Beyond Compliance: Medical Device Product Development

by Noel Sobelman on July 10th, 2008

Increased regulatory scrutiny is a reality in today’s medical device industry. Over the last several years many of the industry’s leading companies have been hit with an injunction, undergone a product recall, or found themselves operating under FDA consent decree. At the same time, the pressure for growth on these companies has never been greater. Driven by Wall Street, the pace of new technology, emerging market opportunities, and competition from well funded start-ups, medical device executives find themselves in an environment where they must continually innovate with flawless execution to survive.

Given this challenging environment, medical device companies are working hard to design and implement effective, high functioning innovation engines while simultaneously ensuring full FDA compliance. Finding the right balance between what can seem like competing objectives – and understanding how leading companies are doing so - is the focus of this paper.

Kalypso examined the innovation and new product development processes of more than 20 leading medical device companies, from start-ups to multibillion dollar corporations, to gain insights into industry best practices.

Topics: Compliance, Decision Making, Innovation, Medical Device, Perspective, Product Development, Project Governance