Episode 151 | Nikki Batista, Vice President at MCRA and Devon Campbell, Founder and Managing Director at Prodct | Setting Up Your Company to be Investable, Acquirable, and Successful: Regulatory
This podcast episode explores the importance of strategic regulatory planning for startups in the medical device industry. It emphasizes the need to consider the end goal and indication for use in regulatory planning and highlights the significance of placing regulatory milestones throughout the product development lifecycle. The episode also discusses the implications of FDA clearance, the challenges of commercialization, the importance of a global regulatory strategy, and the role of the FDA in ensuring product safety. It emphasizes the need to engage with the FDA early in the product development process, collaborate with regulatory consultants, and build a strong team for startup success.