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, […]

The Sunshine Act — 129 Days and Counting

The Sunshine Act — 129 Days and Counting

I may be biased but I strongly believe that medical product innovation cannot succeed without the essential insight of physicians and other health care providers. At first blush, the Sunshine Act, which mandates public reporting of payments to physicians by drug and device manufacturers and kicks-in on August 1st, may seem to threaten this vital […]

Hospital Purchasing — Who’s Calling the Shots?

Hospital Purchasing — Who’s Calling the Shots?

Helping my medtech clients understand clinical needs has always been at the heart of what I do. Traditionally this has been accomplished through in-depth dialogues with clinician providers—doctors and nurses on the front-line of patient care. Increasingly, however, it has become critical to include other hospital stakeholders, especially purchasing managers, in the mix. During a […]

Tissue engineering: Ready or not?

Tissue engineering: Ready or not?

More than a decade ago, back in 2000, I collaborated on a project that brought together some of the world’s leading experts on tissue engineering. During a series of forums covering various topics, these world-class scientists presented groundbreaking research and described the therapeutic promise of innovations aimed at rebuilding fundamental tissue- and organ-level biologic functions. […]

Surgery in the Twenty-First Century

Surgery in the Twenty-First Century

Prognostication is, by its very nature, a risky and uncertain endeavor. Yet a decent roadmap to the future is absolutely vital to the success of any enterprise, be it business or health care or personal finance. History can teach us a lot. Indeed the recent past is essentially the best barometer we have for what […]

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 to 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 […]