Surgical Innovation

two doctors perform surgery

Can complex pediatric surgery interventions be standardized to facilitate telementoring?

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two doctors perform surgery

The study’s authors write, “These discussions are particularly relevant to surgeons in small or rural practices who provide much-needed care to underserved populations and have decreased exposure to these index cases. Conversely, in some developing countries where prevalence of rare congenital surgical conditions is higher, there is a shortage of adequately trained pediatric surgeons. Each of these scenarios involves a mismatch in experience and exposure, which can result in poor patient outcomes and inadequate healthcare delivery.”

How does a surgeon-in-training get enough exposure to rare or complex cases to serve the patients who need them? How does a practicing surgeon perform enough cases each year to maintain proficiency at such index cases?

The authors of a study in the Journal of Pediatric Surgery, including Marc Levitt, M.D., chief of the Division of Colorectal and Pelvic Reconstruction at Children’s National Hospital, write that, “These discussions are particularly relevant to surgeons in small or rural practices who provide much-needed care to underserved populations and have decreased exposure to these index cases. Conversely, in some developing countries where prevalence of rare congenital surgical conditions is higher, there is a shortage of adequately trained pediatric surgeons. Each of these scenarios involves a mismatch in experience and exposure, which can result in poor patient outcomes and inadequate healthcare delivery.”

Telementoring is one strategy being explored by the American College of Surgeons’ Telementoring Task Force initiative. Pediatric anorectal malformations (ARM), pediatric colorectal surgical procedure, posterior sagittal anorectoplasty (PSARP) were the “index” areas for the pilot study. Once the expert established the areas of great need, they will test the feasibility of a curriculum and training program using telementoring in pediatric surgery. The ACS Task Force notes that these conditions are relatively rare and require a particular skill level to manage appropriately, making them good candidates for the study.

The Journal of Pediatric Surgery study presents a process for mapping out a standardized curriculum for these procedures. First, the authors sought expert consensus on three interoperative checklists that form a de facto curriculum for teaching, learning and performing ARM and PSARP procedures. Second, a multidisciplinary team of medical educators and pediatric surgery experts drafted the checklists. The authors then sought review and input from pediatric colorectal surgery experts at 10 institutions worldwide, who comprised the study’s colorectal pediatric surgery subject matter expert panel. To be considered “expert,” participants had to meet or exceed several strict inclusion criteria related to years in practice and experience with these case types.

Institutions of the colorectal pediatric surgery subject matter expert panel.

Institutions of the colorectal pediatric surgery subject matter expert panel.

The process led to a successful set of consensus documents. “To our knowledge, this is the first study to establish and standardize key intraoperative objectives using a modified-Delphi method in pediatric surgery,” the authors write. “Although this process can be quite time consuming, it provides an incredible opportunity to standardize intraoperative teaching and expectations of trainees. Future studies will expand these checklists into developing a competency assessment tool involving assessment for validity and reliability in a clinical setting to ultimately improve patient safety through standardization.”

Dr. Levitt says the overarching goal of this work is “to improve the surgical technique everywhere [to] thereby help as many kids as we can, even those we will never meet.”

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

Pediatric Device Innovators Forum explores state of focused ultrasound

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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.

bisphenol A

Alternative synthetic compound might offer safer solution to children’s health

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bisphenol A

Not only is bisphenol A (BPA) added to medical equipment used to treat patients, it can also be found in 60% of neonatal intensive care unit (NICU) supplies, such as bandages and items for feeding, suggesting that occupational and clinical environments have a higher exposure to this synthetic compound.

Researchers at Children’s National Hospital found that a commonly used plastic, known as bisphenol S (BPS), was the least disruptive to cardiac electrophysiology and may serve as a safer chemical alternative for plastic medical devices used to treat vulnerable populations compared to other compounds, according to a new preclinical study published in Toxicological Sciences.

For decades, the medical device industry has used bisphenol chemicals known to antagonize ion channels, impair electrical conduction and trigger arrhythmias that affect the overall cardiovascular health in children. Not only is bisphenol A (BPA) added to medical equipment used to treat patients, it can also be found in 60% of neonatal intensive care unit (NICU) supplies, such as bandages and items for feeding, suggesting that occupational and clinical environments have a higher exposure to this synthetic compound.

Yet, very little is known about the downstream impact of BPA, BPS or bisphenol F (BPF) exposure on cardiac physiology.

To shed light on the safety profile of BPA and its alternatives BPS and BPF in plastic medical devices, Children’s National researchers present the first study that compares the acute effects of these three chemicals on cardiac electrophysiology in a preclinical model.

According to the researchers, children should continue receiving medical care to treat their condition.

“It is important to investigate iatrogenic plastic chemical exposures in young patients, as biomonitoring studies have reported elevated chemical exposures in NICU and pediatric intensive care unit patients,” said Devon Guerrelli, M.S., a Ph.D. candidate at Children’s National. “Our lab is actively working with cardiac surgeons to investigate patient exposure to both BPA and phthalate plasticizer chemicals. Patients and their parents can rest assured that our team’s priority is safety and advancement of the field.”

Future studies are needed to fully understand the chemicals’ safety on cardiac electrical and mechanical function due to notable biological differences between humans and preclinical models. The researchers call for the scientific community to explore the impact of these compounds on other organ systems by comprehensively assessing intracellular targets, genomic and proteomic expression profiles.

While health concerns remain, there is no consensus among the scientific community on the potential use of safer compound alternatives in pediatric plastic medical devices.

“First, a variety of preclinical models have been used by the scientific community to assess BPA toxicity. But, there is considerable variability between these different models, including differences in ion channel expression, which may produce conflicting results and limit extrapolation of the data to humans,” said Nikki Posnack, Ph.D., principal investigator at Children’s National Sheikh Zayed Institute for Pediatric Surgical Innovation and senior author. “Accordingly, in the presented study, we tested the effects of bisphenol chemicals using three different preclinical models. Second, studies assessing the safety profile of new structural analogs to BPA are limited.”

The researchers compared the cardiac safety profile of BPA, BPS and BPF by using a whole-cell voltage clamping recording on cell lines to study voltage-gated channels Nav1.5, Cav 1.2 and hERG, allowing the measurements of the cell’s electrical properties and total current through all the channels on a membrane in non-human subjects and cardiomyocytes human cell lines. Results of the study found that BPA was the most potent inhibitor of sodium, calcium and potassium channel currents compared to the alternatives BPS and BPF. BPA and BPF exposure also slowed atrioventricular conduction and increased atrioventricular nodal refractoriness.

“Based on our findings, acute exposure to high concentrations of BPA could lead to changes in cardiac electrophysiology,” said Tomas Prudencio, M.S., a research technician at Children’s National and lead author. “This includes slowing of electrical conduction from the atria to the ventricles, which would present as a prolongation of the PR interval in an electrocardiogram.”

multimodal imaging images

Real-time surgical guidance system enables multimodal tissue monitoring

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For the first time, researchers at Children’s National Hospital successfully demonstrated a label-free tissue perfusion imaging in a pre-clinical model, according to a study published in IEEE Transactions on Biomedical Engineering.

Richard Jaepyeong Cha, Ph.D., research faculty associate professor at Children’s National, and colleagues combined visible, near-infrared laser speckle contrast imaging (LSCI) and snapshot hyperspectral (HSI) cameras into a single clinical multimodal imaging device suitable for real-time intraoperative visualization and demonstrated such a device in a surgical model for the first time, to the best knowledge of the authors. This system provides instant microcirculation information about the ischemic regions, normal tissue and transitional ischemic zones with quantitative values that are reproducible.

“Our pre-clinical work demonstrated a novel, dye-free imaging platform for quantitatively assessing bowel perfusion. The ability to identify optimal surgical resection margins can improve surgical performance and patient outcome in terms of more targeted bowel resection and bowel preservation without anastomotic leakage,” Cha said. “This new optical imaging and quantitative assessment technology holds great promise to solving the long-standing issue of suboptimal assessment of intestinal viability.”

Intraoperative imaging techniques for the precise monitoring of blood flow, hemorrhage and oxygen saturation are needed to minimize errors caused by blood vessel ligation to reduce surgical blood loss and successfully isolate and resect ischemic regions.

When the blood flow, hemorrhage and oxygen are not monitored properly, anastomotic leak (AL) is a serious complication of intestinal surgery that can occur due to a technical error, and most frequently because of poorly vascularized intestine.

This complication of intestinal surgery carries with it a reported mortality ranging from 6 to 39%. The best time to prevent a possible AL is during its creation in the operating room.

Creating a healthy and safe intestinal anastomosis requires a good blood supply to the two ends of bowel to be joined. The tools for diagnosing well-perfused bowel intraoperatively are limited and often rely on the subjective evaluation of the surgeon.

“We are hoping that the use and application of multimodal LSCI/HSI imaging, capable of both non-invasive and quantitative gross tissue perfusion assessment, will provide colorectal/general surgeons with a convenient and objective method for assessment of bowel perfusion characteristics and facilitate surgical transection in tissues requiring colorectal anastomosis,” Cha said.

Recently, indocyanine green fluorescence angiography (ICG-FA) was introduced for intraoperative assessment of anastomotic perfusion. Preliminary evidence suggests that ICG-FA may reduce the rate of anastomotic leakage in gastrointestinal surgery.

Perfusion assessment at the site of anastomosis may alter surgical strategy and possibly reduce anastomotic leakage rates. However, ICG-FA evaluation requires an exogenous fluorophore and the surgeon must subjectively assess the quality of perfusion. For an ideal intestinal viability test, it is essential that the technique is easily performed by the surgeon, minimally invasive, objective and reproducible—which is what Lee et al. demonstrate with their new approach.

multimodal imaging system

pediatric cardiac and vascular MRI coil

Overcoming real and perceived barriers to pediatric device innovation

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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

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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.

schematic of Mueller polarimetric imaging

Novel technique improved nerve visualization in head and neck surgery

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In a pre-clinical model, researchers from Children’s National Hospital found that the Mueller polarimetric imaging, a novel technique that improves image contrast, may help identify nerves from other surrounding tissues during neck and head surgical procedures, avoiding accidental nerve damage.

“This technology holds great promise for the possibility of a truly noninvasive imaging approach and may help improve surgical outcomes by potentially reducing inadvertent, ill effects of nerve injuries in head and neck surgery,” said Bo Ning, Ph.D., R&D engineer at Children’s National and lead author of the study.

This pre-clinical study presents the first application of a full-field polarimetric imaging technique in vivo during head and neck surgery to highlight the vagus nerve (VN) and a branch that supplies all the intrinsic muscles to the larynx, known as recurrent laryngeal nerve (RLN).

“Unlike conventional nerve identification devices, this technique is noninvasive and less interruptive to intact tissues without disrupting surgical workflows,” said Ning et al. “Since the technique has an easy mechanism and promising performance in our study, this novel method holds great potential for real-time, noninvasive, and convenient nerve visualization.”

While some promising methods use polarimetric imaging for tissue characterizations, the current literature is still limited to ex vivo conditions due to the system complications and prolonged acquisition speeds.

“Recently, the industry released a new polarimetric camera, which is compact and allows fast and high-definition polarimetric imaging through simple snapshots. Enlightened by this technical advance, we have developed a practical polarimetric imaging method,” said Ning, who also develops compact and practical imaging systems for surgical innovation, including 3D, fluorescent, laser speckle and hyperspectral techniques. “It allows fast polarimetric analysis and can acquire birefringence maps over the whole field of view within 100 milliseconds, which provides an appropriate speed for directly surgical use.”

The new approach proofs that the concept is feasible to set up in live subjects during head and neck surgery, which can also be easily adapted for other surgeries. Among the seven subjects, the VNs and RLNs were successfully differentiated from arteries and other surrounding tissues.

Additional co-authors from Children’s National include Itai Katz, Ph.D., M.S., R&D staff engineer III; Anthony D. Sandler, M.D., Senior Vice President and Surgeon-in-Chief; Richard Jaepyeong Cha, Ph.D., research faculty assistant professor.

schematic of Mueller polarimetric imaging

Researchers at Children’s National used a novel technique that improves image contrast, which may help improve surgical outcomes.

US News badges

For fifth year in a row, Children’s National Hospital nationally ranked a top 10 children’s hospital

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US News badges

Children’s National Hospital in Washington, D.C., was ranked in the top 10 nationally in the U.S. News & World Report 2021-22 Best Children’s Hospitals annual rankings. This marks the fifth straight year Children’s National has made the Honor Roll list, which ranks the top 10 children’s hospitals nationwide. In addition, its neonatology program, which provides newborn intensive care, ranked No.1 among all children’s hospitals for the fifth year in a row.

For the eleventh straight year, Children’s National also ranked in all 10 specialty services, with seven specialties ranked in the top 10.

“It is always spectacular to be named one of the nation’s best children’s hospitals, but this year more than ever,” says Kurt Newman, M.D., president and CEO of Children’s National. “Every member of our organization helped us achieve this level of excellence, and they did it while sacrificing so much in order to help our country respond to and recover from the COVID-19 pandemic.”

“When choosing a hospital for a sick child, many parents want specialized expertise, convenience and caring medical professionals,” said Ben Harder, chief of health analysis and managing editor at U.S. News. “The Best Children’s Hospitals rankings have always highlighted hospitals that excel in specialized care. As the pandemic continues to affect travel, finding high-quality care close to home has never been more important.”

The annual rankings are the most comprehensive source of quality-related information on U.S. pediatric hospitals. The rankings recognize the nation’s top 50 pediatric hospitals based on a scoring system developed by U.S. News. The top 10 scorers are awarded a distinction called the Honor Roll.

The bulk of the score for each specialty service is based on quality and outcomes data. The process includes a survey of relevant specialists across the country, who are asked to list hospitals they believe provide the best care for patients with the most complex conditions.

Below are links to the seven Children’s National specialty services that U.S. News ranked in the top 10 nationally:

The other three specialties ranked among the top 50 were cardiology and heart surgery, gastroenterology and gastro-intestinal surgery, and urology.

newborn baby

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

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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.

sick child in palliative care hospital bed

How POEM may change the standard of care for pediatric achalasia

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sick child in palliative care hospital bed

Today, Drs. Petrosyan and Kane have performed over 35 POEM procedures for children to resolve esophageal achalasia symptoms.

In 2016, pediatric surgeons Mikael Petrosyan, M.D., and Timothy Kane, M.D., published an article in the Journal of Pediatric Surgery reviewing their experience with the surgical treatment of achalasia and how peroral endoscopic myotomy (POEM) was a new technique being used at Children’s National Hospital to treat esophageal achalasia in children.

The procedure, first used in adults to treat esophageal achalasia, uses a different approach than the current minimally invasive standard of care for children, the Heller myotomy. At the time of the initial study, the team had performed only a few POEM procedures for children but was already starting to see the promise this procedure could offer if done correctly.

While esophageal achalasia affects only about one in every 1 million kids (versus one in 100,000 for adults), the condition, which occurs when the esophagus muscles fail to function properly and the lower sphincter of the esophagus doesn’t relax enough to allow food into the stomach, can have serious impacts on daily life. The tight sphincter may cause food backup, heartburn, chest pain, and many other painful symptoms. Unfortunately, medical interventions including balloon endoscopy or Botox injections, are only temporary fixes that don’t last longer than a month or so before further treatment is needed. For kids who have long lives ahead of them, a surgical solution is the best hope for permanent symptom relief.

At the time of the 2016 study, Dr. Kane said that, “Heller myotomy works very well for most kids — that’s why it’s the standard of care. Our study found that patients who underwent the POEM procedure experienced the same successful outcomes as Heller patients, and we already knew from adult data that POEM patients reported less pain following surgery — a win-win for children.”

Today, Drs. Petrosyan, the associate chief, and Kane, the chief, of General and Thoracic Surgery at Children’s National, have performed over 35 POEM procedures for children to resolve esophageal achalasia symptoms. Increasingly, they find themselves recommending the POEM for many reasons, including, of course, the faster recovery. Kids who have a POEM procedure also often go home in one to two days following surgery and report less pain — typically a sore throat from the endoscopy and the anesthesia, but very little pain at the surgical site.

The surgeons say that the while it takes a steep learning curve to perfect the technique of using POEM in children due to the size of the available instruments to perform the procedure coupled with the challenge of a child’s tiny esophagus, the benefits for patients are well worth it.

“There’s only a single incision in the esophagus, and no incision in the abdomen,” says Dr. Petrosyan. “Kids tolerate the surgery really well, report very little pain, and recover very quickly with minimal complications.”

Even better, he continues, unlike the Heller myotomy, POEM can be performed at any point in treatment, even if other therapies or surgical interventions (including a Heller myotomy) have been previously performed. It can also be repeated if needed — though so far, they haven’t needed to do any further revisions in the population at Children’s National.

Drs. Petrosyan and Kane have performed successful POEM procedures for children with esophageal achalasia between the ages of four and 12. Younger children, (under a year of age) with smaller anatomy, continue to be treated using the Heller procedure due to the limitations in size of the surgical instruments.

Children’s National Hospital is one of the only children’s hospitals in the country to offer the option of POEM for treatment of these conditions — and Drs. Kane and Petrosyan combined perform more of these procedures than any other pediatric surgeon in the United States.

A forthcoming peer-reviewed study will highlight the use of POEM for this population and weigh its success against the current standards of care for treating children with esophageal achalasia.

In the meantime, the surgeons at Children’s National continue to offer POEM as a primary intervention for children with esophageal achalasia and are also applying the same approach for pediatric gastroparesis as well.

Colorectal clinic with Marc Levitt, MD, and patient families

Early promise of sphincter reconstruction for Hirschsprung disease

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Colorectal clinic with Marc Levitt, MD, and patient families

A team of surgeons, led by international pediatric colorectal expert Marc Levitt, M.D., has developed a new surgical approach to tighten, or reconstruct, the sphincters of Hirschsprung patients who have true fecal incontinence after a pull-through procedure.

A team of surgeons, led by international pediatric colorectal expert Marc Levitt, M.D., has developed a new surgical approach to tighten, or reconstruct, the sphincters of Hirschsprung patients who have true fecal incontinence after a pull-through procedure.

Early cases using this approach were outlined in a study published in the Journal of Pediatric Surgery. Though only performed in a handful of patients so far, the authors write, “We feel confident to offer this procedure to other patients with a similar anatomic concern.”

The people who care for Hirschsprung disease patients, including the team at the Pediatric Colorectal and Pelvic Reconstruction Division at Children’s National, continue to seek better approaches for these issues because soiling and fecal incontinence are rare but devastating complications that can occur after children have a pull-through procedure.

“In the presence of an intact continence mechanisms, the anal sphincters and the dentate line, patients with Hirschsprung disease should do well and have bowel control.  For some with soiling, this can be improved with treatment of constipation or hypermotility,” the authors write. “However, patients with a damaged anal canal and/or sphincter mechanism are unable to sense stool and distension of the neorectum or hold the stool in, which can lead to true fecal incontinence.”

Currently, there is no optimal treatment for the fecal incontinence that these patients experience. This repair procedure pioneered by surgeons at Children’s National offers a promising option to help get children with Hirschsprung disease one step closer to a happier, less stressful life.

Research & Innovation Campus

A unified vision for children’s health

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Research & Innovation Campus

The nation’s first research and innovation campus focused on children’s health is in the midst of a phased opening. Deemed a one-of-a-kind endeavor to transform pediatric research and health care, the Children’s National Research & Innovation Campus in Washington, D.C., has been years in the making.

How Children’s National Hospital, Virginia Tech, Johnson & Johnson Innovation – JLABS are creating a pediatric and healthcare research hub in Washington, D.C.

The nation’s first research and innovation campus focused on children’s health is in the midst of a phased opening. Deemed a one-of-a-kind endeavor to transform pediatric research and health care, the Children’s National Research & Innovation Campus in Washington, D.C., has been years in the making.

Leaders from Children’s National Hospital, Virginia Tech and Johnson & Johnson Innovation – JLABS detailed how unprecedented partnerships and a shared vision for the future were key to turning a decade-old dream into a reality during a panel discussion on February 24, 2021, at the Healthcare Project Delivery Conference. The virtual meeting brought together more than 150 senior hospital administrators from more than 60 hospitals and health systems, as well as healthcare facility management professionals, healthcare construction leaders, designers and architects.

“The idea for the campus started with an impressive, unique vision to create a pediatric research and innovation ecosystem where we could work alongside best-in-class research partners like Virginia Tech and Johnson & Johnson Innovation to advance discovery, while also allowing Children’s National to expand clinically on the main campus,” said Children’s National president and chief executive officer, Kurt Newman, M.D.. “It is our collective hope that the campus will accelerate the translation of breakthroughs into new treatments and technologies to benefit kids everywhere.”

The research partnership with Children’s National strategically triangulates the Virginia Tech’s billion-dollar investments in Southwest Virginia, the emerging Virginia Tech Innovation Campus in Alexandria and now the Children’s National Research & Innovation Campus in Washington, D.C.

“Fusing together strengths in cancer research, neuroscience, and computer engineering gives Virginia Tech a great opportunity to grow its physical presence in the D.C. area with a holistic purpose,” said Michael Friedlander, Ph.D., Virginia Tech’s vice president for health sciences and technology, and the Fralin Biomedical Research Institute at VTC’s executive director.

Friedlander has worked with Children’s National’s leadership for more than 25 years, and played a pivotal role in establishing the university’s footing on the Washington, D.C., campus.

Together Virginia Tech and Children’s National have launched an annual collaborative brain cancer pilot research program between the two institutions, as well as joint recruitment efforts for the first wave of Fralin Biomedical Research Institute faculty members to work in the campus’s state-of-the-art laboratories.

The 12-acre Children’s National Research & Innovation Campus, part of a 70-acre development that was formerly the Walter Reed Army Medical Center, will also become a hub for commercial innovation. In 2019, Johnson & Johnson Innovation and Children’s National collaboratively announced plans to launch JLABS @ Washington, DC, which aims to strengthen and expand the region’s network to attract the full breadth of science and technology innovators who are focused on developing transformative solutions to improve patients’ and consumers’ lives. The 32,000-square-foot life science incubator will house up to 50 start-up companies from across the pharmaceutical, medical device, consumer, and health technology sectors.

Researchers at Children’s National and Virginia Tech alike will benefit from the opportunity to collaborate with entrepreneurs working at the incubator to commercialize discoveries made in the lab.

“What an incredible opportunity for our researchers who are committed to bringing discoveries out of the lab to benefit the public,” Friedlander said. “These partnerships have established a special opportunity that aligns very well with the university’s strategic plan to grow in health sciences innovation and commercialization.”

Newman and Sally Allain, head of JLABS @ Washington, DC, both commented on how important it was to have an academic partner of Virginia Tech’s stature as one of the new enterprise’s anchoring tenants.

Recruitment for the first wave of Virginia Tech researchers to work on the new campus has just begun. Construction is anticipated to be completed by summer, 2021.

illustration of brain with stem cells

Innovative phase 1 trial to protect brains of infants with CHD during and after surgery

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A novel phase 1 trial looking at how best to optimize brain development of babies with congenital heart disease (CHD) is currently underway at Children’s National Hospital.

Children with CHD sometimes demonstrate delay in the development of cognitive and motor skills. This can be a result of multiple factors including altered prenatal oxygen delivery, brain blood flow and genetic factors associated with surgery including exposure to cardiopulmonary bypass, also known as the heart lung machine.

This phase 1 trial is the first to deliver mesenchymal stromal cells from bone marrow manufactured in a lab (BM-MSC) into infants already undergoing cardiac surgery via cardiopulmonary bypass. The hypothesis is that by directly infusing the MSCs into the blood flow to the brain, more MSCs quickly and efficiently reach the subventricular zone and other areas of the brain that are prone to inflammation. The trial is open to eligible patients ages newborn to six months of age.


Learn more in this overview video.

The trial is part of a $2.5 million, three-year grant from the National Institutes of Health (NIH) led by Richard Jonas, M.D., Catherine Bollard, M.B.Ch.B., M.D., and Nobuyuki Ishibashi, M.D.. The project involves collaboration between the Prenatal Cardiology program of Children’s National Heart Institute, the Center for Cancer and Immunology Research, the Center for Neuroscience Research and the Sheikh Zayed Institute for Pediatric Surgical Innovation.

“NIH supported studies in our laboratory have shown that MSC therapy may be extremely helpful in improving brain development in animal models after cardiac surgery,” says Dr. Ishibashi. “MSC infusion can help reduce inflammation including prolonged microglia activation that can occur during surgery that involves the heart lung machine.”

Staff from the Cellular Therapy Laboratory, led by director Patrick Hanley, Ph.D., manufactured the BM-MSC at the Center for Cancer and Immunology Research, led by Dr. Bollard.

The phase 1 safety study will set the stage for a phase 2 effectiveness trial of this highly innovative MSC treatment aimed at reducing brain damage, minimizing neurodevelopmental disabilities and improving the postoperative course in children with CHD. The resulting improvement in developmental outcome and lessened behavioral impairment will be of enormous benefit to individuals with CHD.

For more information about this new treatment, contact the clinical research team: Gil Wernovsky, M.D., Shriprasad Deshpande, M.D., Maria Fortiz.

Boy with scoliosis during rehabilitation

Children’s National first-use of anterior vertebral body tethering system for idiopathic scoliosis

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Boy with scoliosis during rehabilitation

On Monday, Feb. 1, 2021, Children’s National Hospital performed the first anterior vertebral body tethering procedure for a child in the Washington, D.C., area. The device is a recently approved option for treating children with idiopathic scoliosis, the most common type of scoliosis. It allows for gradual correction of a spinal deformity through the natural growth of the spine, leading to improvements in spinal alignment while maintaining spinal flexibility.

In August 2019, the U.S. Food and Drug Administration (FDA) approved the first spinal tether system for pediatric patients called The Tether – Vertebral Body Tethering System. This device is attached to the spine during a minimally invasive thorascopic procedure performed by a multidisciplinary medical team, which includes orthopaedic surgery, thoracic surgery and anesthesia.

“This promising technology may help maintain the flexibility of the spine as it grows straighter over time,” says Matthew Oetgen, M.D., chief of Orthopaedics at Children’s National. “Novel devices like The Tether offer additional treatment options for idiopathic scoliosis, which have the potential to improve pediatric surgical outcomes and quality of life for children and adolescents with significant spinal deformities.”

The procedure at Children’s National brought together some the region’s best pediatric orthopaedic and thoracic surgeons, including Dr. Oetgen, Shannon Kelly, M.D., associate chief of Orthopaedic Surgery, and Timothy Kane, M.D., chief of General and Thoracic Surgery.

“Children’s National can offer these types of procedures because the hospital is home to many talented pediatric surgeons across specialties, many of whom are experts in minimally invasive techniques for children,” says Dr. Kane. “We collaborate together, often, because we know that’s the best way to continually improve the care we provide to children and their families.”

Idiopathic scoliosis is the most common type of scoliosis and can occur in children between age 10 and 18 or until they are fully grown. Spinal fusion surgery is the most common treatment for children with the most severe spine curvatures and continues to be the “gold standard” for surgical treatment of this condition. It takes about 3 months for a child or adolescent to fully recover from the procedure. While spinal fusion produces excellent and reproducible outcomes, in certain patients with less severe deformities and significant skeletal growth remaining, vertebral body tethering may offer some benefits over spinal fusion. In clinical trials, the spinal tether was shown to shorten recovery time and increase range of motion. Early diagnosis is vital to dictate which treatment will be most beneficial.

Lee Beers

Lee Beers, M.D., F.A.A.P, begins term as AAP president

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Lee Beers

“The past year has been a stark reminder about the importance of partnership and working together toward common goals,” says Dr. Beers. “I am humbled and honored to be taking on this role at such a pivotal moment for the future health and safety of not only children, but the community at large.”

Lee Savio Beers, M.D., F.A.A.P., medical director of Community Health and Advocacy at the Child Health Advocacy Institute (CHAI) at Children’s National Hospital, has begun her term as president of the American Academy of Pediatrics (AAP). The AAP is an organization of 67,000 pediatricians committed to the optimal physical, mental and social health and well-being for all children – from infancy to adulthood.

“The past year has been a stark reminder about the importance of partnership and working together toward common goals,” says Dr. Beers. “I am humbled and honored to be taking on this role at such a pivotal moment for the future health and safety of not only children, but the community at large.”

Dr. Beers has pledged to continue AAP’s advocacy and public policy efforts and to further enhance membership diversity and inclusion. Among her signature issues:

  • Partnering with patients, families, communities, mental health providers and pediatricians to co-design systems to bolster children’s resiliency and to alleviate growing pediatric mental health concerns.
  • Continuing to support pediatricians during the COVID-19 pandemic with a focus on education, pediatric practice support, vaccine delivery systems and physician wellness.
  • Implementation of the AAP’s Equity Agenda and Year 1 Equity Workplan.

Dr. Beers is looking forward to continuing her work bringing together the diverse voices of pediatricians, children and families as well as other organizations to support improving the health of all children.

“Dr. Beers has devoted her career to helping children,” says Kurt Newman, M.D., president and chief executive officer of Children’s National. “She has developed a national advocacy platform for children and will be of tremendous service to children within AAP national leadership.”

Read more about Dr. Beer’s career and appointment as president of the AAP.

Cover of the December issue of Seminars on Pediatric Surger

Reflections on Seminars in Pediatric Surgery December 2020

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Cover of the December issue of Seminars on Pediatric Surger

Marc Levitt, M.D., served as guest editor of a special December Seminars in Pediatric Surgery dedicated to the care and treatment of anorectal malformations.

By Marc Levitt, M.D., chief of the Division of Colorectal and Pelvic Reconstruction at Children’s National Hospital

I was honored to serve as the Guest Editor on the topic of “Anorectal Malformations” in the prestigious Seminars in Pediatric Surgery Volume 29, Issue 6, December 2020.

We had 64 contributing authors from 12 countries; Australia, Austria, Germany, Ghana, Italy, Israel, the Netherlands, Nigeria, Spain, South Africa, the United Kingdom and the United States, and 12 U.S. colorectal collaborating programs; Children’s National, Boston Children’s, Children’s Mercy, Children’s Wisconsin, C.S. Mott Children’s, Cincinnati Children’s, Nationwide Children’s, Nicklaus Children’s, Omaha Children’s, Primary Children’s, Seattle Children’s, and UC Davis Children’s.

There were eight authors from the Children’s National team; myself, Colorectal Director Andrea Badillo, M.D., Colorectal Program Manager Julie Choueiki, MSN, RN, Surgical Center Director Susan Callicott, Katie Worst, CPNP-AC, Grace Ma, M.D., Chief of Urology Hans Pohl, M.D., and Chief of Gynecology Veronica Gomez-Lobo, M.D.

The series of articles included in this collection illustrate new techniques and ideas that over time have made a dramatic and positive impact on the care and quality of life of children who suffer from colorectal problems. With an integrated approach to the care of this complex group of patients, great things can be achieved. As we endeavor to advance this field, we need to always remember that, as Alberto Pena, M.D., often said, “it is not the unanswered questions, but rather the unquestioned answers that one must pursue.”

In my own article on advances in the field, a 2021 update, I reproduce a piece by my daughter, Jess Levitt, who wrote something applicable to the care of children with colorectal problems, with the message that helping to create order is vital to improve a somewhat chaotic medical process traditionally available for the care of complex care. Her essay is reproduced here:

“A” must come before “B,” which must come before “C,” everybody knows that. But what if the Millercamp’s of this world did not have to sit next to the Millerchip’s when it comes to seating arrangements? Can Pat Zawatsky be called before Jack Aaronson when the teacher is taking attendance? Do those 26 letters that make up all the dialogue, signs, thoughts, books, and titles in the English-speaking departments of the world need their specific spots in line? Everyone can sing you the well-known jingle from A to Z, but not many people can tell you why the alphabet is the way it is. For almost as long as humans have had the English language, they have had the alphabet. The good ole ABCs.

However, the alphabet represents the human need for order and stability. I believe that the same thinking that went into the construct of time and even government went into the alphabet. Justifiably, lack of order leads to chaos. Knife-throwing, gun-shooting chaos, in the case of lack of governmental order. Listen to me when I tell you that there is absolutely no reason that the alphabet is arranged the way that it is. Moreover, the alphabet is simply a product of human nature and how it leads people to establish order for things that do not require it. 

Now I know this sounds crazy but bear with me. Only if you really peel away the layers of the alphabet will you find the true weight it carries. People organized the letters of our speech into a specific order simply because there wasn’t already one. Questioning this order will enlighten you on the true meaning of it. Really dig deep into the meaning behind the social construct that is the alphabet. Short and sweet as it may be, the order of the ABCs is much less than meets the eye. There is no reason that “J” should fall before “K!” Understand this. Very important as order is, it is only a result of human nature.  What’s next? X-rays become independent of Xylophones in children’s books of ABCs? 

You know what the best part is? Zero chance you even noticed that each sentence in this essay is in alphabetical order.

Her literary contribution inspired me to do something similar. Take a look at the list of articles in this Seminars edition:

  1. Creating a collaborative program for the care of children with colorectal and pelvic problems. Alejandra Vilanova-Sánchez, Julie Choueiki, Caitlin A. Smith, Susan Callicot, Jason S. Frischer and Marc A. Levitt
  2. Optimal management of the newborn with an anorectal malformation and evaluation of their continence potential. Sebastian K. King, Wilfried Krois, Martin Lacher, Payam Saadai, Yaron Armon and Paola Midrio
  3. Lasting impact on children with an anorectal malformations with proper surgical preparation, respect for anatomic principles, and precise surgical management. Rebecca M. Rentea, Andrea T. Badillo, Stuart Hosie, Jonathan R. Sutcliffe and Belinda Dickie
  4. Long-term urologic and gynecologic follow-up and the importance of collaboration for patients with anorectal malformations. Clare Skerritt, Daniel G. Dajusta, Molly E. Fuchs, Hans Pohl, Veronica Gomez-Lobo and Geri Hewitt
  5. Assessing the previously repaired patient with an anorectal malformation who is not doing well. Victoria A. Lane, Juan Calisto, Ivo Deblaauw, Casey M. Calkins, Inbal Samuk and Jeffrey R. Avansino
  6. Bowel management for the treatment of fecal incontinence and constipation in patients with anorectal malformations. Onnalisa Nash, Sarah Zobell, Katherine Worst and Michael D. Rollins
  7. Organizing the care of a patient with a cloacal malformation: Key steps and decision making for pre-, intra-, and post-operative repair. Richard J. Wood, Carlos A. Reck-Burneo, Alejandra Vilanova-Sanchez and Marc A. Levitt
  8. Radiology of anorectal malformations: What does the surgeon need to know? Matthew Ralls, Benjamin P. Thompson, Brent Adler, Grace Ma, D. Gregory Bates, Steve Kraus and Marcus Jarboe
  9. Adjuncts to bowel management for fecal incontinence and constipation, the role of surgery; appendicostomy, cecostomy, neoappendicostomy, and colonic resection. Devin R. Halleran, Cornelius E.J. Sloots, Megan K. Fuller and Karen Diefenbach
  10. Treating pediatric colorectal patients in low and middle income settings: Creative adaptation to the resources available. Giulia Brisighelli, Victor Etwire, Taiwo Lawal, Marion Arnold and Chris Westgarth-Taylor
  11. Importance of education and the role of the patient and family in the care of anorectal malformations. Greg Ryan, Stephanie Vyrostek, Dalia Aminoff, Kristina Booth, Sarah Driesbach, Meghan Fisher, Julie Gerberick, Michel Haanen, Chelsea Mullins, Lori Parker and Nicole Schwarzer
  12. Ongoing care for the patient with an anorectal malfromation; transitioning to adulthood. Alessandra Gasior, Paola Midrio, Dalia Aminoff and Michael Stanton
  13. New and exciting advances in pediatric colorectal and pelvic reconstructive surgery – 2021 update. Marc A. Levitt

The first letter of each article forms an acrostic of the word “COLLABORATION” which is the secret sauce behind any success in the field of pediatric colorectal care.

Research & Innovation Campus

Children’s National pain expert and innovator shares global summit spotlight

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Research & Innovation Campus

As a Johnson & Johnson Innovation Quickfire Children’s Challenge awardee, Dr. Finkel and AlgometRx will be among the first group of startups taking up residence at the new JLABS @ Washington, DC, located on the Children’s National Research & Innovation Campus, when it opens in 2021 at the historic former Walter Reed Army Medical Center site.

Medical technology innovator Julia Finkel, M.D., principal investigator for the Pain Medicine Initiative of the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Hospital, recently participated in Galen Growth’s 2020 Global Healthtech Summit on a virtual panel featuring resident companies from Johnson & Johnson Innovation – JLABS who are utilizing artificial intelligence (AI) with the aim to create advanced solutions for diagnostics, treatment and clinical trials. The summit, hosted in Singapore, brought the innovators together to discuss their views on their progress, the challenges and opportunities for bringing medtech innovations to market in the current climate, as well as the tools needed to succeed.

Dr. Finkel’s innovation, AlgometRx, is a real-time pain measurement technology that captures a digital image of a patient’s pupillary response to a non-invasive stimulus and applies proprietary algorithms to measure pain type and intensity. AlgometRx, a spin-off of Children’s National, recently received a JLABS @Washington DC Quickfire Children’s Challenge award.

Joining Dr. Finkel on the panel were JLABS resident company leaders Don Crawford, CEO, Analytics 4 Life; Jim Havelka, CEO, Inform AI; and Kim Walpole, CEO, Trials.ai, which leverages AI to help research teams design more effective clinical trials. The 50-minute program, moderated by Kara Bortone, senior director, Portfolio and Sourcing Management, Johnson & Johnson Innovation – JLABS, focused on topics such as how these startups approached the market and regulatory processes as well as the up-and-coming trends in health technology.

A pediatric anesthesiologist, Dr. Finkel explained the significance of achieving real-time, objective pain measurement. “Pain is one word that represents a myriad of conditions,” she says. “Pain from acute post-operative conditions is very different from peripheral neuropathic pain and different from the type of inflammatory pain seen in lupus and rheumatoid arthritis. Being able to discern the drivers of pain, the etiology, is essential to treating it well and to developing better therapeutics in the future.”

Dr. Finkel points out that AlgometRx measures nociception, which is pain fiber activation, and that is also what medications are addressing. “We’re not discounting a patient’s perception of pain, as we recognize that one’s experience of pain is very complex,” she says. “What we aim to measure is the activity being transmitted by the pain nerve and the type of nerve fiber that is doing the transmitting.”

Aiming to identify pain phenotypes is an important part of current AlgometRx development work, says Dr. Finkel, as it could significantly aid clinical decision-making in treating and monitoring patients’ pain. The company’s current regulatory focus is to seek FDA clearance related to its potential use for patients with peripheral neuropathy, which is pain and numbness resulting from damage to the nerves outside of the brain and spinal cord. The company has also identified fibromyalgia cases as a place where the technology could potentially benefit a large number of patients as it considers regulatory clearance targets.

As the COVID-19 pandemic presented many unique challenges to healthcare startups this year, panel participants were asked to discuss the hurdles they faced and how it impacted device development.

Dr. Finkel notes that the pandemic slowed patient enrollment in AlgometRx clinical studies, but also presented some upside. “At first, that had a negative impact, but it wound up being a good thing,” she says. “It gave us a moment to pause, regroup and examine the data we’d already generated. That break gave us improved information and a new, more powerful approach. It changed our trajectory by altering our regulatory path in terms of the order of things in our pipeline, so we’ve been enormously productive.”

As a Johnson & Johnson Innovation Quickfire Children’s Challenge awardee, Dr. Finkel and AlgometRx will be among the first group of startups taking up residence at the new JLABS @ Washington, DC, located on the Children’s National Research & Innovation Campus, when it opens in 2021 at the historic former Walter Reed Army Medical Center site. Along with a one-year residency at the new JLABS @ Washington DC facility,* AlgometRx will receive mentorship from experts at the Johnson & Johnson Family of Companies and grant funding to help support its continued advancement to commercialization.

*Residency at JLABS @ Washington subject to acceptance and execution of a License Agreement with Children’s National.

insta-3D™ imaging from company nView medical

New innovative 3D imaging technology used in pediatric spine surgery

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insta-3D™ imaging from company nView medical

Children’s National Hospital performed the first surgical use of breakthrough medical imaging technology designed specifically for kids. The innovation, insta-3D™ imaging from company nView medical, is designed to make 3D images available in the operating room quickly and safely.

Children’s National Hospital performed the first surgical use of breakthrough medical imaging technology designed specifically for kids. The innovation, insta-3D™ imaging from company nView medical, is designed to make 3D images available in the operating room quickly and safely. The 3D images provide surgeons with better visualization, allowing them to continue improving patient care and outcomes.

Matthew Oetgen, M.D., division chief of Orthopaedic Surgery at Children’s National, is overseeing the first use of this 3D imaging technology in orthopaedic procedures.

“Having a technology like this available in the operating room will potentially help make our surgeries even more precise with 3D imaging available quickly,” says Dr. Oetgen. “We anticipate this improved precision will lead to better outcomes and added value to what we do for our patients.”

Cristian Atria, nView medical’s CEO, commented for the first case.

“Seeing our imaging technology provide critical information during a kid’s surgery reminds us what the purpose of nView medical is all about,” says Cristian. “I would like to thank the surgeons, our backers, the team, and our clinical partners for making this first surgery a success. I couldn’t be more enthusiastic for what’s ahead!”

The potential of nView medical’s insta-3D™ imaging is especially exciting for Children’s National as nView medical is a 2019 Winner of the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) competition “Make Your Medical Device Pitch for Kids!” 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.

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 in areas of critical need where innovation can significantly improve children’s health care.

“Children deserve to benefit from our most advanced medical technologies and we know that improvements in pediatric care can make a positive difference over the lifetime of a child,” 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. “Pediatric hospitals must lead the way in supporting innovation for children’s care. That’s why, through NCC-PDI and our innovation institute, Children’s National helps to provide promising new pediatric devices with resources and expertise that support their journey to the market.”

newborn in ICU

Cardiac technology advances show promise for kids but only if right-sized

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newborn in ICU

“Smaller patients, and those with congenital heart disease, can benefit from minimally-invasive methods of delivering pacemakers and defibrillators without the need for open-chest surgery,” says Charles Berul, M.D.

How to address the growing need for child-sized pacemakers and defibrillators, and finding better surgical techniques to place them, is the topic of an invited session called The Future is Now (or Coming Soon): Updates on New Technologies in Congenital Heart Care at the 2020 American Heart Association Scientific Sessions.

“Smaller patients, and those with congenital heart disease, can benefit from minimally-invasive methods of delivering pacemakers and defibrillators without the need for open-chest surgery,” says Charles Berul, M.D., co-director of the Children’s National Heart Institute and chief of Cardiology at Children’s National Hospital, who presented at the session.

“This unmet need can only be met by innovative pediatric research, geared towards miniaturization technologies for use in the smallest of children,” he says.

His presentation focused on the devices and approaches that have caught the attention of pediatric cardiology, such as pacemakers and subcutaneous defibrillators designed without lead wires, as well as less-invasive surgical approaches that may reduce recovery time for children with congenital heart disease who require these assist devices.

Using them in kids comes with added challenges, however. Often pediatric cardiologists have to be creative in how to make them work for smaller patients, Dr. Berul notes. This reiterates the important point that simply applying an adult technology to a child isn’t the right approach. The subcutaneous defibrillator, for example, is still pretty large for a child’s body. Some studies also show these devices may not be as accurate in children as in adults.

Investigators in the Sheikh Zayed Institute working together with the cardiologists at Children’s National Hospital are focused on product development and commercialization of tools and techniques to allow percutaneous minimally-invasive placement of devices, taking advantage of the newest devices and surgical techniques as they develop.

In his presentation, Dr. Berul stressed that as the technology for adults advances, it creates an opportunity for pediatric cardiology, but only if the devices, and the techniques to place them, are specifically redesigned for pediatric application.

American Heart Association Scientific Sessions 2020
The Future is Now (or Coming Soon): Updates on New Technologies in Congenital Heart Care – On Demand Session
CH.CVS.715
9:00am – 10:00am
Fri, Nov 13  (CST)

Research & Innovation Campus

Boeing gives $5 million to support Research & Innovation Campus

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Research & Innovation Campus

Children’s National Hospital announced a $5 million gift from The Boeing Company that will help drive lifesaving pediatric discoveries at the new Children’s National Research & Innovation Campus.

Children’s National Hospital announced a $5 million gift from The Boeing Company that will help drive lifesaving pediatric discoveries at the new Children’s National Research & Innovation Campus. The campus, now under construction, is being developed on nearly 12 acres of the former Walter Reed Army Medical Center. Children’s National will name the main auditorium in recognition of Boeing’s generosity.

“We are deeply grateful to Boeing for their support and commitment to improving the health and well-being of children in our community and around the globe,” said Kurt Newman, M.D., president and CEO of Children’s National “The Boeing Auditorium will help the Children’s National Research & Innovation campus become the destination for discussion about how to best address the next big healthcare challenges facing children and families.”

The one-of-a-kind pediatric hub will bring together public and private partners for unprecedented collaborations. It will accelerate the translation of breakthroughs into new treatments and technologies to benefit kids everywhere.

“Children’s National Hospital’s enduring mission of positively impacting the lives of our youngest community members is especially important today,” said Boeing President and CEO David Calhoun. “We’re honored to join other national and community partners to advance this work through the establishment of their Research & Innovation Campus.”

Children’s National Research & Innovation Campus partners currently include Johnson & Johnson Innovation – JLABS, Virginia Tech, the National Institutes of Health (NIH), Food & Drug Administration (FDA), U.S. Biomedical Advanced Research and Development Authority (BARDA), Cerner, Amazon Web Services, Microsoft, National Organization of Rare Diseases (NORD) and local government.

The 3,200 square-foot Boeing Auditorium will be the focal point of the state-of-the-art conference center on campus. Nationally renowned experts will convene with scientists, medical leaders and diplomats from around the world to foster collaborations that spur progress and disseminate findings.

Boeing’s $5 million commitment deepens its longstanding partnership with Children’s National. The company has donated nearly $2 million to support pediatric care and research at Children’s National through Chance for Life and the hospital’s annual Children’s Ball. During the coronavirus pandemic, Boeing fabricated and donated 2,000 face shields to help keep patients and frontline care providers at Children’s National safe.