News & Announcements - September 2018

UCSF PDC expands to Stanford, receives new 5-year FDA grant

Michael Harrison, MD (UCSF Pediatric Surgery), Shuvo Roy, PhD (UCSF Bioengineering), and James Wall, MD (Stanford Pediatric Surgery) have been awarded a five-year $6.7 million P50 grant from the U.S. Food and Drug Administration (FDA) for the UCSF-Stanford Pediatric Device Consortium (PDC). The UCSF-Stanford PDC will leverage the strengths of UCSF's program in surgical device innovation, Stanford's renowned Biodesign program, Northern California's top two children's hospitals, and a rich network of device industry and entrepreneurial partners to support pediatric device innovators through the total product development lifecycle. 

Read more: https://www.ucsf.edu/news/2018/09/411551/pediatric-device-consortium-celebrates-future-innovations-67m-fda-grant



Request for Proposals: "Make Your Medical Device Pitch for Kids!" Competition

Application deadline: September 10, 2018

The Sheikh Zayed Institute for Pediatric Surgical Innovation is now accepting proposals for their annual pediatric medical device pitch competition. The challenge competition is open to device innovators that propose a cardiac or vascular device solution that will also be tested in pediatric patients <18 years old. Awards include funding (up to $25k), access to experts at Children's National Sheikh Zayed Institute for Pediatric Surgical Innovation and University of Maryland A. J. Clark School of Engineering, and facilitated engagement in the Institute for Advancement of Clinical Trials in Pediatrics (I-ACT) network.

Apply here: http://www.pediatric-device-symposium.org/competition/



6th Annual Pediatric Device Innovation Symposium - Philadelphia, PA

Sheikh Zayed Institute's 6th Annual Pediatric Device Innovation Symposium is co-locating in Philadelphia, PA in a joint effort with The MedTech Conference powered by AdvaMed. This year's theme is "Using Real-World Evidence to Drive Pediatric Innovation." Stakeholders from industry, government, academia and patient groups will discuss how best to use real-world evidence to drive pediatric device innovation.

Date: Sunday, September 23, 2018
Time: 7:30am - 8:00pm
Location: Pennsylvania Convention Center, Philadelphia, PA

Registration & details: http://www.pediatric-device-symposium.org/



Fogarty Institute for Innovation Incubator Program

Medical device and technology startups are invited to apply for the Fogarty Institute for Innovation's Incubator Program. Participants receive office and lab space, extensive education, full-time mentoring, and access to the Institute's medtech innovation system. The program is located on the campus of El Camino Hospital in Mountain View, CA.

Application & details: http://fogartyinstitute.org/apply.html



FDA Issues Draft Guidance on Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions

The FDA Center for Devices and Radiological Health (CDRH) has released a draft guidance on the Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions. The draft guidance:

  • Elaborates on FDA's consideration of the appropriate uncertainty in benefit-risk determinations for certain premarket submissions and provides factors considered in such determinations;
  • Reemphasizes FDA's flexible, patient-centric approach to assessing the benefit-risk profile of a medical device; and
  • Provides examples of how uncertainty can be acknowledged and appropriately mitigated where FDA is likely to accept greater uncertainty in premarket decisions, such as Breakthrough Devices and devices intended for small patient populations subject to PMA.

If you have any questions regarding this document, please contact CDRH's Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, or by phone at 1-800-638-2041 or 301-796-7100.

Read here: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM619220.pdf



Collaborating Across the Bay to Alleviate Post-Op Pain for Pectus Patients

UCSF Benioff Children's Hospital Oakland profiles a collaboration between UCSF pediatric surgeons Sunghoon Kim, MD, Benjamin Padilla, MD, and Michael Harrison, MD, and their use of cryoanalgesia during the Nuss Procedure, a surgical treatment for pectus excavatum. Cryoanalgesia is a novel approach to reducing post-operative pain, leading to decreased hospital stays and narcotic medication use.

Read more: https://www.childrenshospitaloakland.org/main/cross-bay-collaboration-alleviate-post-op-pain.aspx



FDA Addresses Severe Lack of Pediatric Devices

Jessie Huisinga, PhD, and Leah Taylor, MS, of Agilis discuss FDA's recent public meeting on pediatric device development. Their general takeaways include:

  • "Adult medical devices are often used off-label for pediatric patients"
  • "The development of pediatric medical devices is difficult for sponsors"
  • "The pediatric medical device community is interested in incentives to develop pediatric medical devices"
  • "FDA provides data leveraging options to extrapolate adult data or use quality real-world data"

Read more on MDDI Online: https://www.mddionline.com/fda-addresses-severe-lack-pediatric-devices

FDA Public Meeting - Pediatric Medical Device Development webcast & presentation archive: https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm596777.htm



BIOMEDevice Conference - San Jose, CA

Join medtech industry leaders and experts at BIOMEDevice in San Jose. Learn about Silicon Valley's latest developments, trends, and technologies in the medical device design and manufacturing community, from digital health, sensors, biomedical innovation and minimally invasive devices to surgical robotics, while offering a full spectrum of practical solutions to today's engineering challenges.

Date: December 5-6, 2018
Time: 9:00am - 4:00pm
Location: San Jose Conference Center, San Jose, CA

Learn more: https://biomedevicesj.mddionline.com/

Contact Stacy Kim (stacy.kim@ucsf.edu) to register through the UCSF PDC.