By Benjamin Ross

February 8, 2018 | The winners of the Boston Pediatric Device Strategic Partner Challenge were recently announced by Boston Children’s Hospital. Five projects were chosen by the Boston Pediatric Device Consortium (BPDC), an FDA-funded initiative, to receive funding through grants and in-kind support for design, simulation testing, and business plan development. The challenge was designed to promote the development and innovation of novel pediatric medical devices.

The BPDC reviewed a total of 60 applications during the fall of 2017. These applications came from the US and other countries spanning diverse clinical areas from Cardiovascular and Critical Care/Monitoring to Pulmonology and Urology, and all stages of development. Of the 60 applicants, 12 were invited to Boston in early December to pitch their device to a panel of clinical, business, and technology experts and strategic partner representatives.

The five winners of the challenge were awarded a combination of up to $50,000 in funding per grant award and potential mentorship opportunities with leading medical device strategic partners. The winners are:

• Nivedita Dhar, from Wayne State University and University of Basel, for a device that prevents urethra erosion and urinary incontinence
• Andrea Martin, from Peca Labs, University of Pittsburgh and Carnegie Mellon University, for a cardiovascular conduit that can be expanded to keep pace with the growth of a child, thereby reducing the need for subsequent open-heart surgeries
• Andrew Cothrel, from Xact Medical, for a robotic, one-handed central venous access tool that creates a 3D image of the vasculature and automatically delivers an access needle
• David Zapol, from Third Pole Therapeutics and Massachusetts General Hospital, for a nitric oxide generator to help treat severe persistent pulmonary hypertension
• David Hoganson, from Boston Children’s Hospital, for a cardiac device that allows surgeons to quantifiably measure leaflet coaptation height and success of heart valve repairs

Carla Small, Senior Director of Innovation at Boston Children’s Hospital, told Clinical Informatics News that the BPDC, funded by the FDA Office of Orphan Product Development, has been focusing on early stage medical device development, specifically in pediatrics, since its inception almost 10 years ago. Along with Pedro del Nido, leader of the BPDC and Chief of Cardiac Surgery at Boston Children’s, Small is enthusiastic about supporting this initiative to improve the lives and welfare of children, a small but important population: only 10% of the medical device market was directed toward pediatrics.

“It can be challenging for the big device manufacturers to make the economics work with pediatric focused devices” Small said. “The generally smaller market size, compared to that for adult devices, coupled with the additional resources needed to develop devices that accommodate a child’s growth and active lifestyle, for example, have resulted in a large unmet need for pediatric devices."

In her work with the BPDC, Small realized that the way to successfully improve the development of medical devices for pediatrics was to have strategic partners involved in the process. Without them, she said, a project is going to have a tough time being commercialized.

The IDHA and BPDC reached out to Boston Scientific, Boston Children’s Simulator Program (SIMPeds), CryoLife, Edwards Lifesciences, Health Advances, Johnson & Johnson Innovation, Medtronic, Smithwise, and Ximedica for strategic partnerships in the challenge.

It wasn’t hard getting these companies involved, Small said. Most of the companies seemed to have been waiting for an opportunity like this to come along.

“We even had a major device company we hadn’t asked to join call us and ask to be involved,” she said. “People were eager and really understood the importance of what we were doing.”

As part of the challenge’s reward, the strategic partners will provide in-kind support in such areas as product manufacturing and design, simulation testing, business plan development, and partnering opportunities to accelerate the projects’ path to commercialization.

“For example, Boston Scientific is working with one of the partners and they’re establishing mentorship and really help them with the product development planning and establishing mentorship in milestones, Small said. “And to compliment that, Smithwise, one of the device manufacturing prototyping shops, is providing the prototype development for them.” Small was quick to note that this support varies from project to project.

All of this time and material investment comes at a cost, though, which was something the consortium weighed heavily when judging the applications.

“Some of the analysis before the live-pitching involved analyzing the market side, and what the development cost might entail and whether we thought it was a viable business model,” said Small. There were essentially two parallel analyses going on during the finalists’ live-pitches. One was whether the technology presented made sense to a partner’s business model, and the other was more of a collaborative effort in determining whether the impact of an applicant’s technology was vital for children’s health.

Of the challenge winners, Small pointed to David Hoganson’s heart valve mapping device project for Boston Children’s as having caught the eye of several strategic partners.

“I think some of the appeal of [Hoganson’s project] is you’re making the life of children better,” she said. “But also, commercially if you can solve problems for children you are really creating a tremendous solution for adults down the line, too. This project has broader applications than just pediatrics.”

Small and the rest of the consortium hope this is the first in a long line of similar challenges.

“We’re currently in development for next year,” Small said about the challenge’s future. “The FDA grant process is rolling now, and so we’re applying for next year and that will determine if we continue.”

Regardless of whether or not the challenge is renewed, Small is grateful for what came out of this year’s competition.

“The fact that we had the partners we did, and [seeing] the active partnerships formed out of this, I think we’re going to see a lot of movement on these devices that wouldn’t have been possible without this challenge. I’m proud of that.”