Surgery can be a challenging experience, not only for patients, but their clinicians and caregivers, as well. The lack of innovative medical devices with intelligent software following cardiothoracic surgery provided an opportunity for one MedTech company in particular. Today’s guest is Evan Luxon, co-founder and CEO at Centese. The early stage company achieved 510(k) clearance from the FDA for its intelligent surgical drainage product called, Thoraguard. Centese followed a deliberate and diligent approach to design and development, while right-sizing its quality management system (QMS). Listen to the full episode as this MedTech executive shares key insights, tips and best practices to help other MedTech leaders achieve similar success. Some of the episode highlights include: - Proactive vs. Reactive: Thoraguard’s core principles are safety, intelligence, and efficacy. - No Rest for the Weary: Thoraguard automatically monitors patients without needing to rely on nurses to routinely check on patients. - MedTech Space: Start by addressing a clinical problem that people are willing to pay for to solve clinical needs. - Proof of Concept Prototypes: Reach out to as many surgeons and others early on to optimize lean launchpad methodology for relevant and reliable feedback. - Quality Role and Regulations: Feedback helps medical device companies avoid feature creep and change scope to meet fundamental and required functionality. - How to right-size your QMS: Build out the QMS as the project and company progress by knowing what’s needed at each phase of development.