Is your Biocompatibility Program Knocking your Submission Off Track?

In this episode, our guests are joined by Syntactx’s Dr. Valerie Merkle, Associate Director – Regulatory Strategy, to discuss NAMSA’s recent acquisition of Syntactx.

During this one-hour installment, Dr. Merkle discusses her deep-rooted experience at the FDA and the importance of proper biological safety planning to achieve biomechanical efficiency and successful clinical trial execution. Examples will be provided regarding how and when biocompatibility programs go wrong, which often result in derailment of development efforts. How can manufacturers create biocompatibility programs that are observed favorably by the FDA? Learn helpful tips and strategies to help ensure a successful FDA submission.

“We really wanted to mirror what we were doing at the FDA.” – Valerie Merkle

“You just never know what is going to come in next. It keeps you on your toes for sure.” – Don Pohl

“People think biocomp is just a checklist, but there are a lot of rabbit holes you can go down—a lot of ways you can stray off the path unnecessarily. Definitely not a checklist item.” – Valerie Merkle

“Make good decisions early-on to not derail yourself later.” – Sheri Krajewski-Bibins

“A lot of companies don’t want to provide their thought process. They spend years and years developing and making decisions, FDA only sees what is in front of them and if the background is not there, we see lots of questions.” – Valerie Merkle

Discussion points include:

• Syntactx company overview and strengths they bring to NAMSA
• Material selection and its importance in avoiding derailment of biocompatibility projects
• FDA experiences with manufacturers overlooking material testing
• FDA biocompatibility guidance and its role in regulatory submissions

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

Also be sure to check out our Biocompatibility Strategy Navigator.

Meet the Speakers

Valerie Merkle, PhD; Associate Director – Regulatory Strategy, Syntactx

Valerie Merkle, PhD, of Syntactx, brings extensive knowledge of global medical device regulations and regulatory strategy to manufacturers and is expert at providing assistance to clients seeking product approval and adoption worldwide.

Dr. Merkle has led a remarkably successful career with the U.S. Food and Drug Administration (FDA) in the Center for Devices and Radiological Health (CDRH) as a Lead Reviewer for vascular and endovascular surgical devices. In her role, she managed and reviewed over 650 complex regulatory submissions, including pre-submissions, investigational device exemptions, as well as 510(k) and PMA marketing submissions. She was the lead reviewer for first-of-a-kind vascular devices and served as the FDA lead to the meeting of the Circulatory System Devices Panel. Her additional expertise and outreach includes standards work, cardiovascular materials research and FDA/external research collaborations.

Valerie holds a Bachelor of Science Degree in Chemical Engineering from Bucknell University, a Doctorate in Biomedical Engineering from the University of Arizona and is an Innovation Fellow of the Fogarty Institute. She has co-authored numerous peer-reviewed manuscripts and has presented at multiple academic, scientific and technical conferences. She is the recipient of FDA honors, including the 2019 CDRH Excellence in Premarket Review Team Award (for which she was the Lead Reviewer) and the 2017 FDA Outstanding Service Award.

Sheri Krajewski-Bibins; 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.