pediatric medical device Archives

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Funding opportunity for medical devices addressing youth substance misuse, addiction

June 19, 2024

The Alliance for Pediatric Device Innovation (APDI), a nonprofit consortium led by Children’s National Hospital and funded through the Food and Drug Administration (FDA), today announced a grant opportunity for pediatric medical devices that improve the monitoring, diagnosis or treatment of youth suffering from substance use disorder and addiction. Grants up to $50,000 each are available for pediatric-specific solutions selected by a panel of experts from submitted proposals. Up to $150,000 in grant funds are available for distribution through this program.

The National Institutes of Health (NIH) reports that over 3.6 million U.S. youth, ages 12 to 17, used illicit drugs in 2022. In that same period, an average of 22 youth, ages 12 to 18, died weekly from an overdose. Often, these adolescents did not show the expected warning signs before an overdose, such as problems with alcohol, drugs or prior substance use treatment. Of the teens and tweens who fatally overdosed, only 1 in 10 had a history of treatment for a substance use problem, and only 1 in 7 had ever experienced a prior nonfatal overdose.

“Tragically, drug overdose is now the third leading cause of death among adolescents and, to improve outcomes, we need medical technologies that are specifically designed for the youth,” says Kolaleh Eskandanian, Ph.D., M.B.A., vice president and chief innovation officer at Children’s National and APDI principal investigator and program director. “Teens and tweens are such enthusiastic users of technology. We believe that the time is right for new health technology solutions that can save lives and improve the health of our young people.”

APDI’s call for proposals coincides with the National Advisory Council on Drug Abuse (NACDA) approval last month of the concept “Promoting Medical Device Development for Youth Affected by Drug Addiction and Substance Misuse,” which describes potential funding opportunities. In anticipation of future federal funding from the National Institute on Drug Abuse (NIDA), APDI is providing early support by identifying potential innovations. Along with APDI grant funding, the consortium is providing awardees with support services across all phases of the medical device product lifecycle, including facilitating access to NIDA technical assistance.

Dr. Eskandanian described the kinds of pediatric-focused innovations the grant seeks to attract, which align with NACDA’s listed priorities. They include, but are not limited to, the following:

Artificial intelligence-based algorithms that collect, integrate, analyze and visualize various types of data related to the diagnosis or treatment of drug misuse and addiction in youth.
Stand-alone or add-on digital therapeutics focused on behavioral health interventions to diagnose, treat, prevent and mitigate drug misuse and addiction.
Wearables and connected digital therapeutics at a point-of-need intended to detect, diagnose and treat opioid-induced respiratory depression.
Therapeutic devices, such as neuromodulation, intended to improve SUD treatment outcomes and prevent recurrence.

As most medical devices are designed for adults, Dr. Eskandanian notes that this limits usability and acceptance by adolescents. She adds that existing algorithms supporting medical devices are often based on adult data and are not optimized for adolescents, limiting their usefulness.

“Our goal is to bring more effective pediatric medical devices to market to address the alarming rate of harm substance misuse and addiction is creating for young people and their families,” says Dr. Eskandanian. “Since this is an area of focus for NIDA, we see an opportunity to help create a pipeline of qualified companies that can apply for NIDA follow-on funding.”

Interested innovators can learn more and apply for the APDI funding opportunity online at innovate4kids.org. The application deadline is July 30, 2024.

APDI is one of five nonprofit consortia in the FDA’s Pediatric Device Consortia grant program that receives funding to provide a platform of services, expertise and grants to support pediatric innovators in bringing medical devices to the market that specifically address the needs of children. Along with Children’s National, APDI members include Johns Hopkins University, CIMIT at Mass General Brigham, Tufts Medical Center, MedStar Health Research Institute, MedTech Color and OrthoPediatrics Corp.

Children’s National leaders provide expertise and support to advance SHIP-MD pediatric innovation initiative

March 11, 2021

“Having spent 30 years on the frontlines of pediatric healthcare as a surgeon, I saw so much innovation focused on adult medicine and not on pediatric populations. Instead, we were trying to adapt adult devices for use in children, which is not an effective solution,” says Dr. Newman.

The advancement of children’s medical devices in the U.S. continues to significantly lag behind adult devices for many reasons. A dedicated group of public and private sector healthcare leaders are working together to change that trend. In culmination of its first stage of work, the System of Hospitals for Innovation in Pediatrics – Medical Devices (SHIP-MD) initiative recently held a dynamic 3-day public workshop to further develop this groundbreaking public-private partnership, which is currently in its pre-consortium/conceptual phase.

Children’s National leaders and clinicians were among the pediatric healthcare experts who contributed to robust discussions about how to build and nurture a public-private partnership system that will safely accelerate the advancement of pediatric medical devices.

The workshop was developed and guided by a multi-stakeholder group including the Critical Path Institute (C-Path), the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH), AdvaMed, the American Academy of Pediatrics (AAP) and leaders of pediatric health systems.

“We must strive to improve medical devices for children, which historically lag five to 10 years behind adults. For many children, that can be a lifetime,” says Dr. Beers.

Reflecting its ongoing commitment to bridging the pediatric innovation gap, Children’s National Hospital experts co-led discussions throughout the program, which explored ways to improve children’s health by transforming the existing medical device ecosystem to stimulate investment and innovation in pediatric devices.

Children’s National Hospital President and CEO Kurt Newman, M.D., and Lee Beers, M.D., medical director for the Child Health Advocacy Institute at Children’s National Hospital served as opening session speakers, providing their insights into the current state of innovation in pediatric devices and why a new approach, such as SHIP-MD, is vitally needed.

“Having spent 30 years on the frontlines of pediatric healthcare as a surgeon, I saw so much innovation focused on adult medicine and not on pediatric populations. Instead, we were trying to adapt adult devices for use in children, which is not an effective solution,” says Dr. Newman. “Children’s National Hospital is proud to contribute to SHIP-MD’s pioneering efforts to address this critical disparity and reform pediatric device development in order to ensure that children, regardless of their age or condition, have access to the life-changing treatments and technologies they need to grow up stronger.”

An op-ed recently penned by Dr. Newman in STAT further explores the importance of public-private partnerships like SHIP-MD that are focused on fast-tracking innovation in medical devices for children.

Beers, who also serves as president of AAP, highlighted the fact that, as medical technology continues to advance, children are not reaping the benefits.

“Through the SHIP-MD initiative, we can work to ensure that the discipline of medical device development is equally understood and appreciated by its participating hospitals,” says Dr. Eskandanian.

“We must strive to improve medical devices for children, which historically lag five to 10 years behind adults. For many children, that can be a lifetime,” says Beers. “Much more needs to be done to address the countless hurdles that prohibit children from accessing the technology they need. The disproportionate rate of disease in minority children is another indicator that we must not cut corners as we look to improve pediatric innovation access.”

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 the FDA-funded National Capital Consortium for Pediatric Device Innovation (NCC-PDI), co-led the Qualifying Hospital Criteria panel, which addressed the importance of expanding the SHIP-MD network to medical institutions that have the infrastructure for the safe conduct of research.

“Through the SHIP-MD initiative, we can work to ensure that the discipline of medical device development is equally understood and appreciated by its participating hospitals. As champions of pediatric innovation, we must work to provide equitable access to device trials for every patient that qualifies,” says Eskandanian. “The goal of the Qualifying Hospital Criteria group is to introduce criteria that hospitals must meet in order to provide a safe environment to conduct pediatric medical device research and trials.”

Co-leading the Regulatory panel was Francesca Joseph, M.D., FAAP, a pediatrician at Children’s National Hospital and co-investigator for NCC-PDI. This workshop explored opportunities to address regulatory needs by refining current processes and considering new options to promote advancement of pediatric medical devices.

Co-leading the Regulatory panel was Dr. Francesca Joseph, a pediatrician at Children’s National Hospital and co-investigator for NCC-PDI.

In the closing session, Eskandanian and other panel experts recapped the workshop and discussed core factors that will help determine whether or not SHIP-MD’s network is prepared to enter Phase II, the consortium phase. This phase includes the development of a strategic plan that incorporates the short, medium and long-term goals needed to create and implement the framework enabling the official launch of SHIP-MD.

During his talk, Dr. Newman also shared the strategic steps being taken by Children’s National that complement the SHIP-MD initiative in advancing pediatric device innovation. Among these is the creation of the Children’s National Research & Innovation Campus (CNRIC), the first-of-its-kind pediatric research and innovation hub located in Washington, D.C., which includes on-site partners JLABS, Johnson & Johnson Innovation’s life science incubator, and Virginia Tech University. The campus will nurture a rich ecosystem for pediatric innovation in the nation’s capital.

Annual Pediatric Device Innovation Symposium panelists

Accelerating pediatric device innovation through legislative processes and industry changes

October 16, 2020

While the way we deliver healthcare is changing rapidly, far too often the tools we use to treat children are stuck in the past.

Over the last decade, pediatric medical device innovation, particularly for the youngest, most fragile children, has made dismal progress. Of the Class 3 (high risk/high benefit) medical devices approved by FDA for pediatrics in the last 10 years, less than 4% are for ages 0-2 years old; and even less for neo-natal patients. Simply put, as medical devices advance, children are not seeing the benefit of innovation.

The 8^th Annual Pediatric Device Innovation Symposium presented by Children’s National Hospital in conjunction with the National Capital Consortium for Pediatric Medical Devices (NCC-PDI) featured a keynote panel, “Pediatric Device Innovation: What’s Next?”, to examine the legislative and industry changes needed to speed up device innovation for kids.

One of the keynote panelists, and leading voices on this issue, is Children’s National Hospital president and CEO Kurt Newman, M.D. Dr. Newman, a former pediatric surgeon, knows firsthand that every day in our nation’s pediatric hospitals, surgeons are manipulating adult medical devices to create creative solutions for children’s bodies because it’s the only available option.

“Children need and deserve devices that are conceived and designed with their biology and future in mind,” says Dr. Newman. “While children may only make up a small percentage of our population – maybe 20 or 25% – they are 100% of our future.”

“Children need and deserve devices that are conceived and designed with their biology and future in mind,” says Children’s National Hospital president and CEO Kurt Newman, M.D. “While children may only make up a small percentage of our population – maybe 20 or 25% – they are 100% of our future.”

Dr. Newman also addressed the current barriers to pediatric device innovation, which ranges from limited pediatric clinical trials to a market size that’s not financially appealing.

“The truth is, the frontiers of pediatric medicine are really in the innovative treatments, devices, therapies, and cures awaiting us on the other side of research and development.,” says Dr. Newman.

Former CNN correspondent, Jeanne Meserve, moderated the 45-minute keynote panel discussion, asking questions about the challenges to pediatric innovation, what policy changes need to take place to see improvement in the field of pediatric device innovation, and how federal funding can assist in creating change.

Michelle McMurry-Heath, new CEO of DC-based Biotechnology Innovation Organization (BIO), who joined Dr. Newman on this keynote panel, agreed that more needs to be done in the pediatric space. Dr. McMurry-Heath believes the Food and Drug Administration (FDA) is a public health advocate at heart and that the Pediatric Device Consortia (PDC), which Children’s National Hospital is part of, is starting to make new advancements in pediatric innovation by giving FDA clearance to more start-up companies than we’ve seen in the past.

“The FDA is interested in is what improves the health outcomes for the people and innovation is a huge piece. This is an important part of their mission and it is starting to yield benefits,” says Dr. Michelle McMurry-Heath. “Innovation is a team sport – it’s not easy. It takes a village of expertise and collaboration to progress and projects like the Pediatric Device Consortia is an important piece in this puzzle.”

NCC-PDI is one of five consortia in the FDA’s Pediatric Device Consortia (PDC) Grant Program created to support the development and commercialization of medical devices for children and 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, with support from partners MedTech Innovator, 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.

Dr. McMurry-Heath also addressed the challenge of diseases that don’t exist in adults and posed the question, “How do you create a device for kids if it doesn’t exist in adults?” She cited the lack of market in pediatrics and the difficulty in bringing a device to market as problems that hinder innovation, which is why advocating for these devices is crucial to children’s healthcare everywhere.

“So much of our innovation comes from our small, innovative companies,” say Dr. McMurry-Heath. “For example, my company is working on a COVID-19 tracker now and 70% of the innovation is coming from our smallest biotech companies. It’s a race against time for these companies to bring their innovation to market in order to keep the lights on and pay their scientists; this dog-eat-dog world isn’t immediately obvious to outsiders.

Beyond advocating, Dr. Newman and Children’s National are developing the first-of-its-kind pediatric research and innovation campus, which is currently under construction at DC’s former Walter Reed Army Medical Center site.

“We secured 12 acres to create something that has never been done before and that’s a campus for innovation dedicated to children,” says Dr. Newman. “Our close proximity to federal research institutions and agencies enables the new Children’s National campus to leverage the rich ecosystem of public and private sectors to help bolster biohealth, medical device, and life science innovation.”

As Children’s National continues to champion ways to accelerate pediatric device development, one focus is the on-site incubator Johnson & Johnson Innovation – JLABS, which will help start-up companies strengthen their ideas by working with coaches, having access to mentors and learning how to interact with the FDA. This partnership also offers an audience for their device which could potentially lead to investments.

The Children’s National Research & Innovation Campus will create an ecosystem that can accelerate breakthroughs in pediatric healthcare discoveries and technologies: The new campus is currently under construction and expected to open in the first quarter of 2021.

Both panelists agreed they’d like to see more flexibility with regulators to work with innovators in order create more incentives for them to present their device, like the NCC-PDI “Make Your Medical Device Pitch for Kids!” Competition, which was recently held in September 2020. The six winners received up to $50,000 in FDA-funded grant awards in order to develop their device, eventually bring it to market in order to improve healthcare for kids.

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

June 17, 2020

“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.

Pediatric medical device pitch competition deadline extended

February 12, 2020

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.

Premier annual pediatric medical device competition now accepting submissions

January 21, 2020

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.

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.

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