The medical device industry is well known for its technology, a central aspect that MD&DI covers in each and every issue. Less often noted are the many outstanding people without whom that technology would not exist. In the following pages, MD&DI pays special tribute to 100 of these individuals.
Many outstanding candidates were nominated by this magazine's readers. Not surprisingly, given the nature of this industry, it was a difficult task to choose only 100 people.
Every person in this group has made significant contributions to the industry. But this is not meant to be a “top 100” list. Rather, it is intended to represent the wide diversity of individuals that make up this industry. From CEOs of large corporations to freelance engineers, from physician inventors to public health officials, from the well-known to the unfamiliar, this group reflects the face of the industry.
Practical considerations of space limit the amount of information that can be given for each of these 100 people. However, 16 of them from representative areas of the industry have also been profiled at greater length. Together with their 84 peers, they are examples of what makes this industry so special.
Pamela G. Bailey
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 presidents.
Leading consultant in sterile package design... coauthor of ISO 11607... has written many technical articles and lectured around the world... has served for several years as a juror for the Medical Design Excellence Awards.
Arthur A. Bertolero
Developed products in a small, privately held company... focused on tools for less-invasive surgical approaches for heart-related diseases and defects, including endoscopic coronary artery bypass surgery on a beating heart.
The MedTech Group
Involved in the engineering and manufacturing of disposable products for 41 years... member of the National Association of Manufacturers President's Council... sponsor of the Memorial Sloan-Kettering Cancer Center.
Executive VP and General Manager,
Cochair of AAMI Microbiological Committee and ISO delegate... authored many sterilization and validation articles for industry journals... runs business and technical operations at AppTec's Atlanta facility.
Specialized Medical Devices
Founded Swiss-screw parts manufacturer HDJ Company Inc. in 1962... founder of Specialized Medical Devices Inc. ... is a trustee for the Precision Machines Products Association.
Quality Systems Manager
Recipient of the 1997 Innovation Research Award... author of two publications, one for the IEEE Engineering in Medicine and Biology Conference, and the other for the University of Akron in Ohio.
Peter B. Carstensen
Senior Systems Engineer
Represents CDRH on human factors, anesthesia products, and respiratory devices... human factors engineering team leader at CDRH... convener of two IEC working groups.
Former employee of Johnson & Johnson for more than 23 years... winner of a gold award in the Medical Design Excellence Awards for a catheter safety system... a member of an ISO TC84 committee from 1990 to 2001.
Manager, Clinical Affairs,
Vysis Inc., an Abbott Laboratories Co.
Developed IVD products... presented eight round-tables on outcomes and conduct of industry point-of-care and home-use testing product evaluations... helped develop IVD standards.
Lester M. Crawford
Acting FDA Commissioner
Took over top post at FDA in March 2004 when Mark B. McClellan left to head CMS... was also acting commissioner from February to November 2002... has served FDA in various capacities.
J. Michael Cude
COO and VP of Engineering
Chairman of the Medical Plastics Division of the Society of Plastics Engineers…holds patents for cardiology and surgery devices… helped four separate facilities achieve ISO certifications.
Thirty-year industry veteran has specialized in design and development of disposables... participant in Society of Plastics Engineers and current president-elect... regularly leads materials seminars at MD&M conferences.
of Instruments and Implants
Holds more than 35 U.S. patents for medical devices, neurosurgery, and orthopedic surgery fields... first recipient of the “Patent of Distinction” award given by Medtronic for cardiovascular tined lead patent.
Joel S. Douglas
Chief Technical Officer
Developed the first alternate-site glucose meter and the first FDA-cleared mimimally invasive insulin infusion set... holds 59 U.S. patents and has had 25 products approved by FDA.
Ronald B. Earle
Group Senior VP
B. Braun OEM/ Industrial Div.
Oversees OEM and international divisions of $3 billion device maker... longtime global industry presence in both medical devices and pharmaceuticals... board member for MDMA and Biomet Ltd.
MedSource Technologies Inc.
Cofounder of MedSource Technologies Inc., a manufacturing and engineering services and supply chain managment group... founding partner of Kidd & Co. venture management firm.
Stuart M. Essig
Integra LifeSciences Holdings Corp.
Responsible for building distribution channels, acquiring complementary products, and investing in product development... serves on board of directors for St. Jude Medical Corp.
Bridge Design Inc.
Design engineer from the UK founded a consultancy in 1992... the prolific author has won multiple design awards... projects include a Smiths Medical insulin pump... aficionado of Latin and jazz percussion and guitar.
Douglas G. Evans
Kensey Nash Corp.
Key in development of Angio-Seal vascular closure system and other resorbable products... leading commercialization of Triactiv Embolic Protection System... holder of 32 patents, he is also a dedicated triathlete.
David W. Feigal Jr.
Head of Devices and Biologics Practice Areas
NDA Partners LLC
Headed CDRH for five years until leaving in April 2004... implemented user fees and third-party reviews and inspections reforms... held positions at CBER and CDER from 1992 to 1999.
John P. Friel
President and CEO
His company received the Malcolm Baldrige National Quality Award in 2003… began company's total quality management system 15 years ago… focuses on automation rather than manual processes.
Managing Director, Senior Research Analyst
Follows cardiology and medical companies…spent 25 years covering medical devices, 13 in industry and 12 on Wall Street…focuses on marketing and project management.
Frederick C. Haer
Founder and Owner,
Singularly responsible for the development of microelectrode needles…developed specialized devices essential to nervous system research…founded FHC 34 years ago and developed it into a 60-employee business.
Manager, Plant Operations
Oversees major gamma irradiation facility…holds three medical disposables patents…developed standards for radiation materials selection, testing techniques, and processing methods.
Vice President, Engineering
Led the engineering effort to develop and launch a new bioabsorbable mechanical closure…developed a complex aortic stent…turned an early concept into a viable commercial product.
Founder and President
Founded Qosina in 1980…global insight into the industry enabled him to introduce many new product concepts from one continent to another…built a team of more than 80 people.
President and CEO
Applied Medical Resources Corp.
Testified on bundling and other anticompetitive practices before FTC and the U.S. Senate…committed to finding healthcare solutions at affordable costs…company has 400 patents or patents pending.
Linda Howe Garriz
Manager, Quality Assurance,
Alcon Manufacturing Ltd.
Chair of the Biomedical Division's Southern California Discussion Group…dedicated to providing quality education and training for Southern Californian professionals.
Executive Vice President
Started company that designs and manufactures implants…addresses difficult surgical problems with easy-to-use products…vice president of Surgical Implant Generation Network and ARC Surgical.
VP, Product Development
Oversees all product development efforts…20 years experience in developing medical products… helped establish and improve
Minnetronix's medical device design controls system.
Mae C. Jemison
Founder and President
Former astronaut and physician designs and develops NASA-patented ambulatory equipment… Directed Dartmouth's Jemison
Institute for Advanced Technology in Developing Countries.
Develops and commercializes physiological imaging platforms… uses her experience in clinical nursing, clinical trials, regulatory, and sales and marketing to design and develop medical products.
Hogan & Hartson
Thirty-year veteran in medical device law is author of two authoritative books and numerous articles... has represented hundreds of device companies before FDA... his activities have had a major impact on FDA policies.
Founder and President
Stuart Karten Design
Award-winning designer with 20 years experience... a recipient of a Medical Design Excellence Award... advisor for USC degree program for medical device engineering.
J. Randall Keene
Avail Medical Products Inc.
Cofounder of a major outsourcing provider... 17 years in financial and operations management in the device industry... formerly CFO of a medical products company... director of several privately held companies.
Brian S. Kelleher
Founder of Paragon Medsystems and founder and CEO of EndoMorphix... has 25 years of industry service... recipient of the Von Helmholtz award for outstanding contributions to biomedical engineering.
Medical Product Development Chemist
Adhesives Research Inc.
Worked on blood glucose devices, wound care, and blood coagulation projects…developed a medical adhesive tape system for noninvasive skin-harvesting applications.
Chairman and CEO
A named inventor on more than 30 patents for signal processing, sensors, and patient monitoring…helped start-up company grow to have 300 employees, a global technology-license, and product-distribution agreements.
Director, Office of Combination Products, FDA
Develops policies and procedures for premarket and postmarket regulation of combination products…had two stints at CDRH before taking his current position in 2002... involved in combination product review.
Manager of Research and Technology,
Patient Interface Div., ResMed Ltd.
Invented more than 20 interface mask systems for treating sleep apnea…developed expertise in interface technology to improve patient compliance.
Chief Technical Officer
Arbor Surgical Technologies
Designed a porcine heart valve and a bovine pericardial heart valve…addressed disadvantages of tissue valves, including limited durability…developed various other cardiac-related products.
Robert S. Langer
Professor of Chemical and Biomedical
Has more than 500 issued or pending patents worldwide…received the Charles Stark Draper Prize in 2002…the only engineer to ever receive the Gairdner Foundation International Award.
Curtis L. Larsen
DuPont Medical Packaging
Cochairs IoPP's Medical Device Technical Committee... led packaging-related technical committees for ASTM, AAMI, and AdvaMed... worked in packaging for more than 30 years.
This lawyer runs day-to-day operations of a 200-member industry trade association... an advocate for the concerns of small, innovative device companies on user-fee, reimbursement, and hospital purchasing issues.
Managing director in fundamental equity research... specializes in medical technology… was a member of Emerson Hospital for 10 years and continues to serve as corporator of that organization.
Advanced Sterilization Products
Received Philip B. Hofmann Research Scientists Award for excellence in research in 1987…researches and evaluates new sterilization ideas and technologies…helped develop the Sterrad sterilization process.
EXPERTech Div., Boston Healthcare Associates
Set the tone for medical device regulation while at FDA from 1969 to 1980…first director of what eventually became CDRH…provides guidance in the areas of quality control and validation.
Fresenius Medical Care AG
Helped develop first hollow fiber artificial kidney… led research team that developed the first hollow fiber dialyzer…led R&D into reverse osmosis, medical membranes, blood oxygenation, and artificial kidneys.
Medical Device Development Facility, USC
One inventor of the cochlear implant… original inventor of award-winning Bion neuromuscular stimulator… author of 38 issued patents... wrote more than 200 articles on neurophysiology and neural prosthetics.
Alfred E. Mann
Chairman and CEO
Created a foundation to conduct scientific and medical research for medical disabilities by developing innovative bionic solutions…founder of a manufacturer of microinfusion and continuous glucose monitoring systems.
Former general counsel and senior VP at HIMA… helped shape HCFA's negotiated rulemaking process on diagnostic tests coverage…developed the industry's reimbursement agenda for the 106th Congress.
Gerald E. McGinnis
Founder and Chairman
Named entrepreneur of the year by the Washington and Jefferson College for a benchmark innovation... also received the Entrepreneur award from the Carnegie Science Center.
Chairman and CEO
Cofounded Zevex and built it into a company with more than $25 million in annual revenues and 170 employees… provides medical product design and manufacturing services.
Coauthor of ISO 11607... chair of ASTM F02.60 subcommittee on medical packaging... served as longtime director of packaging technology at Johnson & Johnson before retiring and starting a consultancy in 2003.
S. Fazal Mohammad
Utah Artificial Heart Institute
Expert in the field of device hemocompatibility…played leading role in improving the hemocompatibility of many blood-contacting devices… professor of pathology at the University of Utah School of Medicine.
Conducts safety and performance testing for the device industry…performs FDA-accredited third-party 510(k) reviews…spent 21 years at ECRI, investigating many device problems and hazards.
Walter Mosher Jr.
Precision Dynamics Corp.
Invented first ID bands…pioneered RFID to create ID devices and systems that reduce the risk of medical error…currently developing organic semiconductors and polymer-based RFID devices.
VP of Product Development
Medical Design Excellence gold award and Product Design & Development's engineering award winner... cofounder of Gilero... local high school science and biomedical engineering volunteer.
VP of R&D and Engineering
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.
Nelson Laboratories Inc.
Drafted or contributed to the improvement of many industry standards…provides seminar training in sterilization and cleanroom management…founded company in 1969.
Chairman, President, and CEO
Heads a company that specializes in nucleic acid diagnostics…formerly president of a company focused on treating inherited diseases…was with Pfizer Inc. for 16 years in the United States and overseas.
Advanced Bio Prosthetic Surfaces Ltd.
Inventor of first commercially successful stent… developed the stent graft…he holds 20 patents... his company uses nanotechnology to develop interventional cardiology products.
Product Director, Healthcare Materials
Helps both large and small companies navigate product qualification and regulatory processes for silicone materials... holds three patents for improving elastomer for electrical pacing leads.
Manager of Customer Service
Titan Scan Technologies
Recognized authority on legal issues relating to medical devices…more than 30 years representing device clients… general counsel to MDMA…a key developer of FDA's regulatory program for medical devices.
Victor L. Poirier
Chief Technology Advisor
Inventor of the implantable Heartmate Left Ventricular Assist System for cardiac transplant and destinations therapy... founder of Thoratec Corp... member of the National Academy of Engineering.
Joseph A. Popper
Popper & Sons
Third generation to hold the position of president of family-owned business…manufactures hypodermic needles and supplies reusable medical and laboratory products…manufactures custom specialty components.
Robert R. Reich
Pharmaceutical Systems Inc.
Helped draft guidelines on issues for packaging integrity…has authored more than 70 articles on subjects including bacterial sporulation, biological indicators, package integrity, and medical devices.
Global Program Manager, Medical Devices
Underwriters Laboratories Inc.
First FDA staffer to involve industry in development of guidance documents…member of the ISO/IEC Joint Working Group on Risk Management since its inception in 1996.
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.
Battelle Product Development Solutions
Fiercely dedicated to the art and science of rapid prototyping…multiple device development projects…proponent of involving the prototyper early in a medical device project.
Professor of Surgery
University of Washington Medical Center
Designed and manufactured battery-powered aspirators... helped make disposable collection components, sealed lead-acid batteries, and regulated vacuum standard in EMS field aspirators and hospital-suction devices.
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.
Daniel G. Schultz
Headed CDRH's Office of Device Evaluation... at forefront of implementing user-fee system and other CDRH reforms... had distinguished surgical career before joining CDRH in 1994... became acting director in April 2004.
Frederick F. Schweitzer
Director, Continuing Engineering
Welch Allyn Inc.
Industry member for more than 27 years... worked closely with FDA as an industry representative for design controls... recipient of former Vice President Al Gore's “Hammer Award” in 2000.
Sr. VP, Diagnostics
Div., Bayer HealthCare
Created a worldwide quality management system…was key in obtaining approval of the first PMA for an MRI…serves on AdvaMed's committee for technology and regulations.
Thomas J. Shaw
President and CEO
Retractable Technologies Inc.
Inventor of automated retraction safety needle devices and blood collection devices to eliminate accidental needlestick injuries…developing other medical safety products using friction ring technology.
Principal Engineer Stent Systems Development,
Abbott Vascular Devices
Developed materials for implantable devices…chair of Medical Device Task Force of ASM International…chair of the first Materials and Processes for Medical Devices Conference.
Thomas J. Sommer
In eight years has raised this regional device organization to national prominence... plays key role in luring device companies to Massachusetts... has worked with senior public officials to help shape device law.
Manager EtO TechTeam
STERIS Isomedix Services
Serves on AAMI committees, formulating guidelines for industry…validates process for safe and efficient sterilization for many different types of medical devices.
President, CEO, and Director
Orchestrated acquisition of MedSource Technologies... joined UTI in 2003... had a 20-year career at Smith & Nephew plc, ending as president of its endoscopy division.
Technical Fellow of Packaging
Coauthor of ISO 11607... cochairs IoPP's Medical Device Technical Committee... served on AAMI, ASTM, and AdvaMed packaging technical committees... has worked at Medtronic for 30 years.
Nancy J. Stark
Clinical Device Group Inc.
Dedicated service to clinical device research…speaker, teacher, and author of clinical device educational materials…conducts an annual
survey of clinical studies in the United States and Europe.
Stellartech Research Corp.
Founded company to design, develop, and manufacture medical devices under contract to device companies…designs and manufactures ablation and thermal therapy devices and systems.
John F. Stigi
Director, Division of Small Manufacturers
Has educated the global medical community on FDA policies, procedures, and regulations for more than 25 years... developed accreditation processes for FDA's third-party programs.
Baker & Daniels
Chairs the drug and medical device law practice… counsels medical device companies on a wide range of reimbursement issues…counsel to AdvaMed… invented method for assessing compliance with FDA requirements.
Office of Compliance, CDRH, FDA
Wrote the final quality system regulation and preamble published in 1996... chairs Global Harmonization Task Force Study Group 3... gives presentations on GMP and quality systems.
Paul J. Upman
Director of Scientific Affairs
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.
Peter von Dyck
President and CEO
Zassi Medical Evolutions Inc.
Recent winner of Medical Design Excellence award for the Zassi bowel management system… named the Ernst & Young Entrepreneur of the Year for healthcare and life sciences in Florida.
Founder and CEO
Polymer Technology Group
Developed many biomaterials… developed BioSpan to be used in Ethicon's heart-assist devices… introduced a polyetherurethane for applications that require implant times greater than 90 days.
Matthew B. Weinger
San Diego Center for Patient Safety
Led the development of AAMI's medical device design process guide and guidelines on applied human factors design… researches human factors–related issues pertaining to anesthesia.
Independently investigates complaints from industry about CDRH... resolves CDRH disputes with device sponsors, applicants, and manufacturers... has held a number of counsel positions with FDA and HCFA (now CMS).
VP, Sales and Marketing
Integrated BioSciences Inc.
Has more than 40 years experience in research and development of medical devices... innovator of transfer devices... one of the first advertisers in MD&DI magazine.
American Institutes for Research
Makes devices like heart monitors user-friendly…helped write national and international standards for designing safe devices…chairs Medical Section of Industrial Designers Society of America.
Stephen B. Wilcox
Pioneer in use of observational user research, human factors, and interaction design… serves as VP for IDSA, chairing the human factors division…serves on AAMI/ANSI committee for human factors in medical devices.
W. Robert Worrell
An industrial design and product development consultant to the device industry for 28 years... serves on AAMI committees on design and human factors… collaborated on several Medical Design Excellence Award winners.
Founder and President
BME Tech Ltd.
Formulated an adhesive for ultrasound transmission and improved on ultrasound technology... created outer-control built-in pacemaker and other medical design solutions... 20 years industry experience.
Technical Research Director
Developed and designed a microwave spectrometer to measure EtO concentration and water vapor in the sterilization process…spectrometer has been key to successful parametric release processing.
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