Is the Breakthrough Device Designation Truly a Breakthrough?
Key Takeaways from MedTech MVP’s Breakthrough Device Panel in Minnesota
In June, MedTech Impact Partners’ Kwame Ulmer joined industry colleagues to tackle the controversial topic of deciding which regulatory path to take when getting a medical device through the FDA’s rigorous approval process. In their enlightening session, medtech innovators, investors, and former regulators provided guidance on whether the Breakthrough Device Program will bring value to your device or portfolio investment based on their experience in the program, industry research, and novel insights from the 95 devices that have obtained FDA market authorization to date.
In this blog, we share key takeaways from their discussion–insights that we hope will help you in your journey to market.
The Breakthrough Device Program expedites the development, assessment, and review of groundbreaking medical devices.
The Breakthrough Device Program (BDP) prioritizes devices with the potential to significantly improve how we diagnose, treat, or prevent life-threatening or debilitating conditions.
Choosing the Right Path: Understanding De Novo, PMA, and 510(k)
The De Novo Pathway: Suitable for novel, low-to-moderate risk devices (Class I or II) with no existing predicate devices (substantially equivalent devices on the market).
The Premarket Approval (PMA): The Gold Standard for High-Risk Devices: The most rigorous pathway, required for high-risk devices (Class III) or those with significant risks. It involves extensive data collection and clinical trials.
The 510(k) Pathway: A Streamlined Approach for Similar Devices: The most common pathway for moderate-risk devices (Class II) that demonstrate substantial equivalence to a predicate device.
Main Takeaway from MedTech MVP's Breakthrough Device Panel Discussion:
“While patient impact is advanced by improved times for novel devices (via the De Novo or PMA) there remains opportunity. The 510(k) is the most common application type and the “workhorse” for medtech innovation. Here we can stand to get more innovative solutions.”
The BDP Advantage: Collaboration for Faster Access
Priority review of BDP-designated submissions.
Enhanced communication and guidance from the FDA.
Increased focus on pivotal clinical trials to gather essential safety and effectiveness data
Conclusion
Understanding the various pathways and the BDP's potential empowers you to chart the best course for your medical device, ultimately accelerating patient access to life-changing technologies.
The world of medical devices is constantly pushing boundaries, and navigating the regulatory landscape can feel daunting. However, understanding the De Novo, PMA, and 510(k) pathways is the first step towards bringing your innovation to market and improving patient lives.
The Breakthrough Devices Program (BDP) shines a light on particularly impactful devices, offering an expedited path for groundbreaking solutions. By leveraging the BDP's advantages – faster review, enhanced communication, and streamlined trials – you can get your device into the hands of those who need it most, ultimately accelerating medical progress.
Remember, the "workhorse" of medical device innovation, the 510(k) pathway, remains a valuable tool. Don't be discouraged by the seemingly simpler route – innovation can thrive within established frameworks.