In scenarios where a great device can’t make it past the FDA – or even if it lingers in the regulatory process because of mistakes – the value can start to erode, as do hopes of being acquired by strategic companies with established distribution channels and familiarity with the obstacles to medical device clinical adoption. If a startup has to manage these processes on their own, it can significantly extend the time it takes the technology to reach patients.
We live in a world with an ever-increasing global perspective and reach. Over the past two years, we’ve seen companies shifting their business plans to enter the US market earlier than they had originally planned. This trend is largely due to uncertainty around the new CE mark regulatory requirements in the European medical device approval process. As a result, there are focused ultrasound startup development and commercial teams who are confused about the premarket submission process with its various paths to FDA clearance or approval.
The Foundation often receives inquiries about the correct path. Should it be a PMA (premarket approval) or a 510(k)? If they chose the 510(k) route, what type of clinical trials have historically been required by other companies in the field? Is there any predicate they can use that would be appropriate? Will de novo be required?
If just reading this makes your head spin, you’re not alone. On an ad hoc basis, the Foundation has tried to help when we can and when we feel it’s appropriate. However, we want to maintain our position as an independent third party who advocates on behalf of the field as a whole – not for any particular company. As the field grows, requests for advice have become more frequent, so we’ve had to step back to consider how we can leverage our strengths to help the field navigate this commercialization bottleneck.
Last year, Jessica Foley, our Chief Scientific Officer wrote a blog on how collaborations within the field of focused ultrasound can leverage our position and shorten the timeline across the full spectrum of discovery in the various research programs we fund. As the field continues to expand at exponential rates, and commercialization of the technology is becoming a reality, we find ourselves in need of partners/collaborators. These partners/collaborators can help further our mission of serving as a catalyst to accelerate the development and adoption of focused ultrasound as it relates to commercialization efforts. In the past year we’ve begun fruitful relationships with two fantastic organizations to help us with several of the commercialization hurdles mentioned earlier the Advanced Medical Technology Association (AdvaMed) and the Medical Imaging Technology Alliance (MITA).
MITA is a member-based trade organization that works mainly in advocacy. Their mission is to reduce regulatory barriers, establish standards, and advocate for the medical imaging industry. They represent approximately 90 percent of the global market for advanced medical imaging technologies with a membership base of around 50 companies.
AdvaMed is a much larger and more generalized trade organization. Their mission is to serve as the collective voice of companies producing medical devices, diagnostic products, and health IT. Their membership is 300 strong and growing. They support all aspects of the global commercialization space and host semi-annual educational workshops and an annual conference – the MedTech Conference.
Both AdvaMed and MITA work to develop standards to ensure patient safety and timely market access, improve the regulatory environment to promote growth and innovation, remove barriers, and reduce costs in the US and overseas market place. Additionally, they inform the field on cybersecurity issues related to the medical device sector. Lastly, both organizations are advocating to repeal the medical device tax.
During initial conversations with MITA and AdvaMed, it was clear that the incentives of all parties were closely aligned and the partnership/collaboration was appropriate. We did not bring them a novel medical device, but rather a novel medical technology platform – one with the potential to span more than 100 medical indications in various stages of regulatory development. With both organizations there are opportunities for our community to participate in their existing programming and, where the field has unique challenges, there is enough critical mass to warrant the possible development of new programming. Our relationships with MITA and AdvaMed and opportunities for partnership for additional focused ultrasound companies will be discussed in more depth in a blog by Jessica Foley in the coming weeks. So far, feedback from both the trade organizations and the companies who are participating has been promising.
Our founder and chairman Neal F. Kassell, MD, has said, “The ultimate testimonial to the effectiveness of the Focused Ultrasound Foundation would be if we were no longer needed. Sustainability beyond our current mission is not our goal.”
The Foundation looks to prime the pump by engaging partners where the incentives are aligned in order to help them assume as many of the functions of the Foundation as possible so that our presence in any particular area can diminish in size and stature, and we can free up resources to tackle the next obstacle for the field. And the more time we save, the more lives we can save.
Emily White, MD, is the director of operations at the Focused Ultrasound Foundation.
Additional Reading
Collaboration: Fueling a Changing Focused Ultrasound Landscape