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, […]

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. […]