Biomedical Innovation Manual for Medical Students

BACKGROUND: The UT Southwestern Biomedical Innovation program is modeled to a large degree after the Stanford Biodesign program. The program is based on the hypothesis that innovation can be learned, and it offers a step-by-step process which has been shown to result in successful new biomedical technologies. From a high level, the process involves starting with a broad list of needs in the healthcare sector, selecting a smaller number of these needs to focus on based upon criteria such as group capability, resources, and strategic fitness, devising a number of solutions to these needs, narrowing the number of solutions based upon feasibility, and then iteratively prototyping and testing the leading solution to develop a final working solution. Other academic institutions such as Johns Hopkins Center for Bioengineering and Design, Dukes Institute for Health Innovation, and University of Utah's Bench to Bedside have devised similar but distinct methodologies for teaching the skills involved in innovating new healthcare solutions and bringing those solutions to market. Since the passage of the Bayh-Dole Act in 1980, US universities have become increasingly involved in the business of technology transfer. Entire departments, such as UT Southwestern's Office of Technology Development have been formed for the purpose of protecting intellectual property and licensing it to existing companies or startup ventures. This has the benefit of increasing the chances that a technology with the potential to improve the lives of others will come to fruition while also serving as a source of revenue for universities. The financial and strategic importance of encouraging innovation and pursuing intellectual property and licensing agreements for US universities has become clear. The UT Southwestern Biomedical Innovation program hopes to encourage innovation at UT Southwestern Medical Center through the continued development of the Biomedical Innovation curriculum and organization.
OBJECTIVE: Writing and distributing a primer on Biomedical Innovation to first year medical students will increase their confidence and competence as they embark on their first Biomedical Innovation projects. METHODS: Using Biodesign: The Process of Innovating Medical Technologies as a primary resource, an outline for a 10 chapter primer on medical device design for medical students was developed. Information from several primary resources and from local experts in medical technology development was collected and compiled into a short, accessible manual. Approaches and curricula from other medical schools were also incorporated. Efforts were made to introduce everything a medical student would need to know when embarking on her first medical technology design and development project. RESULTS AND CONCLUSIONS: A 45 page introductory manual targeted at first year medical students learning how to perform their first biomedical innovation program was written. The manual covers topics such as clinical observation, project management, brainstorming, prototyping, patents, and pursuing FDA approval for a medical device. It presents each of these topics at a level appropriate for medical students and includes information relevant to students at UT Southwestern (e.g how to access prototyping resources on campus). The resulting manual will improve the resources available to UT Southwestern medical students interested in Biomedical Innovation and will increase the long-term stability of the Biomedical Innovation program by forming a more permanent body of institutional knowledge and standardizing the curriculum from year-to-year.