Each year in the United States, more than 40,000 congenital heart defects are reported in children. Yet 63 percent of pediatric interventional cardiology procedures use off-label devices – those designed for adults or other indications – because of the lack of size-appropriate options.
Only 9 percent of the high-risk medical devices approved for pediatric populations are for newborns and infants younger than two years. Moreover, adult medical device approvals by the FDA are increasing each year at a rate four times higher than pediatric devices.
Pediatric medical technologies are historically underserved and underfunded. The reason is clear: lack of money. Yet the youngest patients would benefit from innovative medical devices designed to their scale and needs.
"The [pediatric medical technology] market size is a small fraction of the market for adult heart failure, for example. There is, therefore, little incentive for the medical device industry to develop and innovate in this space, and it has resulted in the innovation gap that we have today," explained Emma Moran, PhD, Director of Strategy and Development at CobiCure MedTech, founded in 2022. "We need more investment, more support, and more incentives to make a significant impact in the innovation of pediatric medical devices."
CobiCure MedTech, a Collaboration Resident company at Cure, is a nonprofit company in the Advancium Health Network, a mission-driven public charity founded by Deerfield Management and the Deerfield Foundation to pioneer ways to overcome barriers in healthcare.
Moran spoke with Cure about CobiCure MedTech's mission and programs.
This interview was edited for length and clarity.
Cure: What is the mission of CobiCure MedTech?
Moran: Our mission is twofold. First, we advance the acceleration and development of pediatric medical devices — particularly those in areas of unmet medical need, such as pediatric heart disease and critical care — through direct funding, such as grants and investments, to companies, institutions and researchers.
Second, we have a role as a convener in the ecosystem. There are many different stakeholders all over the country working on pediatric medical devices, and our role at CobiCure MedTech is to bring all of these people together to drive change in this space.
Cure: Where does the name CobiCure come from?
Moran: "Cobi" is for Abraham Jacobi, the father of American pediatrics. And "Cure" is because we are based in the Cure space of the Deerfield ecosystem, in addition to aiming to cure diseases and conditions.
Cure: How do you connect with the device developers CobiCure supports?
Moran: The vast majority of our relationships have been established through networking and word of mouth. We're closely connected with the five Food and Drug Administration Pediatric Device Consortia. These consortia are associated with children's hospitals and universities throughout the country and receive grant funding to accelerate the development of pediatric medical devices.
We continue to build on those relationships to grow our network and get the word out about who we are and how we're trying to advance the space. Our connection to the Cure ecosystem, including through Deerfield Management and Deerfield Catalyst, has also led to many connections and relationships.
We announced the launch of CobiCure in November 2022 at a Cure event that attracted pediatric medical device stakeholders from across the country. We are planning another event at Cure in early November 2024 – a CEO summit for pediatric medtech innovators – and that will help us spread the word as well.
Cure: How do you like being at Cure?
Moran: The Cure ecosystem is incredibly powerful. It is crucial for this role that we are playing as a convener in the pediatric medical devices space. We're also very close with the Deerfield Catalyst incubator, which evaluates medical devices. Making our home in the Cure building positively impacts who we are and our success.
Cure: What is the CobiCure Fellowship for MedTech Innovation?
Moran: This initiative, established in collaboration with the five FDA Pediatric Device Consortia, addresses the critical need for pediatric medical devices by providing specialized training and mentorship to innovators focused on pediatric care. Its goal is to incentivize young biomedical researchers to tackle innovations that will specifically help children – areas of research they might not have otherwise pursued. There are five inaugural fellows.
In addition to financially supporting and coaching the fellows, CobiCure MedTech is organizing educational sessions throughout the year featuring renowned experts in medical device innovation to provide specialized training. Fellows learn about needs-based device innovation, device development and the commercialization of pediatric-focused technologies. Each fellow also receives expert mentorship from Pediatric Device Consortia leaders as they develop new MedTech solutions for pediatric patients.
A lot of our colleagues at Deerfield Catalyst, Deerfield Management, and others are participating in this program, so that's another great way to get the word out both internally to the Cure network as well as externally.
Cure: Do you have any tips you'd like to share with others who are working to start a biotech company?
Moran: I've learned that people want to help. You may be small and have limited internal resources, but there are people out there and resources that you can tap into, so leverage those to the best of your ability.
As a mission-driven organization, it's amazing to see the level of support that we have not only within Cure and its residents but also outside of our network. You can stay small and lean and still achieve great things.