Tag Archive for: Innovation

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

illustration of the brain

LIFU successfully delivers targeted therapies past the blood-brain barrier

illustration of the brain

LIFU offers doctors the first opportunity to open the blood-brain barrier and treat the entire malignant brain tumor.

Children’s National Hospital will leverage low-intensity focused ultrasound (LIFU) to deliver therapy directly to a child’s high-grade glioma. The approach offers doctors the first opportunity to open the blood-brain barrier and treat the entire malignant brain tumor.

Children’s National will be the first hospital in the U.S. to treat high-grade pediatric brain tumors with LIFU to disrupt the blood-brain barrier. Crossing it has been a major hurdle for effective therapy. The barrier, a network of blood vessels and tissue, prevents harmful substances from reaching the brain but also stops molecular targeted therapy and immunotherapy from getting into the tumor site and staying there.

“LIFU gives us a way to potentially transiently open up the barrier, so we can deliver novel therapy directly to the tumor and improve the likelihood of survival,” said Roger Packer, M.D., senior vice president of the Center for Neurosciences and Behavioral Medicine at Children’s National. “It is the greatest breakthrough we’ve potentially had in the past 50 years or more for the management of these tumors. We made great strides in our understanding of molecular genetics and the molecular drivers of tumors, but we have not yet translated that knowledge into better therapies; this may be our most effective mechanism to overcome the barrier.”

In 2020, Children’s National was recognized as the first worldwide Center of Excellence by the Focused Ultrasound Foundation.

Focused ultrasound (FUS) is a non-invasive therapeutic technology with the potential to transform the treatment of many medical disorders by using ultrasonic thermal energy to specifically target tissue deep in the body. The technology can treat without incisions or the need of radiation.

How it works

Doctors at Children’s National will be using LIFU in two different types of procedures:

  • 5-ALA: Doctors will give the patient 5-aminolevulinic acid (5-ALA) with the LIFU treatment. 5-ALA enters rapidly dividing cells and is activated by the ultrasound to a state where it kills the dividing cells of the tumor. The surrounding normal brain cells around the tumor are not dividing, so they do not take up the 5-ALA and are left unharmed after ultrasound therapy.
  • Microbubbles: While receiving different doses of LIFU over a one- to two-hour period, the patient is given “microbubbles,” which are widely used in medical imaging and as carriers for targeted drug delivery. These microbubbles bounce around against the walls like seltzer, opening the blood vessels and transiently opening that space.

Both studies are the first in the world for pediatric gliomas of the brain stem, allowing experts to treat patients 4-6 weeks after radiotherapy. The patient then receives medication orally or intravenously as it passes through the bloodstream. It does not go at high levels anywhere within the brain except where the blood-brain-barrier was opened, allowing oral medication or immune therapies to rush into the tumor.

The launch of this program comes a few months after the hospital successfully performed the first-ever high-intensity focused ultrasound surgery on a pediatric patient with neurofibromatosis.

Watch this video to learn more.

2022 Hackathon logo

Addressing health equity issues through an app innovation competition

Children’s National Hospital launches The Health Equity in Research Hackathon — a team-based collaborative competition that empowers researchers to address health equity issues in the community through innovative apps. A panel of expert judges will select winning app ideas for full development, including finding grant opportunities, access to mentors and collaborators.

The big picture

“This Hackathon is a great chance for our research community to address larger issues related to advancing health equity within translational and clinical research,” said Patrick O’Keefe, administrative director for the Clinical and Translational Science Institute at Children’s National (CTSI-CN). “We are thrilled to see how people collaborate to create solutions for big problems that have traditionally slowed research and contributed to the vast inequities in health we see today.”

Additional details

The 2022 hackathon will be a two-part event. During Part I, slated for June 17, participants will gather in diverse teams to discuss and refine the selected app ideas. They will learn from technical and scientific experts and brainstorm app-based approaches to address health equity.

Each team will pitch their ideas to a panel of judges, and the winning app(s) will advance to Part II of the hackathon planned for Fall 2022, where app developers will build the selected apps.

“We encourage anyone at Children’s or George Washington University to submit an app idea – even if it is not fully formed — as long as they think it would help reduce health disparities through improving the research process,” said Lisa Guay-Woodford, M.D., director for Clinical and Translational Science Institute and Center for Translational Research at Children’s National. “We also hope researchers, staff and students who don’t have app ideas at this time will consider attending anyway to participate in the lively development process of the Hackathon.”

Anyone within the Children’s National and George Washington University research communities can submit an app idea for consideration. No app development experience is necessary to enter.

Why it matters

Health equity also means bringing the community into the research process. Thus, in part II, Children’s National will partner with high schools and universities in the area to incorporate voices who are often under-represented in the science and technology field.

“Our community is home to brilliant young minds at our local high schools and universities,” said Chaya Merrill, Dr.P.H., director for Child Health Data Lab at Children’s National. “We are excited to create an opportunity for them to work alongside experienced app builders – at the intersection of health equity and technology – by engaging in Part II of the Hackathon to build the winning apps!”

The hackathon will take place at Children’s Research and Innovation Campus in partnership with CTSI-CN and the Center for Translational Research.

The app idea submission deadline is on May 20, 2022, by 5pm. You may apply here. If you have questions about completing this submission, please email Patrick O’Keefe at pokeefe@childrensnational.org.

2022 Hackathon logo

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.

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

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.

 

Jacob Smith

Q&A with Pediatric Surgical Innovation Fellow Jacob Smith, M.D.

Jacob Smith

Jacob Smith, M.D.

Jacob Smith, M.D. is currently a fellow with The Joseph E. Robert, Jr. Fellowship in Pediatric Surgical Innovation at Children’s National Hospital. The fellowship provides is an exciting and dynamic post-graduate research experience focused on biomedical innovation. Participants can focus their work on specific areas of interest. Here, Dr. Smith shares some information on his work with the Urology Department.

Q: How has the Joseph E. Robert, Jr., Fellows in Pediatric Surgical Innovation program allowed you to expand your experience in pediatric urology?

A: The Roberts Fellow program has provided me the ability to work with Michael Hsieh, M.D., who has years of experience in UTI and schistosomiasis research. The UTI research has been a focus of mine and we are working on ways to diagnosis and treat UTI faster in patients. One population that this can benefit are those that deal with recurrent UTIs, such as patients in our spina bifida population.

Q: Talk a little about your work on spina bifida and areas of opportunity for research.

A: Briony Varda, M.D. is heavily involved in our spina bifida program here at Children’s National. I am working with Dr. Varda to develop a database that looks at the use of the emergency department (ED) by children with spina bifida in the Washington, D.C. area. We are also conducting interviews with families and other stakeholders in this population to better understand the factors that drive this population to utilize the ED. We hope that this research can give us a better understanding of the spina bifida care in our area and inform us to provide improvement in care.

Q: How will your work to develop methods to diagnose urinary tract infections faster and how will this benefit our patient population?

A: As mentioned before, a common patient population that deals with recurrent UTIs is the spina bifida population. The protocol that we are attempting to develop would provide us quicker results than the standard urine culture and sensitivity testing that can take anywhere between 48-72 hours to result on average. We hope by providing a quicker result, we can better identify the necessary treatment these patients need to treat their infections. Another scenario that we hope this can be utilized in is for those patients that have recurrent UTI symptoms but negative urine cultures. We hope we can determine if there are viable cells that may be too few to culture but still could cause these symptoms.

Q: What are you currently working on that you are most excited about?

A: As you can tell, a lot of my research is conducted around the spina bifida population. I am excited to dive into the data we have collected on this population and determine if there are ways we could improve the care of these patients.

Q: What made you interested in specializing in pediatric urology?

A: Pediatric urology is a great field. It has a very diverse patient population. There are a multitude of problems that could arise from multiple congenital malformations to stones and voiding dysfunctions. There is also a range of cases from minor and major reconstruction, robotics, endourology and laparoscopy. One thing that does differentiate pediatric urology is that many of the problems that we repair are congenital and it is a privilege to be able to help these children and families. In fact, I was a patient myself as a child with a ureteral malformation which required surgery. The concept of helping other children with urology concerns brings an obvious “pay-it-forward” mentality that also attracted me to the field. I am excited to obtain the knowledge and skills necessary to treat my future patients.

MRI Room

Children’s National uses HIFU to perform first ever non-invasive brain tumor surgery

MRI Room

Children’s National Hospital successfully performed the first-ever high-intensity focused ultrasound (HIFU) surgery on a pediatric patient with neurofibromatosis (NF). This is the youngest patient to undergo HIFU treatment in the world. Image provided by Insightec.

Children’s National Hospital successfully performed the first-ever high-intensity focused ultrasound (HIFU) surgery on a pediatric patient with neurofibromatosis (NF). This is the youngest patient to undergo HIFU treatment in the world. The advancement of children’s medical devices in the U.S. continues to significantly lag behind adult devices. This is why this milestone marks a significant advance in making pediatric surgery more precise and less invasive.

The hospital is offering this treatment to patients under an ongoing research clinical trial. Children’s National is one of the first pediatric hospitals in the nation to use HIFU for neuro-oncology patients. It’s also the first hospital in the world to use it to treat a pediatric patient with NF. NF is a condition that occurs in approximately 1 in 3,500 births and causes tumors to form in the brain, spinal cord and nerves.

“Using HIFU to treat our pediatric patients is a quantum leap towards non-invasive surgery for kids,” said Robert Keating, M.D., division chief of Neurosurgery and co-director of the HIFU program at Children’s National. “It’s exciting because the future is now here and it’s significantly better for our kids, in terms of non-invasive surgery with lower risk of complications and no exposure to radiation.”

Focused ultrasound (FUS) is a non-invasive therapeutic technology with the potential to transform the treatment of many medical disorders by using ultrasonic thermal energy to specifically target tissue deep in the body. The technology can treat without incisions or the need of radiation.

FUS, which has been used for adult clinical trials for many decades, can be delivered through high- or low-intensity focused ultrasound (LIFU). HIFU uses non-invasive therapy that uses focused ultrasound waves to thermally ablate a focal area of tissue. Children’s National will now use HIFU to treat low-grade type tumors located in difficult locations of the brain, such as hypothalamic hamartomas and pilocytic astrocytoma, as well as for movement disorders and epilepsy.

An alternative approach, LIFU uses lower levels of energy to disrupt the blood-brain barrier. Unlike medications, which often have difficulty crossing the blood-brain barrier, LIFU can transiently open the blood-brain barrier to chemotherapy. This may allow more effective treatment of tumors and offer opportunities to treat, for the first time, the entire extent of a malignant brain tumor.

“Having focused ultrasound technology as a tool and conducting clinical trials will allow our neurologists and oncologists to offer a non-invasive treatment option to many patients who suffer from neurological conditions,” said Hasan Syed, M.D., co-director of the HIFU center at Children’s National. “The milestone of performing this first HIFU procedure will lead the way to better understanding of the effect of this technology and provide patients with more options.”

At Children’s National, the HIFU program is being led by Dr. Keating and a multidisciplinary team, including clinicians and investigators from the Sheik Zayed Institute for Pediatric Innovation, radiology, oncology, surgery and orthopedics. In an effort to collaborate with the region’s adult hospitals, Children’s National will also treat adult patients on a selective basis who have movement disorders such as essential tremor and Parkinson’s. There is a scarcity of similar resources in the metro region. Many adult patients face one-year wait periods for treatment of their movement disorders, requiring many to travel out of state for treatment.

The LIFU program is scheduled to be operational in 2022. It will likely be the first in the U.S. to treat high-grade pediatric brain tumors with disruption of the blood-brain barrier and provide more effective routes for chemotherapy as well as potential immunotherapy and molecular approaches.

“The use of LIFU with microbubbles to open up the blood-brain barrier is an exciting, potentially game-changing approach for children with these tumors,” said Roger Packer, M.D., senior vice president of the Center for Neurosciences and Behavioral Medicine at Children’s National. “It should safely allow the blood-brain barrier to open and allow delivery of potentially life-saving personalized therapy to the tumor and spare the rest of the brain. It is the most exciting, new development in brain tumor therapy for these malignant midline tumors in the past 50 years.”

Children’s National continues to be a leader in pediatric HIFU use. In 2015, Children’s National doctors became the first in the U.S. to use MR-HIFU to treat pediatric osteoid osteoma – a benign, but painful bone tumor. Successful clinical trial results led to FDA approval in early 2021 for the use of the technology for this treatment. In 2020, the Focused Ultrasound Foundation also designated Children’s National as the first global pediatric Center of Excellence for using this technology to help patients with specific types of childhood tumors.

boy with headache

Kids’ headaches can be disruptive. We need solutions.

Experts leading the Headache Program at Children’s National Hospital recognize how common these disorders are. They also know how disruptive they can be in the day-to-day of children.

Marc DiSabella, D.O., is the director of the program. He is currently leading five pediatric headache trials. In this Q&A, he tells us about the ongoing trials, offering insight into innovative solutions and how he’s carving a new path to improve the quality of life of his patients.

Q: How has your team advised other neurologists on innovative care for patients with headaches that have been refractory to medicines?

A: We receive referrals from outside institutions when they need additional input for diagnostic and management options. We receive patient consult requests from around the country – and sometimes out of the country – to help improve symptoms. In most instances, these headaches tend to be difficult to control and do not respond to available medications. We really try to take a holistic approach to their care, and use treatments in parallel. For example, diagnostic, lifestyle techniques, medications, pain focused cognitive behavioral therapy and physical therapy. We also use complementary medicine as needed, such as acupuncture, injections and infusions.

Q: It is unusual for neurology divisions to run multiple pediatric trials focused on headaches. You are currently leading five that are open. How does this work move the field forward?

A: The medications we offer through our trials allow us to offer treatments that would otherwise not be available to pediatric patients. We do this in hopes of providing them relief while advancing the field. We are hopeful that these new therapies are as effective in pediatrics as they have shown to be in adults. But it is necessary to complete randomized clinical trials to prove this is the case. Historically, pediatric patients in clinical trials investigating painful conditions like migraines have had a disproportionately high placebo response rate. This means even the patients receiving a benign placebo have a high chance of symptom improvement. The newer medications show much better tolerability to the drugs used historically.

Q: What excites you about this work?

A: Pediatric pain disorders are unbelievably gratifying to treat because we take a mysterious disorder that waxes and wanes with no clear reason and give patients back control of their lives. It is extremely frustrating for a patient and their family to know that their day-to-day life can be abruptly derailed by a pain crisis. We work to provide them with several tools they can use daily to take back their lives.

Q: How is this work unique?

A: Our program was created organically over the years through our experiences with our patients. First, we noticed the disruption to patients’ personal and school performance from having untreated pain and recognized the need for pain psychology. Then, we expanded to have physical therapy to recondition patients and perform desensitization. Finally, we recognized our patients need additional medication options not offered through the standard of care. So, we expanded to open our various clinical trials, including those with pharma and internal protocols. As a result, we incorporated the use of Botox injections, for example, and soon will use a novel remote electro-neuromodulatory device.

surgeon doing laparoscopic surgery

Autonomous robotic laparoscopic surgery for intestinal anastomosis

surgeon doing laparoscopic surgery

Children’s National Hospital in collaboration with the University of North Carolina Wilmington and Johns Hopkins University developed an enhanced autonomous strategy for laparoscopic soft tissue surgery.

A new approach to soft tissue surgery could simplify autonomous surgical planning and enable collaborative surgery between an autonomous robot and human, a new study published in Science Robotics finds. This is the first time a robot can complete an autonomous soft tissue surgical task under laparoscopic conditions, forming the foundation for future soft tissue surgeries.

Children’s National Hospital in collaboration with the University of North Carolina Wilmington and Johns Hopkins University developed an enhanced autonomous strategy for laparoscopic soft tissue surgery. The multi-institutional effort made it possible to perform a robotic laparoscopic small bowel anastomosis in phantom and in vivo intestinal tissues. The findings further suggest that autonomous robot-assisted surgery has the potential to provide more efficacy, safety and consistency independent of an individual surgeon’s skill and experience.

The hold-up in the field

Autonomous anastomosis is known to be a challenging soft tissue surgery task. And in the laparoscopic setting, surgeries like these prove to be more challenging because of the need for high maneuverability and repeatability under motion and vision constraints – especially in pediatric patients.

“This work represents the first time autonomous soft tissue surgery has been performed using a laparoscopic technique and is the first step in bridging the gap between human and machine towards completing autonomous surgical tasks in soft tissue surgeries,” says Hamed Saeidi, Ph.D., assistant professor at University of North Carolina Wilmington and lead author of the study.

To overcome the unpredictable motions of the tissue, the experts used machine learning based techniques to track the dynamic motions of the soft tissue during the surgery. These methods also pave the way for markerless methods for tracking the tissue motion in future surgeries.

“Until now, laparoscopic autonomous surgeries were not possible in soft tissue due to the unpredictable motions of the tissue and limitations on the size and capabilities of surgical tools,” says Justin Opfermann, M.S., Ph.D., student and Johns Hopkins University and co-author.

What’s unique

Performing autonomous surgery would require the development of novel suturing tools, imaging systems and robotic controls to visualize a surgical scene, generate an optimized surgical plan and then execute that surgical plan with the highest precision.

The autonomous robot takes its skill one step further when performing surgical tasks on soft tissues by enabling a robot-human collaboration to complete more complicated surgical tasks where preoperative planning is not possible.

Additionally, the robot used in this work uses a novel shared control scheme called “conditional autonomy,” whereby the robot performs the majority of the surgical task, which the surgeon oversees.

Bottom line

“Combining all of these features into a single system is non-trivial,” Opfermann adds. “In 2016, we were the first group to demonstrate feasibility of semi-autonomous small bowel anastomosis with a robot in soft tissue, and now we can perform autonomous laparoscopic anastomosis.”

The resulting anastomosis had more consistency and achieved higher burst strength than surgeons suturing with manual technique, resulting in less anastomotic leak.

In laparoscopic surgeries – and pediatric patients especially – these challenges are even more difficult due to the small size of the patient. Robotic anastomosis is one way to ensure that surgical tasks that require high precision and repeatability can be performed with more accuracy and precision in every patient independent of surgeon skill.

“As a surgeon, I can attest to the potential benefits of improving how we perform surgery on our patients,” says Michael Hsieh, M.D., Ph.D., director of Transitional Urology at Children’s National Hospital. “Working with my engineering colleagues at Johns Hopkins, we’ve been able to develop prototypes of supervised, autonomous suturing robots that may be a step towards such improvements.”

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.

scientist using the HoloUS platform

New platform uses augmented reality glasses for ultrasound-guided procedures

Children’s National experts developed a novel visualization platform, called “HoloUS,” for ultrasound-guided procedures using commercially available see-through augmented reality (AR) glasses, according to a pre-clinical study published in the International Journal of Computer Assisted Radiology and Surgery. The finding suggests that the HoloUS application enhanced the user experience and simplified hand-eye coordination.

“By eliminating head-turning and back-and-forth viewing of the patient and the ultrasound screen, our solution could improve the safety, accuracy, intuitiveness, and length of ultrasound-guided procedures, while making them easier to learn and perform,” said Raj Shekhar, M.S., Ph.D., principal investigator for Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National and senior author in the study.

Ultrasound-guided procedures demand a high degree of hand-eye coordination to advance a needle with one hand while holding the ultrasound probe with another as they visualize the live ultrasound image. With this application, the practitioner will wear the AR glasses that will allow them to visualize the ultrasound image rendered live in their field of view.

“We are excited about the possibility of improving the accuracy and efficiency from augmented reality visualization because these benefits may translate clinically in the upcoming years after conducting carefully designed clinical studies,” said Trong Nguyen, staff scientist for Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National and lead author.

Microsoft’s HoloLense headset, often used for hands-free work and video gaming, set the stage to develop the custom application that would display information from a portable ultrasound machine connected through a wireless network in the form of a hologram. The voice controls on the HoloLense allowed scaling and movement of the ultrasound imaging while displaying in real-time.

Largely driven by video gaming and consumer applications, AR and virtual reality technologies have been growing and are expected to grow at an even faster clip in the coming decade.

“We are a handful of researchers exploring the innovative application of the technology for ultrasound visualization,” said Shekhar. “We are trying to establish ourselves as the leader in the use of AR for pediatric ultrasound procedures.”

To further advance this technology, Shekhar’s team has an IRB protocol pending that will continue to shed light on the benefits through more bench testing and an NIH grant proposal that is also pending. In the meantime, they will adopt second-generation glasses to continue to improve the technology.

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.

Dr. Javad Nazarian

Q&A with Dr. Javad Nazarian on his upcoming work on low-grade gliomas

Dr. Javad Nazarian

Supported by the Gilbert Family Foundation, Dr. Nazarian’s return is part of a special research program within the Gilbert Family Neurofibromatosis Institute that focuses on NF1 research.

Javad Nazarian, Ph.D., M.Sc., associate professor of Pediatrics at George Washington University and professor at the University of Zurich, has expanded his research group at Children’s National to focus on Neurofibromatosis type 1 (NF1) transformed low-grade gliomas (LGGs). Dr. Nazarian will apply his expertise from establishing a successful DIPG (diffuse intrinsic pontine glioma) and DMG (diffuse midline glioma) program in Zurich Switzerland and previously at Children’s National.

In addition to his continued research in Zurich, as a principal investigator at the Department of Genomics and Precision Medicine at Children’s National Dr. Nazarian plans on aggregating his knowledge to the new research and work spearheaded at Children’s National. As one of the first research teams to move to the Children’s National Research & Innovation Campus, Dr. Nazarian’s group is excited to use the opportunity to establish cutting-edge and clinically translational platforms.

Supported by the Gilbert Family Foundation, Dr. Nazarian’s return is part of a special research program within the Gilbert Family Neurofibromatosis Institute that focuses on NF1 research. This research includes associated gliomas with a special emphasis on NF1-associated transformed anaplastic LGGs. His team will develop new avenues of research into childhood and young adult NF-associated LGGs with a special emphasis on transformed high-grade gliomas.

Dr. Nazarian is excited for what’s to come and his goals are clear and set. Here, Dr. Nazarian tells us more about his main objectives and what it means for the future of pediatric neuro-oncology care at Children’s National.

  1. What excites you most about being back at Children’s National?

I have received most of my training at Children’s National, so this is home for me. Being one of the nation’s top children’s hospitals gives a unique advantage and ability to advocate for childhood diseases and cancers. It is always exciting to play a part in the vision of Children’s National.

  1. What are some of the lessons learned during your time working in Zurich? And how do you think these will compliment your work at Children’s National?

We developed a focused group with basic research activities intertwined with clinical needs.  The result was the launch of two clinical trials. I also helped in developing the Diffuse Midline Glioma-Adaptive Combinatory Trial (DMG-ACT) working group that spans across the world with over 18-member institutions that will help to design the next generation clinical trials. I will continue leading the research component of these efforts, which will have a positive impact on our research activities at Children’s National.

  1. How does your work focusing on low-grade gliomas formulating into high-grade gliomas expand and place Children’s National as a leader in the field?

Scientifically speaking, transformed LLGs are very intriguing. I became interested in the field because these tumors share molecular signatures similar to high-grade gliomas (HGGs). Our team has done a great job at Children’s National to develop tools – including biorepositories, avatar models, drug screening platforms, focused working groups, etc. – for HGGs. We will apply the same model to transformed LGGs with the goal of developing biology-derived clinical therapeutics for this patient population.

  1. How will this work support families and patients seeking specific neuro-oncology care?

We will develop new and high thruput tools so that we can better study cancer formation or transformation. These tools and platforms will allow us to screen candidate drugs that will be clinically effective. The main focus is to accelerate discovery, push drugs to the clinic, feed information back to the lab from clinical and subsequently design better therapies.

  1. You are one of the first scientists to move to the Children’s National Research & Innovation Campus. What are some of the valuable changes or advancements you hope to see as a result of the move?

The campus will provide high-end facilities, including cutting-edge preclinical space, and allow for team expansion. The close proximity to Virginia Tech will also provide an environment for cross-discipline interactions.

  1. Anything else you think peers in your field should know about you, the field or our program?

The team at Children’s National includes Drs. Roger Packer and Miriam Bornhorst. Both have provided constant clinical support, innovation and clinical translation of our findings. I look forward to working with them.

control population and population with Williams-Beuren syndrome.

Machine learning tool detects the risk of genetic syndromes

control population and population with Williams-Beuren syndrome.

(A) Control population. (B) Population with Williams-Beuren syndrome. Average faces were generated for each demographic group after automatic face pose correction.

With an average accuracy of 88%, a deep learning technology offers rapid genetic screening that could accelerate the diagnosis of genetic syndromes, recommending further investigation or referral to a specialist in seconds, according to a study published in The Lancet Digital Health. Trained with data from 2,800 pediatric patients from 28 countries, the technology also considers the face variability related to sex, age, racial and ethnic background, according to the study led by Children’s National Hospital researchers.

“We built a software device to increase access to care and a machine learning technology to identify the disease patterns not immediately obvious to the human eye or intuition, and to help physicians non-specialized in genetics,” said Marius George Linguraru, D.Phil., M.A., M.Sc., principal investigator in the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Hospital and senior author of the study. “This technological innovation can help children without access to specialized clinics, which are unavailable in most of the world. Ultimately, it can help reduce health inequality in under-resourced societies.”

This machine learning technology indicates the presence of a genetic syndrome from a facial photograph captured at the point-of-care, such as in pediatrician offices, maternity wards and general practitioner clinics.

“Unlike other technologies, the strength of this program is distinguishing ‘normal’ from ‘not-normal,’ which makes it an effective screening tool in the hands of community caregivers,” said Marshall L. Summar, M.D., director of the Rare Disease Institute at Children’s National. “This can substantially accelerate the time to diagnosis by providing a robust indicator for patients that need further workup. This first step is often the greatest barrier to moving towards a diagnosis. Once a patient is in the workup system, then the likelihood of diagnosis (by many means) is significantly increased.”

Every year, millions of children are born with genetic disorders — including Down syndrome, a condition in which a child is born with an extra copy of their 21st chromosome causing developmental delays and disabilities, Williams-Beuren syndrome, a rare multisystem condition caused by a submicroscopic deletion from a region of chromosome 7, and Noonan syndrome, a genetic disorder caused by a faulty gene that prevents normal development in various parts of the body.

Most children with genetic syndromes live in regions with limited resources and access to genetic services. The genetic screening may come with a hefty price tag. There are also insufficient specialists to help identify genetic syndromes early in life when preventive care can save lives, especially in areas of low income, limited resources and isolated communities.

“The presented technology can assist pediatricians, neonatologists and family physicians in the routine or remote evaluation of pediatric patients, especially in areas with limited access to specialized care,” said Porras et al. “Our technology may be a step forward for the democratization of health resources for genetic screening.”

The researchers trained the technology using 2,800 retrospective facial photographs of children, with or without a genetic syndrome, from 28 countries, such as Argentina, Australia, Brazil, China, France, Morocco, Nigeria, Paraguay, Thailand and the U.S. The deep learning architecture was designed to account for the normal variations in the face appearance among populations from diverse demographic groups.

“Facial appearance is influenced by the race and ethnicity of the patients. The large variety of conditions and the diversity of populations are impacting the early identification of these conditions due to the lack of data that can serve as a point of reference,” said Linguraru. “Racial and ethnic disparities still exist in genetic syndrome survival even in some of the most common and best-studied conditions.”

Like all machine learning tools, they are trained with the available dataset. The researchers expect that as more data from underrepresented groups becomes available, they will adapt the model to localize phenotypical variations within more specific demographic groups.

In addition to being an accessible tool that could be used in telehealth services to assess genetic risk, there are other potentials for this technology.

“I am also excited about the potential of the technology in newborn screening,” said Linguraru. “There are approximately 140 million newborns every year worldwide of which eight million are born with a serious birth defect of genetic or partially genetic origin, many of which are discovered late.”

Children’s National as well recently announced that it has entered into a licensing agreement with MGeneRx Inc. for its patented pediatric medical device technology. MGeneRx is a spinoff from BreakThrough BioAssets LLC, a life sciences technology operating company focused on accelerating and commercializing new innovations, such as this technology, with an emphasis on positive social impact.

“The social impact of this technology cannot be underestimated,” said Nasser Hassan, acting chief executive officer of MGeneRx Inc. “We are excited about this licensing agreement with Children’s National Hospital and the opportunity to enhance this technology and expand its application to populations where precision medicine and the earliest possible interventions are sorely needed in order to save and improve children’s lives.”

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.

The hybrid tracking mount for the LUS transducer

New hybrid approach for AR visualization of ultrasound images has surgical use

Children’s National Hospital researchers combined augmented reality (AR) and ultrasound imaging technologies to improve visualization during laparoscopic procedures. The patent-pending hybrid tracking method improved accuracy compared with hardware-based and computer vision-based approaches, according to the pre-clinical study published in the Journal of Medical Imaging.

“The system that we developed can work reliably under challenging intraoperative conditions, which is exciting for us,” said Raj Shekhar, M.S., Ph.D., principal investigator at Children’s National and senior author in the study. “The surgical view is usually very complex with various tissues, tools, blood and smoke in the view. Our system has been evaluated on pre-clinical models and has shown to provide acceptable overlay accuracy even during extreme conditions.”

Augmented reality for surgery is an emerging trend, consisting of a computer-generated image for the operating surgeon to see. While using ultrasound during surgery allows the doctor to see the organ’s internal structures, when combined, the AR system significantly improves the surgeon’s comprehension of the ultrasound image in the context of the surgical view.

“The AR system that we developed will benefit patients because AR-guided surgeries can be more precise, safer and faster,” said Shekhar. “Through sustained research and development effort and robust clinical-technical partnership, Children’s National is leading in clinical translation and technology transfer of the laparoscopic AR visualization technology. Other solutions are more laboratory-based while our focus has been on building a clinically practical and viable solution from day one.”

Laparoscopic surgery is known to improve outcomes, cause less scarring and speed the recovery process since the surgeons create small incisions with the aid of a camera. Still, doctors have a limited view of anatomic structures and surgical targets below the exposed surfaces.

Given that AR is an emerging technology, this work would not have been possible until recently. According to the researchers, no other scientists in the field take advantage of both tracking hardware and computer vision-based approaches.

“This work is important because it features best of both worlds: relying on tracking hardware to ensure robustness while using computer vision to enhance accuracy. This will generate a more accurate and reliable AR system which is more feasible for clinical use,” said Shekhar.

The hybrid tracking mount for the LUS transducer

The hybrid tracking mount for the LUS transducer. The mount contains a six-DOF EM sensor and an AB with 21 markers fixed on three flat surfaces.

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.