping
Response
Sharing
information
Each person who obtains information generally shares it to the entire
organization
Vendor
database/RI
resources
Available Intelligence database Cortellis
Resources Global footprint and company reputation
Experience Luck and experience of the individuals who have background in regulatory
intelligence. They've developed networks of individuals and groups that
help those individuals learn about changes in the regulatory environment.
Experience Persistence
Experience electronic tools and experience
Sharing
information
Individual performance in the geography and interest in the topic
Collaboration Getting Buy In from multiple departments and collaboration
NA I don't understand this question
Experience I do independent RI in multiple regions of the world to stay on top of the
changing regulatory landscape. My independent research and the RI I get
from the company often complement each other. I have been building my
RI contacts over the last 10 to 15 years and am confident in the source
material.
NA N/a
Vendor
database/RI
resources
subscribing to sites which provide regulatory updates.
Sharing
information
Having the regions being able to report RI data. Although this is also an
issue as we find out about RA late and sometimes not at all.
Vendor
database/RI
resources
Source of info
Sharing
information
Access to info
Timely
communication
Timely communication
Clear owners Actionable steps with clear owners
Business priority Priority that is placed on the intelligence and wide network.
Experience Taking the time to research, vetting the sources
Vendor
database/RI
resources
Purchase subscription services for RI
Vendor
database/RI
resources
Subscriptions to government websites that provide daily email updates,
industry newsletters, and continuous contact with people in government
and industry to stay current with changes.
Experience The gift of NAGGING
Resources Dedicated resource to process, store, evaluate and communicate data
137
Success
grouping
Response
Sharing
information
monthly assignments to specific personnel - it's your month please fulfill the
responsibility
Experience Individual hard work and dedication as well as personal network and
previous experience doing similar work
Experience work ethic of the people in the organization
Vendor
database/RI
resources
Good service provider and good catchers in a central department.
Experience good skills
Experience Dedicated, experienced organization familiar with the tools for gathering RI
around drugs. Expertise is lower, but developing, on the device side. RI
group know when to reach out to internal and external SMEs to gauge
importance and to help interpret RI before disseminating.
138
Appendix E
Survey
Organizational Communication of Regulatory Intelligence
Start of Block: I. Please tell me about yourself
Q23 Thank you for participating in this survey. It examines your views and challenges with the
communication of Regulatory Intelligence (RI) and preferred practices.
Your responses will be anonymous. We would like as many of your valuable insights as possible,
so If you do not feel comfortable with a question, you can skip the question and still go forward.
If you have experience working in multiple companies, please think about one company/position
on which to base your answers.
Q1 How many employees are in your company?
o Micro (1 ‐ 100)
o Small (101 ‐ 2,000)
o Medium (2,001 ‐ 15,000)
o Large (15,001 +)
139
Q72 How is your company best described? (Select best answer)
o Medical Devices/IVDs
o Pharmaceuticals
o Biotech
o Consultant/Third Party
o Other (Please specify) ________________________________________________
Q28 In which type of office are you based?
o Headquarter Office
o International Regional Office
o Other (Please Specify) ________________________________________________
Q6 In your opinion, how would you characterize your company? (Select best answer)
o Global focus
o Primarily in well‐established markets and a few emerging markets
o In well‐established markets only
o In emerging markets only
o In only a few markets
o In one country
o No countries, we are a start‐up
140
Q2 What is your current level in the company?
o VP/Executive
o Sr Director/Director
o Sr Manager/Manager
o Specialist/Associate
o Consultant/Third‐Party
o Other (Please specify) ________________________________________________
Q3 How many years of experience in total do you have in Regulatory Intelligence (RI)?
o 0 ‐ 6 months
o 7 months ‐ 1 year
o 1 + years
o I am not involved in Regulatory Intelligence activities
Skip To: End of Survey If How many years of experience in total do you have in Regulatory
Intelligence (RI)? = 0 ‐ 6 months
End of Block: I. Please tell me about yourself
Start of Block: II. Please tell me about the organizational structure of your company
Q8 Regulatory Intelligence (RI) is responsible for gathering and reporting regulatory changes from
government agencies and other sources that affect the registration/oversight of medical
devices. Using this definition please answer the following questions:
141
Q26 In your opinion, what level of maturity, described below, best describes Regulatory
Intelligence in your company? (Select best answer)
o Initial ‐ the process is unpredictable, poorly controlled and reactive
o Managed ‐ a process has been created but not implemented fully
o Defined – processes are established and followed
o Quantitatively managed – processes are measured and controlled
o Optimized – processes meet expectations, need little oversight and are well trusted
Q9 Where is the Regulatory Intelligence function typically centered in your organization? (Select
all that apply)
Regulatory Affairs
Quality Assurance/Engineering
Legal
Government Affairs
Consultant/Third‐Party
Medical Affairs
We do not have a Regulatory Intelligence function
Other (Please Specify) ________________________________________________
142
Q13 How would you best describe your current Regulatory Intelligence (RI) process? (Select best
answer)
o We don't have an RI process; RI is collected as needed
o We don’t have an RI process, but we have identified resources to put one in place
o We have explored the idea of an RI process but have insufficient resources
o We have an RI process that mostly relies on unstructured processes
o We have an established RI department whose processes are embedded in a formal system
143
Q20 How often does your company gather Regulatory Intelligence from the following sources?
(Select best answer for each row)
Daily/weekl
y
Monthly/Quarterl
y
Semi‐
Annually/Annuall
y
Ad
ho
c
Never
Product Approvals,
your company o o o o o
Product Approvals,
competitors o o o o o
Post Market,
Compliance Issues o o o o o
Regulations, Guidance,
Market Access
requirements
o o o o o
Information from Third
Party Vendor
Database, Advice from
Consultants
o o o o o
Scholarly Reports,
Trade Association
Briefings
o o o o o
Websites, Blogs,
Forums, Social
Networks, Google
o o o o o
Briefing from a
colleague that has met
with a
regulators/governmen
t agencies
o o o o o
Other (Please Specify)
o o o o o
Other (Please Specify)
o o o o o
144
Q10 Which statement best describes the way that Regulatory Intelligence is handled in your
company? (Select best answer)
o Formalized stand‐alone function managed by an internal team
o Formalized function done by primarily by one internal person
o Informal activity done by several internal people
o Activities done by outsourced third party
o Other, if selected see below
Display This Question:
If Which statement best describes the way that Regulatory Intelligence is handled in your
company? (... = Other, if selected see below
Q81 Since you selected Other, please describe how Regulatory Intelligence is handled in your
company.
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
End of Block: II. Please tell me about the organizational structure of your company
Start of Block: III. Regional Office
145
Q67 Do you have International Regional Offices?
No
1 ‐ 3
4 ‐ 10
10 +
Do not know
Skip To: Q30 If Do you have International Regional Offices? = No
146
Q14 At what location do the following activities typically occur? (Select best answer for each row)
Commonly
Headquarters
Office Only
Split between
Headquarters
and
International
Regional
Office
Commonly
International
Regional
Office Only
Not at All
Other
(describe
below)
Gathering
intelligence o o o o o
Analyzing data
o o o o o
Assessing
impact of
regulatory
analysis
o o o o o
Managing a
database that
houses
regulatory
intelligence
o o o o o
Conducting
research
requests
o o o o o
Communicating
Regulatory
Intelligence to
executives
o o o o o
Developing
comments on
draft guidance
o o o o o
Communicating
regulatory
intelligence to
other regional
offices
o o o o o
Other
o o o o o
147
Display This Question:
If At what location do the following activities typically occur? (Select best answer for each row)
= Other (describe below)
Or At what location do the following activities typically occur? (Select best answer for each
row) = [ Commonly Headquarters Office Only ]
Or At what location do the following activities typically occur? (Select best answer for each
row) = [ Split between Headquarters and International Regional Office ]
Or At what location do the following activities typically occur? (Select best answer for each
row) = [ Commonly International Regional Office Only ]
Or At what location do the following activities typically occur? (Select best answer for each
row) = [ Not at All ]
Or At what location do the following activities typically occur? (Select best answer for each
row) = [ Other (describe below) ]
Q82 Since you selected Other as a location in the above question, please describe below:
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
148
Q77 How are Regulatory Intelligence responsibilities distributed between the Headquarter Office
and International Regional Offices? (Select best answer)
o Only Headquarter Office
o Primarily Headquarter Office with some input from International Regional Office
o Equally Headquarter and International Regional Office
o Primarily International Regional Office with some input from Headquarter Office
o Only International Regional Office
o Do not know
Q46 In your opinion, do all International Regional Offices have the same or different levels of
participation with regard to Regulatory Intelligence development or sharing?
o All International Regional Offices participate in the same way
o International Regional Offices participate differently
149
Q71 Where are your International Regional Offices located? (Select all that apply)
Americas (e.g. Canada, USA, South America)
South East Asia and Pacific (e.g. Australia, South Korea, Vietnam)
China (Including Hong Kong, Taiwan, Mongolia)
Middle East (e.g. Afghanistan, Egypt, Iran, Pakistan)
Europe (including Russia, Eastern block)
India (including Indian subcontinent)
Africa
Q75 Where is the most challenging Regional Office? (Select best answer)
o Americas (Canada, USA, South America)
o South East Asia and Pacific (e.g. Australia, South Korea, Vietnam)
o China (including Hong Kong, Taiwan, Mongolia)
o Middle East (e.g. Afghanistan, Egypt, Iran, Pakistan)
o Europe (including Russia, Eastern block)
o India (including Indian subcontinent)
o Africa
150
Q83 In your opinion, what is the best country to work with regarding gathering Regulatory
Intelligence and why?
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
Q42 In your opinion, what is your most challenging country from which to obtain Regulatory
Intelligence and why?
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
Q66 Do International Regional Offices share Regulatory Intelligence with one another without
going through Headquarter Office as an intermediary?
o Yes, commonly
o Yes, occasionally
o No
o Do not know
151
Q35 When gathering Regulatory Intelligence (RI) ... (Select which statement is mostly true)
o Most of the International Regional Offices contribute RI data
o Only a few International Regional Offices contribute RI data
o RI is gathered from a Headquarter Office with minimal or no International Regional Office
participation
Q59 Do you find that it is difficult to obtain Regulatory Intelligence from International Regional
offices?
o Definitely yes
o Sometimes yes
o Sometimes yes, sometimes no
o Sometimes no
o Definitely no
o Do not know
152
Q34 What is the typical frequency in which Regulatory Intelligence is communicated from your
most active international regional office? (Select one per statement)
153
Daily/weekly Monthly/Quarterly
Semi‐
Annually/Annually
Ad hoc Never
Product
Approvals o o o o o
Post Market,
Compliance
Information
o o o o o
Regulations,
Guidance
Documents,
Market
Access
information
o o o o o
Information
from Third
Party Vendor
Database,
Advice from
Consultants
o o o o o
Scholarly
Reports,
Trade
Association
Briefings
o o o o o
Websites,
Blogs,
Forums,
Social
Networks,
Google
o o o o o
Briefing from
a
colleague/or
consultant
that has met
with
government
agencies
o o o o o
Other (Please
Specify) o o o o o
154
Q18 For this question, please consider the international regional office that you consider to be the
most challenging from a Regulatory Intelligence (RI) communications point of view. How
important are the following factors that you have found to impede RI communication?
Always
Most of the
time
About half
the time
Sometimes Never
Non‐verbal
communication
(ie, gestures,
facial
expressions)
o o o o o
Location where
communication
takes place (ie,
private/public,
live/virtual
location)
o o o o o
Culture (ie,
language,
beliefs,
religion)
o o o o o
Voice pattern
(ie, inflection,
accent, word
pronunciation)
o o o o o
Environment
(ie, political,
economic)
o o o o o
Other
o o o o o
Q80 If you have any other comments regarding communication hurdles could you please share
them below.
________________________________________________________________
________________________________________________________________
155
________________________________________________________________
________________________________________________________________
________________________________________________________________
Q76 Still thinking about the most challenging international regional office from an Regulatory
Intelligence (RI) communications point of view, what causes the most trouble?
Always
Most of the
time
About half
the time
Sometimes Never
Inadequate
electronic
tools for the
purpose
o o o o o
Translation of
Regulatory
Intelligence is
difficult to
understand
o o o o o
Interpretation
of Regulatory
Intelligence is
difficult to
understand
o o o o o
Time zone of
the person
reporting the
RI is different
than mine
o o o o o
Other
o o o o o
156
Q30 When thinking about receiving Regulatory Intelligence (RI) communications, how would you
order the method of communications CURRENTLY USED to ensure RI communication flow?
(1 = most common, 6 = least common)
______ One person to another unidirectionally without expectation of interaction
______ One person to another in a two‐way conversation or interaction
______ One person to a group in a two‐way conversation
______ One person to group unidirectionally without expectation of interaction
______ Group to group without expectation of interaction
______ Group to group discussion
Q69 How satisfied are you with the methods of communication that are CURRENTLY USED?
o Extremely satisfied
o Somewhat satisfied
o Neither satisfied nor dissatisfied
o Somewhat dissatisfied
o Extremely dissatisfied
Q45 To what do you attribute your success of gathering data?
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
Q44 If you could change one thing to improve the gathering of Regulatory Intelligence
information, what would it be and why?
________________________________________________________________
157
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
Q70 When thinking about receiving Regulatory Intelligence communications, how would YOU
PREFER TO MANAGE communications to ensure and efficient Regulatory Intelligence
communication flow?
(1 = most common, 6 = least common)
______ One person to another unidirectionally without expectation of interaction
______ One person to another in a two‐way conversation or interaction
______ One person to a group in a two‐way conversation
______ One person to group unidirectionally without expectation of interaction
______ Group to group without expectation of interaction
______ Group to group discussion
Q84 How would you prefer to receive Regulatory Intelligence communication?
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
158
Q37 To describe communication flow within your company from the Regulatory Intelligence
sources listed below the most useful information may be received in either formal or informal
manner. Please identify how most information is conveyed. (Select all that apply)
Formal or structured
communication (messages
may follow the organizational
chart)
Informal or unstructured
communication (Water‐
cooler conversations, email
exchanges)
Product Approvals
Post Market, Compliance
Information
Regulations, Guidance, Market
Access requirements
Information from Third Party
Vendor database/Advice from
Consultants
Scholarly Reports, Trade
Association Briefings
Websites, Blogs, Forums, Social
Networks, Google
Regulators/government
agency briefings from a
colleague
Other (Please Specify)
159
Q79 Do you find that the language of conveyed or received information is troublesome to
understand?
o Yes
o No
Display This Question:
If Do you find that the language of conveyed or received information is troublesome to
understand? = Yes
Q48 Since you indicated that the language of the Regulatory Intelligence communication can be
troublesome to understand, how do you seek clarification? (Select all that apply)
From a subject matter expert
From the person initiating the communication
From staff at Headquarter Office
From staff at International Regional Office
From a Consultant/Third Party
I don't seek clarification
Other (Please specify) ________________________________________________
160
Q50
In your opinion, what is the major issue that causes trouble communicating timely
Regulatory Intelligence (RI)? (Select all that apply)
RI is not reported quickly enough
RI is not submitted
RI needs to be translated
RI needs clarification
RI is too incomplete to be actionable
Other (Please Specify) ________________________________________________
Q85 Finally, in your opinion what are the biggest communication issues between Regional and
Headquarter Offices?
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
Q22 The fact that you are reading this message indicates that you have completed the Survey and
that I owe you a thank you for your generous participation. The information you provided will be
used in sharing how regulatory intelligence is communicated within the medical device
industry. Once again, I am extremely grateful for you contributing your valuable time and your
honest information.
End of Block: III. Regional Office
Abstract (if available)
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Asset Metadata
Creator
Kamrow, Martha Lee
(author)
Core Title
Organizational communication of regulatory intelligence: a survey of the medical device industry
School
School of Pharmacy
Degree
Doctor of Regulatory Science
Degree Program
Regulatory Science
Publication Date
09/18/2020
Defense Date
09/16/2020
Publisher
University of Southern California
(original),
University of Southern California. Libraries
(digital)
Tag
medical device regulatory change,OAI-PMH Harvest,organizational change,regulatory communication
Language
English
Contributor
Electronically uploaded by the author
(provenance)
Advisor
Richmond, Frances (
committee chair
), Bain, Susan (
committee member
), Church, Terry David (
committee member
), Tolomiczenko, George (
committee member
)
Creator Email
kamrow@usc.edu,martha.kamrow@ge.com
Permanent Link (DOI)
https://doi.org/10.25549/usctheses-c89-375583
Unique identifier
UC11666191
Identifier
etd-KamrowMart-8980.pdf (filename),usctheses-c89-375583 (legacy record id)
Legacy Identifier
etd-KamrowMart-8980.pdf
Dmrecord
375583
Document Type
Dissertation
Rights
Kamrow, Martha Lee
Type
texts
Source
University of Southern California
(contributing entity),
University of Southern California Dissertations and Theses
(collection)
Access Conditions
The author retains rights to his/her dissertation, thesis or other graduate work according to U.S. copyright law. Electronic access is being provided by the USC Libraries in agreement with the a...
Repository Name
University of Southern California Digital Library
Repository Location
USC Digital Library, University of Southern California, University Park Campus MC 2810, 3434 South Grand Avenue, 2nd Floor, Los Angeles, California 90089-2810, USA
Tags
medical device regulatory change
organizational change
regulatory communication