Competition Seeks to Bridge Gap for Pediatric Medical Devices

Posted October 9, 2018

“There has to be a better way.”

That was the theme for the healthcare technology innovators, clinicians, regulators, and investors who convened in Philadelphia earlier this fall to discuss, encourage, and—perhaps most important—provide a total $150,000 in grants for six companies developing innovative healthcare technology that focuses on the needs of children.

Now in its sixth year, the Pediatric Device Innovation Symposium and pediatric medical device pitch competition works to bridge the gap for pediatric medical devices, which often lag adult or general-use devices in technology, development, and funding. The goal is to help medical device companies—especially startups—get over the initial funding challenges that impede the development of pediatric devices

"We are honored to recognize these outstanding innovations and we already envision the ways they can advance care for children," said Kolaleh Eskandanian, vice president and chief innovation officer at Children's National Health System, which organized the symposium and competition with support from the National Capital Consortium for Pediatric Device Innovation (NCC-PDI). "We are delighted to welcome these new innovative companies to our family of pediatric device startups and entrepreneurs. Together we can address critical patient needs and bring important new pediatric devices to market."

This year, the symposium and competition focused on cardiovascular pediatric devices. For children, these devices come at a crucial time—they’re often used to repair a congenital heart defect—a constellation of conditions that affect about one million children in the United States, according to the Centers for Disease Control and Prevention. However, like most pediatric medical devices, the development of these life-altering technologies is often constrained by a smaller market.

In this year’s Shark Tank-style pitch competition, a panel of expert judges evaluated a field of 11 finalists (picked from 45 submissions) on how much the medical device alleviates an unmet need in the pediatric medical device space, as well as the company’s management team. Each award winner received a $25,000 grant and advisory support to help their device get through the arduous—and often expensive—path to market. Taking that journey meant that many of the ideas were based on an intense and often personal desire to help children.

One of the six winning pitches came from Houston, TX-based startup PolyVascular, which is looking to “break the cycle” of repeat open-heart surgeries in children. PolyVascular is developing an artificial heart valve made of medical-grade polymers (instead of human or animal tissue) and is designed to be implanted though less-invasive cardiac catherization instead of open-heart surgery.

“A child born with a type of heart defect that requires a valve replacement will unfortunately face repeat valve replacements throughout his or her life. This is largely because of the poor durability of the valves that we currently have available,” said Henri Justino, director of the cardiac catherization laboratory at Texas Children’s Hospital and chief medical officer at PolyVascular. “I saw that the youngest and most vulnerable children are still having to go through multiple open-heart surgeries to replace dysfunctional heart valves. As I cared for these children in the hospital, I thought, there has to be a better way.”

Like many working with pediatric medical devices, Justino often has to adapt adult devices to use in children. For example, he lamented having to shorten and reshape a three-feet-long catheter wire designed for adults to use for premature infants, who only need six inches.

“How do we do this? We have to cut them, heat them, and reshape them, until we have created a custom curve that is suitable for their tiny hearts,” he said.

The $25,000 grant will be used to help PolyVascular address technical aspects of its heart valve, protect its patents, and toward the steps needed for approval, with the hope of having a device ready for clinical trials in three to five years.

To the drumbeat of his device’s pulsating inner workings, Doug Vincent, president of Pelham, NH-based Ventriflo, pitched his company’s True Pulse Pump, which is designed to replicate the contraction and relaxation of a real heartbeat during bypass surgery using a flexible diaphragm. The system does a better job at delivering oxygen during surgery undertaken to repair pediatric heart defects, said Vincent, a mechanical engineer and inventor.

“The more you learn about kids that have congenital heart defects, and the tremendous benefits modern surgery can bring to improve their condition, the more you realize that this is a high-need area that stands to benefit from innovation in blood pumping,” Vincent said. “We’ve reached a positive tipping point—and this win helps further increase the genuine exuberance to get this product into the hands of clinicians in order to help better perfuse patients and improve outcomes.”

Like many in the pediatric medical device space, the road to commercialization is long and expensive—but momentum is building, including from winning $25,000 at the pitch competition. Ventriflo is currently raising $6 million for the work required to obtain Food and Drug Administration (FDA) 510(k) premarket clearance.

The challenges of pediatric medical device development can seem daunting, but every bit helps—especially when it comes to expertise in navigating the regulatory landscape. One award winner, Draper, is raising money to complete pilot animal studies in piglets for its Low-force Expanding/Adaptable Pediatric Valve (LEAP) heart valve, which passively adapts to the size of a child as he or she grows.

While such a device will have a life-changing impact on each recipient, the target population represents fewer than 8,000 infants and children under six each year, said Corin Williams, a senior member of the technical staff at Draper who pitched the LEAP valve at the competition. For Williams, designing medical devices to help children with heart defects is deeply personal—both her brother and best friend died from heart defects when she was a child.

“Getting pediatric devices to commercialization is especially challenging because of the small market size, but we are passionate about getting this technology to the kids who need it most,” Williams said. “We are entering the ‘valley of death’ as we near the end of our prototype phase and aim to gear up for proof-of-concept demonstration in a preclinical animal model. Finding funding to close that gap is especially hard for pediatric technologies. ‘Growing’ devices, although game-changing for the field, are risky, and the market is small compared to the adult space.”

Following the completion of its animal studies, Draper hopes to begin early human feasibility studies in the next three to four years and then pursue a Humanitarian Device Exemption from the FDA.

The winners of the pitch competition at NCC-PDI’s Sixth Annual Pediatric Device Innovation Symposium are:

  • Bardy Diagnostics (Seattle, WA) for a single-patient-use, continuous recording ambulatory electrocochleograph monitor that records for up to seven days.
  • Design Mentor, Inc. (Pelham, NH) for VentriFlo, an extracorporeal blood pump for short-term cardiopulmonary support of pediatric open-heart surgery patients requiring full or partial cardiopulmonary bypass.
  • Draper (Cambridge, MA) for a pediatric valve designed for children, from birth to age 6, that passively expands to a two-fold change in valve diameter to accommodate child growth.
  • NuPulseCV (Raleigh, NC) for a minimally invasive, long-term mechanical circulatory support device for pediatric patients with cardiac dysfunction.
  • PECA Labs (Pittsburgh, PA) for an expandable cardiovascular conduit that uses a minimally invasive balloon catheter to allow for pediatric growth to reduce surgeries.
  • PolyVascular Corporation (Houston, TX) for a minimally invasive pediatric pulmonary valve replacement approach for young children with congenital heart disease.