Tag Archive for: National Capital Consortium for Pediatric Device Innovation

Bloom Standard 2 Portable UltraSound Device being used on a baby

Novel ultrasound device gets FDA breakthrough designation with Children’s National support

The Bloom Standard device enables autonomous, hands-free ultrasound scans to be performed anywhere, by any user.

A novel ultrasound device developed by Bloom Standard received the Food and Drug Administration’s valued  breakthrough device designation with the help of Children’s National Hospital and support provided through an  FDA-funded grant that established the Alliance for Pediatric Device Innovation (APDI), formerly branded as the National Capital Consortium for Pediatric Device Innovation (NCC-PDI). The grant funding, clinical expertise and regulatory guidance demonstrate the hospital’s leadership in pediatric medical device innovation and its commitment to supporting critically needed advancements.

“In many ways, Children’s National has been a key resource as we continue this journey from concept to commercialization,” said Annamarie Saarinen, co-founder of Bloom Standard and the mother of an infant who was diagnosed with a critical heart defect days after her birth.

Why we’re excited

Children’s National Innovation Ventures and APDI leaders saw the value in the Bloom Standard innovation: a device that enables autonomous, hands-free ultrasound scans to be performed anywhere, by any user. The FDA granted the innovation its breakthrough device designation to help streamline the regulatory process so that patients and healthcare providers have more timely access to devices.

Bloom Standard can potentially save lives and improve outcomes for newborns and babies with cardiac and respiratory issues. The technology can eliminate the delay that often occurs for infants who need ultrasound imaging because their medical location lacks the technology. Bloom Standard’s portability and ease of use can potentially reduce mortality and poor outcomes tied to delayed detection of lung and cardiac conditions. It has potential cost savings, too.

Children’s National leads the way

Children’s National supported this novel medical technology for children by engaging in multiple steps through the regulatory process:

  • Grant funding: Bloom Standard participated in pediatric pitch competitions in 2020 and 2022 and each time, because of the merits of the device, was awarded grant funding that helped to support its progression.
  • Regulatory support: Children’s National pediatrician Francesca Joseph, M.D., brings a wealth of expertise navigating the FDA’s regulatory processes and currently service as co-investigator and core regulatory expert for the pediatric device consortium led by Children’s National. Saarinen called Dr. Joseph “an invaluable resource,” explaining that her input and support has been very significant in Bloom Standard’s understanding and navigation of FDA processes. “For a small device company like ours, she has been a lifeline,” Saarinen said.

Saarinen says she is grateful for the continuing relationship with Children’s National as her company enters its next phase on the journey to commercialization.

Children’s National Vice President and Chief Innovation Officer Kolaleh Eskandanian, Ph.D., MBA, PMP, who directs the FDA-funded Alliance for Pediatric Device Development, says that nurturing and supporting life-saving technologies like Bloom Standard is important because the device addresses a dire unmet need in the pediatric space, especially in settings with fewer resources and in public health emergency situations. “Advancements in children’s medical devices continue to lag behind those of adults, and we must use our research and innovation infrastructure to help close that gap and to influence policy changes.”

NCC-PDI Finalists

Pediatric medical device competition names finalists

Five finalists have been named in the prestigious annual “Make Your Medical Device Pitch for Kids!” competition presented by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI). Representing innovations in pediatric technologies that aim to address unmet medical needs for children, these five finalists now have access to a pediatric accelerator program led by MedTech Innovator and will compete for a share of $150,000 in grant funding from the U.S. Food and Drug Administration (FDA) in the final virtual pitch event in October 2022. The pediatric pitch event is part of the 10th Annual Symposium on Pediatric Device Innovation, co-located with the MedTech Conference, powered by AdvaMed.

“Addressing unmet needs across pediatric populations is critical to advancing children’s health and we are delighted to once again work with pioneering companies that seek to bridge this care gap,” says Kolaleh Eskandanian, Ph.D., M.B.A, P.M.P, vice president and chief innovation officer at Children’s National Hospital and principal investigator of NCC-PDI. “As an FDA-funded consortium, NCC-PDI serves as a critical device development resource, bringing together individuals and institutions that support viable pediatric innovations and create faster pathways to commercialization. We congratulate this year’s finalists and look forward to seeing the progress made in the coming months as they navigate the accelerator program.”

The following are the five pediatric device innovations that judges selected for the final competition:

  • CorInnova – Houston, TX – Minimally invasive biventricular non-blood contacting cardiac assist device to treat heart failure.
  • Innovation Lab – La Palma, CA – Mechanical elbow brace stabilizes tremors for pediatric ataxic cerebral palsy to improve the performance of Activities of Daily Living (ADLs).
  • Prapela – Biddeford, ME – Prapela’s incubator pad is the first innovation to improve the treatment of apnea of prematurity in over twenty years.
  • Tympanogen – Richmond, VA – Perf-Fix replaces surgical eardrum repair with a nonsurgical clinic procedure
  • Xpan – Concord, Ont. – Xpan’s universal trocar enables safest and most dynamic access and effortless upsizing in conventional/mini/robotic procedures.

Beginning in June 2022, the five finalists will participate in a pediatric-focused track of the MedTech Innovator accelerator, the world’s largest accelerator of medical devices.

NCC-PDI is one of five consortia 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. NCC-PDI is led by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National 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 nearly 200 medical device sponsors to help advance their pediatric innovations, with 16 devices having received either their FDA market clearance or CE marking.

The accelerator program is the consortium’s latest addition to a network of resources and experts that it provides in support of pediatric innovators.

Eskandanian adds that supporting the progress of pediatric innovators is a key focus of the new Children’s National Research & Innovation Campus, a one-of-its-kind ecosystem that drives discoveries that save and improve the lives of children. On a nearly 12-acre portion of the former, historic Walter Reed Army Medical Center in Northwest Washington, D.C., Children’s National has combined its strengths with those of public and private partners, including industry, universities, federal agencies, start-up companies and academic medical centers. The campus provides a rich environment of public and private partners which, like the NCC-PDI network, will help bolster pediatric innovation and commercialization.

NCC-PDI Finalists social card

NCC-PDI logo

Pediatric medical device competition takes aim at congenital heart disease

NCC-PDI logo

Consistent with its mission of addressing the most pressing pediatric device needs, this year’s competition focused on innovations in electrophysiology devices that monitor and treat congenital heart disease (CHD) and arrhythmias in pediatric patients.

The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announces five awardees chosen in its prestigious annual “Make Your Medical Device Pitch for Kids!” competition to share $150,000 in grant funding from the U.S. Food and Drug Administration (FDA) to support the advancement of pediatric medical devices. In an unprecedented decision, the competition judges determined that all five finalists were deserving of a grant award and recognition for the potential patient benefit and commercial viability of their innovations.

Consistent with its mission of addressing the most pressing pediatric device needs, this year’s competition, conducted by NCC-PDI partner MedTech Innovator, focused on innovations in electrophysiology devices that monitor and treat congenital heart disease (CHD) and arrhythmias in pediatric patients. The virtual pediatric pitch event was part of the 9th Annual Symposium on Pediatric Device Innovation.

This year’s pediatric device innovation awardees are:

  • PeriCor – The Children’s Hospital at Montefiore – New York, NY, and Children’s National Hospital – PeriTorq, a catheter grip tool for use during pediatric cardiac interventional procedures;
  • Inkspace Imaging – Pleasanton, CA – a pediatric cardiac and vascular MRI coil;
  • Karios Technologies – Charlottesville, VA – Tissue Shield, a technology to prevent scar tissue formation (adhesions) on the heart after surgery;
  • Sibel – Niles, IL – ANNE One, ICU-grade wireless sensors for cardiopulmonary monitoring in neonates with congenital heart defects;
  • Starlight Cardiovascular – San Diego, CA – Project Lifeline, a less-invasive way to maintain sufficient circulation in newborns with ductal-dependent circulation that increases safety, procedural success and ease of use.

Congenital heart disease (CHD) affects six out of 1,000 babies born in the U.S. each year and is often complicated by arrhythmias, a condition where the heart beats too rapidly, too slowly or irregularly due to a misfiring of the body’s electrical impulses. While the last decade brought great advances in technologies that improve the care of adult arrhythmias, pediatric patients have been left behind, with only five devices approved for use in children in the same period. As a result, pediatric specialists are often using off-label or improvised devices to treat pediatric arrhythmias, including in the smallest newborns.

“Recognizing this unmet need, NCC-PDI opened the challenge earlier this year to select companies to enter MedTech Innovator’s pediatric accelerator program, made possible by NCC-PDI. The five companies have immensely benefited from the accelerator program and are well-positioned to compete for funding. They have the potential to advance pediatric health and provide a greater standard of care for children living with CHD,” says Kolaleh Eskandanian, Ph.D., M.B.A, P.M.P, vice president and chief innovation officer at Children’s National Hospital and principal investigator of NCC-PDI. “For too long, the unique needs of children have been overlooked in pediatric device development. Thanks to the support of the FDA, we are able to build our challenge competitions around the direst unmet needs, which are determined through a thorough needs assessment and market analysis conducted to inform each request for proposal. The funding incentivizes pediatric innovation and helps more companies navigate the path to commercialization.”

NCC-PDI is one of five consortia 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. 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, with support from partners MedTech Innovator,  BioHealth Innovation and design firm Archimedic.

A pediatric accelerator program, powered by MedTech Innovator, is the consortium’s latest addition to a network of resources and experts that NCC-PDI provides in support of pediatric innovators. All five of this year’s competition finalists had an opportunity to participate in the year-long accelerator program.

Eskandanian adds that supporting the progress of pediatric innovators is a key focus of the new Children’s National Research & Innovation Campus, a one-of-its-kind ecosystem that drives discoveries that save and improve the lives of children. On a nearly 12-acre portion of the former, historic Walter Reed Army Medical Center in Northwest Washington, D.C., Children’s National has combined its strengths with those of public and private partners, including industry, universities, federal agencies, start-up companies and academic medical centers, the campus provides a rich environment of public and private partners which, like the NCC-PDI network, will help bolster pediatric innovation and commercialization.

Drs. Packer and van den Acker at the Pediatric Device Innovators Forum

Pediatric Device Innovators Forum explores state of focused ultrasound

For children living with pediatric tumors, less invasive and less painful treatment with no radiation exposure was not always possible. In recent years, the development of technologies like Magnetic resonance guided high intensity focused ultrasound (MR-HIFU) and Low intensity transcranial focused ultrasound (LIFU) is helping to reverse that trend.

This topic was the focus of the recent Pediatric Device Innovators Forum (PDIF) hosted by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) in partnership with the U.S. Food and Drug Administration’s (FDA) Pediatric Device Consortia (PDC) grant program. A collaboration between Children’s National Hospital and University of Maryland Fischell Institute for Biomedical Devices, NCC-PDI is one of five PDCs funded by the FDA to support pediatric device innovators in bringing more medical devices to market for children.

The discussion, moderated by Kolaleh Eskandanian, Ph.D., MBA, PMP, vice president and chief innovation officer at Children’s National and principal investigator of NCC-PDI, explored the use of focused ultrasound’s noninvasive therapeutic technology for two pediatric indications, Osteoid Osteoma (OO) and Diffuse Intrinsic Pontine Glioma (DIPG), and the ways it can increase the quality of life for pediatric patients while also decreasing the cost of care.

The discussion also examined the most common barriers preventing more widespread implementation of focused ultrasound technology, specifically small sample size for evidence generation, lack of funding opportunities and reimbursement issues that can make or break a technology’s chances at reaching the patients that need it.

Karun Sharma, M.D., director of Interventional Radiology at Children’s National, emphasized the potential for focused ultrasound to treat localized pain relief and treat other diseases that, like OO, do not have any other therapeutic alternative

“At Children’s National, we use MR-HIFU to focus an ultrasound beam into lesions, usually tumors of the bone and soft tissues, to heat and destroy the harmful tissue in that region, eliminating the need for incisions,” says Sharma. “In 2015, Children’s National doctors became the first in the U.S. to use MR-HIFU to treat pediatric osteoid osteoma (OO), a painful, but benign, bone tumor that commonly occurs in children and young adults. The trial demonstrated early success in establishing the safety and feasibility of noninvasive MR-HIFU in children as an alternative to current, more invasive approaches to treat these tumors.”

In November 2020, the FDA approved this MR-HIFU system to treat OO in pediatric patients.

Roger Packer, M.D., senior vice president of the Center for Neuroscience and Behavioral Medicine at Children’s National, also discussed how focused ultrasound, specifically LIFU, has also proven to be an attractive modality for its ability to non-invasively, focally and temporarily disrupt the blood brain barrier (BBB) to allow therapies to reach tumors that, until recently, would have been considered unreachable without severe intervention.

“This presents an opportunity in pediatric care to treat conditions like Diffuse Intrinsic Pontine Glioma (DIPG), a highly aggressive brain tumor that typically causes death and morbidity,” says Packer.

Packer is planning a clinical trial protocol to investigate the safety and efficacy of LIFU for this pediatric indication.

The forum also featured insight from Jessica Foley, M.D., chief scientific officer, Focused Ultrasound Foundation; Arjun Desai, M.D., chief strategic innovation officer, Insighttec; Arun Menawat, M.D., chairman and CEO, Profound Medical; Francesca Joseph, M.D., Children’s National; Johannes N. van den Anker, M.D., Ph.D., vice chair of Experimental Therapeutics, Children’s National; Gordon Schatz, president, Schatz Reimbursement Strategies; Mary Daymont, vice president of Revenue Cycle and Care Management, Children’s National; and Michael Anderson, MD, MBA, FAAP, FCCM, FAARC, senior advisor to US Department of Health and Human Services (HHS/ASPR) and Children’s National.

Anthony Sandler, M.D., senior vice president and surgeon-in-chief of the Joseph E. Robert Jr. Center for Surgical Care and director of the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Hospital, and Sally Allain, regional head of Johnson & Johnson Innovation, JLABS @ Washington, DC, opened the forum by reinforcing both organizations’ commitment to improving pediatric health.

In September 2020, the Focused Ultrasound Foundation designated Children’s National Hospital as the first global pediatric Center of Excellence for using this technology to help patients with specific types of childhood tumors. As a designated COE, Children’s National has the necessary infrastructure to support the ongoing use of this technology, especially for carrying out future pediatric clinical trials. This infrastructure includes an ethics committee familiar with focused ultrasound, a robust clinical trials research support team, a data review committee for ongoing safety monitoring and annual safety reviews, and a scientific review committee for protocol evaluation.

The Pediatric Device Innovators Forum is a recurring collaborative educational experience designed by the FDA-supported pediatric device consortia to connect and foster synergy among innovators across the technology development ecosystem interested in pediatric medical device development. Each forum is hosted by one of the five consortia. This hybrid event took place at the new Children’s National Research and Innovation Campus, the first-of-its-kind focused on pediatric health care innovation, on the former Walter Reed Army Medical Center campus in Washington, D.C.

To view the latest edition of the forum, visit the NCC-PDI website.

Panelists at the Pediatric Device Innovators Forum

The recent Pediatric Device Innovators Forum (PDIF) exploring the state of focused ultrasound was held at the new Children’s National Research and Innovation Campus, a first-of-its-kind focused on pediatric health care innovation.

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.

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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.

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.

Pitch Competition Winners

7th Annual Pediatric Device Innovation Symposium

Melinda Richter and Dr. Newman

The event featured an onstage discussion by Melinda Richter, global head of Johnson & Johnson Innovation – JLABS and Dr. Kurt Newman, M.D., president and CEO of Children’s National Hospital, about the power of collaboration to spur innovation.

The 7th Annual Pediatric Device Innovation Symposium, presented by Children’s National Hospital, recently brought together stakeholders from across the clinical, investor, business and regulatory sectors of pediatric device development for a day-long program focused on closing the wide gap that exists between the number of medical devices developed for adults and the significantly smaller number developed for children.

Co-located with AdvaMed’s The MedTech Conference for the third consecutive year, the symposium featured an opening keynote address by Melinda Richter, global head of Johnson & Johnson Innovation – JLABS, who was later joined Kurt Newman, M.D., president and CEO of Children’s National Hospital, for an on-stage discussion about the power of collaboration to spur innovation.

That collaboration was on display as Dr. Newman and Richter shared details of the recently announced JLABS @ Washington, DC, a 32,000 square-foot facility to be located at the new Children’s National Research & Innovation Campus on the former Walter Reed Army Medical Center campus in the nation’s capital.

“We had this idea at Children’s National to develop the first pediatric research and innovation campus in the world to create a sustainable pipeline and ecosystem of everything needed to bring medical devices from concept to market for children. Seeing what Johnson & Johnson has accomplished with JLABS across the world, we knew they were the right partner,” said Dr. Newman.

Richter highlighted the need to take action, “We have made modest progress in pediatric device innovation, but we need to do better. We need to advance solutions that take into account the unique characteristics of our youngest and most vulnerable of patients. Only then will we achieve real progress for children and their families.” Of all the medical devices approved each year, only 25% are approved for children and most of those are approved for patients over the age of 18. Richter encouraged symposium attendees to leverage collaborations and convenings to move pediatric device development forward and lauded innovators focused on babies and children, calling them “super heroes.”

$150K medical device pitch competition

Pitch Competition Winners

Six innovations that address the significant unmet needs of neonatal intensive care unit (NICU) patients were awarded a total of $150K during the medical device pitch competition at the 7th Annual Pediatric Device Innovation Symposium hosted by Children’s National Hospital at Boston Convention & Exhibition Center. From L to R are: Anthony Sandler, M.D., Children’s National Hospital; Neil Ray, Raydiant Oximetry; Julia Finkel, M.D., AlgometRx, Inc.; Eric Chehab, Ph.D., Novonate; Xina Quan, Ph.D., PyrAmes, Inc.; Mark Lehmkuhle, Epitel, Inc.; Adam Zysk, Ph.D., Rhaeos, Inc.; and Kolaleh Eskandanian, Ph.D., Children’s National Hospital.

Six winners were announced in the symposium’s $150,000 “Make Your Medical Device Pitch for Kids!” competition, sponsored by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) and focused on NICU devices, which the FDA identifies as an area of significant need for innovation. Ten finalists presented their innovations for a panel of 25 expert judges. Each winner receives a $25,000 award and an opportunity to participate in a first-of-its-kind pediatric accelerator program led by MedTech Innovator.

The winning pediatric devices and companies are:

  • AlgometRx, Inc., Washington, D.C. – The AlgometRx Rapid Drug Test is used to detect and monitor neonatal abstinence syndrome, allowing for earlier assessment and intervention of opioid withdrawal to reduce physiological stress.
  • Epitel, Salt Lake City, Utah – Epilog is an inexpensive, discrete and disposable EEG machine that provides real-time monitoring to revolutionize the way neonates suspected of hypoxic-ischemic encephalopathy are managed at community hospitals.
  • Novonate, South San Francisco, Calif. – LifeBubble secures and protects the umbilical catheter insertion site for neonates in intensive care, preventing infection from caregivers and parents.
  • PyrAmes Inc., Cupertino, Calif. – Noninvasive and wireless, the Boppli Band allows for risk- and pain-free continuous blood pressure monitoring for neonates.
  • Raydiant Oximetry, Mountain View, Calif. – Raydiant Oximetry Sensing Systems is a novel, non-invasive technology that more accurately detects fetal distress during labor and delivery, reducing medically unnecessary cesarean deliveries and the occurrence of newborns suffering the consequences of metabolic acidosis.
  • Rhaeos, Inc., Evanston, Ill. – FlowSense is a wearable device that enables noninvasive monitoring of ventricular shunt function in patients who have hydrocephalus, obviating the need for imaging and unnecessary hospital visits and admissions.

“Improved neonatal monitoring devices, such as those among our award winners, can make a critical difference in detecting interventions that could positively impact the long-term developmental trajectory of many children, said Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., vice president and chief innovation officer at Children’s National and principal investigator of NCC-PDI. “We welcome these winning companies into the NCC-PDI network of device startups and entrepreneurs and look forward to helping them accelerate commercialization so that these innovations can benefit children everywhere as soon as possible.”

Julia Finkel

Children’s National anesthesiologist and innovator Julia Finkel, M.D., delivers a winning pitch for her AlgometRx device for detecting and monitoring neonatal abstinence syndrome.

Award-winner AlgometRx is a spinout company from Children’s National Hospital that was founded by anesthesiologist and pain medicine research chief Julia Finkel, M.D.  A non-invasive, handheld and portable device, AlgometRx captures a digital image of a patient’s pupillary light response and applies a series of propriety algorithms to measure pain type, intensity and drug effects in real time. Designed for use in virtually any clinical setting, Dr. Finkel originally developed this objective pain measurement technology to aid in diagnosing and monitoring non-verbal pediatric patients such as neonates. AlgometRx was also selected earlier this year to join the JLABS location in Philadelphia.

This is the ninth pediatric medical device competition sponsored by NCC-PDI, one of five FDA-funded programs focused on addressing unmet needs for pediatric medical devices. The consortium 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. NCC-PDI recently added new accelerators BioHealth Innovation and MedTech Innovator and design firm partner, Archimedic.

The symposium also featured four multidisciplinary panel discussions that followed the theme “Pediatric Device Clinical Trials: Forging a Better Path.” Solutions uncovered during these panels will be highlighted in an upcoming whitepaper that will be used to suggest FDA guidance on pediatric device trial conduct and best practices to safely validate medical devices for children more efficiently and effectively.

Vasum Peiris, M.D., chief medical officer, Pediatrics and Special Populations, Center for Devices and Radiological Health, FDA, gave the closing address, which outlined FDA initiatives focused on pediatric device development. David L. Wessel, M.D., senior vice president for the Center for Hospital-Based Specialties at Children’s National, provided an insightful overview of why NICU device development is so important and shared some of the NICU innovations currently in development at Children’s National, which ranks #1 nationally in NICU care.

NCC-PDI Pitch Winners

NCC-PDI announces medical device pitch winners

NCC-PDI Pitch Winners

Five pediatric medical device innovators each captured $50K in funding and access to a new pediatric device accelerator program in a competition hosted April 30, 2019 by National Capital Consortium for Pediatric Device Innovation that focused on orthopedic and spine devices. Clockwise from front left: Kolaleh Eskandanian, Children’s National Health System; Cristian Atria, nView Medical; John Barrett, Auctus Surgical Inc.; Paul Mraz, ApiFix; Dan Sands, AMB Surgical II; Anuradha Dayal, BabySteps, Children’s National Health System; Paul Grand, MedTech Innovator; (center) Bill Bentley, Robert E. Fischell Institute for Biomedical Devices, University of Maryland.

The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announced five winners of its “Make Your Medical Device Pitch for Kids!” competition held on April 30 at the University of Maryland. Each winner receives $50,000 in grant funding and gains access to the consortium’s first-of-its-kind “Pediatric Device Innovator Accelerator Program” led by MedTech Innovator.

NCC-PDI, one of five FDA Pediatric Device Consortia grant programs that support the development and commercialization of pediatric medical devices, 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 and design firm partner, Smithwise.

A panel of 32 expert judges from business, healthcare, regulatory and legal sectors selected the winners based on the clinical significance and commercial feasibility of their medical devices for children. The competition focused solely on advancing care in the pediatric orthopedics and spine sector which the FDA identified as an emerging underserved specialty lacking innovation.

The competition winners are:

  • 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

“All finalists are winners and we believe that, with NCC-PDI’s support, some of the awarded devices will be available to orthopedic and spine clinicians in the near future. That is vitally important since innovation has been stagnant in this area,” says Kolaleh Eskandanian, Ph.D., MBA, PMP, vice president and chief innovation officer at Children’s National and principal investigator of NCC-PDI. “This competition aims to increase the profile of companies by exposing them to a panel of industry leaders who may become future investors or strategic partners.”

Through the inaugural NCC-PDI “Pediatric Device Innovator Accelerator Program,” MedTech Innovator is providing winners with virtual in-depth, customized mentorship from some of the industry’s leading executives and investors. MedTech Innovator has a proven track record of identifying early-stage medical device companies with the key characteristics required for commercial success and accelerating their growth through its vast ecosystem of resources.

“As a pediatric orthopedic surgeon, I am encouraged by the innovations presented at this competition,” says Matthew Oetgen, M.D., division chief of Orthopaedic Surgery and Sports Medicine at Children’s National, who served on the judging panel. “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. The finalists who competed fully embraced that challenge.”

This was NCC-PDI’s eighth competition in six years and a ninth competition is planned for fall 2019 that focuses on NICU. Including this recent round of winners, the consortium has supported 94 pediatric medical devices and helped five companies receive FDA or CE mark regulatory clearance.

To learn more about the winners and the fall 2019 pitch competition, visit the National Capital Consortium for Pediatric Device Innovation website.

Doctors-working-with-Digital-Tablet

New network will advance treatments for children

Doctors-working-with-Digital-Tablet

Three leaders from Children’s National Health System are among the investigators of a new FDA-funded program created to launch a global clinical trials network. The initial $1 million grant from the Food and Drug Administration (FDA) establishes a network among the Institute for Advanced Clinical Trials for Children (I-ACT for Children), the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) (affiliated with Children’s National), PEDSnet, the James M. Anderson Center for Health Systems Excellence and the Critical Path Institute, to address the unmet medical needs of children by improving quality and efficiency in developing innovative pediatric drugs and devices.

Along with the fiscal 2017 funds, there is a potential for $1 million in funding each year for an additional four years to I-ACT for Children, contingent on annual appropriations and the availability of funding. I-ACT for Children is a new independent, nonprofit organization that works to improve the planning and completion of pediatric clinical trials. PEDSnet and the Anderson Center will serve as the network’s data and learning core, while the Critical Path Institute will serve as the regulatory science core and NCC-PDI will serve as the medical device core.

From Children’s National, the investigators include: Peter Kim, M.D., Ph.D., vice president of the Sheikh Zayed Institute for Pediatric Surgical Innovation; Kolaleh Eskandanian, Ph.D., executive director of the Sheikh Zayed Institute and NCC-PDI and Johannes van den Anker, M.D., Ph.D., division chief of Clinical Pharmacology and vice chair of Experimental Therapeutics.

“We are pleased that this grant addresses innovative reengineering of the pediatric device trials system,” says Eskandanian. “In contrast with drug trials, device trials are generally less optimally understood in academic medical centers and clinical sites.”

She explains that children have medical device needs that are considerably different from adults. Designing devices for children requires considerations such as growth and development, anatomical and physiological differences. Often, the lack of available devices for children forces clinicians to use an adult device off-label or to improvise. Off-label use may be the only option, but such use can bring risks of serious adverse events that could be avoided if there were more FDA–approved pediatric devices.

“Thanks to partnership with I-ACT we will be able to address the pressing need to improve clinical trials and post-market monitoring of pediatric devices,” says Eskandanian.

Leading the network as principal investigator is Edward Connor, M.D., president of I-ACT for Children and an emeritus professor of Pediatrics, Microbiology, Immunology, and Tropical Medicine at George Washington University School of Medicine and Children’s National.

Work has been initiated to integrate network components and engage public and private shareholders. Next steps include selecting priority projects for implementation in 2018 and beyond, and scaling the network in North America and abroad.

Funding for this work was made possible, in part, by the Food and Drug Administration through grant 1 U18 FD 006297. Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.

Pediatric surgical innovation symposium approaches

This year, there were a record number of entries (91) for the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) competition, which will be held  Oct. 8 at the fourth annual Pediatric Surgical Innovation Symposium, hosted by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System. Twelve finalists have been selected to pitch their pediatric medical device innovation, and up to six innovations will be awarded up to $50,000 each, with awards based on presentations given before a panel of expert judges.

The finalists are:

  • PECA Labs, Pittsburgh, Pa. – synthetic vascular conduit for surgical repair of congenital heart defects that’s capable of minimally invasive, controlled expansion to grow with the patient
  • Maternal Life, Palo Alto, Calif. – low-cost closed system that captures and administers colostrum to newborns with zero percent loss
  • Magnamosis, Inc., San Francisco, Calif. – device to provide safer, less invasive repair of the esophagus in newborns with esophageal atresia/tracheoesophageal fistula, a condition requiring surgery that is currently performed by hand
  • JustRight Surgical, Louisville, Colo. – second generation surgical 5mm stapler sized for use with a wider range of pediatric surgical procedures and bringing the benefits of laparoscopy to patients
  • CareTaker Medical, Charlottesville, Va. – disposable, finger cuff for single patient use to continuously and non-invasively monitor neonatal  heart rate without adhesives, electrodes and wires
  • Nebula Industries, Melrose, Mass. – quick release medical tape to prevent neonatal and pediatric skin injuries
  • Lully, San Francisco, Calif. – moisture sensor and Smart Pod monitor, placed under the mattress, that are wirelessly connected to a smartphone app to prevent bedwetting episodes
  • Center for Advanced Sensor Technology, University of Maryland Baltimore County, Baltimore, Md. – low-cost, disposable multifunctional incubator for at-risk, low birth weight babies
  • Multisensor Diagnostics, Baltimore, Md. – non-invasive portable handheld device designed to perform rapid medical assessment of key vitals for pediatric patients
  • May & Meadow, Inc., Redwood City, Calif. – low-cost, mobile medical device for assessing feeding ability in infants at risk for feeding problems
  • PediaStent, Cleveland, Ohio – novel pediatric bioresorbable stent for use in repairing congenital heart lesions
  • Averia Health Solutions, Alexandria, Va. – low-cost concussion screening and management system that uses smartphone technology

“The impressive number of well qualified applications we received from all over the US as well as from other countries speaks to the enthusiasm of Medtech innovators to develop and test devices specifically for children,” said Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., Executive Director of the Sheikh Zayed Institute for Pediatric Surgical Innovation and NCC-PDI. “We are committed to building on this momentum and keeping the conversation going with all who applied and will provide consultation services if needed.”

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