Innovating for Kids: CobiCure is Bridging Gaps in Pediatric MedTech

by Emma Moran

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Two years ago, I had the privilege of attending the CobiCure Pediatric MedTech Innovation Summit, where experts from the pediatric medical technology (MedTech) field came together to tackle a big issue: the slow progress in getting new medical devices for kids developed, approved, and available to patients. This exciting and thought-provoking event brought representatives from the FDA, venture capitalists, industry leaders, and philanthropists together in one room for a full day of discussions and brainstorming solutions.

Driven by the insights and passion ignited at the Summit, I made a bold move: I left my job in the medical device industry to join CobiCure, a 501c3 public charity founded by Deerfield Management and the Deerfield Foundation, to help them address the barriers in pediatric MedTech innovation head-on. In the two years since the Summit, we’ve made amazing progress.

Arguably, the biggest challenge in pediatric MedTech is the economics of “small markets.” Pediatric devices don’t attract the investment needed for development and commercialization due to the small number of patients who will benefit, and for whom medical devices will be reimbursed. For this reason, most for-profit companies do not invest in pediatric innovation and commercialization. Consequently, only a fraction of life-saving devices approved by the FDA have a pediatric indication, and those are mostly for patients 18-21 years old.

CobiCure has addressed these challenges by prioritizing healthcare impact over financial returns. We drive innovation through grants, investments, and collaborations, supporting technologies that can significantly impact children’s health. As an example, we gave a $2M grant to PolyVascular, a company developing a transformative heart valve for young children with congenital heart disease. Our funding helped the company progress their technology through milestones that have de-risked the platform and brought them closer to first-in-human clinical studies.

This past summer, we launched the CobiCure Fellowship for MedTech Innovation in collaboration with five FDA-funded Pediatric Device Consortia (PDCs). This fellowship program incentivizes the development of solutions for underserved markets that are challenging to finance using traditional investment mechanisms. Each of our five fellows is working on novel pediatric MedTech solutions. For example, one fellow is investigating devices for fetal cardiac interventions, for which there are only about 50 procedures annually in the United States (US). The fellowship also provides specialized training and mentorship, nurturing the growth of innovators in pediatric care.

CobiCure understands that challenges in pediatric device development affect all aspects of the product lifecycle. We continually gather key stakeholders in the for-profit and non-profit sectors to devise solutions and ensure kids have access to approved devices. Recently, we convened 35 CEOs of leading pediatric medical device companies at our New York City headquarters to drive discussion, collaboration, and problem-solving. We also brought in experts to discuss topics such as funding for smaller markets, pediatric clinical trial conduct, and product contracting and distribution to children’s hospitals. I truly believe that the connections made and ideas generated at this summit will drive significant change in the pediatric MedTech industry.  

We’re also a key partner in the FNIH-led public-private partnership for pediatric medical devices (SHIP-MD). This program aims to streamline, incentivize, and accelerate clinical evidence generation and product translation. Participating in the development of this program has connected us with like-minded experts in industry, healthcare, academia, and government. We will continue collaborating with SHIP-MD and other initiatives focused on pediatric devices across the country and globe.  

At CobiCure, we are always open to amplifying the message about the challenges and opportunities in pediatric MedTech innovation. Over the past two years, I’ve had the chance to speak at several events and conferences, driving insightful discussions and highlighting incredible innovations in pediatric MedTech. These meetings have also been valuable for identifying specific device and technology needs within the community. This past spring, we partnered with the Alliance for Pediatric Device Innovation and JLabs in Washington DC on a symposium to drive innovative solutions for pediatric cardiac and neurocritical care. We’ve also had the privilege to chart new territory at “adult” device conferences that have recognized the importance of the pediatric space. For example, I recently joined a pediatric-focused panel at the Octane Cardiovascular Tech Forum in Newport Beach, CA, where most of the event centered on innovations for adult patients. By spreading awareness of pediatric device needs and opportunities, we have recruited new stakeholders in the MedTech industry to help us tackle this problem.  

At CobiCure MedTech, kids and devices are at the heart of everything we do. We believe every child deserves access to the best care and treatment, regardless of their condition. We’re proud of what we’ve achieved over the last two years and beyond excited about our future endeavors to drive change and deliver more innovative devices to kids who need them!

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