How to develop a medical device

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 available - it's someone who's navigated 0-to-1 product development in regulated industries→ Cross-functional collaboration skills matter more than pure technical depth because medtech requires constant coordination between engineering, regulatory, clinical, and business teams→ Remote engineering teams can work in medtech, but you need different processes for documentation and knowledge transfer due to regulatory requirementsThe Economics of Medtech Engineering Decisions→ Design for manufacturability from day one - Jeremy reveals that manufacturing constraints kill more medtech products than technical feasibility issues→ The "good enough" philosophy from software doesn't apply to medtech where incremental improvements can mean life or death for patients→ Budget 30-40% more time and resources for testing and validation than you would for non-medical devices - this isn't optional padding, it's realityNavigating the Innovation vs. Regulation Tension→ The most successful medtech companies treat regulatory strategy as a product feature, not a barrier - it becomes part of their competitive moat→ Innovation happens within constraints, not despite them - Jeremy's teams use regulatory requirements as design inspiration rather than limitations→ The biggest breakthrough opportunities exist where regulation is evolving - AI/ML in medical devices is the current frontier with massive potentialFuture-Proofing Your Medtech Engineering Career→ Learn to speak the language of business outcomes, not just technical specifications - your ability to connect engineering decisions to patient outcomes and revenue determines your ceiling→ Develop expertise in emerging areas like digital therapeutics, AI-enabled devices, and remote monitoring - these are where the growth opportunities will be→ Build relationships across the entire medtech ecosystem including regulatory consultants, clinical partners, and manufacturing specialists - your network is your net worth in this industryBest Quotes:"Most engineers think about regulatory as this thing that happens at the end. But if you're not thinking about it from day one, you're setting yourself up for failure. The FDA isn't your enemy - they're actually trying to help you build better products.""The biggest mistake I see engineering leaders make is staying in their comfort zone. You can't just be a great engineer anymore. You need to understand the business, understand the market, understand the regulatory landscape.""Quality systems aren't overhead - they're actually your competitive advantage. When you have robust processes, you can iterate faster, you can scale better, and you can respond to regulatory feedback more quickly.""Innovation doesn't happen despite constraints - it happens because of constraints. Some of our best product decisions have come from regulatory requirements that forced us to think differently."Want more insights on medtech innovation? Subscribe to the channel so ...