In this episode, DeAndre Harakas and Grant Chapman sit down with Geoff Hutchins, VP of Operations at IntuiTap Medical, to discuss how the company developed the first FDA-cleared device for imaging and localizing lumbar puncture sites. Geoff shares insights from 30+ years across Formula 1 engineering, large medtech corporations, and early-stage startups, offering a masterclass on navigating concept development, De Novo submissions, design controls, clinical risk, and value-based care. This conversation breaks down the real challenges of building a medical device company from aligning teams around the true clinical problem to raising capital, mitigating risk, planning milestones, and managing technical and organizational complexity.
