What if the biggest barrier to medical innovation isn’t science, but everything around it? In this episode, veteran R&D leader Kyle Lapin unpacks the hidden friction behind getting orthopedic devices from sketch to surgery. He exposes why most ideas never make it, how red tape quietly kills progress, and why solving the right problem is more radical than inventing the next “big thing.” We move a fictitious product through the development process, highlighting the frequent pitfalls of being first to market, and discuss how packaging failures have led to the bankruptcy of entire companies. This isn't just a technical chat; it’s an inside look at the human, strategic, and systemic challenges that shape what actually reaches patients.

You’ve read the studies. You’ve shared the articles. But have you ever paused to question what kind of evidence you’re putting in front of your customers?

In this conversation, clinical affairs expert Erin Mundstock shares insight into a part of an orthopaedic business that is frequently misunderstood by sales professionals. Erin will help describe why not all evidence is equal, why randomized trials carry a different weight than case reports, and why the words “clinically proven” mean nothing without the right foundation to back them up.

Listen now if you want to begin coming across as more credible to your customers when discussing “the literature.”

What if the reason a medical device fails isn’t bad design, but a communication gap? In this episode, we dig into a topic often overlooked but absolutely critical: quality in MedTech.

Patrick is joined by Travis Christman of Priority Medical, a problem solver at heart with deep expertise in ensuring that medical devices don’t just meet regulations, but truly meet patient needs. With insights from Joe Majewski, Senior SalesDirector at ZB Wisco, this episode connects the dots between the OR, the salesforce, and the manufacturing line.

From real-life quality holds and FDA audits to the difference between user error and product failure, this episode lifts the veil on how quality affects everyone, from engineers to surgeons to patients.

Whether you’re a sales rep, engineer, or just curious how the MedTech ecosystem truly works, this episode will challenge how you think about quality and why it’s everyone’s responsibility.

Ever wondered why some medical devices make it to market while others disappear into oblivion? Why some "game changing" innovations take years or decades to get approved? It all comes down to one often misunderstood word: Regulatory.

In this episode, we dive into the real story behind regulatory affairs with Christine Scifert, Partner at MRC Global, and Al Nanni, Founder of North MedTech Advisors and Pivot Med Tech. From navigating the FDA’s complex approval process to debunking myths about product clearances, this conversation reveals why regulation isn't just red tape—it's the invisible force shaping much of the MedTech industry.

Whether you're in sales, product development, or just curious how medical devices really works, this episode will change how you view every medical device you touch.

Listen now and learn how the rules explain why things are the way they are!