Recent News

Pediatric Device Consortium Celebrates Future Innovations with $6.7M FDA Grant

September 4, 2018

A hand-held, low-cost gadget that detects pneumonia in children who don’t have access to chest X-ray, a pressure sensing device that sends data to a physician’s office to track how long a child with a chest deformity is wearing their brace and an appliance that fits over the mouth of an infant with cleft palate enabling them to breastfeed. These are among the intriguing inventions developed for pediatric patients.

Now a $6.7 million grant to the newly named UCSF-Stanford Pediatric Device Consortium will enable the development of new gadgets for those medical conditions calling for a collaboration of geniuses.

The grant from the U.S. Food and Drug Administration, announced Aug. 23, 2018, will be received over five years, in accordance with a program launched in 2009 under a mandate from Congress to stimulate the development of devices for the underserved pediatric market.

The consortium, which was founded at UC San Francisco in 2009, will be boosted by a partnership with the Stanford University School of Medicine, which will bring to the table its own fleet of physicians and other clinicians, engineers, IT and industry experts, and clinical fellows from its renowned Stanford Byers Center for Biodesign. Thanks to the zeal and energy of the participants, problems presented by clinicians in a weekly think tank meeting can result in a fully-fledged prototype just weeks later. Read more >>

Symposium Unites Academic, Industry, and Government Partners Around Children's Health

June 4, 2018

On May 17, UCSF and the UCSF Benioff Children's Hospitals hosted the Second Annual Engineering for Children's Health Symposium at Mission Bay Conference Center. Over one hundred clinicians, engineers, scientists, administrators, industry professionals, and government partners gathered to discuss groundbreaking research and developing technologies in pediatric medicine. The event included research talks by faculty, pediatric device demos, a design workshop, a panel on incentivizing innovation in pediatrics, and a keynote by Vasum Peiris, MD, MPH, Chief Medical Officer of FDA's Center for Devices and Radiological Health. Read more >>

A Bold New Treatment Unlocks a Cure

February 1, 2018

By Beth Tagawa

When Tom and Diane Fitch learned their baby would be born with a severe birth defect, they were devastated. But an innovative treatment at UCSF Benioff Children’s Hospital San Francisco gave their daughter a chance at a normal life.

An ultrasound revealed their growing baby had esophageal atresia, a rare condition in which the esophagus develops as separate pouches. The child is unable to eat normally and can have difficulty breathing; immediate intervention is required.

At UCSF Benioff San Francisco, the Fitches met Michael Harrison, MD, the world-renowned surgeon who pioneered fetal surgery. Typically, Dr. Harrison explained, a section of the infant’s own bowel would be used to connect the pouches, but results are not always ideal.

But, he told them, he had an idea for an experimental procedure: threading balls through the two pouches to draw them slightly closer each day, eventually fusing them together. For Tom and Diane, the choice was a no-brainer — a risk, but one that could bear a huge reward.

Dr. Harrison’s remarkable expertise and contagious optimism made it easy to say yes. “As soon as we met him, he lifted our spirits,” Tom says. “It was like pixie dust. If he wanted to do the surgery blindfolded, I wouldn’t have complained.”

The day after Annabelle was born, Dr. Harrison performed the operation. Over the next month, the two pieces of her esophagus were pulled together by tightening the thread connecting the balls. Meanwhile, she was fed through a valve implanted in her stomach.

Eventually, as Dr. Harrison had theorized, Annabelle’s esophagus became united. She initially had trouble swallowing, and a follow-up surgery was required to remove scar tissue. But within a few years, Annabelle had no lingering issues — not always true for kids treated with the typical surgery. They can experience choking, difficulty swallowing, or reflux for their entire lives.

Today, Annabelle is a college freshman studying English, with plans to become a teacher. And the procedure that Dr. Harrison pioneered with Annabelle is now being reimagined using magnets to draw the two esophageal pouches together. This research is being supported by UCSF’s Pediatric Device Consortium, a center dedicated to cultivating innovative medical advances for children.

“This kind of work is totally incredible,” Tom says. “It saves children’s lives. And that’s as important as it gets. It changed everything for our family.”

As for Annabelle, though she doesn’t remember much about her time as a UCSF patient, she’s grateful that Dr. Harrison’s out-of-the-box thinking has allowed her to live a normal life.

“If not for his idea, I probably would have a lot more problems,” Annabelle says. “It’s really impressive that UCSF is constantly trying to improve what can be done to help kids.”

UCSF PDC Holds Inaugural Accelerator Competition

November 30, 2017

On Tuesday, November 14, the UCSF Pediatric Device Consortium (PDC) held its inaugural Pediatric Device Accelerator Pitch Competition at UCSF’s Mission Bay campus. The competition awarded a total of $252,500, funded by FDA’s Office of Orphan Products Development and the UCSF Department of Surgery, to teams developing novel medical devices for children.

Eight finalists, selected from a pool of 55 applicants from across the world, had just under 10 minutes to pitch their product ideas to a judges’ panel of five industry professionals: Mike Billig (CEO of Experien Group), Dan Burnett (President and CEO of TheraNova), Denise Forkey (Consultant at Denise Forkey Medical Device Development Solutions), Chris Jones (Consultant at Orb Product Development), and Russ Lindemann (Co-Founder of JustRight Surgical). The presentations, which included the pediatric clinical need, proposed technology, potential market, commercialization approach, and current development status, were followed by Q&A from the judges.

After the pitches, the judges presented prizes in increments of $50,000, $30,000 and $20,000. Top honors were awarded to InkSpace Imaging, Inc. and Auctus Surgical, Inc. Read more >>

Electronics 'like a second skin' make wearables more practical and MRIs safer for kids

November 15, 2017

UC Berkeley Professor of Electrical Engineering and Computer Sciences Ana Claudia Arias is using printers to develop novel medical devices with electronics that are thin and flexible. Devices include a pulse oximeter the size of a Band-Aid and blanket-like MRI coils for children. Continue reading

Silicon isn't just for computers. It can make a pretty good kidney, too.

October 6, 2017

For nearly two decades, UCSF Bioengineering professor Shuvo Roy, PhD, William Fissell, MD, and David Humes, MD, have been developing an implantable bioartificial kidney as an alternative treatment for end-stage renal disease. Under the guidance of FDA and a new expedited regulatory plan, the team has completed two years of preclinical testing and plans to move into humans in early 2018 and gain regulatory approval by 2020. Continue reading

UC Berkeley, UCSF team getting attention for device that helps diagnose pneumonia

September 19, 2017

Adam Rao, UCSF medical student and UC Berkeley-UCSF PhD candidate, is developing Tabla, an affordable device to detect pneunomia in children. Using the "percussion technique" and machine learning, the device detects sound frequencies in a patient's body to determine whether the lungs may have fluid accumulation. This past year, the team won the Rudd Family Foundation's Big Ideas at Berkeley grand prize and Fast Company's Innovation by Design student category. ABC 7 interviewed the team to learn more about the design and development process. Continue reading

Student-designed medical device wins Fast Company award

September 11, 2017

Tabla, a medical device used to diagnose pneumonia, was awarded top honors in the student category of Fast Company's 2017 Innovation by Design Awards. The low-cost device detects changes in sound waves during percussive physical examinations, providing a more accessible and affordable alternative to chest X-rays. The team includes Adam Rao, a medical student at UCSF and Bioengineering Ph.D. student at UC Berkeley/UCSF, and UC Berkeley graduates Chen Bao and Jorge Ruiz. The team also won the Rudd Family Foundation Big Ideas at Berkeley Competition in April.

Benjamin Padilla and Michael Harrison Awarded NIH R03 for Cryoanalgesia Study

August 29, 2017

The Eunice Kennedy Shriver National Institute of Children Health & Human Development (NICHD) at the National Institutes of Health (NIH) has awarded pediatric surgeons Benjamin Padilla, MD, and Michael Harrison, MD, a two-year grant to study the use of cryoanalgesia as a novel method of pain control in the Nuss Procedure. This study is a prospective, randomized trial comparing cryoanalgesia to thoracic epidural analgesia in post-operative pain control on adolescent and young adult patients who have undergone the Nuss Procedure. Cryoanalgesia is an innovative technology that locally freezes the peripheral nerves, causing nerve axons to degenerate. The result is temporary prevention of pain transmission, with complete axonal regeneration occurring in approximately 4-6 weeks. If effective, this pain control strategy could shorten hospital stays and decrease pain and opiate usage among Nuss procedure patients. Continue reading

Magnetic Compression Anastomosis (Magnamosis): First-In-Human Trial

August 24, 2017

Dr. Michael Harrison and PDC team members are halfway through a first-in-human trial for their magnetic compression anastomosis ("Magnamosis") device. Initial results have been published in the Journal of the American College of Surgeons (JACS). The device is a pair of self-centering magnetic rings that create an intestinal anastomosis without sutures or staples. The first five patients successfully underwent small bowel anastomoses with Magnamosis and did not have any anastomotic complications. Continue reading