Breakthrough Device Designation - BDD?

Breakthrough Device Designation (BDD) is an FDA program designed to accelerate the development, assessment, and review of innovative medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions.

The BDD pathway offers speed, visibility, and collaboration—but it also demands a strategic and evidence-backed approach to succeed. At Lonsberry Consulting™, we specialize in helping MedTech companies not only qualify for BDD, but also leverage it as a foundation for reimbursement, including New Technology Add-On Payment (NTAP)and CMS coverage.

If granted, Breakthrough status provides:

✅ Priority review by the FDA
✅ Interactive and frequent engagement with FDA reviewers
✅ Early feedback on clinical trial design and endpoints
✅ Streamlined development and submission process
✅ A gateway to faster CMS engagement and potential NTAP approval

BDD can significantly reduce your time to market—but only if your regulatory, clinical, and reimbursement strategies are aligned from day one. That’s where our PRECODE™ System comes in.

At Lonsberry Consulting™, we help you:

• Assess BDD eligibility and strategic fit
• Craft compelling submission narratives
• Align your clinical evidence with FDA and CMS expectations
• Use BDD as a launchpad for NTAP, TPT, and long-term coverage
• Avoid common pitfalls in trial design, patient selection, and economic modeling

• Early-stage innovators with a novel technology or mechanism of action
• Oncology, cardiovascular, neurology, orthopedic, and digital health products
• Startups seeking to increase valuation, speed to market, and payer visibility

BDD is not just about speed—it's about strategy. When used correctly, it sets the stage for market access success, including faster adoption, higher pricing, and payer alignment. But when done reactively, it can create delays and missed opportunities.

We help you do it right the first time.