At a panel at LSI USA '24, industry experts gathered to share their perspectives on FDA Breakthrough Device Designation. The panel included Lishan Aklog, CEO of Lucid Diagnostics; Nate Beaver, FDA Attorney at Foley & Lardner; Carolina Aguilar, Co-Founder and CEO of INBRAIN Neuroelectronics; and Kwame Ulmer, Managing Partner of MedTech Impact Partners. Their experiences highlight the strategic value and challenges of pursuing this designation.

Understanding Breakthrough Device Designation

Breakthrough Device Designation aims to accelerate the development and review process for medical devices that offer significant improvements over existing treatments for life-threatening or debilitating conditions. To qualify, devices must meet specific criteria, including providing a more effective treatment or diagnosis and offering significant advantages over existing alternatives.

Nate Beaver explained the benefits: “You get more feedback, and you get it faster. You get faster collaboration with the FDA, priority review, and additional resources. The intent from an FDA perspective is to push these through the process as quickly as possible. The caveat is that this doesn’t necessarily mean faster."

The Journey and Benefits

Achieving the designation is just the start. The collaborative process with the FDA is both rigorous and rewarding. Kwame Ulmer noted, "If you have data-hungry investors, maybe you want to apply for Breakthrough Device Designation. But if you're a 510(k) device, the benefits may not be significant."

Carolina Aguilar shared her positive experience: “We meet the FDA every month. The meetings have been substantial and promising. It's an effective way to test and validate our path."

Impact of Regulatory and Legislative Changes

The shift from the Medical Coverage of Innovative Technologies (MCIT) to the Transitional Coverage for Emerging Technologies (TCET) has introduced new challenges. Lishan Aklog remarked, "There was a sense that CMS did not want to be a rubber stamp. The new TCET process is moving forward extremely slowly and is less useful for companies."

Aklog further emphasized the impact, "TCET explicitly excludes diagnostics. Without coverage, it’s not worth it to pursue the breakthrough designation."

Maximizing Breakthrough Device Designation

To maximize the benefits of the designation, companies need a well-structured approach. Carolina Aguilar advised, "Have a roadmap for discussion topics and be prepared. Use the designation to get early input and validate your path."

Kwame Ulmer added, "Set up structured sprint meetings and know what you want to get out of every single session. This proactive approach ensures you get the maximum benefit."

The Role of TAP and Enhanced Collaboration

The Total Product Life Cycle Advisory Program (TAP) provides enhanced support and collaboration, making it a valuable addition to the breakthrough designation. Lishan Aklog explained, "TAP is what breakthrough should be in many ways. It brings an entrepreneurial spirit to the FDA and includes external experts from the physician and payor communities."

Carolina Aguilar noted the practical benefits, "It serves as an incentive for our team to be ready. I also use it internally to push topics we already need to discuss and be ready for those meetings to have effective outcomes."

Strategic Considerations

Ultimately, the decision to pursue Breakthrough Device Designation should be based on a thorough assessment of its benefits and alignment with the company's goals. Lishan Aklog reflected on his company's experience, "Breakthrough alone, without the promise of coverage, was not worth it for us. But breakthrough plus TAP is a compelling combination."

Nate Beaver emphasized the importance of a strategic approach, "Go into your submission with a clear design and advocacy for why you qualify. Think strategically about the criteria and supporting data to build a strong case."

Conclusion

The full recording of the panel can be found in LSI’s resource hub at the link below:

• FDA Breakthrough Designation: ROI and Considerations With Shifts in Coverage

The panel discussion at LSI USA '24 provided valuable insights into FDA Breakthrough Device Designation. While the designation offers several benefits, including faster feedback and priority review, its true value lies in strategic implementation and leveraging additional programs like TAP. For medical device investors and companies in the medtech market, understanding and navigating these processes is crucial for success. As the medtech landscape evolves, these insights will be instrumental in guiding future innovations and regulatory strategies.