For residents interested in medical technology innovation and entrepreneurship, the Innovation Pathway provides the opportunity to work alongside surgical innovators, bioengineering faculty and graduate students, and medical device industry professionals to design and implement novel, cost-effective solutions to pressing clinical needs. Projects are selected from among various device development efforts underway in the Department of Surgery, which include new devices and approaches to problems such as decubitus ulcers, dialysis and renal failure, complications of fetal intervention, incisional hernias, and scoliosis. This pathway will provide residents with an in-depth understanding of the technical, regulatory, and business realities involved in bringing novel medical devices to the market while providing hands-on experiential learning in the process of device design, testing, and startup formation.
There are four possible research tracks for residents entering this pathway:
- Master of Translational Medicine (MTM) Track
For residents interested in obtaining an advanced degree during their research years, the UC Berkeley-UCSF Master of Translational Medicine Program is a one-year full-time master’s program that trains students in applying translational research and engineering approaches to solve fundamental problems in healthcare delivery. Residents will choose capstone projects from among the projects submitted by Surgery faculty, and will continue working with their faculty mentor in their second research year to advance the project towards clinical implementation.
- Entrepreneurship Track
For residents interested in pursuing device research and development full-time while being exposed to the business realities involved in bringing a new product to the market, the Entrepreneurship Track provides a framework for advancing device innovations to the startup or licensing stage. Projects will have been previously vetted by an industry advisory panel for commercial viability.
- The Kidney Project
Residents in this track have the unique opportunity to take part in a national research effort to develop a surgically implantable bioartificial kidney to treat end-stage renal disease. Working among an interdisciplinary team of bioengineers, surgeons, nephrologists and others to design and carry out preclinical animal studies, residents will gain hands-on exposure to the latest bioengineering advances while laying the groundwork for the clinical translation of this first-of-its-kind device.
- Other Project of Pathway Mentor
Residents interested in working on a particular device or technology development project that is not part of the three tracks above may do so with the approval of the Pathway Director.
Innovation Pathway residents will receive core didactic training on topics relevant to translational medicine and medical device development, including intellectual property, regulatory and reimbursement considerations, clinical trials, cost-effectiveness analysis, and entrepreneurship. Pathway residents are expected to take one class per semester, to be chosen in consultation with the Pathway Director based on the nature and goals of the resident’s project and the resident’s interests.
Bioengineering/Clinical R&D Courses
- Bioe 260 – Translational Challenges in Medicine (Fall)
- Bioe 270 – Translational Challenges: Diagnostics, Devices & Therapeutics (Winter)
- Epi 260 - Development and Approval of Drugs and Devices (Spring)
Business and Entrepreneurship Courses
- Bioe 285 – Healthcare Finance & Economics (Fall)
- Lean Launchpad for Life Sciences and Healthcare (Fall)
- Biochem 241 – Idea to IPO…& Beyond (Winter)
General Research Courses
- Epi 150.03 (1 month) or Epi 202 (2 months) - Designing Clinical Research (Summer or online)
- Scientific Writing (Fall and Spring)
- Biostat 193 – Introduction to Statistical Analysis (Fall)
Advanced Degree Option
The Master of Translational Medicine (MTM) program is a professional master's program run jointly between the College of Engineering at UC Berkeley and the Schools of Medicine and Pharmacy at UC San Francisco. The program is 11 months long (August-June), and is well-suited for scientists, engineers, and clinicians who have a strong interest in medical technology innovation, including medical devices, new drug development, technical design, and the business and regulatory aspects of the med-tech and healthcare industries. Graduates of the program receive a unique Master of Translational Medicine degree from two world-class institutions. More information is available at http://bioeng.berkeley.edu/mtm. Interested applicants may contact the UCSF MTM Faculty Director, Shuvo Roy, PhD, at Shuvo.Roy@ucsf.edu with specific questions.
Surgical Innovation Fellowship
The Department of Surgery offers 1-2 sponsored fellowship slots per year to exceptional residents interested in pursuing innovation-related research and training during their research years. Please note that, in order to direct departmental resources to projects that have been vetted for merit/viability and potential return on investment to the Department, residents choosing Track 4 above are not eligible for this fellowship.
Open Grant-Funded Positions
Faculty mentors participating in this pathway may have grant funding to support a research resident. Such opportunities will be listed here as they arise.
- For the general list of fellowships and other grant opportunities for the resident research program, click here.
- Resident gains first-hand knowledge of the device development process and related topics such as intellectual property, quality systems, and regulatory, reimbursement, and business considerations
- Resident gains basic prototyping skills (CAD modeling, 3D printing, etc.) and an appreciation for engineering processes
- Resident gains skills in the design and conduct of animal models and human trials
- Resident gains experience developing a business plan and pitching to investors
- Resident gains the leadership skills necessary for successful multidisciplinary collaborations
- Completion of primary project
- General milestones
- Year 1: Abstract/paper submitted describing prototype development, proof-of-concept testing, etc.
- Year 2: Abstract/paper submitted on results of preclinical or clinical testing, as applicable
- Exact milestones/goals identified with mentor depending on project specifics
- Completion of pathway coursework
- Twice-weekly Innovators Meetings attendance
- Regularly scheduled meetings with faculty mentor
- Other Surgical Innovations meetings and events