NCC-PDI Archives

Bloom Standard 2 Portable UltraSound Device being used on a baby

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

March 6, 2024

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.”

Healthcare leaders join to advance pediatric innovation

December 21, 2022

Children’s National Hospital and the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) have opened a request for proposal to solicit companies interested in obtaining pediatric labeling for medical devices that may address an unmet need in the pediatric population and that already have clearance or approval for adult use by the U.S. Food & Drug Administration (FDA). The objective of this program is to generate the real-world evidence (RWE) needed to facilitate the pediatric regulatory pathway for U.S. market clearance. The deadline to apply is 5 p.m. EST on Feb. 9. To learn more and apply, visit http://www.innovate4kids.org.

Instead of assessing medical devices based on data derived from clinical trials, this pioneering initiative is focused on leveraging real-world data (RWD) that can be translated into RWE to gain FDA clearance or approval for use with children.

Convening a coalition of healthcare leaders

The new partnership aims to address the significant gap that exists between devices labeled for adults and children. Additional coalition partners include:

CobiCure
MedStar Health Research Institute
Center for Technology Innovation in Pediatrics (CTIP)
UCSF-Stanford Pediatric Device Consortium
Pennsylvania Pediatric Device Consortium
Southwest National Pediatric Device Consortium

Funded by the FDA and facilitated through NCC-PDI and the Office of Innovation Ventures at Children’s National, this program will provide winning companies with technical expertise, including but not limited to regulatory, study design and data science services.

“We are delighted to partner with this coalition of trusted healthcare leaders that share our vision for advancing pediatric health. We know all too well that pediatric device development presents several unique challenges and that children have medical device needs that are considerably different from adults,” says 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. “There are already a number of medical devices on the market that have been FDA cleared or approved and proven viable, and this partnership will help provide important evidence generation and other wraparound services to guide device creators through the regulatory path for pediatric labeling.”

Using RWE to facilitate the regulatory pathway

While Randomized Clinical Trials (RCT) have traditionally been the gold standard when investigating a medical product’s efficacy and safety, many important populations, including children, are excluded from RCTs for ethical reasons. This means that pediatric researchers must make safety and efficacy decisions in the absence of data from such trials. RWE, including data from electronic health records (EHRs), healthcare claims data, disease registries and data gathered through other health applications, can close this gap in pediatric studies. She said that MedStar Health’s capabilities in applying RWE will be a formidable asset to the chosen applicants.

Proposals for companies seeking pediatric labeling for their medical device will be reviewed by an esteemed panel of judges specializing in data science, medical device development, evidence generation, post-market surveillance and the FDA’s regulatory pathway. Children’s National and members of the coalition will provide selected companies with technical expertise in support of their effort to achieve pediatric labeling. This will include:

Access to mentors
A design study protocol implementing RWE generation best practices
Facilitation of IRB submission and study implementation
Data science support
Regulatory, reimbursement and supply chain consultation

About NCC-PDI

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. 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 and design firm Archimedic.

Children’s National Innovation Day aims to advance pioneering pediatric life science projects

August 23, 2022

Children’s National Research & Innovation Campus’ Innovation Day will feature life science projects focused on improving pediatric care.

Pioneering life science projects focused on improving pediatric care will be on display at the Children’s National Research & Innovation Campus when the hospital hosts its 2022 Innovation Day on Friday, August 26. Hosted by Children’s National Innovation Ventures, the program’s goal is to showcase life sciences and healthcare projects that are mature enough to look for a co-developer, strategic partner, investor or licensing vehicle.

“For us, a successful Innovation Day means we are able to match these entrepreneurs with the strategic partner they need at this stage of their device development journey,” says Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., vice president and chief innovation officer at Children’s National Hospital and executive director of the Sheikh Zayed Institute for Pediatric Surgical Innovation.

“Data continues to show that the national Capital Region (NCR) remains one of the most robust life sciences and technology hubs in the country with no shortage of visionary leaders. There is no better place to conduct this important work as we seek more ways to advance pediatric medical technologies to improve health outcomes.”

A total of 17 projects will be showcased at the event, with each having up to 10-minute window to make their presentation. All attendees will be provided a survey, enabling valuable feedback for presenters as they look to take their next strategic step on the pathway to further development and commercialization.

In addition to presenting projects, the 2022 Innovation Day will also feature startup companies whose mission is aligned with Children’s National’s quest to bring novel pediatric medical products to patients and families. Throughout the day, attendees will have the opportunity to meet with the hospital’s researchers, academic entrepreneurs and prominent stakeholders in the life science and healthcare innovation ecosystem in the region. Interested investors and strategics can also request one-on-one meetings with startups and research teams.

Eskandanian, who also serves as the executive director of the FDA-funded National Capital Consortium for Pediatric Device Innovation (NCC-PDI), notes that accelerating this pathway to commercialization for pediatric products will bring more viable technologies to market, an important step in addressing the ongoing development disparity in innovations developed for children versus adults.

“For too long, children have been left behind in the development and commercialization of medical products and we remain committed to altering the trend,” Eskandanian says. “Children’s National’s Innovation Ventures team is working closely with the presenting innovators to provide any and all support that we can to get these products to the next stage.”

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, helps to bolster pediatric innovation and commercialization.

Pediatric medical device competition names finalists

June 3, 2022

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 10^th 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.

Medical device pitch competition returns with $150K in FDA awards

April 12, 2022

“This pitch competition helps to recognize and support the advancement of innovations that can specifically address the needs of pediatric patients,” 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.

Recognizing the continued gap in the development and commercialization of medical devices for children versus adults, the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), in collaboration with MedTech Innovator, is accepting applications through April 22, 2022, for its annual “Make Your Medical Device Pitch for Kids!” competition. Recognizing the wide range of unmet needs for diagnostic and therapeutic devices designed especially for children, this year’s competition is open to any innovation in medical technology that addresses a significant unmet need in pediatric medical care.

“As one of the five FDA Pediatric Device Consortia, NCC-PDI is focused on seeking out and addressing significant unmet needs in pediatric medical technology,” 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. “While great advances are made in adult medical devices, children are often left behind because the pediatric market is small and there are not incentives to develop for pediatrics. This pitch competition helps to recognize and support the advancement of innovations that can specifically address the needs of pediatric patients.”

Using a virtual format, semi-finalists chosen from all submissions will make their first pitch on May 20, 2022. Up to six finalists selected from this first round will earn participation in a special pediatric-focused track of the MedTech Innovator accelerator program, the largest medical device accelerator in the world, beginning in June 2022. These innovators will then participate in the competition finals in the fall 2022 where judges will award up to $150,000 in FDA-sponsored grants to the devices selected as most impactful and commercially viable.

Unlike devices for adults, the development and commercialization of pediatric medical devices lags behind by approximately five to 10 years. Programs like the NCC-PDI pitch competition and MedTech Innovator accelerator program offer innovators access to expert insight and consultation to help overcome regulatory hurdles and advance the product’s development path.

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. 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.

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.

Applications for the “Make Your Medical Device Pitch for Kids!” competition are open now through April 22 for innovations that address unmet pediatric needs.

Pediatric medical device competition takes aim at congenital heart disease

December 13, 2021

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 9^th 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

August 18, 2021

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.

PeriTorq, a catheter grip tool for use during pediatric cardiac interventional procedures

Five finalists selected in prestigious pediatric medical device pitch competition

May 20, 2021

Electrophysiology device innovators gain access to pediatric accelerator and will compete in September 2021 final showcase.

Creating accessible platforms for innovation is essential to advancing children’s health

April 12, 2021

Children’s National Hospital continues in its efforts to educate and advocate about ways to address the unique challenges facing pediatric medical device innovation, such as small market size and a lack of industry investment. In a recent commentary for IEEE Pulse, the publication of the IEEE Engineering in Medicine and Biology Society, 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 the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), discussed how the FDA and children’s hospitals are stepping in to bridge critical funding gaps and build an accessible infrastructure that safely accelerates the development and commercialization of pediatric medical devices.

“Our goal is to provide direct funding [with] expert advising and support services to innovators of pediatric medical devices,” says Eskandanian.

“Our goal is to provide direct funding [with] expert advising and support services to innovators of pediatric medical devices,” says Eskandanian. “The notion that innovation follows investment, that really gave us the idea of competitions where if we announced a challenge and we could put grant money behind it—and open it to the entire world — then we could attract small businesses and start-up companies that could come forward and start thinking about developing a medical device more specifically for the pediatric population.”

Now in its 8^th year, NCC-PDI’s “Make Your Medical Device Pitch for Kids!” competition focuses on identifying and supporting innovators that address specific unmet pediatric needs. This year’s competition focuses on innovations in pediatric devices that treat congenital heart disease (CHD), with an emphasis on electrophysiology (EP) devices such as pacemaker systems, ablation catheters, wearable monitoring devices and related technologies that address arrhythmias in children. 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.

To learn more about the consortium’s efforts to advance pediatric innovation, visit the NCC-PDI website.

Medical device pitch competition focuses on pediatric electrophysiology devices for CHD

March 25, 2021

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.

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 the smallest newborns.

Recognizing this unmet need, the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), in collaboration with MedTech Innovator, is accepting applications through April 12, 2021, for its annual “Make Your Medical Device Pitch for Kids!” competition. This year’s competition focuses on innovations in pediatric devices that treat CHD, with an emphasis on electrophysiology devices such as pacemaker systems, ablation catheters, wearable monitoring devices and related technologies that address arrhythmias in children.

“NCC-PDI was created, with the support of the Food and Drug Administration (FDA), to seek out and address significant unmet needs in pediatric medical devices,” 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. “We have learned from the experts that pediatric-specific technologies for treating arrhythmias would be a game changer in the care of their patients, so we are focusing our competition and grant awards on this opportunity.”

“We have learned from the experts that pediatric-specific technologies for treating arrhythmias would be a game changer in the care of their patients, so we are focusing our competition and grant awards on this opportunity,” 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.

Using a virtual format, semi-finalists chosen from all submissions will make their first pitch on May 12, 2021. Up to 10 finalists selected from this event earn participation in a special pediatric-focused track of the MedTech Innovator accelerator program, the largest medtech accelerator in the world, beginning in June 2021. These innovators then participate in the pediatric competition finals in September 2021 where judges will award up to $150,000 in FDA-sponsored grants to the devices selected as most impactful and commercially viable.

How significant is the need for pediatric devices to address arrhythmias? In a recent survey of members conducted by the Pediatric and Congenital Electrophysiology Society (PACES), the vast majority (96%) said they believe there is a deficiency in devices available to serve the needs of pediatric patients. Conducted with the U.S.FDA, the survey also asked respondents to identify the biggest unmet need, which physicians identified as cardiovascular implantable electronic devices that are smaller, have better battery life and have pediatric-specific algorithms. Specifically, a leadless pacemaker designed for pediatric care was consistently on the most-wanted list.

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 advancement 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.

Eskandanian says that enhancing access to resources for pediatric innovators is also one of the aims of the Children’s National Research & Innovation Campus, a first-of-its-kind focused on pediatric health care innovation, with the first phase currently open 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 incubator Johnson and Johnson Innovation – JLABS, the campus provides a rich ecosystem of public and private partners which, like the NCC-PDI network, will help bolster pediatric innovation and commercialization.

New innovative 3D imaging technology used in pediatric spine surgery

December 1, 2020

Children’s National Hospital performed the first surgical use of breakthrough medical imaging technology designed specifically for kids. The innovation, insta-3D™ imaging from company nView medical, is designed to make 3D images available in the operating room quickly and safely.

Children’s National Hospital performed the first surgical use of breakthrough medical imaging technology designed specifically for kids. The innovation, insta-3D™ imaging from company nView medical, is designed to make 3D images available in the operating room quickly and safely. The 3D images provide surgeons with better visualization, allowing them to continue improving patient care and outcomes.

Matthew Oetgen, M.D., division chief of Orthopaedic Surgery at Children’s National, is overseeing the first use of this 3D imaging technology in orthopaedic procedures.

“Having a technology like this available in the operating room will potentially help make our surgeries even more precise with 3D imaging available quickly,” says Dr. Oetgen. “We anticipate this improved precision will lead to better outcomes and added value to what we do for our patients.”

Cristian Atria, nView medical’s CEO, commented for the first case.

“Seeing our imaging technology provide critical information during a kid’s surgery reminds us what the purpose of nView medical is all about,” says Cristian. “I would like to thank the surgeons, our backers, the team, and our clinical partners for making this first surgery a success. I couldn’t be more enthusiastic for what’s ahead!”

The potential of nView medical’s insta-3D™ imaging is especially exciting for Children’s National as nView medical is a 2019 Winner of the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) competition “Make Your Medical Device Pitch for Kids!” 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.

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 in areas of critical need where innovation can significantly improve children’s health care.

“Children deserve to benefit from our most advanced medical technologies and we know that improvements in pediatric care can make a positive difference over the lifetime of a child,” says 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. “Pediatric hospitals must lead the way in supporting innovation for children’s care. That’s why, through NCC-PDI and our innovation institute, Children’s National helps to provide promising new pediatric devices with resources and expertise that support their journey to the market.”

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.”

Dr. Kurt Newman in front of the capitol building

“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.

Real-world evidence and the impact on pediatric device innovation

October 16, 2020

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

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) 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, 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.

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

October 2, 2020

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

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

July 23, 2020

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

July 15, 2020

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.

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.

7th Annual Pediatric Device Innovation Symposium

October 11, 2019

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 7^th 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

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.”

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.

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