August 2004
Medical Device & Diagnostic Industry
Selected Contents
EDITOR'S
PAGE:
The
Next 25
Reflections
The
Early Years: The Advent of a Total Quality System
Allen M. Hans
Medical
manufacturing benefited from the critical methods developed for military and
aerospace, leading to sophisticated devices such as
pacemakers and biological sensors.
25
Years of DSMA and FDA: Ah Yes, I Remember It Well!
Neal Dunning
DSMA has acted as an
important liaison between government and industry during the past quarter
century, and both have prospered because of it.
Training
in the Early Days of Medical Device Regulation
Andrew
Lowery
A newly
regulated medical device industry found itself in need of lots of training. FDA
and industry worked closely together to make it a success.
Regulating
the Last 25 Years: Medical Device Reporting
James
G. Dickinson
A longtime MD&DI
columnist reflects on what he sees as the most significant developments in the
last quarter century of medical device regulation.
Industry
Perspectives
AdvaMed:
On the Cutting Edge of Advocacy
Pamela G.
Bailey
Like MD&DI,
AdvaMed has grown up with the industry. As the voice of the industry, the
association fosters innovation and helps to ensure industry progress.
MDMA:
Empowering the Industry with Information
Mark
Leahey
MDMA is
committed to advocating on behalf of small device manufacturers. While the
association has been successful in the advancing industry positions, there is
still much work to be done.
AAMI:
A Historical Perspective on Standards and Education
Michael J.
Miller
With an
increasing focus on global standards, AAMI has helped the industry understand
and participate in the standards-making process.
Breakthroughs? You Voted for...
The medical device and diagnostic
industry thrives on new ideas and further refinement of those designs. We
surveyed you, our readers, to find out just what you thought were the most
innovative inventions of the last 25 years.
Into
the Vault: An FDA Historian’s Perspective
Heather Thompson
The history of medical devices began
long before MD&DI’s first issue in 1979. Actually, the history of
medical devices is much longer—and perhaps more sinister—than a 25th
anniversary issue could begin to cover. It is full of brilliant ideas,
not-so-hot ideas, and ideas that never got off the ground.
Retrospectives
Portfolio
A
Photographic Gallery by Roni Ramos
The
Medical Device Market: Up, Up, and Away
Sherrie Conroy
With
successful devices like balloon catheters, the medical device market rose like a
hot air balloon over the last 25 years.
Device
Regulation: Policies, Practices, and Procedures
Jonathan
S. Kahan
The Medical Device Amendments of 1976 changed the landscape of FDA regulation of
medical devices. With these changes came new policies and procedures that have
transformed the industry.
Human
Factors: Moving in the Right Direction
Michael
E. Wiklund
Device manufacturers have increased their use of human factors experts over the
past 25 years—but the discipline is still fighting an uphill battle.
A
Long Road: 25 Years of Clinical Research
Nancy J. Stark
Part 812 in 1980 recognized the need for clinical research laws for medical
devices. Many revisions later, the industry’s clinical trials practices came
into their own.
Changing
Perspectives: The Reimbursement Roller Coaster
Ted Mannen
The changes witnessed during the last quarter century are both confounding and
simplifying. Although we now possess improved systems and capabilities for
taking on tough reimbursement issues, many of them remain unresolved.
Boston
Scientific: Making the Most of Its First 25 Years
Erik
Swain
The stunning growth of the company during its 25-year history reflects
the upward and sometimes explosive growth of the device industry as a whole.
Building
on 25 Years: A Look into the Industry’s Global Future
John Conroy
GMPs and technological advancements highlighted the last 25 years. The next 25
years? How about a two-system regulatory model and a single global audit?
25 Years of
Medical Manufacturing Technology
Sterilization
Sterilization
Methods Stand the Test of Time
Karl J.
Hemmerich, John Masefield, and Jerry R. Nelson
The development of biological indicators and parametric release has led to
improvements in sterilization processes and shifts in industry preferences.
Sterilization Validation
Sterilization Validation: A 25-Year
Retrospective
Robert R.
Reich
While techniques of sterilizing medical devices have not changed much over the
past quarter century, the levels at which they are monitored and controlled
have.
Biocompatibility
Biocompatibility: A Quarter Century of Progress
Richard
F. Wallin
In the early years of the modern medical device industry, ensuring
biocompatibility was a major challenge. Much progress has been made.
Polymers
Polymers: Paving the Road of Medical
Device Progress 
Len Czuba
Some dramatic developments in medical polymers have enabled device developers to
push the technological envelope.
Package
Testing
Medical
Package Testing: It’s Come A Long Way, Baby
Stephen
Franks
A series of significant events provided the impetus to shift the importance of
package testing and package quality much closer to that of the device itself.
Packaging
1979–2004: Milestones in Medical Device
Packaging
Carl D.
Marotta
The past 25 years have been revolutionary for medical packaging, but it just may
be that the best is yet to come.
Sidebar: The Role of Heat-Seal Coating
in Seal-Peel Medical Packaging
Labeling
25 Years of Change: Medical Device
Labeling
Dave
Olson
Labeling techniques have undergone many changes since 1979. As a result,
the industry has been required to develop new regulations and attitudes toward
medical device labels.
EMC
Too Close for Comfort: EMI Meets Medical
Electronics
William
D. Kimmel and Daryl D. Gerke
The microprocessor revolution and the proliferation of electronics that followed
introduced the medical industry to electromagnetic interference.
Design and Engineering 
Advancing the Design of Medical
Electronics
Robert
Kay
The advent of visualization and integrated tools has enhanced the design
process and has provided an inherent ability to help document the resulting
design.
Contributors
MD&DI Authors: 1979–2004
Without the efforts of its hundreds of contributors, MD&DI would not have
flourished for 25 years. We gratefully acknowledge those authors here, and offer
our apologies to any whose names we have inadvertently omitted below.
In the Beginning
MD&DI: 25 Years of Helping Industry
Grow and Prosper
Sherrie Conroy
When Van Shears saw the need for a publication to serve the newly regulated
device industry, not even a snowstorm would stop her from making it happen.
Industry Pioneers
In this issue, MD&DI profiles
the following 25 medical device industry pioneers.
John Abele
Earl Bakken
Brian Baldwin
James Benson
Robert G. Britain
Annette Campbell-White
Bill Cook
H. Neal Dunning
Robert Fischell
Thomas Fogarty
Wilson Greatbatch
William Fred Hooten
Peter Barton Hutt
Andrew Lowery
Carl Marotta
John Masefield
Michael J. Miller
George Miser
Kshitij Mohan
Rodney R. Munsey
William P. Murphy Jr.
Paul G. Rogers
Manuel E. Villafaña
John Villforth
Richard Wallin
