In this episode of Focus on Precision, host Justin Starbird welcomes back Clay Schwabe, VP of Business Development at Precision Optics, and special guest Tiffini Wittwer, COO and Founder of MedEdge, for an in-depth discussion on one of the most challenging and rapidly evolving parts of medical device innovation: regulatory strategy.
Tiffini brings over two decades of experience in clinical, regulatory, and quality leadership, and she shares how MedEdge was founded to fill a critical gap for startups navigating the increasingly complex path to commercialization. From accelerating time-to-market to reducing the burden on small teams, she explains why today’s environment allows innovators to bring ideas to life without massive internal infrastructure, if they have the right expert partners!
The conversation dives into:
How regulatory pathways have transformed over the last 10–20 years
Why the FDA’s evolving stance on software, AI, and cybersecurity especially impacts optics-driven devices
The growing role of de novo classifications, and why more startups are choosing this route
The challenges of finding predicate devices in a world of rapidly advancing technologies
Why investors are pushing for earlier clinical evidence, and how that influences strategy
How optics innovations often sit at the forefront of the FDA’s expectations for next-gen medical devices
With practical insights, honest stories, and real-world examples, this episode is a must-listen for medical device engineers, startup founders, and anyone navigating the path from concept to clearance.
Whether you’re building imaging systems, developing software-driven devices, or gearing up for your first 510(k), you’ll walk away with a clearer understanding of the regulatory landscape, and what it takes to succeed.