Medical Devices: "Pediatric conditions often require pediatric-specific engineering"

Interview with Dr. Matthew Maltese, principal investigator at the Philadelphia Pediatric Device Consortium (PPDC)

Children are not just small adults and they cannot be treated as such. Physicians have recognized this but manufacturers of medical devices have a hard time here: the market for pediatric medical devices is very small and researchers have difficulties to turn their ideas into commercially successful products.


Photo: Dr. Matthew Maltese

Dr. Matthew Maltese; © Childrens Hospital of Philadelphia

The Philadelphia Pediatric Device Consortium (PPDC) and the Food & Drug Administration (US-FDA) support researchers, physicians and engineers in their enterprise to acquire manufacturers for new pediatric devices. talked to Dr Matthew Maltese, principal investigator of the PPDC, about the consortium’s activities and the challenges developers of new devices face.

Regarding the treatment with medical devices, why is it not outright possible to use equipment that has originally been designed, tested and build for adults in “smaller sizes” to treat children?

Matthew Maltese: Many times it is as simple as scaling down an adult device to treat a child, but not always. Pediatric conditions often require pediatric-specific engineering. Implantable devices face the unique challenge that children grow and so, for example, the prosthetic valve installed in infancy needs replacement in early childhood. The material properties of pediatric tissue are different than those of adults, a fact that requires consideration in certain designs. Of course, there are many diseases and conditions that are uniquely pediatric that call for completely new approaches. This is for example the case of devices needed for fetal surgery.

What are characteristic properties of devices that are made for pediatric care?

Maltese: There is no one characteristic of the pediatric devices. Rather, in the process of developing those devices one must consider pediatric conditions at the earliest stages of device development.

Are there specific difficulties to develop and test pediatric devices? What keeps researchers from realizing their ideas?

Maltese: The biggest challenge is market size. The pediatric market is small but can be profitable. Often, the biggest challenge is attracting capital investment away from the adult market, where patient counts are 10, 100 or 1000 times larger. Still, there is good reason to invest first in pediatric device development, as it is often the case that devices built for pediatric conditions are scaled up to adult conditions. Extracorporeal Membrane Oxygenation (ECMO) is one of many examples. And, there are examples of companies in existence for decades developing and marketing products solely for the pediatric space. So, even with the small pediatric market size, there are profitable business models.
Photo: Doctor and Girl

Children are not just small adults: treating them sometimes requires more than "scaling down" existing devices for adults. Then, completely new products need to be designed; © Images

How does the Philadelphia Pediatric Device Consortium support researchers?

Maltese: In most instances, we provide advice on IP securement, the regulatory path, pre-clinical and clinical trials, reimbursement, and fundraising from seed funding to investors. In some instances, we provide seed funding for innovative ideas. We are especially adept at pairing innovators, including small and large companies, with clinicians to refine device designs, and to perform clinical trials of new devices from internal and external innovators. Our end goal is to bring pediatric medical devices to market to ease the suffering of children, and so we are flexible in supporting any project with that same goal.

Has the consortium already successfully supported researchers to bring a device into a prototype or trial stage?

Maltese: Yes! Even though we are young (3.5 months old) we have enjoyed early success. We have been working with a large medical device company on developing ventilation support capability for young patients, and are currently working with a small company on an innovative device to clear clogged feeding tubes. Other devices are not as far along, but there has been tremendous excitement generated regionally and nationally since the inception of this renewed effort by the FDA to develop pediatric medical devices. It is an exciting time.

To you, is this research network an idea that could be promising in other countries as well, or does it address problems specific to the US?

Maltese: The challenges facing pediatric device development are not unique to the US, and forging international collaborations around pediatric device development will be beneficial to all. Too often medical devices that are developed in the US end up solely in the European market due to the relative ease of regulatory approval there. Collaboration among US and European clinicians, innovators, and regulators could help bring medical devices with good safety and effectiveness histories in the European clinics, back to the US and elsewhere around the world.
Photo: Timo Roth; Copyright: B. Frommann

© B. Frommann

The interview was conducted by Timo Roth.