The medical device R & D handbook

376 Pages·2006·8.132 MB·English

by  Theodore R. Kucklick

The
Medical Device
R&D
Handbook

The
Medical Device
R&D
Handbook
Theodore R. Kucklick
2717_Discl.fm Page 1 Friday, September 30, 2005 11:20 AM
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Library of Congress Cataloging-in-Publication Data
The medical device R & D handbook / edited by Theodore R. Kucklick.
p. ; cm.
Includes bibliographical references and index.
ISBN 0-8493-2717-2
1. Medical instruments and apparatus--Design and construction--Handbooks, manuals, etc. I. Title:
Medical device R and D handbook. II. Kucklick, Theodore R.
[DNLM: 1. Biomedical Technology--Interview. 2. Entrepreneurship--Interview. 3. Equipment
Design--methods--Interview. 4. Research--methods--Interview. W 82 M4883 2005]
R856.15.M43 2005
610'.28--dc22 2005049422
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ABOUT THIS BOOK
The Medical Device R&D (Research and Development) Handbook is the
fruition of a personal desire to see some of the practical information on
how to develop medical devices compiled in one place. I wanted to write
a book that I wish had been available when I first started in medical
device design.
This book contains three main threads. The first thread is practical.
There are many excellent books that give in depth theory on specialized
medical and technology subjects in medical device engineering, but not
a general practical how-to manual. This part of the book seeks to serve
that need.
There is a great deal of practical skill, developed by very intelligent
and clever people, to be found in specialized areas of the medical device
industry. Having worked for a succession of medical device start-up
companies, each new area seemed to have its own fund of “tribal knowl-
edge” that, for various reasons, did not seem to percolate much out of
the tribe. Working for start-ups and developing products for different
medical specialties was somewhat like joining a succession of guilds.
There is also little cross-over between certain fields such as engineering
and medical illustration. One of the goals of this book is to collect some
of the knowledge of these practical skills, such as medical device proto-
typing, plastics selection, and catheter construction and make them more
readily accessible to the hands-on designer. The skills may be well known
to those who work in a specialized area, but not as well known to those
outside that specialty. Some of this information is usually learned “on the
job” if you happen to have that kind of a job. This book brings you this
type of information. Having knowledge of these practical skills can allow
the designer to combine and apply these specialized techniques in new
and innovative ways, and save valuable time.
v
vi (cid:2) The Medical Device R&D Handbook
Another thread is entrepreneurial. This book contains interviews with
some of the top leaders in the medical device industry. These are people
who know by experience how to develop innovative new medical tech-
nology and how to start and grow successful companies. Each of them
was unfailingly gracious and exceptionally generous with their time and
insight, and they have my enduring gratitude for allowing me to interview
them and pester them with my questions. Hearing them share their
knowledge, experience, and wisdom has been one of the most enjoyable
aspects of producing this book. The insights shared represent decades of
distilled top-level experience. These are people that have helped build
some of the most successful companies and key technologies in the
medical device industry. They share what works, and what doesn’t. These
interviews are valuable resources that will reward the reader with fresh
insights as they are read, and re-read. Where available, there are lists of
additional material and resources on these individuals. This section will
be of special interest to the designer with an idea for an innovative
technology, the student, and the physician-entrepreneur.
Yet another thread in this book is historical. In my experience I am
sometimes asked to design a product that is similar to or is inspired by
a device already in use. Early on, I remember an incident, where one of
our scientific advisors suggested that we look at a Veress needle for ideas
on how to solve a design problem. Once that suggestion had been made,
and he left, we looked at each other, and asked one another “what is a
Veress needle?” Being new and green, I did not know, but the engineering
managers in this medical device company did not know either. With
apologies to Santayana, “Those who do not know history are condemned
to reinvent the wheel.” In the technical chapters I have made an effort
to dig out the historical background of various technologies, and put them
in a useful context. In the chapters on needles and catheters, for example,
I have compiled glossaries with detailed historical footnotes. This will
help the R&D engineer understand how certain devices developed and
for what purpose.
In this thread you meet fascinating personalities — often people solving
a problem just like you —who, through hands-on development, arrived
at important solutions. People like Harvey, Veress, Luer, Forssmann, Sones,
Tuhoy, Dotter, Gruentzig, Fogarty, Foley, and numerous others who solved
important clinical problems are recognized today for their groundbreaking
contributions. It is important, as a medical device designer, to know these
personalities, what they developed, and why, how they sometimes col-
laborated, and some of the technical challenges and institutional barriers
they overcame to succeed.
Finally, the introductory chapter is on the subject of innovation and
how it applies to medical device technology in particular and explores
About This Book (cid:2) vii
a useful framework for approaching the subject of creativity, invention,
and innovation.
Taken together, this book helps give the working engineer, manager,
technician, designer entrepreneur, or student some of the tools to more
quickly and efficiently develop innovative medical devices, and to see
their role in a larger business and societal context. This book covers a
fair bit of ground; however, it is only a start. Examples of subjects not
covered are patents, the role of industrial design in medical device
development, adhesives, catheter tubing extrusion, operating room pro-
cedures and protocol, new company formation, and how and where to
raise start-up capital among many other important topics. These areas are
all as equally important to medical device design and development as
the material already covered. These topics and several more are planned
for future volumes. This book has also been designed with sufficiently
wide margins to add your own notes, and to turn this into your own
customized handbook.
The help, support, and encouragement of the many contributors,
reviewers, and collaborators involved in this project are gratefully acknowl-
edged, as well as those people those who have provided the opportunities
and mentoring I needed to work in diverse areas of this endlessly fasci-
nating medical device industry.
One resource especially useful in researching this book is the PubMed
database of the National Institutes of Health (NIH), National Center for
Biotechnology Information (NCBI), and the National Library of Medicine
(http://www.ncbi.nlm.nih.gov/). Hundreds of medical journals and thou-
sands of article abstracts are easily searchable with this resource, for free.
PubMed has to be one of the better uses of taxpayer money and is an
essential research tool for the medical device designer.
I would also like to acknowledge Taylor & Francis for its interest and
support in publishing this title, as well as all of the work and support of
the Taylor & Francis staff and editors.
This is the beginning of what is intended to be a work in progress
and designed to be responsive to the needs and input of you, the reader.
Your suggestions for future topics are welcome. Please email suggestions,
feedback and questions to: [email protected]
Ted Kucklick
Los Gatos, California