The medical device industry consists of products, processes, and technology. These are covered in almost every issue of MD&DI. But it also consists of people, without whom none of the amazing advances in medical science and technology would be possible.
In this issue, MD&DI honors some of the people who make these advances possible and who ensure that those devices can treat patients safely and effectively. If we tried to list everyone who has made a significant contribution to medical technology, we would have to publish an issue larger than a phone book. So we're highlighting 100 of them on the following pages.
It wasn't easy coming up with a representative list. We started with nominations from readers, Editorial Advisory Board members, and staff. We took those who made particularly notable contributions to the industry and made sure that we had as diverse a group as possible. On the list you'll find a sampling of inventors, executives, consultants, engineers, academics, and regulators. Some of them you'll know from previous coverage in MD&DI or accolades elsewhere. Others you might be hearing of for the first time.
We hope you enjoy their stories.
Consults for U.S., Canadian, and European organizations…ASQ-certified quality engineer and quality auditor…participates in industry and FDA panels on design control and product submissions.
Advocates chemical and material characterization in medical devices…has more than 25 years of lab experience in biochemistry and pharmacology… member of AAMI and several other industry organizations.
Board of Directors, CoAptus Medical
Invented Rotablator…invented and coinvented devices for endoscopic control of gastric bleeding, an electrosurgical device for transcatheter hemostasis, and bipolar forceps for neurosurgical bleeding.
R. Lewis Bennett
Has more than 50 years of experience in industry…has held senior positions at NuVasive Inc., Sofamor Danek, and Smith & Nephew…founder of Howmedica Corp.
King & Spalding LLP
Recognized lawyer with expertise in regulatory counseling, compliance program development, advertising and promotion, and civil and criminal investigations…thought leader for the device industry.
Mortimer Berkowitz III
President and Managing Dir.
Responsible for $450 million investments into musculoskeletal industry...instrumental in increasing the revenues of four device companies.
Micro Engineering Solutions
Specializes in tiny microscopic components and assemblies...has helped hundreds of development engineers complete their goals of compliance for minimally invasive surgical devices.
Michigan State University School of Packaging
Vice-chair of ASTM Committee D10.32, Committee on Consumer, Pharmaceutical, and Medical Packaging...U.S. expert on ISO/TC 122 inclusionary packaging guideline.
VP of Sales and Marketing
B. Braun Medical Inc., OEM Division
Has more than 20 years of OEM industry experience with B. Braun…frequently speaks on trends and management issues…expertise sought by industry publications.
The MedTech Group
Founded plastics technology firm dedicated to engineering and manufacturing of disposable medical products 30 years ago...corporate research sponsor of the Memorial Sloan-Kettering Cancer Center.
FOI Services Inc.
Began educational audioconferences that address critical issues in the device industry…provides industry with unpublished FDA information via the Freedom of Information Act…speaker and author for RAPS.
President and CEO
Has grown a small dental implant company into a firm that has a 35% annual growth rate…recently acquired dental software company ILS to enable users' access to software technology.
John Broad SM, RM, NRM
Has been a leader in industrial microbiology and sterilization for nearly 30 years…has served on several standards committees for AAMI and ISO.
President, CEO, and Chairman
Transoma Medical Inc.
Has written more than 25 articles in bioengineering and medical publications…holds more than 25 patents in the field of implantable medical devices…in the industry for more than 25 years.
Developed custom resorbable and regenerative implants…submitted a patent for 3-D structures created from bioresorbable nonwoven BioFelt…more than 20 years of experience in biomaterials.
Devon C. Campbell
Eng. Manager, Primary Staining
Ventana Medical Systems Inc.
Engineer of two MDEA-winning products…mentors students to pursue careers in medical field…established engineering internship program.
Thomas Colonna, PhD, JD
Johns Hopkins University
Spearheaded internship program for CDRH and Johns Hopkins University…works in school's bioscience regulatory affairs to promote understanding of device regulations.
Kevin L. Cornwell
Chairman & CEO
Utah Medical Products
Heads firm that makes products for women's and children's health…In 2005, the company defeated FDA in court over inappropriate enforcement actions.
VP, Biomaterials Research
Focuses on polymeric biomaterials for implantable electronic, hydrogel, and drug-delivery devices…received 2007 Innovation and Technology Development Award of the Society for Biomaterials.
Barrett C. Craner
Director, Quality Assurance
Lipid Sciences Inc.
Four certifications from ASQ, and RAC certification from RAPS…on the White House Council on Y2K (medical devices)…Pacific Region Industry Perspective speaker at 2006 FDA centennial celebration.
Robert Crockett, PhD
Assoc. Professor, Interim Chair of Biomedical and Engineering
California Polytechnic State Univ.
Developed MEDITEC program to facilitate projects between students and device OEMs…develops materials and manufacturing processes.
Promoted coextrusion as technique for manufacturing catheter tubing applications…helped develop technology that has enabled medical device companies to design more-sophisticated catheters.
VP, Global Regulatory Affairs
Advanced Medical Optics Inc.
Formerly VP of global regulatory affairs at Kinetic Concepts Inc.…more than 25 years of regulatory and professional management experience in the medical device industry.
William Duffell Sr.
Director, Government Relations
Gambro BCT Inc.
Helps foster relationships between industry and FDA, focusing on education…part of a group that worked with FDA to develop the first AAMI course and QSR exam.
Signe Erikson, PhD
Director of R&D
Ophthalmology Business Unit
Key to the invention and development of the I-vation system that delivers drugs to the back of the eye…winner of SurModics' Catalyst Award for her contributions.
David R. Fischell, PhD
Angel Medical Systems
Founder and cofounder of nine device firms…holds 86 patents…inventions include arterial access needles, balloon catheters, and neurostimulators…helped design BX Velocity and Cypher stents.
Donald A. Goer, PhD
Chief Scientist and Cofounder
Intraop Medical Inc.
Expert on linear accelerator technology…developed Varian's cancer therapy equipment…Intraop provides the only mobile and self-shielded electron linear accelerator.
Director of Operations
Gyrus ACMI Inc.
Made strong contributions to Gyrus's urology division…supports training and leads development of new digital technology…seeks ways to make technology affordable to patients.
Founder and President
Pacific Bridge Medical
Frequent speaker and author on Asia business development and regulatory issues…his firm has helped more than 200 companies get a foothold in various Asian countries.
Professor of Bioengineering
Pioneered pulse ultraviolet excimer lasers for biomedical applications…consults to ODE and to the Army's West Coast Telemedicine and Advanced Technology Research Center.
Statistical Programming Quintiles
International healthcare industry expert and speaker…developed best practices in SAS statistical programming training courses…wrote three books on SAS software.
Chief Technical Officer and Cofounder
Developed nanotechnology to address need for small-diameter vascular grafts with high patency rates shown at six months…cofounded NanoVasc to license the technology.
Brought Biocoat from a small set of patents held by the nonprofit research arm of a college to a player in the biocompatible coatings industry…company is now entering the in vitro fertilization market.
William H. Howell
First Principal Asst. for Acquisition
U.S. Army Medical Research and Materiel Command
Runs product development and acquisition for the Army…works on adopting medical technologies for the battlefield.
President and CEO
Precision Dynamics Corp.
Heads patient identification products firm, focusing on patient safety and quality...company developed the first patient ID wristband and helped pioneer bar coding and RFID systems in the patient setting.
Human Factors Program Manager
Cochair of AAMI's human factors engineering standards committee…member of the ISO-IEC work group on device usability, and of the NAS committee on human-system design support.
Stellartech Research Corp.
Developed RF heating and ablation systems for cardiology, gastroenterology, urology, and skin-tightening applications…named inventor on 34+ U.S. patents…
25+ years of product development.
Mark C. Jones
President and Founder
Fortress Medical Systems LLC
Launched Clindex, the first integrated software for medical device trials…enables firms to conduct clinical trials efficiently and cost-effectively with validated tools.
Senior Product Manager
Pilgrim Software Inc.
Worked with FDA on development of new CDRH eMDR program, providing input into eMDR document requirements to improve the efficiency of the eMDR submission process.
Raju Kammula, PhD
RK Consulting Services LLC
International expert in materials toxicology…guided development of first FDA guidance to evaluate biocompatibility…served as technical expert ISO 10993.
Office of Science and Engineering Laboratories
Serves as chair of Global Harmonization Task Force, which fosters regulatory harmonization among developed nations, and provides a blueprint for developing nations.
Joe E. Kiani
Chair and CEO
In the midst of a two-year term as chairman of the Medical Device Manufacturers Association's board of directors…instrumental in getting group purchasing organizations to reform their practices.
President and CEO
Alphatec Spine Inc.
Achieved significant milestones at Alphatec by improving new technology pipelines, reaching record revenues, and attracting a strong executive team…former president of Aesculap Inc.
Robert S. Langer, PhD
Professor of Chemical and Biomedical Engineering
Holds 600+ patents…Forbes and Bio World named him one of 25 most important individuals in biotech…only engineer to receive Gairdner Foundation International Award.
PaxMed International LLC
Chair for Subcommittee ASTM F4 and Subcommittee 8 on dental implants for ADA…regulatory, quality, and clinical trials consultant to orthopedic and dental device firms.
Mark B. Leahey
Heads trade association representing small, innovative makers of medical devices, diagnostics, and information systems…lobbies Congress, FDA, and CMS on user fees and reimbursement.
ATech Designs Inc.
Inventor of SmartSite needle-free valve…designer of percutaneous mitral valve repair devices, devices to treat abdominal aortic aneurysms, and laparoscopic suturing devices…holds several patents.
Director of Marketing
Combined clinical and business background to drive development and sales of wound care, ostomy, and incontinence products, including a 2007 MDEA winner…participates in advocacy groups.
Founded firm to bridge device industries in United States and Eastern Europe…has written more than 20 papers on devices, ultrasonics, and precision technologies…holds four U.S. patents.
Gerald E. McGinnis
Board Chair and Advanced Technology Officer
Founder of Respironics…sold firm to Phillips in 2007 for more than $5 billion…internationally published author…holds more than 15 patents.
Cofounder and CEO
Pioneer in the field of medical robotics...cofounded Intuitive Surgical Inc. and Origin Medsystems…was medical director of Guidant's Surgical Device Division, and is on the board of Mako Surgical.
Gregg A. Mosley
Biotest Laboratories Inc.
Has more than 35 years of experience as a microbiologist, chemist, and biochemist…has presented courses and seminars for FDA, AAMI, and the American Society for Quality.
Expert Regulatory Review Scientist [Software Compliance]
Office of Compliance, CDRH
Internationally known expert on regulatory compliance of device software…serves as CDRH's rep on the Part 11 committee.
Lawrence Muscarella, PhD
Chief, Infection Control and Director, R&D
Custom Ultrasonics Inc.
Expert in infection control and endoscope reprocessing…editor-in-chief of The Q-Net Monthly…developed reprocessing guidelines.
Michael A. Mussallem
Chairman and CEO
Heads world leader in heart valve technologies…engineered firm's spin-off from Baxter International in 2000…elected in March as two-year-term chair of AdvaMed's board of directors.
More than 22 years in product development for artificial heart electronics, cardiopulmonary bypass systems, and laser imaging…patents include telemetry systems for implants and networked cardio bypass systems.
Director, Office of Combination Products, FDA
Coordinates U.S. regulation of combination products…in previous post as director of ODE's Premarket Approval Section, led effort to ensure that ODE reviewers met MDUFMA goals.
Robert A. North
Human Centered Strategies
Has more than 30 years of experience in human factors research…serves on AAMI's Human Factors Standards Committee, which developed the HE-75
Certified Compliance Solutions
Trains firms for field investigators and prepares inputs for FDA validation guidance documents…is an ISO 9001 RAB–certified lead auditor and a reviewer for ISO work group 10.
President and CEO
Created leadership model for area biotechnology and medical device trade groups…represents more than 570 device, biotech, and pharmaceutical companies in Southern California.
Albert P. Pisano, PhD
FANUC Chair, Dept. of Mechanical Engineering
Founder of six start-up companies in drug delivery, sensorized catheters, and MEMS…holds several patents…fellow of the American Society of Mechanical Engineers.
Ramon E. Poo
Biorep Technologies Inc.
Holds numerous patents and helped develop equipment to isolate islet cells from the pancreas, enabling advanced-stage diabetics to receive transplants that allow them to live insulin-free.
Has provided technical assistance for more than a decade, specializing in precise temperature measurement and helping clients find products with accuracy and stability.
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 the world's thinnest, strongest, and smallest heat-shrink tubing.
Helps firms prepare for FDA marketing applications and provides regulatory assistance for clinical trials and quality systems compliance…provides training on joint efforts with FDA.
Genisis Design Inc.
Has 15 years of experience in the medical device industry…produced mechanical designs for more than 30 projects including catheters, guidewires, and stent-delivery devices…inventor in 19 patents.
John Saunders, MD
Vice President MR Systems
Lead developer of high-field MR scanner that takes images in an operating theater without moving the patient during surgery…scanner used in more than 1500 neurosurgeries worldwide.
President and Founder
Schena Ostomy Technologies
Invented an irrigation and cleansing system for a colostomy bag called the Schena Ostomy EZ Clean System, following a colorectal cancer diagnosis more than four years ago.
Daniel G. Schultz
Heads center that is responsible for U.S. regulation of medical devices and diagnostics…has made postmarket surveillance of devices a priority for FDA…implemented a number of reforms mandated by MDUFMA.
John Scoville Jr.
Fellow, Regulatory Affairs Sterilization Technology
Active in the AAMI sterilization standards development…has 14 patents for devices in electrosurgery, biological and chemical indicators, and disinfectant sterilants.
Executive VP of Research and New Product Dev.
Developed about 75 types of devices for endoscopy, laparoscopy, plastic surgery, and microsurgery—products that generated hundreds of millions of dollars…holds 15 patents.
Ronald Sherman, MD
Cofounder and Laboratory Director
Monarch Labs LLC
Conducted clinical studies of medicinal maggots for treating chronic wounds, leading to Medical Maggots (first live animal to achieve FDA marketing clearance).
Unilife Medical Solutions
Founded company to try to eliminate the transmission of blood-borne diseases such as hepatitis and HIV. He developed a single-use safety syringe to further efforts in this field.
Senior VP, Corporate Regulatory and External Affairs
Responsible for all regulatory activities within BD worldwide…frequent speaker at various professional meetings…active in FDLI, AdvaMed, and RAPS.
Wilmer L. Sibbitt Jr., MD
Prof. of Internal Medicine, Rheumatology, and Neurology
University of New Mexico
Cofounded companies in interventional radiology and cardiology, and magnetic resonance contrast agents…supported by NIH grants.
Paul J. Silver
Huron Consulting Group
Compliance and regulatory expert with 20+ years of experience…considered a thought leader…works with firms to improve operations, mitigate risk, and support legal counsel.
Founded the Medical Technology Learning Institute within AdvaMed to train on FDA/CMS requirements…produces seminars and training…conducts benchmarking surveys and shares data.
Founder and CEO
Founded Aperio to develop digital pathology technologies, including digitization of a glass slide…dramatically improved the efficiency and quality of pathology services.
Northern Operations, Mack Molding Co.
Headed Mack's move into medical devices, expanding quality management systems and manufacturing technologies…firm is now recognized as successful in the device market.
Sales Manager, USA
Degania Silicone Inc.
Led the development of polyimide/thermoplastic hybrid tubing designs for microdiameter catheters, which corrected thermal bonding problems and paved the way for assembly bonding.
President and Principal Technical Lead
Mystic Pharmaceuticals Inc.
Developed a novel platform for precise unit-dose and multidose intranasal and ocular delivery of drugs to offer more-efficient packaging and safer dispensation.
Wayne Taylor, PhD
Taylor Enterprises Inc.
Expert in process validation, including writing an annex of a GHTF guideline…developer of analyzer software…consults and trains on the Six Sigma approach…frequent author.
G. Lawrence Thatcher
Tesco Associates Inc.
Helped develop and select materials for more than 225 medical implants device firms…has worked diligently in the background to advance biomaterials science.
Office of Device Evaluation, CDRH, FDA
Heads office for premarket approvals…began FDA career in 1994 reviewing ob-gyn devices…was ODE deputy director of technology and review policy before being tapped to run office.
Chairman and CEO
U.S. Army veteran boosted local employment by venturing into medical manufacturing…founded company that specializes in contract injection molding and assembly.
Gerald Timm, PhD
Founder and President
GT Urological LLC
Prolific developer of urological devices for incontinence and erectile dysfunction for 40+ years…pioneered research on electrical bladder stimulation and fluid energy transfer systems.
Kimberly A. Trautman
Medical Device Quality System Expert
Frequent speaker on device quality and regulatory compliance…played significant role in CDRH taking a more risk-based and systems-based compliance approach.
A noted expert on packaging material selection, shelf-life testing, performance testing, and equipment validation…serves on the AAMI working group for ISO 11607 and TIR 22.
Stephen J. Ubl
President and CEO
Has led the world's largest medical technology association since 2005…in previous stint at AdvaMed, headed federal government relations office…named a top association lobbyist by The Hill in 2007.
Timothy A. Ulatowski
Director, Office of Compliance
Manages four divisions that promote quality and enforce device and radiological health regulations…has been with FDA since 1974, and with the Office of Compliance since 2003.
Kips Bay Partners LLC
Leading device industry entrepreneur and marketer…founded several device companies including St. Jude Medical, GV Medical, ATS Medical, CABG Medical, and Cardiac Pacemakers.
Intertech Engineering Associates
Facilitates product design compliance with QSR through product verification and validation for software-based instrumentation…frequent industry contributor and speaker.
Martin Von Dyck
Biosearch Medical Products
Has designed nasogastric feeding tubes, coagulation probe catheters, biliary stents, jejunostomy catheters…architect of medical coatings used to coat urological and cardiovascular microcatheters.
Andrew C. von Eschenbach
Sworn in as FDA's 20th commissioner in December 2006…previously headed the National Cancer Institute and is a cancer survivor himself…is a nationally recognized urologic surgeon and oncologist.
Responsible for independently investigating industry complaints about CDRH…has handled and helped resolve more than 800 complaints and disputes since taking the post in 2000.
Quality System Expert
Identifies and recommends new policy and regulatory approaches in complex situations in which no precedent exists…reviews proposed enforcement actions and determines if they are appropriate.
Spent 24 years at FDA, cowrote the quality system inspection technique (QSIT) that modernized CDRH's inspection…his firm guides companies to compliance with regulations and quality standards.
Forrest R. Whittaker
Avalign Technologies Inc.
Founded a device outsourcing company focused on precision machined surgical instruments and implants…brings together a comprehensive array of manufacturing capabilities.
Rance A. Winkler
President and CEO
Integrated Molecular Diagnostics LLC
Designed the MammoSite RTS [radiation therapy system], a five-day breast cancer treatment that has replaced a standard six-week treatment…holds more than 50 patents.
Jean Woloszko, MD, PhD
VP, Chief Technical and Scientific Officer
Revolutionized the application
of RF-generated plasma field to
ablation of soft tissue in minimally
invasive surgery...holds 27+ patents
and 70+ patent applications.