UCSF PDC Members

This group is a collection of all registered users. You can find general updates and other PDC news within this group.

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.

Sheikh Zayed Institute for Pediatric Surgical Innovation - Sept 23 Symposium & Pitch Competition in Philadelphia

Pediatric Medical Device Pitch Competition 

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.

Submission deadline: September 10, 2018, Midnight PST

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

6th Annual Pediatric Device Innovation Symposium

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

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

News & Announcements - June 2018

FDA Issues Draft Guidance on Humanitarian Device Exemption (HDE) Program

The FDA has released a draft guidance on the Humanitarian Device Exemption program, including FDA actions on HDE applications, post-approval requirements, and special considerations for devices marketed under the HDE Program. Comments may be submitted to Federal Register docket number FDA-2014-D-0223 until August 13, 2018. 

Read here: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm389275.pdf



Request for Proposals: UC Berkeley-UCSF MTM Capstone Projects

Submission deadline: June 30, 2018

Medical device developers are invited to submit projects to the UC Berkeley-UCSF Master of Translational Medicine program. Interdisciplinary teams of ~4 students, with backgrounds in engineering, life sciences, and medicine, spend a year working to bring a new medical innovation closer to the clinic. Throughout the year, they work on both technical and business development, exploring regulatory, reimbursement, and IP considerations. Project mentors must have adequate resources available for students to dive into projects and be able to commit time to help students advance their goals. 

Application instructions: https://gallery.mailchimp.com/8261aabf939f27a4994c67a65/files/24312994-c8c2-4f80-9414-7ca8197ba2af/MTM_project_solicitation_2018_19_FINAL.pdf



FDA Public Meeting: Pediatric Medical Device Development - Silver Spring, MD

Registration deadline: August 6, 2018

The Food and Drug Administration is holding a public meeting to identify strategies that enhance the medical device ecosystem toward development and innovation and devices that serve the complex needs of children. The FDA invites all stakeholders, including members of the medical device industry, academia, medical provider organizations, and individuals or organizations representing patients and consumers, to attend.

View the program: https://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM606958.pdf
Register here: https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm596777.htm

Date: August 13-14, 2018
Time: 9:00am - 5:00pm
Location*: FDA White Oak Campus, Silver Spring, MD

*Remote viewing option available via WebEx



Pediatric Innovation Retreat - Pittsburgh, PA

The McGowan Institute, in collaboration with Children's Hospital of Pittsburgh, SciVelo, and the Philadelphia Pediatric Device Consortium, is hosting the 2nd Annual Pediatric Innovation Retreat on July 13, 2018 at the William Pitt Union. The program will be comprised of "game changing" technology presentations, translational practicums, a keynote luncheon, and moonshot pitches.

Date: July 13, 2018
Time: 8:00am – 3:30pm
Location: Alumni Hall, Connolly Ballroom, University of Pittsburgh, 4227 Fifth Ave, Pittsburgh, PA 15260

View the agenda & register here: https://www.eventbrite.com/e/2nd-annual-pediatric-innovation-retreat-registration-45779316167



UCSF Surgical Innovations and TheraNova Form New Partnership to Accelerate MedTech Innovation

The UCSF PDC’s partner program, Surgical Innovations, and San Francisco-based medical device developer TheraNova have formed a partnership that will allow for co-development of medical device technologies between them. Under the new arrangement, UCSF-affiliated innovators will have a streamlined mechanism to work with TheraNova engineers and product developers to move products closer to commercialization.

Read more: https://surgicalinnovations.ucsf.edu/news--events/ucsf-news/79465/UCSF-Surgical-Innovations-and-TheraNova-Form-New-Partnership-to-Accelerate-MedTech-Innovation



Turning Surgeons Into Innovators Without Taking Them Out of the OR

Medical Device and Diagnostic Industry (MDDI) profiled UCSF Surgical Innovations highlighting how its dynamic infrastructure allows physicians to develop novel medical devices and technologies while remaining clinically active. With its core team of faculty, engineers, trainees, and staff -- many of whom are involved in the UCSF PDC -- along with its widespread network of industry and government partners, Surgical Innovations is paving the way for surgeons to collaboratively and creatively problem-solve around real clinical challenges. Resources provided by the organization include clinical and technical feedback, prototyping services, seed funding, research fellowships, regulatory and reimbursement advising, and market analysis. 

Read more: https://www.mddionline.com/turning-surgeons-innovators-without-taking-them-out-or