David brings over 40 years of expertise in the medical device industry, specializing in sterilization, biological evaluation, microbiology, and risk assessment. Throughout his career, he has become a trusted consultant, navigating complex regulatory compliance and product safety challenges. In 2020, after retiring from his career, he founded Sterwell, LLC to continue supporting the industry. With a client-focused approach and a deep commitment, he leverages his extensive experience to deliver tailored consulting services, ensuring each project receives the highest level of care and attention.
Education:
- M.B.A., Wilmington University, 1991
- B.S., Medical Technology, Thomas Jefferson University, 1978
- B.A., Zoology/Animal Biology, Rutgers University, 1976
Professional Experience:
- Founder and Principal Consultant, Sterwell, LLC, 2020 - Present
- Director, Global Sterilization and Biological Safety, ECOLAB, 2012 - 2020
- Director, NAMSA Advisory Services, 2003 - 2012
Publications:
- Author - "Overcoming negative test results during manufacture", Biocompatibility and Performance of Medical Devices, 2nd edition. Boutrand, JP (ed) Elsevier, Inc. 2020
- Author - "Making use of a biological safety evaluation plan", Biocompatibility and Performance of Medical Devices, 2nd edition. Boutrand, JP (ed) Elsevier, Inc. 2020
- Author - Biological Safety: More than just test data - MD&DI. 2009
- Author - "How.to use a contract laboratory". Sterilization of Medical Devices. Booth, A. (ed). Taylor and Francis. 1998
- Co-Author - Reusable Devices: Validating Reusable Medical Devices: An Overview. Medical Device and Diagnostic Industry. 1996