How to Establish a Solid Foundation for Fundraising and Product Success by Focusing on Regulatory

What this episode covers

Isabella Schmitt, a regulatory affairs consultant at Proxima Clinical Research, joins host John Spear to discuss how a strong regulatory strategy underpins fundraising and product success for medical device companies. Schmitt advises startups to avoid starting with technology without a clear problem, emphasizing the importance of Minimum Viable Products (MVPs) and design controls to prevent perpetual iteration. She highlights the '1/10/100 rule' to illustrate how early validation reduces costs and increases company value by hitting major milestones like animal studies or clinical trials. The conversation also covers selecting regulatory pathways (PMA vs. 510(k)) based on market size and reimbursement, and navigating current global regulatory landscapes like the EU MDR and FDA requirements.