Biomedical Community Lunches and Learns in Fremont
Last week, a classroom at the Ohlone College Newark Campus was bustling with people—eager to learn, as you would expect. But, they were not your average college students assembling for English 101. Rather, it was a cohort of working professionals from across the biomedical and life science industries who were attending the region’s first Medical Device Lunch & Learn event. This event was the result of a partnership between YourEncore, BioCom, The Biomedical Manufacturing Network, and Fremont’s Economic Development Department.
YourEncore cultivates and nurtures a network of experts in the biomedical industry that are rich in experience and technical know-how related to flexible resourcing and consulting engagements. Our experts help clients to outthink, outpace, and outperform the competition by supporting critical decisions, filling resource gaps, and solving complex problems.
The hot topic during the Lunch & Learn? Medical devices and combination products. The discussion was led by YourEncore’s own lauded Minnie Baylor-Henry, whose experience in both the public and private sectors proved invaluable when talking about regulation and policy. With experience ranging from executive positions with Johnson & Johnson to the FDA, Baylor-Henry offered an in-depth look at the increasing complexities of new proprietary products and the process by which the Federal Food and Drug Administration classifies them.
An overall theme of the day was the idea that new companies (or companies introducing new products) should use caution when determining their products’ primary mode of action (PMOA) as well as which FDA category it falls under – Drug, Device, or Biologic. If the product falls into the combination product category, it must be categorized as Drug-Device, Drug-Biologic, Device-Biologic, or Drug-Device-Biologic. A key message was to not second-guess the designation process or try to push a product into a certain category based on review time. It’s better to explore options fully on the front end in order to avoid discrepancies later.
As a regional hub for innovation in the medical device and equipment fields, the City of Fremont is an important player in one of the most prominent industries in the Bay Area. That’s why the term “combination products” is so relevant in a community like Fremont, where IoT is driving the merging of various technologies into a single product like never before. With hardware representing an increasingly important share of biomedical innovation, YourEncore looks forward to continuing our partnership with Fremont and the City’s efforts to support the Bay Area’s growing biomedical industry.