Posts

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.

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.