FDA Thoughts On Chemical Characterization

In this episode, our hosts are joined by NAMSA Associate, Dr. Darin Kent, and second-time guest, Dr. Ted Heise, to discuss the new paper released by the FDA and the American Chemical Society. The intention of this latest FDA publication is to examine specific topics that promote continuous discussion around the disparities between where the industry currently stands and how alignment and proper development may occur. Listen in as these industry experts explore the topics covered by the FDA within this document, as well as the challenges faced by medical device manufacturers and testing laboratories regarding chemical characterization testing. They also examine how the FDA fared in the attempt to answer many industry questions.

“The paper really is more about what is being done in devices and what is known about the work in devices.” – Dr. Ted Heise

“It’s striking really, the lack of literature out there about how these technologies and ideas could be used in an NTA [non-targeted analysis] type situation.” – Dr. Darin Kent

“There’s a fundamental need for basic research.” – Dr. Darin Kent

“In terms of giving solutions of how to deal with the challenges, I think it’s less true and part of that is simply that the state-of-the-art is just not well enough developed.” – Dr. Ted Heise

“It provides arrows pointing to potential solutions.” – Dr. Darin Kent

“Does current state-of-the-art product devices that are safe or are there areas we have not uncovered yet?” – Don Pohl

“What we do better in characterizing medical devices has to bring additional value.” – Dr. Ted Heise

“One of the concerns is the level of burden that is imposed by the expectations wrapped up in this work.” – Dr. Ted Heise

Discussion points include:

• Thoughts on where to go from here
• FDA’s perspective on alignment in the industry
• “State-of-the-art” and where that has us today with the chemical characterization of medical devices

*Please note that the opinions discussed throughout the podcast are their own and do not reflect that of their current or former employers.

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Meet the Speakers

Ted Heise, PhD, RAC; Vice President Regulatory & Clinical Services, MED Institute

Theodore (Ted) Heise has over 25 years of experience in regulatory and clinical affairs, and currently serves as Vice President Regulatory & Clinical Services at MED Institute. In this capacity, Dr. Heise leads efforts to develop scientifically robust regulatory and clinical study strategies for the company’s clients—entrepreneurs, consultants and developers bringing new medical products through the complex steps of the development process.

Graduating Magna Cum Laude with a Bachelor of Science Degree in chemistry from the University of Nebraska at Omaha, Dr. Heise went on to earn a PhD in analytical chemistry from Iowa State University (Ames, IA). He has been a member of the Regulatory Affairs Professionals Society since 1993, and the American Chemical Society since 1988.

For the past 12 years, Dr. Heise has been a U.S. delegate to ISO TC 194, the technical committee for international consensus standards that govern biocompatibility testing and clinical investigations of medical devices.  He currently serves as convener of TC 194/WG 14, where he leads the process of re-writing ISO 10993-18 to reflect current best practices in chemical characterization, including evaluation of extractables and leachables.

Dr. Darin Kent; Senior Principal Toxicologist, NAMSA

Darin has been working in the medical device toxicology field for over 18 years, developing expertise in the interpretation of biocompatibility and chemical characterization data in the context of the risk assessment of medical devices and materials. He has performed risk assessments and developed biological safety evaluation plans for a wide variety of medical devices and materials in support of successful regulatory submissions to the FDA, Notified Bodies and a variety of other regulatory agencies. Darin holds a Bachelor of Science Degree in biochemistry from San Francisco State University and a Master of Science Degree and PhD in chemistry from the University of California, San Diego. He is also Diplomate of the American Board of Toxicology.

Sheri Krajewski; Product Marketing Manager – Biological Safety, NAMSA

Sheri joined NAMSA in 2003 and currently serves as Global Product Marketing Manager of Biological Safety. She has supported customers in a variety of commercial operations and management roles, and was an integral leader in the development of NAMSA’s biological safety consulting business. Additionally, Sheri created the much sought-after NAMSA Training Series for the biological evaluation of medical devices. Prior to NAMSA, Sheri was the marketing lead for a mechanical fatigue laboratory and consulting business where she worked primarily with cardiovascular implant manufacturers. Sheri holds a Bachelor’s Degree from the University of Nebraska.

Don Pohl; Principal Product Development Strategist, NAMSA

Don has over 25 years of experience in the preclinical evaluation of medical devices for biological safety. During his career, he has held a variety of positions ranging from laboratory supervision/management, GLP Study Director, Technical Specialist for Laboratory Information Management System, Technical Specialist and Project Manager for Biological Safety and Biological Risk Assessment consultation. He has specific expertise in the evaluation process outlined in ISO 10993-1, as well as the expectations of the U.S. FDA and other global regulatory bodies in their interpretation of the biological safety evaluation of medical devices. Don holds a Bachelor’s degree from Ohio State University.