Mark has been involved in preclinical safety and performance evaluations of class II and III medical devices for the past 15 years. He has been associated with medical device design and testing, operating over a wide range of therapeutic areas, including cardiovascular, structural heart, electrophysiology, neurostimulation, pulmonary therapies, GI systems and oncology. He has been primarily involved in successful study design and negotiations with the U.S. Food and Drug Administration (FDA) and other regulatory groups when questions or issues arise surrounding medical device submissions.
Mark’s time in the Pharmaceutical and MedTech industries also includes 20+ years in Pharmaceutical Discovery, which has provided him a thorough understanding of complex devices and combination products in the preclinical arena, including managing large animal interventional and surgical research. Dr. Smith is also responsible for oversight of assay development and strategies in hemocompatibility assessment of medical devices, specifically in thrombogenicity, with the continuing development of an In Vitro ovine blood loop assay.
Dr. Smith was one of the co-founders and served as Chief Scientific Officer at American Preclinical Services (APS), established in 2005. With the acquisition of APS by NAMSA in 2021, Mark transitioned to a role with the Commercial Team and now works directly with the Technical Advisors and Business Development Executives engaging in initial Client interactions and early program strategies, study design and planning.
- Brought pulmonary assay systems and methodologies to APS/NAMSA
- Helped design strategies for drug-eluting balloons along with assessment of the pharmacokinetics and toxicokinetics of active drugs associated with balloon-mediated drug delivery
- Led the scientific effort to improve an In Vitro ovine Blood Loop model for assessment of ISO10993-4 hemocompatibility testing; this model led to the AAALAC 3R’s award in 2017
- Served as a member of the AAMI TC194 working group on hemocompatibility testing
- Continuing efforts in improvement of hemocompatibility testing working with FDA staff on enhancing assay design and optimization for eventual application for an MDDT
- Designing and optimizing a communication tool for Clients to submit to FDA when non-GLP studies on medical device safety and performance have been used in submissions
- Serving as a training resource for Technical Advisors in complex medical device performance and safety study design and optimization