Date/TimeOctober 13, 2022
Early product development planning is a critical time for medical device manufactures, as decisions made during this process can affect timelines and budgets. NAMSA understands first-hand the intricacies of models and testing methods, along with the ultimate goal of successful regulatory review and approval, to move on to clinical trials.
Join us for this webinar, presented by preclinical expert Mark Smith (NAMSA’s Strategic Advisor for Laboratory and Consulting), as we discuss strategies to optimize your preclinical testing with an emphasis on complex Class II and Class III medical devices focused in the cardiovascular therapeutic area. Highlighted will be an overview of cardiovascular device conceptualization, prototype and iterative design, model selection and how to build a foolproof pivotal safety-testing plan.
We will also review key steps in the project development pathway—from a novel solution to address an unmet medical need through to approval for first-in-human trials—and provide best practices on how to avoid the traps and pitfalls that can unexpectedly derail or significantly delay a project.
Attendees can expect the following topics to be addressed throughout the webinar:
- Overall Processes in Discovery and Product Concept Identification for Medical Devices
- Main Issues in the Primary Areas of Cardiovascular Device Utilization
- Highlights of U.S. FDA Guidance for Preclinical Testing of Class III CV Medical Devices
- Key Learnings to Enhance the Regulatory Success of Pivotal GLP Safety Studies
Mark E. Smith, BA, PhDStrategic Advisor - Laboratory & Consulting
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.