Enhanced Design Experiences for Duke BME Students George A. Truskey Department of Biomedical Engineering Duke University

Current Situation – Several distinct and non-interacting activities Students select from a suite of one-semester design courses covering a range of topics Students may also take BME 120 to learn about developing a successful business plan Co-curricular activities such as Duke Start-Up challenge and DuHatch No exposure to idea generation and needs finding

Goal Create an enhanced and integrated design experience so that students are involved in all aspects of the design process including clinical needs finding and validation, project identification and definition, design, prototyping and early stage translation

Specific Aims Create a course on Biomedical Device Innovation Establish a Clinical Needs Finding Practicum Offer expanded design sequence Integrate BME design experience with curricular and co-curricular activities in technology translation and entrepreneurship

1. Create a course on Biomedical Device Innovation Introduced in Spring 2011 for undergraduates and Fall 2011 for masters students. Students work in teams (a) literature review and immersion in a medical specialty area (b) needs specification, regulatory and legal issue assessment, prioritization, and conceptual design (c) comprehensive plan for detailed design

2. Establish A Clinical Needs Finding Practicum Two teams of four students One week of introductory material Two clinical rotations from list of four Develop list of needs and discuss top 3 needs Present work to BME and Medical Center faculty mediasite02.win.duke.edu/prattdl/SilverlightPlayer/Default.aspx? peid=bbc8fbea6e764048806aade44216cbfe Team leaders spent an additional two weeks refining needs.

Clinical Practicum Four experiences Observed procedures Mechanical cardiovascular assist devices Neuroradiology Ophthalmic surgery Physical therapy Observed procedures Met with physicians, residents, staff and engineers Established criteria to filter and state needs Identified 124 needs Challenge – identifying needs w/o bias towards solution

Lessons Learned Students and clinical faculty were extremely enthusiastic about program Establish closer interactions with Surgery Identified needs used in design courses, biomedical device innovation course, and business development course Issues to examine Integrating needs finding with design courses Balance between future needs identification and further developing needs identified One or two clinical experiences Providing depth in Biomedical Device Innovation Course

Going Forward Present summary of program to date to advisory board Begin work on Aims 3 and 4 Develop an organized program for undergraduates and masters students integrating innovation and design

Acknowledgments NIH R25 EB013127 Clinical mentors: James Provenzale, MD; Michael Richard, MD; Joseph Rogers, MD; Kathy Shipp, PhD Andrew DiMeo, NCSU Bob Barnes, PhD Ricardo Pietrobon, MD, MBA The students