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FDA Issues Draft Guidance on Humanitarian Device Exemption (HDE) Program

The FDA has released a draft guidance on the Humanitarian Device Exemption program, including FDA actions on HDE applications, post-approval requirements, and special considerations for devices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. 

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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:

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:
Register here:

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:

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.

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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. 

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