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 Expert  723905

Expert in Medical/Surgical Device Design, Management, Marketing, Regulatory

Available for your Consulting and Expert Witness Needs

North Carolina (NC)
Education Work History Career Accomplishments Consulting Services Expert Witness

Summary of Expertise:

Listed with other top experts in: 

A results-oriented professional with proven domestic and international experience in health care administration, medical devices, marketing, staff development, product development and management, luminary and customer liaison, public relations, technology assessment and transfer, intellectual property, research and development, clinical trials, regulatory affairs and compliance, quality systems, market and business development, professional, industry and vendor relations, volunteer management, customer retention, sales support, communications, emerging technologies, information systems and P & L management. Adept at identifying problem areas and implementing corrective actions. A team builder and leader providing motivation, training and support by example with solid communication skills at all levels. Experienced in ISO manufacturing, TQM and work with the FDA, NIH, DOD, DARPA and U.S. Air Force Research Laboratory.

biomedical instrumentation


biomedical product development


health care marketing


intellectual property




medical device


medical instrument


new product development


new product development management


research and development


medical device marketing

Show Secondary and Basic Areas of Expertise
Expert may consult nationally and internationally, and is also local to the following cities: Charlotte, North Carolina;  Raleigh, North Carolina;  Greensboro, North Carolina;  Durham, North Carolina;  Winston Salem, North Carolina;  Cary, North Carolina;  High Point, North Carolina;  Gastonia, North Carolina;  Concord, North Carolina;  and Roanoke, Virginia.

Year   Degree   Subject   Institution  
1974   Doctor of Science (D.Sc.)   Biochemistry, Biophysics   U of London, Sussex College  
1987   MHA   Hospital Management   U of NC at Chapel Hill - Kenan School of Management  
1969   Bachelor of Science (B.S.)   Ultrasonics and Anatomy   Bowman Gray School of Medicine  

Work History:
Years   Employer   Department   Title   Responsibilities

1994 to







CONTRACT CONSULTANT to academia, venture capitalists and medical device manufacturers providing direction and assistance in staff development, technology assessment and transfer, new product development, oncology treatment planning, surgical and cosmetic implants, regulatory submissions/defense/compliance, corporate management, staffing, professional and customer relations, staff training and retention, clinical trials and market development. Initiated and maintained strategic liaisons between manufacturers, luminaries, inventors and investors.

1992 to 1994


InfiMed, Inc





Directed new medical imaging products development team and clinical trials; regulatory submissions and defense; initiated new market launch for the Asia/Pacific theatre and Asian OEMs; managed R & D group and technology transfer; Domestic and International travel averaged 45 per cent. Reported to Executive Vice President.

1990 to 1992


Medrad, Inc





Managed worldwide clinical trials, regulatory submissions, technology transfer, marketing and highly successful international launch of new MR imaging devices for imaging the human prostate, cervix and breast; directed regulatory compliance, research and development, advertising and OEM accounts; travel 50 per cent. Reported to Senior Vice President.

1986 to 1990


Wake Forest University


Bowman Gray School of Medicine




Administration of 450 personnel including 150 faculty and house staff; managed grants, managed care contracts, physician recruitment and an annual budget of $25,000,000+. Reported to Chairman / Associate Dean.

1978 to 1986


Picker International Corporation





INTERNATIONAL PRODUCT MANAGER for Ultrasound, Nuclear and Clinical Lab/RIA product lines; directed worldwide sales, regulatory submissions and compliance, technology transfer, marketing and service for 96 dealers and 3 OEMs in 105 countries; International travel 85 per cent. Reported to Vice President, International Division.

1977 to 1978


Litton Industries


Medical Division




MANAGER OF PRODUCT PLANNING, APPLICATIONS AND PROFESSIONAL EDUCATION for Ultrasound division; directed new digital imaging project, regulatory affairs, product planning, vendor liaison, professional education and research & development; International travel 80 per cent. Reported to Vice President of Marketing.

1969 to 1977


Wake Forest University


Bowman Gray School of Medicine




CLINICAL SCIENTIST, INSTRUCTOR AND INVESTIGATOR in diagnostic and therapeutic Ultrasound, Neurology and Neurosurgery. Investigator for projects in hydrocephalus, peripheral vascular disease, cerebrovascular disease and acute head trauma; Supervision of technical and research staffs; Management of ultrasound research grants; Designed and maintained biostatistics database. Reported to ultrasound pioneer / neurologist Expert M. McKinney, MD.

Career Accomplishments:

· Full Member, Society of the Sigma Xi · Full Member, American Institute of Physics (AIP) · Full Member, Federation of American Scientists (FAS) · Full Member, North Carolina Academy of Science (NCAS) · Emeritus Member, New York Academy of Sciences (NYAS) · Member, Medical Group Management Association (MGMA) · Member, International Society for Optical Engineering (SPIE) · Member, Association of University Technology Managers (AUTM) · Full Member, American Association of Physicists in Medicine (AAPM) · Member, IEEE – Engineering in Medicine and Biology Society (IEEE-EMB) · Senior Member and pending Fellow, American Institute of Ultrasound in Medicine (AIUM)


Certified Clinical Surgical Specialist


· Awarded Duke Endowment Fellowship to the Hospital Management Institute, Graduate School of Business Administration, Kenan Flagler School, University of North Carolina at Chapel Hill, 1985 · Proofed and edited Vascular ultrasound of the neck: an interpretive atlas by Antonio Alayon, MD, PhD and Expert M. McKinney, MD; published by Lippincott Expert & Wilkins; 1st edition November, 2000 · Elected to Group on Business Affairs, Association of American Medical Colleges (AAMC), 1986 · Emeritus member of the New York Academy of Sciences (NYAS) · Executive Secretary of the American Institute of Ultrasound in Medicine (AIUM), 1973 – 1977 · Editorial and Research Advisor to Emeritus Faculty of the Wake Forest University School of Medicine · Service on numerous standing and ad hoc committees of the American Institute of Ultrasound in Medicine · Successfully negotiated the first sale of U.S.-manufactured ultrasound and nuclear medicine equipment to the People's Republic of China through a ten-day seminar held in Shanghai · Voting Delegate of the AIUM to the World Federation of Ultrasound in Medicine and Biology (WFUMB) · Tapped into the Society of the Sigma Xi (Honorary scientific research society), 1973 · Tapped into the Scientific Research Society of North America, 1973

Consulting Services:
Recent Client Requests:
  • New product transfer to supplier and manufacturing expert for consulting on Design Transfer.
  • Expert for consulting on compressor blade hardning - gas turbine engines.
  • Expert in quality systems and auditing for FDA regulatory affairs.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.


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