FDA Regulatory Strategy and Value Proposition for better medical product development
Rob Morgan, Laurie Clarke, and Eduardo von Ristow have a round table discussion about how to integrate FDA regulating strategies and a well-crafted value proposition into medical device development and the benefits of this one-team approach. The event focuses on real issues faced by those involved in developing, assuring compliance and quality, investing, and marketing medical devices. Kate Marchio asks the table questions on how to navigate the 510(k), de novo, and PMA routes to market, translate concepts into products and maximize their chance of success by better understanding different stakeholders' needs, technology feasibility and commercial viability. They share real-world examples of design, approval, and value-based product differentiation challenges, as well as practical tips for overcoming them based on their experiences with a wide range of medical devices.