Fortunately, the industry has taken notice of this void in available technologies for children and responded in a number of ways. One of those methods involved the creation of an innovation competition through an FDA-sponsored program.
With the 7th Annual Pediatric Device Innovation Symposium coming up during The MedTech Conference in Boston in September, MPO took a moment to speak with Kolaleh Eskandanian, Ph.D., MBA, PMP, vice president and chief innovation officer of the Children’s National Health System and principal investigator for the National Capital Consortium for Pediatric Device Innovation. In addition, Matthew Oetgen, M.D., division chief of Orthopaedic Surgery and Sports Medicine at Children’s National shared some thoughts.
Sean Fenske: What is the National Capital Consortium for Pediatric Device Innovation?
Dr. Kolaleh Eskandanian: The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) is one of five FDA Pediatric Device Consortia (PDC) grant programs supporting the development and commercialization of pediatric medical devices. Now in its sixth year, NCC-PDI’s goal is to advance the development of pediatric medical devices and, through the newly created accelerated program, help participating innovators bring their device to market.
Companies who have participated in one of NCC-PDI’s eight “Make Your Medical Device Pitch for Kids!” competitions in the past six years attribute their success to the consortium’s funding, mentorships, partner support and facilitated networking with investors and other innovators.
NCC-PDI is led by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System and the A. James Clark School of Engineering at the University of Maryland. The consortium recently added new accelerators BioHealth Innovation and MedTech Innovator, as well as Archimedic as its design firm partner.
Fenske: Why is the FDA advocating for pediatric innovation?
Dr. Eskandanian: Device needs of pediatric patients often differ from those of adults. For example, often devices must grow with the patient and be less invasive. The FDA recognizes the unique needs of children and has committed to advancing new avenues to encourage the development of safe, effective pediatric medical devices. The PDC grant program is one example of FDA initiatives that promote the development of devices specifically designed and tested for children.
Fenske: How did BioHealth Innovation and MedTech Innovator become involved in this initiative?
Dr. Eskandanian: We invited two established accelerators, BioHealth Innovation and MedTech Innovator, to NCC-PDI because we recognized an opportunity to provide even more wrap-around services to our portfolio companies that will guide them through the regulatory and commercialization processes. Each of our partners brings a unique capability to the consortium and adds specific value and expertise to our competition winners as they move forward.
BioHealth Innovation, a Maryland-based innovation intermediary, supports the transformation of research projects into new business opportunities. Through their Entrepreneurs-In-Residence Program, BioHealth Innovation will offer pitch coaching to all competition finalists.
California-based MedTech Innovator is a virtual startup accelerator that matches healthcare industry leaders with early-stage, emerging growth medtech companies for mentorship and support. They are leading the first-of-its-kind NCC-PDI “Pediatric Device Innovator Accelerator Program” that will provide competition winners mentorship and access to a network of experts consisting of medtech executives, investors, specialty pediatricians, and FDA regulatory and business consultants.
Fenske: What role does Archimedic play in this effort?
Dr. Eskandanian: Archimedic is our design partner and they advise innovators regarding the impact of design decisions on a device such as ease of use, ease of manufacturing, materials availability, cost, and other key aspects.
Fenske: As this is the sixth year of operation for the consortium, can you share some of the success stories that have come out of it?
Dr. Eskandanian: To date, NCC-PDI has supported over 94 pediatric medical devices. Additionally, we’ve helped five companies receive FDA or CE mark regulatory clearance. Previous NCC-PDI pitch competition winners have raised more than $83 million combined, subsequent to their participation, in part because of the networking opportunities we’ve provided them.
I’m proud that prior to this year’s selection of pediatric orthopedics and spine as a subspecialty focus, we’ve already had winners from this sector: Green Sun Medical and LIM Innovations.
Previous winners and their stories can be found at Innovate4Kids.org.
Fenske: How many entries did you receive for the competition that took place earlier this year?
Dr. Eskandanian: That competition was the first time we focused specifically on pediatric orthopedic and spine devices. With even such a narrow focus, we still received close to 50 submissions.
Fenske: Speaking of the competition from earlier this year, what was the outcome? Who won?
Dr. Eskandanian: Winners were announced during the April 30 competition. Each finalist had a chance to win up to $50,000 in grant funding and access to the newly created NCC-PDI “Pediatric Device Innovator Accelerator Program,” led by MedTech Innovator.
The competition took place at the University of Maryland, College Park and featured live pitch presentations from the finalists and their thought-provoking exchanges with the multi-disciplinary panel of judges. There was a patient advocacy panel discussion about incorporating the patient’s perspective into the research and development of innovative pediatric medical devices.
The 2019 NCC-PDI “Make Your Medical Device Pitch for Kids!” competition winners were:
- AMB Surgical, LLC, Dayton, Ohio – FLYTE, a device designed to reduce invasive and repetitive surgery in children and teens with orthopedic illnesses such as scoliosis and limb abnormalities
- Auctus Surgical, Inc., San Francisco, Calif. – Auctus Surgical Dynamic Spinal Tethering System, a mechanism used to correct the scoliotic spine in pediatric patients through a tethering procedure
- ApiFix Ltd, Boston, Mass. – ApiFix’s Minimally Invasive Deformity Correction (MID-C) System, a posterior dynamic deformity correction system for surgical treatment to provide permanent spinal curve correction while retaining flexibility
- Children’s National Health System, Washington, D.C. – Babysteps platform to improve initial assessment of clubfoot deformity and predict the magnitude of correction
- nView Medical, Salt Lake City, Utah – Surgical scanner using AI-based image creation to provide instant 3D imaging during surgery to improve imagery speed and accuracy
Fenske: Will this continue as an annual event?
Dr. Eskandanian: Yes, NCC-PDI hosts a pitch competition for pediatric innovators at least one to two times annually, and in fact, applications are now being accepted for our $150K NICU pitch competition, which will be held during the 7th Annual Pediatric Device Innovation Symposium in September. Innovators and startup companies with devices designed to improve neonatal or NICU care are invited to apply by Aug. 19, 2019 for a chance to receive awards up to $50,000 and participate in the newly created “Pediatric Device Innovator Accelerator Program” led by MedTech Innovator. [Click here to apply.]
Fenske: Dr. Oetgen, do you have any comments you’d like to share before we close?
Dr. Matthew Oetgen: The pediatric orthopedics and spine sector was the subspecialty focus of the April 30 “Make Your Medical Device Pitch for Kids!” competition in part because it has been identified by the FDA as one of the emerging underserved specialties that is lacking innovation.
As a pediatric orthopedic surgeon, I’m grateful for the many advancements that have been made to develop less invasive and more precise pediatric orthopedic devices, but far too often, I still have to manipulate adult devices to fit them for use in children. We need more devices that compensate for the smaller size of children compared to adults and that can adapt as children’s bones continue to grow and develop.
I was excited by this past pitch competition to see the unexpected solutions identified by innovators as something we can do more efficiently and effectively even though, as surgeons, we may have discounted it as “business as usual” since we’ve been working with the standard of care for so long.