Medical Device Pitch Competition Goes Virtual

Thirty semi-finalists have been named in the annual "Make Your Medical Device Pitch for Kids!" competition presented by the National Capital Consortium for Pediatric Medical Devices (NCC-PDI). The competition is adopting a virtual format for the March 23rd event to eliminate the need for travel or an in-person gathering due to the COVID-19 pandemic. Organized by nonprofit accelerator MedTech Innovator, contestants and judges will connect in online meeting rooms for the pitch presentations, which feature innovations in cardiovascular, orthopedic and spine, and NICU devices.

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. 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.

Up to 10 finalists selected from this event will participate in a newly created pediatric track in the MedTech Innovator accelerator program and advance to the October 2020 competition finals in Toronto as part of the 8th Annual Pediatric Device Innovation Symposium hosted by Children's National Hospital. Finalists will pitch for a share of up to $250,000 in grant awards.

"There is a pressing need for more medical devices created especially for children, so we are proceeding with the semi-final pitch event in a virtual format to safely accommodate innovators and judges and maintain the schedule," said Kolaleh Eskandanian, Ph.D., MBA, PMP, vice president and chief innovation officer at Children's National Hospital and principal investigator of NCC-PDI. "Given the high quality of submissions received, we want our finalists to have the benefit of the pediatric accelerator as well as adequate time to prepare for the finals. We are grateful to everyone involved for being flexible so that this important work can continue."

The following are the 30 pediatric device innovations selected for the semi-finals:

Adipomics, Inc. - Cambridge, MA, - gestational pre-diabetes diagnostic to prevent birth defects
AireHealth, Inc. – Orlando, FL – portable nebulizer and connected care app for respiratory care
Ben Guard Healthcare Solutions LLC - Glen Ellyn, IL – wearable catheter securement device for pediatric DVCs and other tubing
BioMotum, LLC – Flagstaff, AZ – therapy device to improve movement disorder treatment
BioSense - Beverly Hill, MI – first working non-contact EKG for constant, non-invasive monitoring
Bloom Standard, Ltd. – St. Paul, MN – wearable AI-driven ultrasound device for low-resource countries, infant CHD and pulmonary screening
Brain Stem Biometrics – Palo Alto, CA – Microsensor patch to monitor sleep and neurodevelopment in premature infants
CorFix – University of Maryland, College Park, MD - VR surgical planning system for cardiovascular disease diagnosis and graft design and optimization
Dsseca – University of Maryland, College Park, MD - platform device to rapidly discover biomarker signatures of oxidative stress
Eclipse Regenesis, Inc. – Menlo Park, CA – first restorative therapy for short bowel syndrome (SBS) via distraction enterogenesis
Heamac Healthcare Pvt. Ltd - Hyderabad, India – diagnostic tool to measure parameters of a neonate with jaundice
Innara Health – Olathe, KS – Ntrainer biofeedback device to train premature infants and newborns in the neurophysiological aspects of feeding
Lactation Innovations – Canterbury, CT – Manoula measures amount of breastmilk consumed during infant feeding
Lifespan – Providence, RI – Positioning device to improve success in performing spinal tap in febrile infants
Little Sparrows Technologies, Inc. – Winchester, MA – Portable, high-intensity phototherapy for neonatal jaundice treatment
Medicsen – Leeds, UK – Needle-free Smartpatch for painless drug delivery for kids
Novonate – South San Francisco, CA – secures and protects the umbilical catheter insertion site for neonates in intensive care
OCBrace – Orange, CA – 4D ultrasound brace design system using real-time measurements of the spinal deformity to maximize correction and brace efficacy
OpticSurg Inc. – Wilmington, DE – Augmented reality-enhanced telemedicine platform
Ostiio – Philadelphia, PA – An implantable, magnetic distraction system for expansion of the craniomaxillofacial skeleton
Pediafeed – Baltimore, MD – optimizing pediatric gastrostomy feeding tubes
PediaMetrix, Inc. – Rockville, MD – a mobile app for early detection and treatment of infant flat head syndrome
Promedix Inc. – Portland, OR – Measures distal blood flow for early diagnosis of shock in children
Renata Medical – Costa Mesa, CA – growth stent for treatment of congenital narrowed lesions in neonatal patients
SpineGuide Technologies Inc. – Dover, DE – 3D multi-segment growth guidance rod system for scoliosis to provide good correction & growth
Spino Modulation, Inc. – Montreal, Canada – anterior vertebral body tethering for adolescent idiopathic scoliosis
TheraB Medical – East Lansing, MI – wearable, portable neonatal jaundice treatment promoting bonding and breastfeeding
Tremedics Medical Devices – North Richland Hills, TX – Illusicor, a bioresorbable stent to treat congenital heart disease
Ventora Medical Pty Ltd – Flemington, Australia - real time monitoring of infant lung pressure to improve the accuracy of non-invasive respiratory support for neonates
VitaScope – Toronto, Canada - provides quick and accurate newborn heart rate to facilitate high quality resuscitation.

"To get a medical device to market, innovators have always needed to be flexible when pitching their concept to investors, clinicians or other key stakeholders," said Paul Grand, CEO of MedTech Innovator. "In the coming months, innovators will likely be giving more virtual pitches than ever before, and we think this online event will be very meaningful in helping them hone their virtual presentation skills as an additional benefit to the opportunity to get live feedback from our ecosystem of industry leaders."

"Perhaps now more than ever it is important to foster innovations in human health," said William E. Bentley, Ph.D., director of the University of Maryland's Robert E. Fischell Institute for Biomedical Devices. "It is critical that we pursue any means available to further pediatric medical device development efforts while ensuring the health and safety of our pitch competition participants and judges. I am thrilled that this newly adapted virtual event will achieve both missions without delay."

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. 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.

In addition to the efforts of NCC-PDI, Eskandanian said that supporting the progress of pediatric innovators will be a key focus of the Children's National Research & Innovation Campus, a first-of-its-kind campus opening in December, 2020, on the site of 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, and on-site accelerator Johnson & Johnson Innovation – JLABS, the campus will foster a rich ecosystem of public and private partners which, like the NCC-PDI network, will bolster pediatric medical device innovation and commercialization.

About Children's National Hospital
Children's National Hospital, based in Washington, D.C., celebrates 150 years of pediatric care, research and commitment to community. Volunteers opened the hospital in 1870 with 12 beds to care for Civil War orphans. Today, 150 years stronger, it is the nation's No. 6 children's hospital. It is ranked No. 1 for newborn care for the third straight year and ranked in all specialties evaluated by "U.S. News & World Report." Children's National is transforming pediatric medicine for all children. In 2020, it will open the Children's National Research & Innovation Campus, the first in the nation dedicated to pediatric research. It has been designated twice as a Magnet® hospital, demonstrating the highest standards of nursing and patient care delivery. This pediatric academic health system offers expert care through a convenient, community-based primary care network and specialty outpatient centers in the D.C., metropolitan area, including the Maryland and Northern Virginia suburbs. Children's National is home to the Children's National Research Institute and Sheikh Zayed Institute for Pediatric Surgical Innovation and is the nation's seventh-highest NIH-funded children's hospital. It is recognized for its expertise and innovation in pediatric care and as a strong voice for children through advocacy at the local, regional and national levels.

About the University of Maryland
The University of Maryland, College Park is the state's flagship university and one of the nation's preeminent public research universities. A global leader in research, entrepreneurship and innovation, the university is home to more than 40,000 students,10,000 faculty and staff, and 280 academic programs. Its faculty includes two Nobel laureates, three Pulitzer Prize winners and 58 members of the national academies. The institution secures $514 million annually in external research funding. The university's Robert E. Fischell Institute for Biomedical Devices seeks to catalyze the transformation of basic research into clinical practice and commercial success. The Institute aims to drive innovation by immersing creative and energetic scientists and engineers in a nurturing and rewarding research environment where engineered health systems are conceived of and investigated. The Institute is comprised of staff, resources, facilities, and a network of experts who not only facilitate prototyping and manufacturing expertise, but who also facilitate venture creation, intellectual property creation, and product passage through various clinical, regulatory and reimbursement hurdles. For more information about the University of Maryland, College Park, visit www.umd.edu [umd.edu].

About MedTech Innovator
Based in Los Angeles, Calif., MedTech Innovator is the premier nonprofit startup accelerator in the medical technology industry. Its mission is to improve the lives of patients by accelerating the growth of companies that are transforming the healthcare system. MedTech Innovator matches healthcare industry leaders with innovative early-stage and emerging growth medtech companies for mentorship and support. Founding sponsors include Johnson & Johnson and RCT Ventures, and annual program sponsors include Baxter, Boston Scientific, NIPRO Medical, Olympus Medical Systems, W. L. Gore, Asahi Intecc, BTG, Fujikura, HOYA, Jabil, JOHNAN, Maxim Integrated Ventures, EdgeOne Medical, Experien Group, Greenlight Guru, Proxima Clinical Research, Westwood & Wilshire, and Ximedica. The organization's industry partners include AdvaMed, Health+Commerce, MedTech Strategist, and Wilson Sonsini Goodrich & Rosati. For more information about MedTech Innovator, visit https://medtechinnovator.org/ [medtechinnovator.org] and follow @MedTechAwards on Twitter.

Published March 20, 2020