The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) serves as a critical device development resource by providing expert advice, support services, and fund management of pediatric device innovation. Our long-term objective is to improve pediatric health care by increasing the number of effective pediatric medical devices and contribute to the national effort to address the unmet need for pediatric medical devices.
Members of the NCC-PDI business core are experts and entrepreneurs who have gone through the startup formation and have relationships built across multiple stakeholders including industry and investors. The business resources include consultation services on 1) business plan creation 2) intellectual property 3) sources of funding 4) pitch perfecting coaching 5) startup formation and management coaching.
A key strength of the business core is its familiarity with the federal system and obtaining funding through federal and non-federal services.
The collective expertise of our regulatory members will cover all market submission options: Class I/II exemptions; premarket notification 510(k), including the de novo route; premarket approval; and humanitarian device exemption and most pediatric specialties including surgery, cardiovascular, orthopedics, anesthesiology, and rare diseases.
All initial consultations are done with Drs., Francesca Joseph, Lester Schultheis, and Martha Wang. Dr. Joseph, a former Medical Officer in the Office of Orphan Products Development, was heavily involved in the Humanitarian Use Device program and also with the administration of the Pediatric Device Consortia Grant Program. Dr. Schultheis, a research professor at the University of Maryland and formerly with the FDA CDER and CDRH, has expertise in the full spectrum of regulatory matters, having worked with device sponsors of startups and established medtech companies. Dr. Wang is a device regulatory expert with a bioengineering background, and has specialized expertise in FDA-compliant manufacturing, including cGMP/GTP manufacturing, quality assurance, protocol development for ISO 10993 biocompatibility testing, in vivo studies, and 3D printing.
NCC-PDI places a strong focus on reimbursement planning early in the total product life cycle to add efficiency to the regulatory pathways, including careful selection of clinical indications for initial market entry and longer-term product diversification. As part of the Pediatric Device Innovator’s Launchpad (PDIL) roadmap, device innovators will be guided to answer potential questions from health insurance payers such as:
- How does the device improve net health outcomes compared to alternatives?
- What is the economic impact on the payer, provider, and patient?
- How will you meet the evidence requirements necessary for your type and class of device?
NCC-PDI’s experts in the reimbursement core will guide device innovators on considering the use of real-world data to translate to real-world evidence, in such a fashion that datasets show improvement outside of carefully controlled clinical trials. Obtaining that data, along with economic impact/cost effectiveness data, should be started early in product development, and certainly at the design and implementation of clinical trials.
Medical & Scientific Resources
NCC-PDI pediatricians are all physician-scientists with vast pre-clinical and clinical trials experience, having conducted an impressive array of research studies throughout their careers. They are also innovators of one or more medical devices, supported by NCC-PDI. This team of pediatricians will continue to evaluate device applications for scientific merit and clinical unmet need as well as:
- Serve as key opinion leader(s) in their respective clinical area of expertise
- Connect device innovators to pediatric specialists within Children’s National and our network of children’s hospitals for purposes of interview and concept validation
- Contribute to research subject cohort discovery and clinical trials design
- Assist with defining safety and efficacy endpoints.
NCC-PDI has access to more than 600 clinician-researchers at Children’s National, as well as to its many research networks, including the CTSA network, the I-ACT Global Pediatric Clinical Trials Network, Clinical Trials Transformative Initiative (CTTI), and through our collaboration with PEDSnet.
Engineering and Prototyping Resources
Substantial engineering and prototyping capabilities are available through NCC-PDI members, particularly at Children’s National and the University of Maryland. One or more mentors will work with each device innovator to create a high-level journey map, detailing key milestones, timelines, and costs.
If prototyping and engineering tasks are required, device innovators are then referred to the engineering and prototyping core. Examples of services we provide include:
- Assisting device innovators to develop a comprehensive set of technical specifications and performance thresholds required of the materials, components, sub-assemblies, and the finished product
- Risk assessment, failure mode and effect analysis
- Prototyping using Children’s National or the University of Maryland’s rapid prototyping facilities
- Assistance with pre-clinical protocol development including in vitro and in vivo testing that includes: biocompatibility testing, safety, materials composition testing, and final device testing.
Device innovators that have manufacturing needs for an ISO-certified facility or require engineering tasks that are beyond the leader members’ capacity will be connected to NCC-PDI affiliated medical device design and manufacturing members, Archimedic, Cadence, and Medical Murray.
NCC-PDI is also establishing its own Quality Management System (QMS) and has access to quality management tools.
NCC-PDI will address the methodological challenges specific to pediatric populations and rare diseases (e.g. small sample size and potential biases in analyses due to the confounding of outcomes due to changes correlated with growth and development) and continue its efforts in developing new methods and tools to more effectively design studies in these special populations.
NCC-PDI will address methodological challenges in disparities research including target population definition, sampling frame, and issues of non-response.