OTW POD Episode 6 - Carter Lonsberry

Navigating the Fast Track: How BDD and NTAP Can Accelerate Your Medical Device to Market with Carter LonsburyIn this episode, we sit down with Carter Lonsberry, a 20-year industry veteran and consultant specializing in breakthrough device pathways. Carter breaks down the often-confusing world of Breakthrough Device Designation (BDD) and New Technology Add-on Payment (NTAP) - two critical FDA and CMS programs that can fast-track innovative medical devices to market while securing enhanced reimbursement.From his personal journey starting as an 18-year-old in the OR to building his own distribution company, Carter shares hard-won insights about bringing life-saving technology to patients faster. He explains how these programs work together to solve the classic medical device challenge: getting innovative products approved AND paid for.Key Topics Covered:- What BDD and NTAP actually mean for device companies and hospitals- The step-by-step process and timeline for applications- Real-world examples, including icotec and MiRus success stories- Why timing your application before 510K submission is critical- How enhanced Medicare reimbursement removes adoption barriers- Common pitfalls and compliance requirements- Upcoming policy changes under the new administrationWhether you're a startup developing your first device, an established company looking to accelerate market entry, or a sales professional who needs to understand reimbursement dynamics, this episode provides actionable intelligence you won't find anywhere else.