{"type":"rich","version":"1.0","provider_name":"Transistor","provider_url":"https://transistor.fm","author_name":"The Medtech Innovation Podcast","title":"How to develop a medical device","html":"","width":"100%","height":180,"duration":2935,"description":"I'm joined by Jeremy Ridley, Senior Director of Engineering at Delve, as we explore how the best engineers design and develop complex medtech innovations, from managing regulatory constraints to building breakthrough products that actually make it to market.The Hidden Reality of Medtech Engineering Leadership→ Most engineering leaders underestimate the time required for regulatory alignment - Jeremy reveals it should be happening from day one, not after product development→ The biggest career mistake engineers make is staying in their technical comfort zone instead of developing business acumen and market understanding→ Successful medtech engineers must become \"translators\" between technical teams, regulatory bodies, and business stakeholders - it's a skill that separates leaders from individual contributorsWhy Traditional Product Development Fails in Medtech→ The waterfall approach that works in other industries creates dangerous blind spots in medtech where regulatory changes can kill projects overnight→ Jeremy's contrarian take: spend more time in the problem definition phase rather than rushing to solutions - most failed medtech products solve the wrong problem elegantly→ User research in healthcare requires a completely different approach than consumer products - you're often designing for three users: patients, clinicians, and administratorsThe Regulatory Reality Check Every Founder Needs→ FDA conversations should start 18-24 months before you think you need them - waiting until you have a \"complete\" product is a recipe for expensive pivots→ The Pre-Submission process is your secret weapon for getting regulatory clarity early, but most startups use it wrong by asking vague questions→ Quality systems aren't just compliance checkboxes - they're competitive advantages that enable faster iteration and better products when implemented correctlyEngineering Team Building Secrets for Medtech Startups→ The ideal early engineering hire isn't the most senior person...","thumbnail_url":"https://img.transistorcdn.com/SKJTlzh1Dih_UjWAMpaf9asEOJluhYL_CM3FATuVvVc/rs:fill:0:0:1/w:400/h:400/q:60/mb:500000/aHR0cHM6Ly9pbWct/dXBsb2FkLXByb2R1/Y3Rpb24udHJhbnNp/c3Rvci5mbS8yM2U1/NjA3NjAzY2M1NDA0/ZDZkYTRiY2Y3Mjky/MTRmNi5wbmc.webp","thumbnail_width":300,"thumbnail_height":300}