Weighing Market Needs Against Regulatory Risks

Weighing Market Needs Against Regulatory Risks

  Working in collaboration with my esteemed partner Joe Kalinowski of Trilogy Associates, I recently had the opportunity to organize and moderate a series of key opinion leader panels to assess the clinical viability of a promising IVD product concept. Our client had hinged their commercialization strategy to a 510k regulatory pathway. To the contrary, […]

Tapping India’s Medical Device Market

Tapping India’s Medical Device Market

Welcome to the inaugural issue of FGA Index, a bimonthly newlettter focused on topics we deem relevant┬áto our medtech clients. In this issue I share insights from industry leaders on India’s emerging medical device market and explore perspectives from hospital administrators on the evolving dynamics in the hospital purchasing process. I wrap-up with a look […]