Devices & Diagnostics, Startups

How can we derisk innovation in pediatric medical devices?

Pediatric medical devices tend to be a neglected market, despite a serious market need. The Sheikh Zayed Institute for Pediatric Surgical Innovation is working to encourage entrepreneurs to develop new technologies in this field.

Sometimes, kids need intensive medical treatment – and the tools used for adults aren’t necessarily suitable to treat smaller, growing bodies. This presents a unique challenge for surgeons and clinicians, who find themselves with limited options when treating sick children.

That’s where the Sheikh Zayed Institute for Pediatric Surgical Innovation comes in. It’s a division of the Washington, D.C.-based Children’s National Health System – and focuses on making pediatric surgery more precise, less invasive and, ideally, pain-free.

Kolaleh Eskandanian, executive director of the Institute, spoke with MedCity News about the unique challenges in pediatric medical device innovation – and ways they’re helping jumpstart entrepreneurship in this small but important market.

Challenges in surgical innovation

Millions of adults have cardiomyopathy – an inherited disease of the heart muscle that at times needs surgical intervention. About 100,000 children have the same condition, but there’s no treatment tailored for these kids. The solution? Doctors often have to implant pacemakers made for adults in children.

“Surgeons and clinicians often to have to improvise with what they have,” Eskandanian said. “Often, they have to do it on the fly and modify a device when performing a surgery.”

Such a dearth of options stems from a chronic lack of funding for innovation in this space. Pediatric medical devices represent a very small market. Kids tend to be healthy – so the subset of ill children is often so miniscule that many companies avoid developing pediatric devices. There just isn’t enough of a financial incentive. If there’s innovation in the pediatric space, it tends to come from startups – the big fish don’t typically get involved.

“Traditional device companies focus on their bottom lines, and their shareholders,” she said. “It’s not often that you’ll see a large medical device company with a pediatric division.”

Legislative fixes needed

There hasn’t been much legislation supporting pediatric surgical innovation. The Orphan Drug Act was put in place in 1983, but it wasn’t until 2007 that childrens’ surgical needs were addressed with the Pediatric Medical Device Safety and Improvement Act.

“The FDA has done great work in this area, but we’re still way behind,” Eskandanian said. “In a nutshell: We strongly believe that more incentives are needed.”

Eskandanian works very closely with federal regulators to improve incentives for devicemakers to innovate further in the pediatric space.

One of the issues the Institute is currently working on to get in front of the Senate: Legislation surrounding the Humanitarian Device Exemption. For conditions that are very rare, drug and device manufacturers are incentivized with a shorter regulatory pathway in which they only have to demonstrate safety and probable benefits to health – but not efficacy.

However, the FDA put a cap of 4,000 individuals on this – “which is excessively low,” Eskandanian said, as it discourages companies from developing devices for rare diseases. “We’re lobbying to raise that number.”

Business goals at the Institute 

The Institute opened its doors in April 2011, thanks to a $150 million gift from the government of Abu Dhabi. It has funding available to help startups jumpstart their pediatric medical device ideas – and is supporting about 40 at present.

That’s because the so-called “valley of death” in startup formation is hard to traverse for pediatric medical device companies in particular. This is because venture capitalists are reluctant to support upstarts if their products haven’t yet been derisked. And, frankly, the pediatric device market is so niche that it’s risky from the get-go.

So the Institute serves as a device-derisking incubator, with aims to help entrepreneurs with business planning, regulatory support, clinical trials, prototyping and preclinical work. Because the Institute is directly affiliated with a children’s hospital, the innovators have ready access to field experts and patient populations.

“Our clinicians and researchers are constantly developing devices,” Eskandanian said. “But to make sure we’re a translational medicine institute, anything we work on is addressing an unmet medical need.”

[IMAGE: Flickr user Pink Chicken]