A 1-2 year research experience for clinical residents and fellows
For residents interested in medical technology and surgical innovation, the Biodevice Innovation Pathway provides rigorous hands-on research experiences developing and translating novel medical devices and techniques for unmet clinical needs alongside surgical innovators, bioengineering faculty and graduate students, and device industry professionals. Projects are selected from among various device development efforts underway in the Surgical Innovations program and in the laboratories of the pathway mentors, which include new devices and treatment approaches for sleep apnea, decubitus ulcers, kidney disease, diabetes, incisional hernias, and tissue retraction. This pathway will provide residents with an in-depth understanding of the technical, regulatory, and business realities involved in bringing novel medical technologies to the market while providing experiential learning in device design, animal model development, clinical trials, and startup formation.
Eligibility: Surgery residents or residents from other surgical disciplines from UCSF or outside universities with one or two years to devote full-time to research.
Current openings: We have two funded fellowship slots for Innovation Pathway residents beginning July 2017. Contact Elizabeth.Gress@ucsf.edu to learn more and begin the application process.
Biodevice Innovation Pathway Team
- Edward Chang, MD – Neurological Surgery
- Michael Conte, MD – Vascular & Endovascular Surgery
- Tejal Desai, PhD – Bioengineering & Therapeutic Sciences
- Emily Finlayson, MD – General Surgery
- Julius Guccione, PhD – Cardiothoracic Surgery & Bioengineering
- Hobart Harris, MD, MPH – General Surgery
- Michael Harrison, MD – Pediatric Surgery
- Steven Hetts, MD – Interventional Radiology
- Hanmin Lee, MD – Pediatric Surgery
- Jeffrey Lotz, PhD – Orthopaedic Surgery
- Theodore Miclau, MD – Orthopaedic Surgery
- Shuvo Roy, PhD – Bioengineering & Therapeutic Sciences
- Marshall Stoller, MD – Urology
- Qizhi Tang, PhD – Transplant Surgery
- Valerie Weaver, PhD – Surgery & Bioengineering
Innovation Pathway residents will receive core didactic training on topics relevant to translational medicine and medical device development, including scientific writing, clinical trial design, intellectual property, regulatory and reimbursement considerations, cost-effectiveness analysis, and entrepreneurship. Pathway residents are typically expected to take one class per quarter, to be chosen in consultation with the Pathway Directors based on the nature and goals of the resident’s project and the resident’s interests.
General Research Courses
- EPI 150.03 – Designing Clinical Research
- Department of Surgery Scientific Writing Course
- BMS 214 – Ethics and Responsible Conduct of Research
- BIOSTAT 200 – Biostatistical Methods in Clinical Research
- EPI 212 – Publishing Medical Research
- CTSI Grant Writing Workshop
- Software/specialized training as required by project (e.g., Intro to ANSYS, SolidWorks, etc.)
- BIOE 270 – Translational Challenges: Diagnostics, Devices & Therapeutics
- Establish and maintain first-hand knowledge of the device development process and related topics such as intellectual property, quality systems, and regulatory, reimbursement, and business considerations.
- Gain fluency in foundational clinical and translational research skills such as experimental design, biostatistics, research ethics, and grantsmanship
- Apply basic prototyping skills (CAD modeling, 3D printing, etc.) and demonstrate an appreciation for bioengineering processes.
- Develop and troubleshoot animal models of surgical diseases.
- Develop a business plan and pitch to investors.
- Develop leadership and communication skills and work effectively in multidisciplinary teams.
- Completion of primary project
- General milestones
- Year 1: Presentation at major engineering conference; grant submission
- Year 2: Manuscript preparation and submission; presentation at major surgical conference
- 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
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 up to two sponsored fellowship slots per year to exceptional residents interested in pursuing innovation-related research and training during their research years.
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.
- Project: Magnetic Duodeno-Ileal Bypass for Metabolic Syndrome in Rhesus Monkeys
Mentor: Michael Harrison, MD
Funding Source: NIDDK SBIR 1 R44 DK112453-01
Key Tasks: In vivo studies, surgical technique development, histologic analysis
Collaborating Institutions: UC Davis, Columbia University
Description: Type 2 diabetes mellitus (T2DM) associated with obesity can now be successfully treated by bariatric surgery. The metabolic effect is rapid – in part independent of the effect on weight loss – and mediated by gut factors. We are exploring the possibility that this beneficial effect on T2DM can be achieved without major surgery by creating a small side-to-side magnetic compression anastomosis between the duodenum and the ileum (Magnetic Duodenal-Ileal Bypass, or “DIPASS”). Our preliminary data in mini-pigs suggest that, by diverting a small amount of digestive juices (gastric, biliary, pancreatic) to the ileal mucosa, this intestinal short cut is able to mimic the beneficial metabolic and hormonal effect of bypass surgeries on glucose metabolism. This proposal will test: 1) the feasibility of inserting the intestinal short cut (DIPASS) in a non-human primate model of metabolic syndrome; 2) the efficacy of the DIPASS procedure, versus sham operation, on improving metabolism; and 3) the mechanism by which DIPASS exerts its effect on glucose metabolism.
- Project: Bioinspired Polymers for Fetal Membrane Pre-Sealing
Mentor: Michael Harrison, MD
Funding Source: NIBIB 1 R01 EB022031-01 (UC Berkeley prime)
Key Tasks: In vivo studies, benchtop testing, tissue analysis, delivery technique development
Collaborating Institutions: UC Berkeley, Caltech
Description: The goal of the project is the development and testing of a bio-adhesive for sealing the amniotic membrane after fetal intervention. The synthesis of the bio-adhesive will be done in Dr. Phil Messersmith’s laboratory at University of California, Berkeley. To test the utility of the bio-adhesive for sealing the amniotic membrane, bench top and animal studies will be performed at UCSF. The bench top studies will be performed on human fetal membranes procured from the UCSF maternity ward. Burst pressure tests will be performed to test the effectiveness of the bio-adhesive in sealing the membrane. A rabbit animal model will be employed to test the efficacy of pre-sealing fetal membranes with the bioinspired sealants in vivo. Primary outcome measures will include fetal survival rates and amniotic fluid leakage.
- For the general list of fellowships and other grant opportunities for the resident research program, click here.