Tag Archive for: Eskandanian

Baby wearing Gabi SmartCare device

Supporting breakthroughs in at-home pediatric monitoring

Baby wearing Gabi SmartCare device

The child-sized, lightweight, wearable band enables at-home monitoring of patient vital signs.

As their infant daughter recovered from a life-threatening virus, tech executive Jonathan Baut and his wife lived in a constant state of alert for any signs of a change in her condition. That experience prompted Baut to look for an at-home vital signs monitoring solution for parents facing medical challenges at home.

He located the technology in Belgium and found the clinical support to advance the innovation at Children’s National Hospital, tapping into its leadership of a pediatric device consortium funded by the Food and Drug Administration (FDA), the Alliance for Pediatric Device Innovation (APDI).

The technology platform, called Gabi SmartCare, features a tiny, lightweight, wearable band made for children that enables at-home monitoring of a patient’s vital signs including oxygen saturation,  and heart rate movement. It also supports the collection of other data about health conditions through health assessment.

The big picture

Wireless home-based monitoring could reduce hospital stays while improving the transitional care provided to patients at home. It could also aid in the home care of chronically ill patients.

Recently, Gabi SmartCare received its FDA clearance as a class II device for monitoring use. Baut says the multifaceted support he received from Children’s National and APDI helped him achieve this critical milestone, including the hospital’s role as one of two U.S. clinical trial sites for the device.

He explained that the APDI team also connected him with experts in device trials, regulatory processes and reimbursement, which helped him better understand the U.S. market and the nuances of the pediatric continuum of care.

Gabi SmartCare monitoring screens

Physicians can remotely monitor patient’s oxygen saturation and heart rate movement.

As he focuses on getting his product into hospitals, Baut already has additional monitoring features in development for Gabi SmartCare including respiratory rate, actigraphy, skin auto-calibration and sleep phases.

Why it matters

Reliable at-home monitoring tools can expand a pediatric hospital’s capabilities to support patients beyond the hospital setting. They can also help reduce trips to the emergency room and reduce the stress and anxiety parents experience when providing home care. Helping to advance devices like these can deliver those benefits to patient families at Children’s National and beyond.

“The pandemic underscored a great need for technologies that improve remote monitoring for children,” said Kolaleh Eskandanian, Ph.D. M.B.A., P.M.P., Children’s National vice president and chief innovation officer and program director of APDI. “At-home monitoring devices enable remote and continuous surveillance of pediatric patients, ensuring timely intervention and optimal care delivery even in remote or resource-limited settings. These technologies are needed now, and even more during public health emergencies.”

child with a tracheostomy tube

Inequity complicates care for children with tracheostomies

child with a tracheostomy tube

Study finds healthcare inequities complicate care of children with tracheostomies.

Approximately 4,000 children in the United States annually undergo tracheostomies, a lifesaving procedure for severe respiratory compromise or upper-airway obstruction. While children with tracheostomies are living longer because of technological advances, their caretakers encounter a variety of issues once at-home care begins, as reported in a study published in Qualitative Health Research.

The study identified lingering problems from the lack of equitable access to appropriate support for patient families and caregivers. Jules Sherman, M.F.A., director of the Biodesign Program at Children’s National Innovation Ventures, led the research in collaboration with Kyle L. Bower, Ph.D., a researcher and instructor at The University of Georgia, and Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., vice president and chief innovation officer at Children’s National.

The big picture

Interview subjects were 11 primary caregivers of children ages 16 months to 11 years who had a tracheostomy and were supported by multiple lifesaving devices at home such as a ventilator, humidifier and other required medical supplies.

Subjects were questioned about influences and relationships they believed impacted the trajectory of care given to children with tracheostomies. Three themes emerged:

  • Insufficient peer support: Caregivers struggled to find groups who shared similar experiences to help them navigate the uncertainty surrounding their child’s medical care, and content on social media peer groups sometimes heightened their sense of worry.
  • Ineffective trach-care training:
    • For families — Caregivers said the trach-care training they received at their respective hospitals did not reflect real-time situations at home, resulting in high levels of anxiety, multiple home emergency situations and routine calls to 911.
    • Home health nurses — Caregivers shared instances of poor decision-making by at-home nurses in emergency situations, lack of communication with primary caregivers and lack of respect for their input.
  • Challenges facing integrated care: The absence of cohesion between medical professionals, durable medical equipment (DME) companies and insurance providers creates many challenges for caregivers. Due to the excessive cost of lifesaving medical devices and negative interactions by caregivers with insurance companies and DMEs, some caregivers reported turning to the black market to purchase needed medical supplies.

Why it matters

In the United States, 60 percent of children with tracheostomies are readmitted to the hospital for tracheostomy-associated respiratory infection within the first six months of the surgery. This study highlights systemic failures and inequities within the healthcare system, beginning at the hospital and following affected families into their homes, indicating that improvements in the support system, training and healthcare coverage are sorely needed.

The need for a better tracheostomy solution was introduced to Children’s National’s Innovation Ventures by two hospital physicians who are otolaryngologists, Habib Zalzal, M.D. and Rahul Shah, M.D., M.B.A. Followed by an initial market study and design by design firm Archimedic, study author, Sherman, continues working with clinicians at Children’s National and engineers at the University of Oregon and University of Maryland to enhance the prototype developed at Children’s National. The device, called as Trach Sense, is designed to detect accidental decannulation and obstruction events, which are leading causes of tracheostomy-related complications.

This study was supported by the Food and Drug Administration grants P50FD006430 and P50FD007965. The contents are those of the authors and do not necessarily represent the official views of, nor an endorsement, by the FDA, Department of Health and Human Services or the U.S. government.

Participants at the annual “Make Your Medical Device Pitch for Kids!”™ competition

Two pediatric medical device companies awarded at pitch competition

Participants at the annual “Make Your Medical Device Pitch for Kids!”™ competition

Winners and finalists competed at UCLA during annual L.A. MedTech Week 2024. Left to right are: Nada Hanafi, MedTech Color Board treasurer; Vernessa Pollard, MedTech Color Board secretary; Dr. Sanna Gaspard, CEO and founder of Rubitection, (winner -$35,000 first prize); Dr. Kolaleh Eskandanian, Children’s National vice president and chief innovation officer; Kwame Ulmer, MedTech Color founder and board chair. Photo credit: MedTech Color

Alliance for Pediatric Device Innovation (APDI), a federally funded consortium led by Children’s National Hospital, and member MedTech Color announced the winners of the recent edition of the Make Your Medical Device Pitch for Kids!™ competition, which focused on recognizing and supporting African American and Hispanic pediatric medical device innovators. The awardees received a combined $50,000 in grant funding from APDI, made possible by the U.S. Food and Drug Administration (FDA) to support the advancement of pediatric medical technologies to the market.

The winners were selected from a field of five finalists who gave pitch presentations on their innovation’s attributes, benefits to patients and pathway to commercialization before a panel of five expert judges. The event was held on March 15 at the University of California, Los Angeles, as part of the annual MedTech Color Pitch Competition during L.A. MedTech Week 2024, powered by BioscienceLA.

The award-winning pediatric devices and companies are:

  • Rubitection, Pittsburgh, Pa.– A low-cost skin assessment management tool for chronic wounds, Rubitection measures the properties of the skin. The system allows the user to monitor incremental changes in skin health to predict risk, monitor progression and customize care.
  • Kofimi Technology Inc., Danvers, Mass. – This patent-pending pulse oximeter device is designed specifically for pediatric populations to provide superior accuracy for all levels of skin pigmentation. A pulse oximeter measures oxygen levels in the blood.

Why we’re excited

“Funding innovators of African American and Hispanic backgrounds is crucial for advancing diversity, equity, and inclusion initiatives because it addresses systemic barriers and inequities that have historically hindered this group from accessing resources and opportunities in the life sciences sector,” said Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., vice president and chief innovation officer at Children’s National and APDI program director and principal investigator. “Supporting a diverse group of innovators enriches the research and development process by bringing a variety of perspectives and viewpoints representing all populations.”

Along with the grant award, all finalists receive access to a network of supportive resources and expertise as part of their connection to APDI and MedTech Color.

Along with the pitch presentations, the event program included a keynote talk from Tonya Kinlow, vice president of Community Engagement, Advocacy and Government Affairs at Children’s National, highlighting advocacy initiatives leading to an all-inclusive system of care for children.

Children’s National leads the way

Julia Finkel, M.D., pediatric anesthesiologist at Children’s National and principal investigator for APDI, participated in the panel discussion “Inequity within Inequity,” which highlighted how racial disparities in pediatric healthcare remain a critical challenge across the United States. APDI’s goal is to advance pediatric devices that meet patient needs while promoting a more inclusive approach to discovering and supporting talented innovators.

“We believe there is a community of companies focused on platforms that treat or diagnose pediatrics,” said Kwame Ulmer, founder of MedTech Color. “This partnership allows us to significantly increase the support we provide for entrepreneurs in this area. We are delighted to be a part of the Children’s National community to drive positive patient outcomes.”

The patient benefit

Founded in 2017, MedTech Color is a nonprofit organization built on the same ideal: diverse leadership in the medical technology ecosystem leads to greater innovation and better outcomes. The organization works to advance the representation of people of color in the medical device industry and to nurture the next generation of founders. For more information on MedTech Color, visit medtechcolor.org.

APDI is one of five nonprofit consortia in the FDA’s Pediatric Device Consortia program that receives funding to provide a platform of services, expertise and grants to support pediatric innovators in bringing medical devices to the market that address the needs of children. Along with Children’s National, APDI members include Johns Hopkins University, CIMIT at Mass General Brigham, Tufts Medical Center, Medstar Health Research Institute, OrthoPediatrics Corp. and MedTech Color.

Advancements in pediatric medical devices continue to lag significantly behind those of adults, which is why APDI is focused on helping more pediatric medical device innovations achieve commercialization. For more information on APDI, visit innovate4kids.org

ARPA-H logo

Children’s National selected as member of ARPA-H Investor Catalyst Hub spoke network

ARPA-H logoThe hospital will advocate for the unique needs of children as part of nationwide network working to accelerate transformative health solutions.

Children’s National Hospital was selected as a spoke for the Investor Catalyst Hub, a regional hub of ARPANET-H, a nationwide health innovation network launched by the Advanced Research Projects Agency for Health (ARPA-H).

The Investor Catalyst Hub seeks to accelerate the commercialization of groundbreaking and accessible biomedical solutions. It uses an innovative hub-and-spoke model designed to reach a wide range of nonprofit organizations and Minority-Serving Institutions, with the aim of delivering scalable healthcare outcomes for all Americans.

“The needs of children often differ significantly from those of adults. This partnership reflects our commitment to advancing pediatric healthcare through innovation and making sure we’re addressing those needs effectively,” said Kolaleh Eskandanian, Ph.D., M.B.A., vice president and chief innovation officer at Children’s National. “Leveraging the strength of this hub-and-spoke model, we anticipate delivering transformative solutions to enhance the health and well-being of the patients and families we serve.”

Children’s National joins a dynamic nationwide network of organizations aligned to ARPA-H’s overarching mission to improve health outcomes through the following research focus areas: health science futures, proactive health, scalable solutions and resilient systems. Investor Catalyst Hub spokes represent a broad spectrum of expertise, geographic diversity and community perspectives.

“Our spoke network embodies a rich and representative range of perspectives and expertise,” said Mark Marino, vice president of Growth Strategy and Development for VentureWell and project director for the Investor Catalyst Hub. “Our spokes comprise a richly diverse network that will be instrumental in ensuring that equitable health solutions reach communities across every state and tribal nation.”

As an Investor Catalyst Hub spoke, Children’s National gains access to potential funding and flexible contracting for faster award execution compared to traditional government contracts. Spoke membership also offers opportunities to provide input on ARPA-H challenge areas and priorities, along with access to valuable networking opportunities and a robust resource library.

Alliance for Pediatric Device Innovation consortium members

Children’s National awarded nearly $7.5 million by FDA to lead pediatric device innovation consortium

Alliance for Pediatric Device Innovation consortium membersChildren’s National Hospital was awarded nearly $7.5 million in a five-year grant to continue its leadership of an FDA-funded pediatric device consortium. Building upon a decade of previous consortium leadership, the new consortium is Alliance for Pediatric Device Innovation (APDI) and features a new and expanded roster of partners that reflects its added focus on providing pediatric innovators with expert support on evidence generation, including the use of real-world evidence (RWE), for pediatric device development.

Collaborating for success

With the goal of helping more pediatric medical devices complete the journey to commercialization, APDI is led by Children’s National, with Kolaleh Eskandanian, Ph.D., M.B.A., vice president and chief innovation officer, serving as program director and principal investigator, and Julia Finkel, M.D., pediatric anesthesiologist and director of Pain Medicine Research and Development in the Sheikh Zayed Institute for Pediatric Surgical Innovation, serving as principal investigator.

Consortium members include Johns Hopkins University, CIMIT at Mass General Brigham, Tufts Medical Center, Medstar Health Research Institute and MedTech Color. Publicly traded OrthoPediatrics Corp., which exclusively focuses on advancing pediatric orthopedics, is serving as APDI’s strategic advisor and role model for device innovators whose primary focus is children.

Why we’re excited

Consortium initiatives got underway quickly with the announcement of a special MedTech Color edition of the “Make Your Medical Device Pitch for Kids!”™ competition that focuses on African American and Hispanic innovators. Interested innovators can find details and apply at MedTech Color Pitch Competition. The competition was announced at the recent MedTech Color networking breakfast on Oct. 10,2023 at The MedTech Conference powered by AdvaMed.

“We all benefit from greater equity and inclusion among pediatric MedTech founders, decision-makers, investigators and developers in more effectively addressing the needs of the entire pediatric population,” said Eskandanian. “We need the expertise and insights of innovators from diverse backgrounds, and we want to provide these talented individuals with more opportunities to present their work and share their perspectives on pediatric device development.”

Additional details

APDI is one of five FDA-funded consortia created to provide a platform of services, expertise and funding to help pediatric innovators bring medical devices to the market that specifically address the needs of children.

 

Motor neuron connecting to muscle fiber

FDA approves muscular dystrophy drug built on Children’s National research



Motor neuron connecting to muscle fiber

Duchenne muscular dystrophy (DMD) is the most common hereditary neuromuscular disease.



Boys with Duchenne muscular dystrophy (DMD) have a clinically proven, new treatment option with the Food and Drug Administration’s approval of vamorolone, a steroidal-type, anti-inflammatory drug developed based on research performed at Children’s National Hospital.

Created by ReveraGen BioPharma Inc., vamorolone has a molecular structure similar to traditional corticosteroids, which are currently used to treat DMD. Yet its structure was found to be chemically different enough to reduce unwanted side effects, including brittle bones and reduced stature. Nearly two decades ago, ReveraGen leaders – President and CEO Eric Hoffman, Ph.D., and Vice President for Research Kanneboyina Nagaraju, D.V.M., Ph.D. – launched research efforts into the drug when they led the Center for Genetic Medicine Research at Children’s National. They worked with then-Chief Academic Officer Mark Batshaw, M.D., on the new clinical option.

“Throughout my career, I have treated children with DMD, and I have seen over time how their shorter heights and brittle bones impact them physically and emotionally – in terms of their self-esteem and ability to participate in activities,” Dr. Batshaw said. “This drug should help these boys function more effectively and prevent certain long-term complications.”

The patient benefit

Muscular dystrophy includes a group of degenerative genetically inherited neuro-muscular diseases that strike only boys. DMD is the most common, severe and life-threatening form of muscular dystrophy. ReveraGen studied vamorolone for patients ages two years and up in the hopes of providing a new, FDA-approved treatment option for these children. In clinical trials, daily treatment with vamorolone improved muscle strength and stature with results comparable to prednisolone, but without some of the most impactful side effects of steroids, particularly the stunted growth and weakened bones.

Children’s National Hospital leads the way

Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., vice president and chief innovation officer for Children’s National, said Drs. Hoffman and Nagaraju’s work on the drug paved the way for entrepreneurship at the hospital, as they were the first faculty members to launch a spin-off company. Since then, more than 130 faculty members have been named as inventors on 132 patents. Children’s National is now home to Innovation Ventures, the hospital’s intellectual property development and commercialization arm, which provides guidance and resources to academic entrepreneurs who introduce a concept for pediatric medical products.

“We cannot wait to see the tremendous effort behind vamorolone in the hands of patients and clinicians treating Duchenne muscular dystrophy,” Eskandanian said. “Today’s FDA approval for ReveraGen shows the importance of supporting clinicians and researchers who are developing solutions to advance healthcare for children.”

Why we’re excited

Hoffman said the drug has been through a series of clinical trials showing advantages over the current treatment options. In 2024, Catalyst Pharma will market vamorolone under the trade name Agamree in the United States.

“Vamorolone was developed using a different business model and drug development approach, including partnerships with the National Institutes of Health, Department of Defense, the European Commission and more than a dozen international nonprofit foundations,” Dr. Hoffman said. “The collaborative, community-engaged approach—including 32 academic clinical sites in 11 countries — and the participation of hundreds of DMD families led to this approval today.”

RFP collage of logos

Healthcare leaders join to advance pediatric innovation

RFP collage of logosChildren’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.

NCC PDI 2022 pitch competition winners

Five winners selected in prestigious pediatric device competition

The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announced five awardees chosen in its prestigious “Make Your Medical Device Pitch for Kids!” competition. Each received a share of $150,000 in grant funding from the U.S. Food and Drug Administration (FDA), with awards ranging from $20,000 to $50,000 to support the advancement of pediatric medical devices.

Consistent with its mission of addressing the most pressing pediatric device needs, this year’s competition, moderated by MedTech Innovator, welcomed medical device technologies that address the broad unmet needs of children. The pediatric pitch event was part of the 10th Annual Symposium on Pediatric Device Innovation, co-located with the MedTech Conference, powered by AdvaMed.

This year’s pediatric device innovation awardees are:

  • 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.

“We are delighted to recognize these five innovations with critical NCC-PDI funding that will support their journey to commercialization. Improving pediatric healthcare is not possible without forward-thinking companies that seek to address the most dire unmet needs in children’s health,” 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 know all too well how challenging it is to bring pediatric medical devices to market, which is why we have created this rich ecosystem to identify promising medical device technologies and incentivize investment. We congratulate this year’s winning innovators and applaud their efforts to help bridge these important care gaps that are impacting children.”

Empowering Innovators

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 and design firm Archimedic.

A pediatric accelerator program, powered by MedTech Innovator, the largest medical device accelerator in the world, is a key part of the 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.

To date, NCC-PDI has mentored 250 medical device projects to help advance their pediatric innovations throughout all stages of the total product life cycle (TPLC).

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.

NCC PDI 2022 pitch competition winners

A total of $150K was awarded to five pediatric innovations during the medical device pitch competition at the 10th Annual Symposium on Pediatric Device Innovation, hosted by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI). Award winners include (from left to right): Zaid Atto, founder and CEO at Xpan; John Konsin, CEO and co-founder of Prapela; Elaine Horn-Ranney, co-founder and CEO at Tympanogen; William Altman, CEO at CorInnova; and Sharief Taraman, pediatric neurologist at CHOC and University of California-Irvine partnering with Innovation Lab. (Photo credit: Children’s National Hospital)

Healthcare icons

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

Healthcare icons

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.”

Registration for Children’s National’s 2022 Innovation Day is currently open. Those interested in attending the day-long showcase can register at https://conta.cc/3CrAfTl.

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.

NCC-PDI Finalists

Pediatric medical device competition names finalists

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 10th 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.

NCC-PDI Finalists social card

NCC-PDI announcement

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

Kolaleh-Eskandanian

“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.

NCC-PDI announcement

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

 

life sciences industry imagery

Grand Rounds analyzes the state of life sciences industry in Maryland

life sciences industry imagery

A recent Children’s National Grand Rounds panel analyzed the state of the life sciences industry in the region and the potential steps that can be taken to accelerate the manufacturing landscape.

The BioHealth Capital Region, consisting of Maryland, Virginia and Washington, D.C., has surged in recent years to become one of the nation’s strongest biopharma clusters. While the region does not lack opportunity to cultivate and grow innovation, manufacturing business related to scientific research and development in Maryland is lagging compared to other leading states.

That was the message from Martin Rosendale, CEO of the Maryland Tech Council, who was recently the featured speaker of the Children’s National Grand Rounds panel, which analyzed the state of the life sciences industry in the region and the potential steps that can be taken to accelerate the manufacturing landscape. The Maryland Tech Council is a not-for-profit collaborative community actively engaged in building strong life sciences and technology industries.

Moderated by Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., vice president and chief innovation officer at Children’s National Hospital, the panel cited data recently compiled by the Milken Institute Center for Regional Economics that demonstrated the degree to which Maryland’s life sciences manufacturing industry needs to catch-up.

“On the manufacturing business front, we’ve actually been lagging compared to the rest of the country. Other metros have grown faster than we have over the last five years, but that presents an opportunity,” says Rosendale. “We have the opportunity to work more with academia and medical institutions like Children’s National to produce more companies, more intellectual property and more startups.”

According to the Milken data, when compared to other leading states including Massachusetts (2nd), California (3rd), New York (8th), Florida (9th) and Texas (12th), Maryland ranked as the 20th state for life sciences manufacturing growth over a five-year period. Of the growth that occurred over that time, the greatest came in the Washington-Arlington-Alexandria and Baltimore-Columbia-Towson metros, where industry wages tend to be higher.

Kolaleh-Eskandanian

Kolaleh Eskandanian, vice president and chief innovation officer at Children’s National Hospital, recently moderated the Children’s National Grand Rounds panel, which analyzed the state of the life sciences industry in the BioHealth Capital Region.

Highlighting the region’s status as a rich biopharma cluster, and the fact that the innovation sector is growing up in and around Washington, D.C., Rosendale identified the key to help bolster life sciences manufacturing in the region – sustaining life sciences business spending in Maryland. Evidence has demonstrated that incentives are a core component of supporting business research and development, and sustained spending has helped support high-tech business formation and high-wage job creation. It has also generated job creation in occupations that require fewer credentials, such as non-tech-intensive industries.

Growth in these areas can be bolstered by Maryland’s existing life sciences landscape, which ranks as one of the strongest and most robust in the nation. It contributes more than 54,000 high paying jobs in the state with over 2,700 life science firms and more than 500 biotech firms, according to a recent Milken Institute report.

“The District of Columbia has a robust pipeline of up-and-coming talent to further develop the life sciences industry in the region. The potential this expertise offers is a key focus of the new Children’s National Research & Innovation Campus, to drives discoveries that save and improve the lives of children,” says Eskandanian. “Children’s National has combined our strengths with those of public and private partners, including industry, universities, federal agencies, start-up companies and academic medical centers, to provide a rich environment to help bolster pediatric innovation and commercialization to further advance the life sciences industry.”

Data from Genetic Engineering & Biotechnology News (GEN) continues to show that Maryland and the greater BioHealth Capital Region remains one of the country’s premier hubs for innovation companies. The rankings are based on five criteria including NIH funding, VC funding, patents, lab space and jobs. In 2021, the BioHealth Capital Region held its top-four ranking and is expected to rise to a top-three cluster by 2023. The current top-three clusters ranked in the United States are Boston/Cambridge, MA (1st), the San Francisco Bay Area (2nd) and New York/New Jersey (3rd).

NCC-PDI logo

Pediatric medical device competition takes aim at congenital heart disease

NCC-PDI logo

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 9th 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.

Kolaleh Eskandanian

Health IT Panel Focuses on Leveling the Playing Field for Women in Healthcare Leadership

Kolaleh-Eskandanian

Kolaleh Eskandanian, PhD, MBA, PMP, vice president and chief innovation officer at Children’s National Hospital, spoke on gender gaps in healthcare leadership during the 6th annual Health IT + Revenue Cycle Conference hosted by Becker’s Healthcare.

Although women account for nearly half of entry-level jobs in the healthcare industry, female clinician-scientist executives continue to be sparse among healthcare leadership ranks. Less than a third of C-suite roles – approximately 26 percent – are filled by women and tend to focus on human resources or marketing, according to a recent analysis by Becker’s Hospital Review.

Addressing and bridging this gender gap in healthcare leadership was the focus of the recent panel, “Leveling the Playing Field for Women in Healthcare at Macro and Micro Levels,” as part of the 6th annual Health IT + Revenue Cycle Conference hosted by Becker’s Healthcare. Moderated by Alya Ellison of Becker’s Hospital Review, the panel examined the different ways that leading healthcare institutions are working to improve mentorship and leadership opportunities for women to create a more equitable path to the C-suite.

Among those participating in the discussion was Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., vice president and chief innovation officer at Children’s National Hospital, who noted that some organizations may require one or two cycles of leadership change for more female clinician-scientist executives to reach the C-Suite. Even so, Eskandanian emphasized that the desire and strategy to bridge this gap should be imprinted in the DNA of every major healthcare organization.

“Hopefully, many organizations started thinking about diversity and inclusion years ago. At Children’s National Hospital, this is deeply engrained within our culture and is something that we consciously focus on,” Eskandanian says. “In addition to focusing on inclusion at the leadership level, we also work diligently with medical school graduates in our residency program to ensure that both the micro and macro levels of balance are in place.”

Eskandanian adds that Children’s National Hospital also has developed and implemented a program for physicians and scientists known as W@TCH (Women @ Children’s Hospital) to help address the specific needs of women in academic medicine. Led by Naomi Luban, M.D., vice chair of Faculty Affairs and medical director for the Office for the Protection of Human Subjects, the program began as a series of informal lectures designed to address the challenges faced by women in medicine and academia and, with the help of junior faculty, has expanded to include a yearly “brown bag” seminar series with a formal W@TCH-related Grand Rounds that includes a half-day Career Development Workshop and a growing organizing committee of junior faculty.

Senior W@TCH members, many of whom are division chiefs at Children’s National Hospital, also oversee the selection of faculty members to attend different Association of American Medical Colleges (AAMC) programs including Women in Medicine and Science (GWIMS) Professional Development Seminars for early and mid-level faculty and minorities.

“This incredible program started organically at the hospital and has proven highly successful, so we hope that many organizations can follow the same organic process, which truly demonstrates the kind of leadership we need in order to be problem-solving organizations that lead to positive outcomes,” Eskandanian says.

Eskandanian and fellow panelists Tracy Donegan of MLK Community Health and Amy Schroeder of Lexington Regional Health agreed that, as there are still inequities in healthcare leadership roles, it is up to organizations to acknowledge disparities in order to start a dialogue that creates a more inclusive culture focused on manageable strategic goals that make awareness actionable.

Drs. Packer and van den Acker at the Pediatric Device Innovators Forum

Pediatric Device Innovators Forum explores state of focused ultrasound

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.

facial recognition of noonan syndrome

Commercialization of novel facial analysis technology can improve diagnosis of rare disorders in pediatric patients

facial recognition of noonan syndrome

Children’s National Hospital has entered into a licensing agreement with MGeneRx Inc. for its patented pediatric medical device technology using objective digital biometric analysis software for the early and non-invasive screening of dysmorphic genetic diseases such as Noonan syndrome.

Children’s National Hospital has entered into a licensing agreement with life sciences technology company MGeneRx Inc. for its patented pediatric medical device technology using objective digital biometric analysis software for the early and non-invasive screening of dysmorphic genetic diseases. The technology, developed by a multidisciplinary Children’s National team led by Marius George Linguraru, D.Phil, M.A., M.Sc., of the Sheikh Zayed Institute for Pediatric Surgical Innovation and Marshall Summar, M.D., director of the Children’s National Rare Disease Institute (CNRDI), can provide a more advanced diagnostic tool for regions of the world with limited access to geneticists or genetic testing.

The application utilizes artificial intelligence (AI) and machine learning to analyze biometric data and identify facial markers that are indicative of genetic disorders. Physicians can capture biometric data points of a child’s face in real time within the platform, where it scans facial biometric features to determine the potential presence of a genetic disease, which can often be life-threatening without early intervention. Research studies conducted in conjunction with the National Human Genome Research Institute at the National Institutes of Health further enhanced the development of the application in recent years, showing the potential to detect, with a 90 percent accuracy, early diagnosis of 128 genetic diseases across pediatric subjects in 28 countries. These diseases include DiGeorge syndrome (22q11.2 deletion syndrome), Down syndrome, Noonan syndrome and Williams-Beuren syndrome.

“We are delighted to enter into this licensing agreement through Innovation Ventures, the commercialization arm of Children’s National Hospital, which seeks to move inventions and discoveries from Children’s National to the marketplace to benefit the health and well-being of children. Our mission is to add the ‘D’ in development to the ‘R’ in research to accelerate the commercialization of our intellectual property,” says Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., vice president and chief innovation officer at Children’s National and managing director of Innovation Ventures. “It is through partnerships with startups and the industry that we can achieve this goal and thus we highly value this new partnership with MGeneRx Inc. The acceleration and commercialization of this objective digital biometric analysis technology will not only help diagnose rare genetic disorders – it will also allow for earlier interventions that improve the quality of life for the children living with these conditions.”

Eskandanian adds that the social impact of this technology is especially profound in lower income nations around the world, where there is a high prevalence of rare genetic conditions but a severe lack in the specialty care required to diagnose and treat them. Additional data collected through the expanded use of the technology will help to further develop the application and expand its capabilities to identify and diagnose additional rare genetic conditions.

The licensing agreement was arranged by the Children’s National Office of Innovation Ventures, which is focused on the commercialization of impactful new pediatric medical device technologies and therapies to advance children’s health care. Created to catalyze the ongoing translational research of the Children’s National Research Institute (CNRI) as well as inventions by hospital’s clinicians, Innovation Ventures focuses on four core pillars to advance pediatric medical technologies including a Biodesign program, partnerships and alliances to augment internal capacity, seed funding to de-risk technologies and validate market and clinical relevance, and back-office operations to manage intellectual property and licensing activities. Since 2017, Children’s National intellectual property has served as the basis for over 15 licensing or option agreements with commercial partners.

Providing access to an array of experts and resources for pediatric innovators is 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 will help bolster pediatric innovation and commercialization.

pediatric cardiac and vascular MRI coil

Overcoming real and perceived barriers to pediatric device innovation

pediatric cardiac and vascular MRI coil

A working group of innovators, engineers and clinicians from Children’s National Hospital and other institutions came together to address the real and perceived barriers to the creation of pediatric devices, such as this pediatric cardiac and vascular MRI coil developed by Inkspace Imaging.

A working group of innovators, engineers and clinicians from Children’s National Hospital, Children’s Hospital of Orange County and other institutions came together to address the real and perceived barriers to pediatric device innovation through opportunities that may change the return-on-investment in this market and improve health outcomes.

The new report, published in the Journal of Translational Engineering in Health and Medicine, mentions barriers that impede the advancement of pediatric devices, including excessive limitations for testing and validation, lack of incentives, inadequate research models and inconsistent pediatric-related knowledge among companies, regulatory experts, ethic review panels and government reviewers.

To remove the real and perceived barriers fostering excessive limitations, the researchers suggest reducing the perceived risk by establishing guidelines that standardize the review process and ethical research models, incentivizing small companies to participate in pediatric device innovation.

To increase incentives, the researchers call for the development of pediatric versions of adult devices with or without enforcement of regulations, develop incentives for small, medium and large-size companies, extend patent protection and more.

Since science corroborates the device’s effectiveness and safety, tailored pediatric research models are needed to help advance pediatric device innovation. While randomized trials in well-defined cohorts are commonly used in the scientific quest, they do not reflect the clinical practice in the pediatric devices field.

“Overcoming this barrier will require greater opportunity for creativity in the design of clinical trials, including delayed entry, intent-to-treat analysis, personalized outcome measures, and post-hoc subgroup analysis,” said Terence et al. “Effective research for pediatric device innovation will require greater ability to rely on ‘real-world’ data from post-market use of the proposed device or similar devices.”

On the education side, stakeholders, such as device sponsors and researchers, must receive an improved education on pediatric devices, according to the authors. Pediatricians should also be added to the regulatory review panels and advisory boards, so decision-makers can receive the pediatric perspective and fold it into their considerations.

“The consensus outcome of this meeting is that there are multiple opportunities, and a flexible combination of new programs and regulatory changes can be created to benefit the multiple stakeholders in pediatric device development,” said Terence et al. “An essential component will be building a cadre of experts with the development, regulatory, and clinical expertise to support all innovators.”

Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., vice president and chief innovation officer at Children’s National Hospital adds that supporting and expanding pediatric innovation is a key focus of the new Children’s National Research & Innovation Campus, the 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, the campus provides a rich ecosystem of public and private partners which will help bolster pediatric innovation and commercialization.

Authors from Children’s Hospital Orange County include Terence Sanger, M.D., Nadine Afari, M.S., Anthony Chang, M.D., William Feaster, M.D., Sharief Taraman, M.D., Debra Beauregard, Brent Dethlefs, Tiffani Ghere, R.D., C.S.P., Mustafa Kabeer, M.D., and George Tolomiczenko.

girl with smart brain imagination doodle

Children’s National provides clinical validation, IP for health challenge designed to advance pediatric innovation

girl with smart brain imagination doodle

Reinforcing its commitment to expanding innovation in pediatric care, Children’s National Hospital has joined a strategic partnership with the Center for Advancing Innovation (CAI) , along with collaborators Resonance Philanthropies and Digital Infuzion, to launch the 2021-2022 Innovate Children’s Health Challenge. This year’s event, Innovate Children’s Health II, focuses on technologies that address pandemic resiliency and prevention in the pediatric population and seeks to advance diagnostics, therapeutics and digital health tools that address pediatric mental health.

The initiative matches entrepreneurial talent with breakthrough inventions to launch startups and connect them with capital. For this challenge, more than 15 startups will compete for the opportunity to commercialize promising mental health solutions from a variety of research partners, including Children’s National. Nationally recognized for its expertise and commitment to innovation in pediatric care, Children’s National will contribute to the clinical validation of selected technologies.

“In addition to our role in providing clinical validation, this initiative provides the opportunity for intellectual property (IP) developed by leading clinicians at Children’s National Hospital, as well as other great pediatric institutions, to be considered for partnership with entrepreneurs who can help bring these technologies to market,” says Kolaleh Eskandanian, PhD, MBA, PMP, vice president and chief innovation officer at Children’s National Hospital. “Our mission is to improve children’s healthcare and Innovate Children’s Health II is a great way to harness this trifecta model — innovation, talent and capital — in order to develop breakthrough solutions that address the unique needs of pediatric patients.”

Kolaleh-Eskandanian

“In addition to our role in providing clinical validation, this initiative provides the opportunity for intellectual property (IP) developed by leading clinicians at Children’s National Hospital, as well as other great pediatric institutions, to be considered for partnership with entrepreneurs who can help bring these technologies to market,” says Kolaleh Eskandanian, PhD, MBA, PMP, vice president and chief innovation officer at Children’s National Hospital.

There are three ways to participate in Innovate Children’s Health II:

  • Entrepreneurial-minded people, alone or as members of multidisciplinary teams, may compete to commercialize vetted inventions;
  • Existing startups may enter the challenge with other public health-related inventions, including their own and/or others to which they have access;
  • Participants may submit ideas that they believe will improve emergency preparedness and pandemic response.

Inventors and technology licensing officers may submit inventions to be evaluated and made available for licensing to challenge winners. Innovate Children’s Health II will accept invention submissions until September 1, 2021. Anyone with an entrepreneurial spirit and interest in stopping current and future pandemics is invited to sign up to learn more about the challenge. Teams may also enroll in the challenge to choose a featured invention, bring in a third-party invention or get matched with an invention based on area of interest.

“The COVID-19 pandemic has made our children anxious, depressed and pessimistic about their futures. Through Innovate Children’s Health II, CAI and our strategic partner Children’s National will strive to give our children hope,” says Rosemarie Truman, founder and CEO of CAI. “We are grateful to Digital Infuzion and Resonance Philanthropies for their support, which makes this challenge possible.”

Eskandanian adds that supporting and expanding pediatric innovation is a key focus of the new Children’s National Research & Innovation Campus, the 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 will help bolster pediatric innovation and commercialization.

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

Five finalists selected in prestigious pediatric medical device pitch competition

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

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newborn baby

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

newborn baby

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.

Kolaleh-Eskandanian

“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 8th 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.