Originally Published EMDM November
2004
Special Section
Notable People in Medical Technology
What do an engineer who developed segmental crimping technology, a knighted
CEO, and a now-retired trailblazing inventor who crusades for the practice of
holistic medicine have in common? They have all made an indelible impact on
medical technology. Not coincidentally, they are profiled in this section.
Over the summer, we polled a sampling of our readers, who made numerous recommendations
for this feature. Their choices were supplemented by some of our own, in consultation
with industry sources. Each of the individuals appearing in this section has
made a singular contribution to the medical device industry, but they are not
alone.
A handful of influential people who were nominated declined our invitation.
I recall one letter in particular, in which the reader lobbied passionately
for his choice: a “modest guy and unsung hero” in the orthopaedics
sector. His description was apt: the person was, indeed, modest to a fault,
and asked not to be included. That rejection and a small number of others were
disappointing, of course, but we felt an obligation to respect their wishes.
It should also be noted that the manufacturing focus of EMDM pointed us in a
direction that a more purely medical-oriented magazine might not have taken.
That is why you will find a certain number of entrepreneurs and major contract
manufacturers mentioned. From our perspective, they have been instrumental in
the evolution of the medical device industry, even though they may be largely
invisible to the public at large.
For these and some other reasons—not the least of which are the space constraints
of the print media—our salute to medical technology notables should not
be construed as an exhaustive list. There are hundreds, if not thousands, of
people whose contributions to the medical-technology industry deserve recognition.
In this section, we are proud to present some of them.
Heribert Argauer
Product Development Manager–Medical Plastics Systems
Wilden AG
Has worked in Wilden’s product development department since 1980 . . .
developed Softclix lancing devices for diabetics in cooperation with Boehringer
Mannheim (now Roche Diagnostics).
Pamela G. Bailey
President
AdvaMed
Heads the world’s largest medical-technology association, representing
more than 1100 firms . . . involved in health policy issues for more than 30
years . . . has served on the domestic policy staffs of two United States presidents.
Earl Bakken
Founder
Medtronic
Inventor of the first wearable, battery-operated external pacemaker . . . founded
Medtronic in 1949 . . . now retired, he is president emeritus of the North Hawaii
Community Hospital, which adheres to his code of holistic medicine.
Bill Castell
President and CEO
GE Healthcare
Was appointed to his present position in April 2004 after serving as CEO of
Amersham plc . . . member of the UK Medical Research Council . . . knighted
in 2000 for services to the life sciences industry.
Drago A. Cerchiari
CEO
Sorin
Was named CEO in January 2004 . . . has worked for Smith-Kline in the United
States and Latin America, Squibb in Latin America, Erbamont in Asia, and Medtronic
at its European headquarters in Switzerland.
Thierry Chignon
Principal Consultant, Managing Director
Quintiles Consulting
Former EC expert for medical devices and biological products . . . developed
directives 2000/70/EC, 2003/32/EC, 2004/23/EC . . . co- author of EN 12442 series
and chairman of CEN TC 316 and ISO TC 194 working groups.
Lester M. Crawford
US FDA Commissioner
Served as administrator of the Food Safety and Inspection Service and Deputy
Commissioner of FDA . . . Advisor to the World Health Organization . . . member
of the National Academy of Sciences Institute of Medicine.
Bjarne Flou
Managing Director
RTX Healthcare
In 1991, cofounded Penell, which pioneered the
development of wireless medical devices using Bluetooth . . . heads all healthcare
activities within RTX, which acquired Penell, and is managing director of RTX
Healthcare.
Adrian Flowerday
Founder
Docobo
Founded Docobo in 2001 to develop and market the doc@home service for home-based
monitoring of patients with chronic diseases . . . deployed across Europe, the
service received the World Summit Award for eHealth in 2003.
Roland Gerard
Director of Regulatory Compliance
St. Jude Medical Europe
Oversees government affairs, reimbursement, and regulatory compliance for Europe,
the Middle East, and Africa . . . member of the Global Harmonization Task Force
steering committee . . . sits on various EC committees.
Clive Gunther
CEO
Runfold Medical Ltd.
Founded Runfold Medical in 2000 to provide international med-tech OEMs with
a specialist outsourcing service for the design and manufacture of medical devices
in facilities that meet US FDA and ISO requirements.
David Harding
Director General
Sterile Barrier Association
Appointed SBA Director General in June 2004 . . . served as European operations
director for Rexam Medical Packaging from 1996 to 2003.
Brian K. Hutchison
Chairman, President, and CEO
Regeneration Technologies Inc. (RTI)
Joined RTI as president and CEO in December 2001 after 12 years with Stryker
Corp. . . . named a Technology Pioneer by World Economic Forum in 2004 for allograft
tissue sterilization technology.
J. Randall Keene
President and CEO
Avail Medical Products Inc.
Cofounder of a major outsourcing provider . . . established office in Luxembourg
in 2003 . . . 17 years in financial and operations management in the device
industry . . . formerly CFO of a medical products company.
Edward R. Kimmelman
Regulatory Affairs and Quality Systems Consultant
Convenor of ISO/TC 210 Working Group 1 on quality systems . . . has held engineering,
product management, and senior management positions at DuPont Co. and Roche
Diagnostics Corp., and served as chairman of HIMA (now AdvaMed).
Peter Kinast
President
Melab
Founded Melab, a Stuttgart University spin-off that produces quality assurance
equipment in 1984 . . . chairman of DIN Group B1 for injection systems . . .
is a lead auditor for ISO 13485 compliance and CE marking of medical devices.
António Lacerda de Queiroz
Head of Sector
Medical Devices, DG Enterprise, European Commission
Monitors and ensures implementation of medical devices legislation at European
level . . . responsible for international cooperation with third-country regulators.
Ruedi G. Laupper
Founder, Chairman Emeritus, and CTO
Swissray
Pioneered digital imaging technology with the introduction of the ddRMulti-System
in 1997. . . the company has received numerous awards, including the Frost &
Sullivan Market Engineering Award in 2002.
Ben Lipps
CEO
Fresenius Medical Care AG
Helped develop first hollow- fibre artificial kidney . . . led research team
that developed the first hollow-fibre dialyzer . . . led R&D into reverse
osmosis, medical membranes, blood oxygenation, and artificial kidneys.
Yoh-Chie Lu
Founder
Biosensors International
Founded Sun Instruments Japan, Sunscope International in California, and Biosensors
International in Singapore . . . was named 2004 cardiovascular CEO of the year
by Frost & Sullivan.
Jacques Marescaux
President
IRCAD, EITS
Founded IRCAD, which trains 3000 surgeons annually in laparoscopic surgery in
Strasbourg, France, and the European Institute of TeleSurgery in 1994 . . .
performed the first long-distance surgery between Strasbourg and New York in
2001.
Larry Minix
CEO
Swiss Medical Care S.A.
Founded Swiss Medical Care in 2003, which developed the CT Exprés Advanced
Contrast Delivery System, a recipient of the 2004 Medical Design Excellence
Awards . . . has more than 30 years of senior management experience in the global
healthcare industry.
Tom Motsenbocker
VP of R&D and Engineering
Machine Solutions Inc.
A founding partner of Machine Solutions Inc. . . . patent holder for core technology
and inventor of segmental stent- crimping, marker band–swaging, and balloon-processing
applications.
Steen Juel Nielsen
Managing Director
Torsana
Co-founded Torsana a/s, a Danish company involved in tissue- and cell-based
cancer therapies and innovative diabetes monitoring . . . chairs Eucomed’s
Innovation and New Technologies Task Group.
Dale R. Olseth
CEO and Chairman
SurModics Inc.
Steered SurModics from a small R&D company in 1986 to a public firm with
revenues exceeding $43 million . . . company holds more than 50 patents . .
. its surface-modification and drug-delivery technologies are used on more than
70 devices.
Jim Orkney
Managing Director
Kinneir Dufort
Leads a team that integrates design and prototyping for user interaction, aesthetics,
mechanical, electronics, and software innovation as well as packaging and brand
development . . . responsible for many award-winning designs for global healthcare
firms.
Miroslav Palat
Director, Clinical and Economic Outcomes, Central Europe
Johnson & Johnson
Chairs Eucomed’s Enlargement Focus Group. . . contributed to making the
2004 EU enlargement a success for the med-tech industry. . . board member of
CzechMed.
Guenter Paret
Project Manager
Philips Medical Systems
Participated in the development of the Avalon CTS Cordless Fetal Transducer
System, which received a 2004 Medical Design Excellence Award . . . holds patent
on device that optimizes fetal heart rate assessments.
Mike Pearson
Managing Director
Pearson Matthews Ltd.
Founded company in 1983 to design and develop products and devices for the medical
sector . . . Developed Persona contraceptive system, Clearblue pregnancy tests,
blood glucose monitors, and numerous invasive and noninvasive devices.
Patrick Peignot
Technical Director
NuSil Technology-Europe
Joined NuSil in 1999, following a career at Dow Corning, where he held various
technical positions . . . is named in two extrusion and moulding process patents
. . . has established a fully functional technical facility in Sophia Antipolis,
France.
Mark A. Saab
Co-owner and President
Advanced Polymers Inc.
Holds more than 30 medical device patents and has developed 1000 different medical
balloons . . . inventor of widely used heat-shrinkable tubing that is thin,
strong, and small . . . at C.R. Bard, developed industry’s highest pressure
PTCA balloons.
Joachim M. Schmitt
Director General
BVMed-German Medical Technology Association Heads BVMed . . . founded MedInform
in 1992 . . . authored commentary on and was one of the initiators of the German
Medical Devices Act (MPG) . . . represents the German medical device industry
at health ministry roundtable.
Michael Scholla
Senior Consultant
DuPont Medical Fabrics and Packaging
Cochair of ISO working group on medical packaging . . . chairs AdvaMed task
group on sterilization and packaging . . . holds six patents . . . expert on
antimicrobial activity in polymers.
Dan Schultz
Director
Center for Devices and Radiological Health (CDRH), US FDA
Named director of CDRH in July 2004 . . . served as chief of surgery at the
PHS Indian Hospital in Santa Fe, New Mexico, USA, for 11 years . . . former
director of the FDA Office of Device Evaluation.
Sharon V. Schulzki
Chief Operating Officer
MacroPore Biosurgery Inc.
Oversees the CE-marked Hydrosorb family of resorbable spine and orthopaedic
implants for lumbar and cervical interbody fusion procedures . . . manages development
of spine and orthopaedic applications for regenerative cell technology.
Jacques Seguin
Founder, Chairman, CEO
CoreValve S.A.
Launched several companies in the cardiac surgery and interventional cardiology
fields before founding CoreValve, which is dedicated to percutaneous aortic
heart valve replacement . . . has performed more than 4000 open-heart surgeries.
Henrik Søbygaard
Managing Director
Søbygaard Machine Design
Founded company in 1996 after a long career as head of production in leading
medical device companies . . . the firm’s manual to fully automated catheter
production equipment has been installed in global locations.
Ron Sparks
President, CEO, and Director
UTI Corp.
Orchestrated acquisition of MedSource Technologies in 2004 . . . joined UTI
in 2003 . . . had a 20-year career at Smith & Nephew plc, ending as president
of its endoscopy division.
Mike Tuke
Managing Director
Finsbury Orthopaedics Ltd.
Cofounded Finsbury in 1978 . . . innovator in the field of joint replacement
hips, knees, and related instrumentation . . . world leader in mobile knee design
and key figure in the initiation of metal-on-metal hip
resurfacing . . . holds 43 patents.
Paul J. Upman
Director of Scientific Affairs
NAMSA
Worked in the industry for nearly 30 years . . . developed models and protocols
for biocompatibility . . . adapted numerous methods of evaluating the blood
compatibility status of biomaterials and devices.
Willem van den Bruinhorst
CEO
Gurit Medical Business/Medisize
Developed a portfolio of airway management products . . . transformed Medisize
from a regional supplier into an international company with development and
subcontracting services.
Michael Weiner
President and CEO
Biophan Technologies
Develops technologies to make pacemakers and other life-sustaining medical devices
safe and compatible with MRI and associated equipment . . . has partnered with
NASA to develop implantable nanoengineered thermoelectric materials.
Kent Woods
Chief Executive
Medicines & Healthcare products Regulatory Agency (MHRA)
Took up chief executive position at MHRA in January 2004 . . . holds personal
chair in the department of cardiovascular sciences at Leicester University.
* Another med-tech notable, EMDM will celebrate 15 years of serving
the medical device industry in 2005! Don’t miss the party, starting with
the January/February issue.
Copyright ©2004 European Medical Device Manufacturer
