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Managing Medical
Devices within a
Regulatory Framework
Edited by
Beth Ann Fiedler, PhD
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Elsevier
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ISBN: 978-0-12-804179-6 (print)
ISBN: 978-0-12-804192-5 (online)
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I would like to dedicate this book to friends whose presence at timely
points in my life, whether far or near, have made it better:
Alice DiCroce, Brian Gerrits, and Cynthia Sweet.
List of Contributors
Y. David
Principal, Biomedical Engineering Consultants, LLC Houston, TX, USA
A. Farid
PE, MS, ITIL, CPAS Rawalpindi Institute of Cardiology (RIC) Rawalpindi, Punjab
Pakistan
M. Ferguson
Senior Director, Global Health Economics and Outcomes Research, AtriCure
Minnetonka, MN, USA
B.A. Fiedler
Independent Researcher, Jacksonville, FL, USA,
L.J. Greathouse
MPA Volusia County Fire Services, St. Augustine, FL, USA
M. Sanchez, Esq.
Managing Partner FDA Atty, Washington D.C. USA
xix
Foreword
In her latest book, Managing Medical Devices Within a Regulatory Framework, Dr.
Beth Ann Fiedler offers a unique, focused, and extremely well-referenced overview
of medical device acquisition, use, and management, not within the context of health-
care, but rather at its beginnings in the milieu of device regulation, clinical trials, and
the often arduous path to eventual marketing that is applicable to the clinical envi-
ronment. While readers may initially assume that this book deals only with medical
device regulation in the US, ie, through and via its, federal Food and Drug Adminis-
tration (FDA), they will be introduced early on and throughout to those requirements
within the EU as well. In contrasting the similarities and differences between these
two regulatory bodies, Dr. Fiedler and her impressive and seasoned list of contrib-
uting authors bring a larger and essential global perspective to this entire topic of
medical device regulation. For medical device designers and those involved in the
regulatory and marketing process, such awareness and perspective is simply crucial
if their products are ever to find their way into use at the patient bedside.
As a review of Dr. Fiedler’s other books and publications would also reveal, she
brings a distinctive mix of policy analysis and regulatory insight, not only from the
US medical device industry, but from an international perspective as well, the latter
being particularly essential given the ever-expanding global nature of the medical
device marketplace. Having also worked within hospital-based biomedical engineer-
ing environments, Dr. Fiedler also brings a unique level of application and reality to
this work as well.
In addition to the copious and detailed references, readers should also welcome
both the end of chapter summaries contained within each of the book’s six major
sections, as well as glossaries of key definitions and recommendations for additional
reading. These sections include:
1. medical device development and regulatory overview
2. defining and meeting regulatory challenges in clinical engineering
3. European markets
4. equipment acquisition, integration, and maintenance
5. data management, patient safety, and efficacy
6. future of healthcare
It is in and throughout these section topics that Dr. Fiedler and her contribut-
ing authors construct the regulatory framework that surrounds and directly impacts
the manner in which medical devices are used and managed within the healthcare
environment. Most of the book’s 19 chapters (within these six sections) also contain
helpful case studies that further reinforce key chapter concepts.
Even though this book is not directly targeted toward clinicians or other end users
of medical devices, this audience would likely be amazed and perhaps comforted by
the rigor and requirements promulgated by both the FDA and EU, all to insure the
highest level of device efficacy and safety. Additionally, given the dependency device
xxi
xxii Foreword
manufacturers and the regulatory process have on a continual need for timely medi-
cal input and review, clinicians may also find opportunities within this process where
they could contribute as well.
Historically, the clinical engineering and medical device management literature
has contained somewhat of a void when it comes to addressing the regulatory factors
affecting its work and processes. Dr. Fiedler’s new book makes a sizable contribution
toward filling this gap.
Larry Fennigkoh, Ph.D.
March 2016
Preface
Managing Medical Devices Within a Regulatory Framework came about when I
found that there was a gap in material that did not address the various variables and
stakeholders in the medical device total product life cycle: development, manufac-
turing, clinical review, and application to the patient in a healthcare environment.
Existing resources aptly provide a study of one topic of interest from subject matter
experts (SMEs) with in-depth knowledge, which I have relied upon in many aspects
of this book. What seemed to be missing was the foundational information that out-
siders did not have, which meant that some of the insightful material was lost to the
novice and to some extent, even researchers with a doctorate like myself. However,
the absence of a comprehensive understanding that linked all of the pieces of the
puzzle together was evident, and I believe that this problem prohibited many from
entering the realm of medical device development. You cannot participate in what
you don’t understand. Thus, I began to gather information from credible biomedical
organizations, webinars, industry leaders, medical device groups on social media,
and literature to form the notion that this information was becoming increasingly
important in the face of changing regulatory requirements.
However, an appropriate venue for such a book was lacking, despite the intent
to systematically relay the complex nature of medical device development to help
eliminate the frustration of innovators, quality personnel, risk managers, health
administrators, health technology managers, biomedical and clinical engineers, and
clinicians. Then I opened up my LinkedIn account to find an invitation to submit
proposals from Fiona Geraghty, Acquisitions Editor, for Elsevier Publishing in the
United Kingdom. Through the course of this year-long journey after contracting with
Elsevier, I have appreciated Fiona and Alex White, Editor, for their feedback and
availability. I am also grateful to a dear friend, Brian Gerrits, who provided a space
for me to write, and to Larry Fennigkoh for his kind words and encouragement.
Of course, the proposal and contract was just the beginning of the process.
I conducted several systematic literature searches (eg, EBSCO host, Proquest ABI,
PubMed, and the United States National Library of Medicine at the National Insti-
tutes of Health) spanning the major sections of the book that formed the current
sections. The databases represent input from business leaders, SMEs in clinical
engineering and information systems, regulators, health administrators, and aca-
demic and clinical researchers. My focus was to see how people fit into the new
regulatory framework equation to help bring forth solutions to unmet medical needs
using knowledge of regulation and personal experience with medical devices as a
biomedical engineering technician and occasional patient. These sections include
(1) Medical Device Development and Regulatory Overview; (2) Defining and
Meeting Regulatory Challenges in Clinical Engineering; (3) European Markets;
(4) Equipment Acquisition, Integration, and Maintenance; (5) Data Management,
Patient Safety, and Efficacy; and (6) the Future of Healthcare. Topical information
was also researched through supplemental searches to fill in gaps in important
xxiii
xxiv Preface
information as these chapters developed. Contributing authors also conducted
their own literature searches. I am thankful for the insightful information that the
contributing authors provided to inform and add to the overall depth of the book.
Several items emerged true to my initial intuition: the misunderstood relevance
of the medical device total product life cycle; the need to produce evidence support-
ing medical device decisions based on the increase in value-based purchasing that
drives development, regulatory approval, and reimbursement; and the not-so-simple
device classification process. That, my friends, is just some of what the first section
has to offer.
The second section provides a specific regulatory overview of the current chal-
lenges in clinical engineering: biocompatibility, risk management, and sterility, while
the third section focuses on regulation specific to the European Union. In Section 4,
the topics revolve around methods to evaluate new equipment purchases and reim-
bursement strategies with a focus on legal responsibilities that will serve to reinforce
earlier concepts in the book.
Section 5 takes the readers into a new way to look at evidence strategies, access
to portals to obtain information on manufacturing recalls, and how health econom-
ics research is invading medical device development. Finally, Section 6 looks at the
future of health technology management, challenges of securing patient confidential-
ity and interoperability of medical devices, and how to better manage applications for
digital technology. Also in this section, my Goddaughter Olivia Grace Adams debuts
her first graphic publication by honoring my request for a unique interpretation of
the developments in technology with homage to Leonardo Da Vinci’s Vitruvian Man
in Chapter 17. I am so excited to include this talented young artist in my book.
Finally, no book is without limitations. The more I delved into the details of
such topics as reimbursement or biocompatibility, the more I realized how much
more I could write. But, there are space limitations in every book. Nevertheless, I
feel that this book has met the objective to inform the multiple stakeholder medical
device environment of care with operational and clinical practice recommenda-
tions to regulatory changes for risk management, continuing education units to
maintain credentials, and medical equipment practices that contribute to organi-
zational quality. I hope that you and your patients benefit tremendously from this
information.
CHAPTER
1
Reframing Product Life
Cycle for Medical Devices
B.A. Fiedler1, Y. David2
1Independent Researcher, Jacksonville, FL, USA
2Principal, Biomedical Engineering Consultants, LLC Houston, TX, USA
1.1 INTRODUCTION
Product management through its life cycle is critical to end users and the companies that
produce and market them. Major considerations include (1) production of operationally
safe and effective devices; (2) financially positive return on investment made throughout
the product development and manufacturing; (3) clinical improvement in care; and (4)
the overarching element of “do no harm.” “The regulation of medical devices is as much
about risks as it is about markets and companies” (Altenstetter, 2012, p. 364). While
medical product legislation in the US had its beginning in 1938 under the Federal Food,
Drug, and Cosmetic Act (FDA, 2012, 2014a), the significant impact on the design and
manufacturing of medical products was the result of the Medical Device Amendment of
1976 (FDA, 2014a) that introduced the risk classification scheme giving the US Food and
Drug Administration (FDA) the authority to require a premarket review process.
These legislative developments and others that followed both in the US and the
world aimed at the establishment of a regulatory environment where processes and
methods have been evolved to ensure the safety and effectiveness of medical prod-
ucts while promoting innovation. Therefore, understanding the FDA total product life
cycle (TPLC) (FDA, 2015a) and the EU Medical Device Certification (MDD) (2009)
processes for medical device development that leads to commercial distribution is
important to achieving both consumer safety and product innovation. The global rel-
evance is demonstrated by examining the US and the US medical device markets that,
when combined, represent more than three-fourths share in a $300+ billion dollar
industry (Kalorama Market Report, 2014; Eucomed, n.d.; Fierce Medical Devices
Newsletter, 2012) that is growing at a rate of 4.4% a year (Eucomed, n.d.).
The introduction of the regulatory process distinguishes the medical device PLC
from other industry concepts, such as the well-known product life cycle: introduc-
tion, growth, maturity, and decline. For example, the human factors element has
gained a strong presence in medical device development as well as in the hospi-
tal environment of care (Duffy, 2011; Fennigkoh, 2005). Consequently, human fac-
tors engineering has driven changes in regulation guiding the medical PLC. The
Agency for Healthcare Research and Quality recognizes the patient safety value of
human factors engineering and the inherent risks, as interactions between and among
Managing Medical Devices within a Regulatory Framework. http://dx.doi.org/10.1016/B978-0-12-804179-6.00001-0 3
Copyright © 2017 Elsevier Inc. All rights reserved.
