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Pitch Competition Winners

7th Annual Pediatric Device Innovation Symposium

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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,ooo “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.

Gustavo Nino

Gustavo Nino, M.D., honored with national award from American Thoracic Society

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Gustavo Nino

Gustavo Nino, M.D., a pulmonologist who directs the Sleep Medicine program at Children’s National, was honored by the American Thoracic Society with The Robert B. Mellins, M.D. Outstanding Achievement Award in recognition of his contributions to pediatric pulmonology and sleep medicine.

“I am humbled and pleased to be recognized with this distinction,” says Dr. Nino. “This national award is particularly special because it honors both academic achievements as well as research that I have published to advance the fields of pediatric pulmonology and sleep medicine.”

After completing a mentored career development award (K Award) from the National Institutes of Health (NIH), Dr. Nino established an independent research program at Children’s National funded by three different NIH R-level grants, an R01 research project grant; an R21 award for new, exploratory research; and an R4 small business/technology transfer award to stimulate research innovation.

The research team Dr. Nino leads has made important contributions to developing novel models to study the molecular mechanisms of airway epithelial immunity in newborns and infants. He also has pioneered the use of computer-based lung imaging tools and physiological biomarkers to predict early-life respiratory disease in newborns and infants.

Dr. Nino has published roughly 60 peer-review manuscripts including in the “Journal of Allergy and Clinical Immunology,” the “European Respiratory Journal,” and the “American Journal of Respiratory and Critical Care Medicine,” the three top journals in the field of respiratory medicine. He has been invited to chair sessions about sleep medicine during meetings held by the Pediatric Academic Societies, American College of Chest Physicians and the American Thoracic Society (ATS).

Dr. Nino also has served as NIH scientific grant reviewer of the Lung Cellular and Molecular Immunology Section; The Infectious, Reproductive, Asthma and Pulmonary Conditions Section; and The Impact of Initial Influenza Exposure on Immunity in Infants NIH/National Institute of Allergy and Infectious Diseases Special Emphasis Panel.

In addition to his research and academic contributions, over the past five years Dr. Nino has led important clinical and educational activities at Children’s National and currently directs the hospital’s Sleep Medicine program, which has grown to become one of the region’s largest programs conducting more than 1,700 sleep studies annually.

He has developed several clinical multidisciplinary programs including a pediatric narcolepsy clinic and the Advanced Sleep Apnea Program in collaboration with the Division of Ear, Nose and Throat at Children’s National. In addition, Dr. Nino started a fellowship program in Pediatric Sleep Medicine accredited by the Accreditation Council for Graduate Medical Education in collaboration with The George Washington University and has served as clinical and research mentor of several medical students, pediatric residents and fellows.

Dr. Kurt Newman in front of the capitol building

Kurt Newman, M.D., shares journey as a pediatric surgeon in TEDx Talk

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Kurt Newman, M.D., president and chief executive officer of Children’s National, shares his poignant journey as a pediatric surgeon, offering a new perspective for approaching the most chronic and debilitating health conditions. In this independently-organized TEDx event, Dr. Newman also shares his passion for Children’s National and the need to increase pediatric innovations in medicine.

Andrew Dauber

Andrew Dauber, M.D., joins Children’s National as Chief of Endocrinology

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Andrew Dauber

“Researchers, clinicians and medical trainees are pressed for time,” says Andrew Dauber, M.D. “Merging these three arenas into a joint infrastructure powers institutional collaboration and fuels transformative, cutting-edge care.”

Imagine an endocrinology division staffed with endowed researchers, clinicians and specialists, that serves as an engine of innovation, making it easy for pediatricians to make the right referrals, based on the best research, to endocrinologists who can provide families with cutting-edge care.

Andrew Dauber, M.D., MMSc, the new chief of endocrinology at Children’s National, is turning this dream into a reality. Over the next few years, Dr. Dauber will work with a nationally-ranked endocrinology and diabetes center to build a clinical endocrinology research program, housing specialty clinics for Turner’s syndrome, thyroid care and growth disorders, amongst others.

“Researchers, clinicians and medical trainees are pressed for time,” notes Dr. Dauber. “Merging these three arenas into a joint infrastructure powers institutional collaboration and fuels transformative, cutting-edge care.”

To put his real-life hypothesis of providing an engine for innovation into practice, Dr. Dauber led the interdisciplinary growth center at Cincinnati Children’s Hospital Medical Center and organized a Genomics First for Undiagnosed Diseases Program to study genetic clues for undiagnosed diseases. At Boston Children’s Hospital, he was the assistant medical director for the clinical research unit and held academic appointments with Harvard Medical School.

Dr. Dauber finds it’s critically important to merge clinical practice with research and education. He received his medical degree and a Master’s of Medical Sciences in Clinical Investigation from Harvard Medical School. He has published more than 65 studies examining genetic clues to endocrine disorders, with a focus on short stature and growth disorders.

Dr. Dauber conducted the majority of his research – ranging from studying genetic clues for rare growth disorders and causes of precocious puberty to genes that regulate the bioavailability of IGF1, insulin-like growth factor – while counseling patients, advising students and fellows, managing grants, reviewing studies and speaking at international pediatric endocrinology conferences.

He’s harnessing this data by combining genomic insights with electronic health records and patient registries. While some of this information can be used immediately to identify a high-risk patient, other conditions may take years to understand. Dr. Dauber views this as an investment in the future of pediatric endocrinology.

“I’m excited to join Children’s National and to work in Washington, where we can power our city and the nation with premier partnerships and collaboration,” adds Dr. Dauber. “In addition to using genetic clues to investigate growth disorders, we’re just as enthusiastic about investing in and expanding access to youth-focused diabetes education and care.”

The Division of Diabetes and Endocrinology works with the National Institutes of Health, conducts independent research and received support from the Washington Nationals Dream Foundation for its diabetes program, the largest pediatric diabetes program in the region, which provides community education and counsels 1,800 pediatric patients each year.

IV Bag

New study examines treatment for diabetic ketoacidosis

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IV Bag

Brain injuries that happen during episodes of diabetic ketoacidosis (DKA) – where the body converts fat instead of sugar into energy, and where the pancreas is unable to process insulin, such as in type 1 diabetes – are rare, and happen in less than 1 percent of DKA episodes, but these injuries can carry lasting consequences – including mild to severe neurological damage.

A new 13-center, randomized, controlled trial published on June 13, 2018, in the New England Journal of Medicine finds two variables – the speed of rehydration fluids administered to patients and the sodium concentrations in these intravenous fluids – don’t impact neurological function or brain damage.

“One medical center would never be able to study this independently because of the relatively small volume of children with DKA that present to any one site,” says Kathleen Brown, M.D., a study author, the medical director of the emergency medicine and trauma center at Children’s National Health System and a professor of pediatrics and emergency medicine at George Washington University School of Medicine. “The strength of this research lies in our ability to work with 13 medical centers to study almost 1,400 episodes of children with DKA over five years to see if these variables make a difference. The study design showcases the efficiency of the Pediatric Emergency Center Applied Research Network, or PECARN, a federally-funded initiative that powers collaboration and innovation.”

Researchers have speculated about the techniques of administering intravenous fluids, specifically speed and sodium concentrations, to patients experiencing a DKA episode, with many assuming a faster administration rate of fluids would produce brain swelling. Others argued, from previous data, that these variables may not matter – especially since higher levels of brain damage were noted among children with higher rates of dehydration before they were treated. Some thought DKA created a state of inflammation in the brain, which caused the damage, and that speed and sodium concentration wouldn’t reverse this initial event. The researchers set out to determine the answers to these questions.

The PECARN research team put the data to the test: They created a 2-by-2 factorial design to test the impact of providing 1,255 pediatric patients, ages zero to 18, with higher (.9 percent) and lower (.45 percent) concentrations of sodium chloride at rapid and slow-rate administration speeds during a DKA episode. They administered tests during the first DKA episode and again during a recurrent episode. After analyzing 1,389 episodes, they found that the four different combinations did not have a statistically significant impact on the rate of cognitive decline during the DKA episode or during the 2-month and 6-month recovery periods.

“One of the most important lessons from this study is that diabetic ketoacidosis should be avoided because it can cause harm,” says Dr. Brown. “But the best way to treat diabetic ketoacidosis is to prevent it. Parents can monitor this by checking blood sugar for insulin control and taking their children for treatment as soon as they show signs or symptoms that are concerning.”

According to the National Institute of Diabetes and Kidney Disease, symptoms of diabetic ketoacidosis include nausea and vomiting, stomach pain, fruity breath odor and rapid breathing. Untreated DKA can lead to coma and death.

An accompanying video and editorial are available online in the New England Journal of Medicine.

The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the Health Resources and Services Administration. The PECARN DKA FLUID ClinicalTrials.gov number is NCT00629707.

Children’s National Health System’s Division of Pediatric Emergency Medicine has been a lead site for the PECARN network since its inception in 2001.

test tubes

2016: A banner year for innovation

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test tubes

In 2016, clinicians and research scientists working at Children’s National Health System published more than 1,100 articles in high-impact journals about a wide array of topics. A Children’s Research Institute review group selected the top articles for the calendar year considering, among other factors, work published in top-tier journals with impact factors of 9.5 and higher.

“Conducting world-class research and publishing the results in prestigious journals represents the pinnacle of many research scientists’ careers. I am pleased to see Children’s National staff continue this essential tradition,” says Mark L. Batshaw, M.D., Physician-in-Chief and Chief Academic Officer at Children’s National. “While it was difficult for us to winnow the field of worthy contenders to this select group, these papers not only inform the field broadly, they epitomize the multidisciplinary nature of our research,” Dr. Batshaw adds.

The published papers explain research that includes discoveries made at the genetic and cellular levels, clinical insights and a robotic innovation that promises to revolutionize surgery:

  • Outcomes from supervised autonomous procedures are superior to surgery performed by expert surgeons
  • The Zika virus can cause substantial fetal brain abnormalities in utero, without microcephaly or intracranial calcifications
  • Mortality among injured adolescents was lower among patients treated at pediatric trauma centers, compared with adolescents treated at other trauma center types
  • Hydroxycarbamide can substitute for chronic transfusions to maintain transcranial Doppler flow velocities for high-risk children with sickle cell anemia
  • There is convincing evidence of the efficacy of in vivo genome editing in an authentic animal model of a lethal human metabolic disease
  • Sirt1 is an essential regulator of oligodendrocyte progenitor cell proliferation and oligodendrocyte regeneration after neonatal brain injury

Read the complete list.

Dr. Batshaw’s announcement comes on the eve of Research and Education Week 2017 at Children’s National, a weeklong event that begins April 24. This year’s theme, “Collaboration Leads to Innovation,” underscores the cross-cutting nature of Children’s research that aims to transform pediatric care.

It took an act of Congress to save lives

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Boosting research and innovation to find cures and develop new medical devices for children and adults who carry childhood and rare diseases will transform our health system and save lives.

Until now, medical research and innovation have been severely limited in the U.S. by regulations and lack of funding. On behalf of healthcare systems and medical innovators across the U.S., we applaud the House and Senate for their tremendous bipartisan effort to pass the 21st Century Cures Act that will transform our health and research system and enable us to more effectively fight diseases.

We are encouraged by the provisions in the act that break down regulatory barriers and expedite the approvals of drugs and devices. We are particularly excited about the provisions to increase funding to the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), as well as the establishment of precision medicine, the cancer moonshot initiatives and new programs that will improve our mental health system and fight the worsening opioid epidemic. Boosting research and innovation to find cures and develop new medical devices for children and adults who carry childhood and rare diseases is at the core of our mission at Children’s National. Our researchers are working to find new biomarkers, map the human genome, develop medical devices for children and personalize medicine to make treatment and cures more targeted and effective. They are also studying pain and looking at new ways to detect the presence of opioids and cannabinoids. Thanks in large part to funding from the NIH, institutions like ours are able to continue groundbreaking biomedical research. This legislation brings hope to our children and their families, especially those who volunteer to participate in research, that our scientific breakthroughs will be translated to drugs, therapeutics and medical devices safer and faster.

Another victory for all of us in the pediatric medical device field is the expansion of the Humanitarian Use Device program to include devices used by up to 8,000 individuals rather than the current 4,000 individual cap. The hard cap at 4,000 individuals was excessively restrictive and was a significant disincentive blocking the development of devices for rare diseases and conditions, especially those affecting children. The 4,000 limit was also an obstacle for the development of diagnostic devices, since the FDA interprets the limitation to apply to the number of patients that would receive the diagnostic test, rather than the number of individuals affected or manifesting the rare disease.

Currently, medical device development for children lags woefully behind adults. Children have medical device needs that are considerably different from adults. The subtleties of developing devices for pediatric patients are fundamentally different than those for adults. The challenges include small markets, scarce financial incentives, regulatory issues, and the procedural dissimilarities of premarket clinical trials and post-market surveillance. The lack of available pediatric devices often forces clinicians to treat pediatric patients by using or modifying adult devices, adjusting implants designed for other purposes, and using implants designed decades ago. Because devices are being used “off-label,” clinicians and regulators are not able to collect information on their effectiveness. This act promises a faster regulatory approval process, which increases the enthusiasm of the venture community in investing in drug and device development, which in turn can help startup companies in the field secure private capital.

Thank you to everyone who worked tirelessly to create this bill and to those who lobbied on its behalf. It’s efforts like the 21st Century Cures Act, that break down regulatory barriers and provide the resources to expedite the approvals of life-saving drugs and devices, that save children’s lives.

About the Author

Kolaleh Eskandanian, Ph.D.
Executive Director
Sheikh Zayed Institute for Pediatric Surgical Innovation
Research interests: device development, entrepreneurship, innovation in health care