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, […]