Mack Molding has made a substantial investment in its medical product development capabilities, acquiring Synectic Engineering Inc. (Milford, CT), a full-service product development company that ...

The Food and Drug Administration (FDA) defines regulatory science as the science of developing new tools, standards, and approaches to assess the safety, effectiveness, quality, toxicity, public ...

Paul Levesque, a principal at the management consulting firm MedStar Partners, identifies some key aspects of medical product development. In today's increasingly competitive medical technology market ...

Randomized, controlled clinical trials (RCTs) have traditionally served as the gold standard for evidence generation in support of medical product development and approval. However, it is increasingly ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

The Fast Company Impact Council is an invitation-only membership community of leaders, experts, executives, and entrepreneurs who share their insights with our audience. Members pay annual dues for ...

Grey Matter’s President and Founder, Holley Miller, discussed what medical device companies often overlook when launching ...