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chest x-ray showing pacemaker

Medical device pitch competition focuses on pediatric electrophysiology devices for CHD

chest x-ray showing pacemaker

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.”

Kolaleh-Eskandanian

“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.

For more information and to apply for the upcoming NCC-PDI pitch competition, visit the NCC-PDI website.

 

Dr. Kurt Newman in front of the capitol building

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

Dr. Kurt Newman in front of the capitol building

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

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

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

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

Lee Beers

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

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

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

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

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

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

Kolaleh-Eskandanian

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

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

Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., vice president and chief innovation officer at Children’s National Hospital and principal investigator for the FDA-funded National Capital Consortium for Pediatric Device Innovation (NCC-PDI), co-led the Qualifying Hospital Criteria panel, which addressed the importance of expanding the SHIP-MD network to medical institutions that have the infrastructure for the safe conduct of research.

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

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

Francesca Joseph

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

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

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