The UCSF-Stanford PDC supports pediatric device innovators by providing mentorship and advising in clinical needs-finding, technical design, product development, intellectual property and patenting, business development, regulatory strategy, manufacturing, and commercialization. Read more about how to access our resources here.
UCSF and Stanford University are leading biomedical research and education institutions. With our large network of clinical collaborators and proximity to the UCSF Benioff Children’s Hospitals and Lucile Packard Children’s Hospital, we are within arm’s reach of leading clinical experts in all areas of pediatric medicine.
Services include: clinical feasibility and needs assessment; clinical collaborators
In parallel to our clinical strengths, the PDC offers science and engineering expertise in-house and through faculty at UCSF and Stanford. Our in-house and external partners’ facilities have 3D printing, rapid prototyping, and manufacturing capabilities.
Services include: early-stage technical vetting; design and prototype development; benchtop testing
Our network of product development experts, led by Director Chris Jones, assists PDC members with the later stages of the engineering process. In addition to this network, the UCSF PDC has a collaboration agreement with medical device incubator TheraNova, providing PDC members with certified processes and facilities for manufacturing of medical equipment.
Services include: prototype testing; manufacturing; quality systems
Our Commercialization Advisory Board provides perspective on all aspects of business development, value landscaping, and commercialization strategy for pediatric device innovators. Synergistic programs, such as Stanford Biodesign, QB3’s Rosenman Institute, UCSF Entrepreneurship Center, and Fogarty Institute for Innovation offer ongoing educational workshops and speaker events as well.
Services include: go-to-market and commercialization strategizing
Our Regulatory Core provides extensive regulatory, reimbursement, and quality assurance capabilities. On-site expertise is provided by PDC Clinical-Regulatory Engineer Alex Balus. In addition, the PDC works closely with the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) to provide educational opportunities for pediatric device innovators.
Services include: assistance with FDA inquiries and submissions; up-to-date advising on FDA guidelines and initiatives; reimbursement consulting
A crucial aspect to device development is navigating whether your invention or technology is protectable and whether you have freedom to operate (FTO). The PDC works with well-respected patent attorneys and patent agents in the medical device field to assist in meeting the intellectual property needs of PDC members. For UCSF investigators, the PDC facilitates connections to the UCSF Office of Innovation, Technology, and Alliances to disclose inventions.
Services include: FTO analysis; patent drafting; legal advising
The business planning component of the PDC is led by Entrepeneur-in-Residence Dan Burnett, with additional support from the PDC’s Industry Council, Value Analysis Core, and Commercialization Advisory Board. The entrepreneurs and industry leaders provide ongoing office hours and mentorship to our PDC members.
Services include: market analysis; business planning; value landscaping; hospital purchasing analysis
Utilizing the Stanford Biodesign process, Vivian de Ruijter coaches PDC members develop, refine, and implement in their device projects throughout all stages of the development process.
Services include: needs finding; concept generation; strategy development