Competition Bolsters Pediatric Device Innovation

Call them the forgotten bunch.

Overlooked by industry. Pas-sed over by doctors. Slighted by medtech developers.

They are members of the smallest patient population segment yet they represent a sizable market opportunity. And they’re relatively healthy, but are not immune to disease.

For decades, these patients have been treated largely the same way as everyone else, even though they are not like most of their ailing counterparts.

Indeed, these patients are not like the majority of others.

They’re children. And, to reference a phrase cited quite frequently in pediatrics, “children are not little adults.”

Nevertheless, they are treated as such in the medical arena. For certain diseases, no medical device options exist; in many cases, juvenile patients are fitted with adult devices that are modified and used off-label with little or no safety/efficacy data.

Despite attempts to better prioritize juvenile patients, there is still a dearth of medical devices made specifically for kids.

“Infants and children have different diseases and clinical problems,” said engineer George Wodicka, the Vincent P. Reilly Professor of Biomedical Engineering at Purdue University. “So, the research and development of pediatric devices is a distinct undertaking with a unique set of challenges.”

Those challenges include paltry healthcare spending (less than 10% is dedicated to pediatrics, according to JAMA), small market size, and human biology. Children undergo dynamic anatomic, physiological, and developmental changes as they grow, and they require products that address and respond to these changes.

Various programs established over the last decade or so are helping to tackle these challenges and tackle the disparity in pediatric medical device development. Purdue University, the Indiana University School of Medicine, and Cook Medical, for example, have forged a new alliance to address clinical needs in pediatrics, while the U.S. Food and Drug Administration (FDA) has jointly operated the Pediatric Device Consortia Grants Program with American Academy of Pediatrics for the last 15 years, expanding funding opportunities for juvenile device research and design.

In addition, the Alliance for Pediatric Device Innovation (APDI), a federally funded consortium led by Children’s National Hospital, has been holding competitions specifically focused on juvenile medical devices.

The latest competition (earlier this year) featured five finalists who competed for a share of up to $50,000 in FDA grants funded that will help pediatric device developers commercialize their products.

“The children we serve come from diverse backgrounds, so nurturing diversity among our innovators will help us ensure their needs are met,” said Kolaleh Eskandanian, Ph.D., vice president and chief innovation officer at Children’s National Hospital and APDI program director and principal investigator.

The five pediatric medical device finalists, chosen from a pool of 27 applicants, included:

Kofimi Technology Inc.: This Danvers, Mass.–based firm created a patent-pending pulse oximeter device that provides improved accuracy for all levels of skin pigmentation.

Rubitection: Based in Pittsburgh, Pa., this company developed a low-cost skin assessment management tool for chronic wounds. The system allows users to monitor incremental changes in skin health to predict risk, monitor progression, and customize care.

SealCath LLC: This Mount Pleasant, S.C.–headquartered firm created a double balloon catheter, SethCath. The product aims to treat infants facing bowel disorders. Specifically designed for mucous fistula refeeding, the catheter offers a gentle and precise method to provide essential nutrition and support.

TNC Medical Solutions: Located in Los Angeles, this firm produced an advancement in gastrostomy tube (g-tube) reinsertion to help improve the quality of life for kids dependent on enteral feeding.

WearableDose Inc.: Based in Bowie, Md., this company harnessed artificial intelligence for real-time, precise dosimetry in cancer treatment. WearableDose improves radiotherapy using an electronic polymer detector that accurately detects, directs, and measures radiation to tumors.

“We believe there is a community of companies focused on platforms that treat or diagnose pediatrics,” said Kwame Ulmer, founder of MedTech Color, a nonprofit organization promoting diverse leadership in the medtech ecosystem. “This partnership allows us to significantly increase the support we provide for entrepreneurs in this area. We are delighted to be a part of the Children’s National community to drive positive patient outcomes.”

Judges chose Kofimi Technology and Rubitection as the winners. The pair received a combined $50,000 in grant funding from APDI and access to a network of supportive resources and expertise.

“The competition’s additional investment in companies developing technologies for the pediatric population is significant,” Ulmer said. “This means more patients will get access to medtech ecosystem accelerants. As more pitch finalists from diverse backgrounds finally get access to funding, this will provide more opportunities for children and young adults in overlooked communities.”