February 2024 Spotlight

Pediatric Device Dedication: UCSF-Stanford PDC Pitch Competition and the 5th Annual Michael R. Harrison Innovation Symposium  

As there remains an unmet need for pediatric devices and innovation in the pediatric arena, the UCSF-Stanford Pediatric Device Consortium (PDC) sustains its efforts in providing opportunities for propelling innovation and improving health outcomes in pediatric populations. The annual Pediatric Device Accelerator Pitch Competition is one mechanism that follows this mission, igniting creativity among innovators from academic, business or startup backgrounds, with an emphasis on pediatric needs. This year, we are enthusiastic to announce that a total of $250,000 in seed grants will be awarded to the winners of the competition, made possible through the U.S. Food & Drug Administration Pediatric Device Consortia Grants Program, The Frederick Gardner Cottrell Foundation, and the Hooper Family. These funds, along with customized mentoring and other support from PDC and its extensive advisory network, will provide innovators with necessary resources and propel device innovations forward, with the goal of bringing more devices specifically labeled for pediatric population toward market availability. In addition, this year, selected candidates will have an exciting opportunity to work with Fogarty Innovation, a world-class medical device incubator, as another resource to advance pediatric device development. Applications have officially closed for this cycle and selected finalists will present their devices at the pitch competition, to be held on March 22, 2024, as part of the 5th Annual Michael R. Harrison Innovation Symposium.  

Dr. Michael Harrison, Professor Emeritus of Surgery, Pediatrics, and Obstetrics, Gynecology & Reproductive Sciences at UCSF, a well- known pediatric and fetal technology innovator and founder of the UCSF Fetal Treatment Center and Pediatric Device Consortium, recounts lab meetings as one of his favorite weekly activities. As he remains passionate about the lab meeting setting and the collaboration of ideas amongst individuals that this setting foster, the Annual Michael R. Harrison Symposium seeks to emulate these sentiments, while it serves as another event dedicated to innovations in pediatric device development and care. The symposium provides an environment for valuable discussions among individuals of diverse backgrounds, including academics, clinicians, engineers, and biomedical and industry professionals. Continuing research efforts will be discussed and highlighted, including use of Real-World Evidence (RWE), artificial organs, and artificial intelligence in medicine. These topics and projects exemplify the ideal of creating better health outcomes through continued dedication to research, education, and innovation, which are the driving forces of the UCSF-Stanford PDC.  

January 2024 Spotlight

Dr. Hanmin Lee & Lee Lab: Current Projects and New Developments

Dr. Hanmin Lee, is a Professor of Pediatric Surgery and the Surgeon-in-Chief at UCSF Benioff Children’s Hospitals, Principal Investigator (PI) of the UCSF-Stanford Pediatric Device Consortium, Clinical Lead of the UCSF Surgical Innovations and the Director of UCSF Fetal Treatment Center. For more than a decade, Dr. Lee’s research focus had been data driven technological innovations that can address some of the critical unmet needs of patients and healthcare economics as well as improving surgeon ergonomics, which will significantly impact surgical outcomes. One of Lee lab research projects is developing a technology guided intervention to prevent decubitus ulcers, a costly and serious clinical problem now considered a “Never Event.” For the last few years, he has been working with a multidisciplinary team of clinicians, engineers, and entrepreneurs at UCSF to determine the best approach for building a comprehensive system that can predict high risk patients for developing pressure ulcers, a smart sensor that can monitor relevant parameters and a mechanical turning device, to relieve pressure points and prevent ulcer formation. They have since developed SmartDerm, a sensor patch that detects the formation of pressure ulcers, and AURA, a digital app with an algorithm that utilizes electronic health record (EHR) data to predict which patients are at higher risk for them. As a surgeon innovator, he seeks to solve unmet needs through innovation, while mentoring students and collaborating with multidisciplinary teams. Dr. Lee works closely with second year Surgical Innovation fellows, Dr. Tejas Sathe and Dr. Tom Sorrentino, who share a passion for generating novel solutions for surgical needs.    

Interested in exploring the utility of the popularized AI tool created by OpenAI, ChatGPT, Drs. Lee, Sathe, and Sorrentino sought to understand the potential for this tool to contribute positively to surgical academia and improve surgical outcomes. The capacity of ChatGPT-4, released in March of 2023 and representative of generative AI tools, was asked to compose a paper detailing the current challenges faced by surgeons, answering the question, “what are the most common problems in academic surgery and how can we address them?” GPT-4 composed an academic piece detailing seven challenges faced by surgeons and proposed viable solutions, while acknowledging limitations to the arguments presented in the paper. The article was published in the Surgical Innovations October 2023 issue of Sage Journals, under the section title, GPT-4 a Creative Copilot for Navigating Academic Surgery, concluding that generative AI may prove a pivotal role in the innovation landscape through providing valuable insights and considerations for addressing challenges faced in medicine, while providing a valuable tool in the efficiency of generating academic writing.  

In addition to AI, Dr. Lee mentors SI fellows on continuing projects relating to sustainability in surgery and proper surgical ergonomics. With awareness of the large amount of carbon emissions in surgery, relating to sterilization protocols, Dr. Sathe sought to combat this sustainability issue through a project coined as ‘ORDash.’ Tracking procedures for sterilizing surgical instruments for the OR is one mechanism to reduce operating room waste and reduce carbon emissions that are produced as a consequence of sterilization cycles. As proper ergonomics while operating is a common challenge to general surgery residents, Drs. Sathe and Sorrentino collaborated in the UCSF Maker’s Lab to address this challenge. Together, they developed a portable laparoscopic trainer that simulates OR conditions for surgical residents to utilize while outside of the operating room, generating muscle memory of proper ergonomic practices. By practicing laparoscopic procedures outside of the OR, this endeavor aims to decrease surgeon morbidity associated with poor ergonomics over time.   

Through exploring productive uses of AI, sustainability in the operating room and improved surgeon ergonomics, the Lee Lab is a meaningful contributor to surgical innovations, promoting the evolution of surgical education and practices.   

 December 2023 Spotlight

The Roy Lab: Recent Developments & Achievements

Shuvo Roy, PhD, the Engineering Lead for Surgical Innovations (SI) and the Technical Lead of the UCSF-Stanford Pediatric Device Consortium (PDC), joined UCSF in 2008. He is a Professor in the Department of Bioengineering & Therapeutic Sciences specializing in the development of microelectromechanical systems (MEMS) for unmet clinical needs. In his Biodesign (Roy) Lab, the team is applying MEMS technology for wearable and implantable medical devices. Lab research spans several foci, including the development of an implantable bio-artificial kidney under the auspices of The Kidney Project; medical devices designed with a child’s specifications in mind with PDC collaborators; and several other stand-alone device projects involving miniature sensors.

Dr. Roy’s team recently published a major paper in Nature Communications, titled “Feasibility of an implantable bioreactor for renal cell therapy using silicon nanopore membranes.” The work demonstrates a proof-of-concept bioreactor offering immunoprotection to encapsulated human renal epithelial cells for the implantable artificial kidney. Former SI Fellow, Caressa Chen, was a co-first author of the paper, and other authors include former SI Fellows Jarret Moyer and Rebecca Gologorsky. SI faculty member Shant Vartanian also contributed to the paper.

This past summer Dr. Roy and his lab visited Washington DC to participate in the Congressional Life Sciences Fair. There, the team presented and demonstrated work on the implantable artificial kidney. They also visited Congressional offices to explain the urgent need for innovation in treating kidney disease and for increased federal funding through KidneyX and other federal agencies.

Aside from artificial kidney technology, the Roy Lab works with other artificial organs as well. The team has been collaborating with David Blauvelt, a former UCSF Critical Care Fellow, working towards adapting extracorporeal membrane oxygenation (ECMO) to the development of an artificial placenta. To note, Dr. Blauvelt also won funding through UCSF-Stanford PDC Shark Tank competitions. The artificial placenta simulates intrauterine physiology and may enable normal development outside of the uterus and assist in supporting extremely preterm (EPT) infants who struggle to stay alive due to underdeveloped lungs. This project was recently granted an NIH Exploratory/Developmental Research Grant Award, and the team plans on expanding the research to help explore this healthcare solution among our youngest pediatric patients. US Congressional House Representative and Speaker Emeritus Nancy Pelosi wrote a letter of congratulations to Dr. Roy, for his receipt of this Department of Health and Human Services Grant on Research for Mothers and Children.

Roy Lab forges ahead to make the necessary scientific and engineering advances towards improving global healthcare. To find out more, visit Roy Lab. To find out more about the development of the implantable artificial kidney, visit The Kidney Project.

November 2023 Spotlight

The Harrison Lab: Recognitions for Magnetic Devices

With over 40 years of experience, Dr. Michael Harrison and the UCSF Surgical Innovations have been leaders in magnetic surgical device developments. Through extensive research devotion, Dr. Harrison has sought to develop minimally invasive magnetic devices as novel treatment approaches for a wide spectrum of disorders, in efforts to decrease morbidity and mortality associated with conventional therapies. The Harrison Lab has targeted many conditions with magnetic devices, ranging from fetal congenital anomalies, such as esophageal atresia, to obstructive sleep apnea in adults. Recent projects led by Dr. Harrison have provided a deeper understanding of various implementations of magnetic devices and explored the use of magnets for preventing obstructive sleep apnea, which has led to the acceptance of two papers for publication.  

One recent project sought to understand current uses of magnetic devices in clinical applications, beyond the predominant utility in the gastrointestinal track. The Harrison Lab conducted a comprehensive review of scenarios where magnetic forces have been used to treat disorders and uncovered magnetic device implementation in the respiratory, musculoskeletal, genitourinary, and cardiovascular systems. The culmination of this project is detailed in “Beyond the Gut: Spectrum of Magnetic Surgery Devices,” which highlights various implementations of magnetic force in biodevice innovation and discusses the core technical principles and key considerations involved in magnetic device development. This endeavor not only served to compile diverse uses for magnetic devices, but to emphasize the utility of magnetic devices in applications beyond the gastrointestinal tract.  

In another recent project, the Harrison Lab sought to implement a magnetic device to prevent airway collapse, as a novel intervention for patients with obstructive sleep apnea (OSA), and as an alternative to current sleep apnea devices (CPAP machines). While the study was interrupted by the COVID-19 pandemic, leading to difficulties with tracking patient outcomes through in-lab polysomnograms, protocols were adjusted to study patients through home sleep apnea testing (HSAT). Despite modifications to study methods, valuable insights were gathered, which led to the composition of “Use of Home Sleep Apnea Testing to Mitigate the Effects of COVID-19: Modification of the Phase I Magnap Clinical Trial Protocol.” This paper not only highlights an innovative approach to treating obstructive sleep apnea, but it also displays the safety and feasibility from preliminary results of the ongoing Phase I first-in-human clinical trial. Additionally, the study’s use of remote sleep monitoring systems provides a potential mechanism for increasing patient accessibility to novel sleep-related therapies. 

October 2023 Spotlight

FDA Awards $7.4 Million grant to the UCSF-Stanford Pediatric Device Consortium, for another 5 years!

UCSF-Stanford Pediatric Device Consortium (PDC) receives $7.4Million from FDA (P50FD007967), over the next 5 years, to facilitate development of innovative medical devices specifically for children.  There is a critical unmet need for novel pediatric devices that are designed explicitly for the unique needs of children and the FDA launched the Pediatric Device Consortia (PDC) Grants Program in 2009, to address this. As an inaugural PDC, UCSF has been a leading institution since 2009 and the 2023 grant award makes UCSF the longest running continually funded consortium of this type, with a successful history in supporting several hundred pediatric devices on their path to commercialization and patient access. In 2018, the UCSF PDC teamed up with Stanford University to expand it to the UCSF-Stanford PDC.  

UCSF-Stanford PDC combines the outstanding resources and unique innovation ecosystems available in two world-class universities and two leading children’s hospitals with the unsurpassed entrepreneurial network in the heart of the Bay Area, to equip pediatric innovators at all stages of development to translate their innovations into high-value, commercially viable, and equitable products that are accessible to all populations. The PDC is now further expanding its scope and impact through a partnership with world-class device incubator Fogarty Innovation, the diversification of leadership with actionable plans to promote diversity, equity and inclusion (DEI) in device development, and the expansion of real-world evidence (RWE) consulting and education through a collaborative PDC Service Center as well as a new partnership with a leading RWE firm, Aetion. 

Over the next 5 years, Hanmin Lee, MD, Professor of Pediatric Surgery and Surgeon-in-Chief at UCSF Benioff Children’s Hospitals will serve as the Principal Investigator and Director of the PDC. He will lead a highly accomplished and experienced leadership team from UCSF (Michael Harrison, MD; Shuvo Roy, PhD; Usha Thekkedath, MD and Willieford Moses, MD) and from Stanford (James Wall, MD; Janene Fuerch, MD and Kunj Sheth, MD), as well as numerous academic and industry collaborators and a network of expert advisers, passionate about developing innovative technological solutions for pediatric clinical needs. 

 The UCSF-Stanford Pediatric Device Consortium remains one of the five centers to participate in the national program aimed at accelerating the development of and availability of medical devices designed specifically for children. With this grant, the PDC looks forward to further its mission, “to improve health, safety, and quality of life of pediatric patients by accelerating high-value, high impact pediatric device solutions at all stages to the total product lifestyle towards commercialization.”