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Pediatric Device Innovation Symposium graphic

Real-world evidence and the impact on pediatric device innovation

Pediatric Device Innovation Symposium graphic

The 8th Annual Pediatric Device Innovation Symposium presented by @ChildrensNatl in conjunction with @Devices4kids took place Sept. 28-30.

The 8th Annual Pediatric Device Innovation Symposium presented by Children’s National Hospital in conjunction with the National Capital Consortium for Pediatric Medical Devices (NCC-PDI) kicked off on Monday, Sept. 28, 2020 with a panel featuring three fellow members of the FDA-funded Pediatric Device Consortia (PDC) Grants Program discussing real-world evidence and the vital role that innovation and technology play in advancing healthcare for the pediatric population.

As described by the FDA, real-world evidence (RWE) is the clinical evidence regarding the usage and potential benefits or risks of a medical product, derived from the analysis of patient data. RWE can be generated by different study designs or analyses, including but not limited to, randomized trials, including large simple trials, pragmatic trials and observational studies (prospective and/or retrospective).

The symposium panel, “Pediatric Device Consortia Update on the Use of Real-World Evidence (RWE) for Pediatric Device Innovation” examined real-world evidence (RWE) demonstration projects from Southwest Pediatric Device Consortium, UCSF-Stanford Pediatric Device Consortium and the West Coast Consortium for Technology and Innovation in Pediatrics (CTIP). The panel was moderated by Juan Espinoza, M.D., FAAP, director of CTIP.

“Real-world evidence projects are critical to the advancement of pediatric medical device innovation,” said Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., vice president and chief innovation officer at Children’s National Hospital, and principal investigator for NCC-PDI. “Bringing together our colleagues in pediatric healthcare through the symposium helps us together identify solutions that will bring medical device innovations to the market faster to benefit the children and families we all serve.”

Here are some of the key discussion points made by panelists regarding current RWE demonstration projects:

  • Emerging medical and consumer technologies are enabling the diabetes community to take great strides toward truly personalized, real-time, data-driven management.
  • “Connected” technologies such as smartphone apps, wearable devices and sensors create an ecosystem of data driven-tools that can link patients and care teams for precision management of conditions like diabetes, including predicting a hypoglycemic event.
  • RWE has an important future in treating rare diseases by using existing data and harnessing that to improve treatment among pediatric patients.
  • Through the rich data in academic healthcare systems, practitioners are better equipped to provide RWE to address important regulatory and research questions.
  • The creation of a pediatric device patient database, which provides real-time updates to clinical, device and patient-generated health data, offers several regulatory, safety and research advantages in advancing device innovation.
Kolaleh-Eskandanian

Kolaleh Eskandanian, PhD, MBA, PMP, vice president and chief innovation officer at Children’s National Hospital, and principal investigator for NCC-PDI.

The FDA currently supports RWE demonstration projects that are focused on understanding data quality, improving RWE tools and evaluating RWE approaches to study design and data analytics. Dr. Espinoza highlighted the importance of ongoing dialogue on the use of RWE as it pertains to innovations that advance pediatric healthcare across the board.

“Thank you to the NCC-PDI team for creating this opportunity for PDCs to talk about the impact of real-world evidence on pediatric medical device development and the projects we have to move that field forward,” said Dr. Espinoza, director of CTIP and principal investigator on the PDC’s RWE Demonstration Project. “These projects are intended to inform the FDA and the industry’s approach to RWE including study design, data standards, fitness for use and regulatory decision making and reproducibility. This is complicated work that involves research, IT infrastructure, clinical care and operations.”

NCC-PDI, which is led by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Hospital and the A. James Clark School of Engineering at the University of Maryland, is one of five members of the FDA’s Pediatric Device Consortia Grant Program. To date, NCC-PDI has mentored over 100 medical device sponsors to help advance their pediatric innovations, with seven devices having received either their FDA market clearance or CE marking.

NCC-PDI device competition

Medical device competition announces six winners to share in $250K

Judges award grants for pediatric medical devices that address cardiovascular, NICU, and orthopaedic and spine device innovations.

screenshot of pitch competition

“COVID-19-edition” of pediatric medical device competition announces winners

NCC-PDI-COVID19-Edition-Competition

“COVID-19-edition” of pediatric medical device competition announces finalists

Sixteen finalists have been selected in the “Make Your Medical Device Pitch for Kids!” special COVID-19 edition competition presented by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI). Representing innovations in COVID-19-related pediatric medical devices, the finalists will compete in a virtual pitch event held on July 20,2020 where up to $250,000 in awards will be given. Winners will receive grant funding of up to $50,000.

The competition is led by NCC-PDI co-founders the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Hospital and the A. James Clark School of Engineering at the University of Maryland and powered by nonprofit accelerator and NCC-PDI member, MedTech Innovator.

This competition focuses on pediatric medical devices that support home health monitoring and telehealth, and improve sustainability, resiliency and readiness in diagnosing and treating children during a pandemic.

“As COVID -19 continues to threaten the health of families and children across the nation, we must continue to seek new and better ways to deliver quality care during a pandemic and offer technology solutions to reopen more safely,” says Kolaleh Eskandanian, Ph.D., MBA, PMP, vice president and chief innovation officer at Children’s National Hospital and principal investigator of NCC-PDI. “Competitions like this are vital to get ahead of the healthcare challenge that COVID-19 presents in the world of pediatrics. By supporting innovation, we provide critical breakthroughs that can positively impact the lives of the children and families we serve.”

Along with grant funding, one company from the competition will be selected by Johnson & Johnson Innovation – JLABS to receive a one-year residency at JLABS @ Washington, DC, which will be located on the new Children’s National Research & Innovation Campus currently under construction. In addition to the 2021 JLABS residency, the awardee will have access to the JLABS community and expert mentoring by the Johnson & Johnson family of companies.

The 16 pediatric device innovations that judges selected for the final competition include:

  • Adipomics – simple and fast, one-step COVID-19 diagnostic kit for home or school use
  • Bloom Standard (Kaaria) – wearable, AI-driven ultrasound for infant cardiac and pulmonary screening and diagnostics
  • CereVu Medical – remote COVID-19 sensor, monitor and centralized data hub that measures blood oxygen saturation, muscle aches, temperature and trouble breathing
  • Children’s Hospital of Philadelphia – a transparent reusable DIY origami facemask that reveals facial expressions & improves communication
  • Children’s National Hospital – Lab-on-a-chip device for high-throughput combination drug screening
  • Hopscotch – gamified cognitive behavioral therapy-based computer exercises to encourage kids to stay engaged and complete treatment programs
  • Medichain – cost effective, accurate COVID-19 test with results in minutes and can detect the virus in the early stage
  • Medipines – monitor device that displays critical respiratory parameters analyzed from a patient’s breathing sample
  • OtoPhoto – a smart otoscope that quickly and accurately aids diagnosis of ear infections for home telehealth use
  • OxiWear – continuous wear oxygen-monitoring device used to reduce patient insecurity
  • REALTROMINS – real time, continuously updated predictive analytics to identify impending mortality in children
  • SurgiPals – digital assistant and urine biochemical sensor to aid in outpatient care of children with COVID-19
  • TGV-Dx – a novel, phenotype-based test system for rapid selection of effective antibiotic regimen
  • VitaScope – quick, accurate infant vital signs to facilitate high-quality virtual care
  • Vitls – wearable platform for remote patient monitoring of the vitals clinicians require to assess a patient
  • X-Biomedical – rugged, portable smart ICU ventilator for pediatric and adult patients

Funding for the competition is made possible by a grant from the Food and Drug Administration (FDA) and a philanthropic gift from Mei Xu, founder of e-commerce platform Yes She May, a site dedicated to women-owned brands.

In addition to this COVID-19 special edition event, NCC-PDI recently revealed the ten finalists in its prestigious 8th annual “Make Your Medical Device Pitch for Kids!” competition. Cardiovascular, NICU, and orthopaedic and spine device innovations are the focus of the fall competition, taking place October 7, 2020 as part of the 8th Annual Symposium on Pediatric Device Innovation, presented by Children’s National and co-located with The MedTech Conference powered by AdvaMed.

pitch competition finalists

NCC-PDI-COVID19-Edition-Competition

NCC-PDI launches special pediatric medical device competition focused on covid-19 innovations

Kolaleh-Eskandanian

“Innovation in children’s medical devices consistently lags behind that of adults and we need to change that if we are to confront the challenge to children’s health of COVID-19 and future pandemics,” said Kolaleh Eskandanian, Ph.D., MBA, PMP, vice president and chief innovation officer at Children’s National Hospital and principal investigator of NCC-PDI. 

As medical data increasingly highlights the serious impact of COVID-19 on children’s health, the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announces a special pitch competition focused on COVID-19-related pediatric medical devices that support home health monitoring and telehealth, and improve sustainability, resiliency and readiness in diagnosing and treating children during a pandemic.

The “Make Your Medical Device Pitch for Kids!” COVID19 edition is led by NCC-PDI co-founders the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Hospital and the A. James Clark School of Engineering at the University of Maryland and powered by nonprofit accelerator and NCC-PDI member, MedTech Innovator. The finals in the virtual pitch event will be held on July 20, 2020. Winners will each receive a grant award of up to $50,000.

“Despite early reports that COVID-19 posed less of a threat to children, a recent study published by Children’s National shows that considerable numbers of pediatric patients are hospitalized and become critically ill from the disease,” said Kolaleh Eskandanian, Ph.D., MBA, PMP, vice president and chief innovation officer at Children’s National Hospital and principal investigator of NCC-PDI. “Innovation in children’s medical devices consistently lags behind that of adults and we need to change that if we are to confront the challenge to children’s health of COVID-19 and future pandemics.”

Funding for the competition is made possible by a grant from the Food and Drug Administration (FDA) and a philanthropic gift from Mei Xu, founder of e-commerce platform Yes She May, a site dedicated to women-owned brands.

Along with grant funding, one company from the competition will be selected by Johnson & Johnson Innovation – JLABS to receive a one-year residency at JLABS @ Washington, DC, which will be located on the new Children’s National Research & Innovation Campus currently under construction. In addition to the 2021 JLABS residency, the awardee will have access to the JLABS community and expert mentoring by the Johnson & Johnson family of companies.

Submissions for the competition are being accepted now through Monday, July 6, 2020z at the NCC-PDI website, Innovate4Kids.org, where complete details can be found.

NCC-PDI is one of five members in the FDA’s Pediatric Device Consortia Grant Program created to support the development and commercialization of medical devices for children, which lags significantly behind the progress of adult medical devices. Along with Children’s National, University of Maryland and Medtech Innovator, NCC-PDI members include accelerator BioHealth Innovation and design firm Archimedic.

To date, NCC-PDI has mentored over 100 medical device sponsors to help advance their pediatric innovations, with seven devices having received either their FDA market clearance or CE marking. The consortium hosts a major pediatric pitch competition annually that showcases and awards promising pediatric innovations and provides a first-of-its-kind pediatric-focused accelerator program for finalists.

NCC-PDI-COVID19-Edition-Competition

2019 pitch competition

Pediatric medical device pitch competition deadline extended

2019 pitch competition

Pediatric innovators pitch for up to $250,000 in FDA-funded grant awards.

The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announced today that the application deadline for its annual “Make Your Medical Device Pitch for Kids!” competition is extended one week to Feb. 22 at midnight EST. Innovators and startup companies with devices in the pediatric cardiovascular, orthopedic and spine, or NICU sectors are invited to apply for a share of up to $250,000 in FDA-funded awards and access to a newly created NCC-PDI pediatric device accelerator program led by MedTech Innovator. Submissions are being accepted now.

Up to 30 companies will be selected for the first round of competition scheduled for March 23, 2020 at the University of Maryland, College Park. Up to 10 finalists chosen from that event will compete for up to $250,000 in grant awards in Toronto, Canada on October 4. Finalists also receive a spot in the MedTech Innovator 2020 Accelerator – Pediatric Track, which provides a customized curriculum and in-depth mentorship.  Finalists will be announced in May, 2020.

This is the ninth competition in seven years hosted by NCC-PDI, one of five FDA Pediatric Device Consortia Grant Program members supporting the development and commercialization of pediatric medical devices. NCC-PDI is led by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Hospital and the A. James Clark School of Engineering at the University of Maryland. Additional consortium members include accelerators Medtech Innovator, BioHealth Innovation and design firm partner Archimedic.

“This year’s competition focuses on three medical device areas of critical need for pediatric patients, so we want to give innovators as much time as possible to prepare their submissions,” said Kolaleh Eskandanian, Ph.D., MBA, PMP, vice president and chief innovation officer at Children’s National Hospital and principal investigator of NCC-PDI . “Our goal is to support devices that will improve care for children by helping them advance on the pathway to commercialization. We have seen how this competition can provide significant momentum for pediatric innovations, so we want to encourage as much participation as possible.”

To date, NCC-PDI has mentored over 100 medical device sponsors to help advance their pediatric innovations, notes Eskandanian, with six devices having received either their FDA market clearance or CE marking. Along with the positive exposure of presenting at this competition, she notes that the success of NCC-PDI’s portfolio companies is attributed to funding, mentorship, support from partners and facilitated interactions between device innovators and potential investors.

Eskandanian notes that enhancing access to resources for pediatric innovators is one aim of the Children’s National Research & Innovation Campus, a first-of-its-kind campus focused on pediatric healthcare innovation, currently under development on the former Walter Reed Army Medical Center campus in Washington, D.C. With its proximity to federal research institutions and agencies, universities, academic research centers, as well as on site accelerator Johnson & Johnson Innovation – JLABS, the campus will create a rich ecosystem of public and private partners which, like the NCC-PDI network, will help bolster pediatric innovation and commercialization. Opening is scheduled for December 2020.

Pediatric device competition

Premier annual pediatric medical device competition now accepting submissions

Pediatric device competition

Pediatric innovators pitch for grant awards and participation in a special accelerator program.

The official call for submissions is underway for the premiere annual pediatric medical device competition, sponsored by National Capital Consortium for Pediatric Device Innovation (NCC-PDI). The competition is led by Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Hospital, the A. James Clark School of Engineering at the University of Maryland and non-profit accelerator MedTech Innovator. The three organizations are all an integral part of the FDA-funded NCC-PDI, which aims to facilitate the development, production and distribution of pediatric medical devices. Additional NCC-PDI members include accelerator BioHealth Innovation and design firm Archimedic.

The competition focuses on pediatric devices in three areas of critical need: cardiovascular, orthopedic and spine, and neonatal intensive care (NICU) and is now accepting applications. Contestants will pitch for a share of up to $250K in grant awards and the opportunity to participate in the MedTech Innovator 2020 Accelerator – Pediatric Track.

The first stage of competition will be held on March 23 at the University of Maryland and will include up to 30 companies selected from all submissions received. Up to 10 finalists selected from that event will move on to the “Make Your Medical Device Pitch for Kids!” finals on October 4, 2020 in Toronto, Canada. Finalists from the March qualifying round will be notified in May, 2020.

“While there is a great need for pediatric devices in many specialty areas, the development and commercialization process is very challenging because of the small market size and dynamic characteristics of the patient population,” says Kolaleh Eskandanian, Ph.D., MBA, PMP, vice president and chief innovation officer at Children’s National Hospital and principal investigator of NCC-PDI. “To provide pediatric innovators with greater support in meeting these unique challenges, we must go beyond grant funding, which is why we are collaborating with MedTech Innovator to offer an accelerator program with a pediatric track.”

To date, NCC-PDI has mentored over 100 medical device sponsors to help advance their pediatric innovations, notes Eskandanian, with six devices having received either their FDA market clearance or CE marking. She says the success of NCC-PDI’s portfolio companies is attributed to funding, mentorship, support from partners, facilitated interactions between device innovators and potential investors, and being discovered during their presentations at the signature “Make Your Medical Device Pitch for Kids!” competitions.

While advancements have been made in some pediatric specialties, there is still a critical need for novel devices in cardiovascular, orthopedic and spine, and NICU areas. On average over the past decade, only 24 percent of life-saving medical devices approved by FDA – those that go through PMA and HDE regulatory pathways – have an indication for pediatric use. Of those, most are designated for children age 12 or older. “Devices designed specifically for the younger pediatric population are vitally needed and, at this early stage of the intervention, can significantly improve developmental outcomes for a child,” Eskandanian said.

For more information and to apply for the upcoming NCC-PDI pitch competition, visit https://medtechinnovator.org/pediatricapply/.

Enhancing access to resources for pediatric innovators is also one of the aims of the Children’s National Research and Innovation Campus, a first-of-its-kind focused on pediatric healthcare innovation, currently under development on the former Walter Reed Army Medical Center campus in Washington, D.C. and opening in December, 2020. With its proximity to federal research institutions and agencies, universities, academic research centers, as well as on site accelerator Johnson and Johnson Innovation – JLABS, the campus will create a rich ecosystem of public and private partners which, like the NCC-PDI network, will help bolster pediatric innovation and commercialization.

NOTE: The deadline for submissions has been extended to February 22 at midnight EST.