The MedTech Innovation + Entrepreneurship curriculum is a comprehensive, end-to-end exploration of medical device development—from identifying unmet clinical needs to navigating post-market distribution and surveillance. This 30-credit program is anchored by three cornerstone courses: BME 501, 502, and 503. In these team-based courses, students progress through the full innovation cycle: uncovering unmet needs in clinical settings (BME 501), designing, prototyping, and testing solutions (BME 502), and building go-to-market strategies to launch new medical technologies (BME 503).
BME 501: Needs Discovery
This course equips students with practical tools and frameworks for front-end healthcare innovation. Through clinical observations, stakeholder interviews, and secondary research, students learn to identify unmet clinical needs and evaluate potential value propositions. Emphasis is placed on understanding patient and provider perspectives, disease state fundamentals, market dynamics, and barriers to adoption. Students will develop core competencies in ethnographic research, value proposition development, and effective communication with key healthcare stakeholders.
BME 502: Design & Innovation
This course teaches an early-stage, iterative approach to prototyping and development for healthcare technologies. Students learn to translate user needs into functional requirements, identify and reduce technical and business risks through targeted experiments, and develop a “minimum awesome” prototype that aligns with defined performance criteria. Guest lectures and site visits provide exposure to real-world medtech development, including IP, usability, startup formation, and funding. The course builds practical skills in design, experimentation, technical communication, and innovation strategy.
BME 503: Product Development
This course teaches students how to take a medical device prototype through a medical device development process to market approval and post-market distribution and surveillance. Students will continue to iterate their solution while assessing and mitigating risk, applying design for manufacturing and assembly principles, refining verification and validation plans, and fundraising to support the execution of business milestones.
BME 504: Medical Device Materials & Manufacturing
This course takes students on a journey from material science to finished, packaged medical device. Students learn all of the manufacturing activities required to fabricate, assemble, package and label a single-use medical device. This includes CAD design, detailed drawings, tolerance analyeses, tooling design, manufacturing process instructions, packaging design and process development activities such as installation and operational qualifications. Each student leaves this course with a packaged, labeled medical device they built themselves from raw materials to completion.
MBA / Entrepreneurship Courses
Explore the path from innovation to impact with a range of courses in technology commercialization and entrepreneurship. TEC I & II (MBA/MSE 576 & 577) at NC State guide students through evaluating technologies, building value propositions, and creating business plans for startups or spinouts. At UNC, Start the Startup (GRAD 718) offers hands-on experience using Lean Startup methods to test business ideas with expert coaching, while Technology Commercialization Fundamentals (GRAD 755) is a short, online course focused on market assessment, IP, licensing, and university-based tech transfer. These are just some of the options available to students.
Supplemental Courses
The curriculum is enhanced by a technical elective, a course on regulatory strategy and requirements, and the option to pursue a for-credit internship. The technical elective enables students to gain deeper expertise in a specialized area of interest through at least three credit hours of 500- or 700-level coursework. These components provide flexibility to tailor the program to individual career goals while building practical knowledge and industry-relevant experience.
In addition to the cornerstone courses, students gain knowledge of medical device materials and manufacturing in BME 504, regulatory expertise in BEC 575, and complementary technical depth in an elective of their choosing. The curriculum also includes three MBA/entrepreneurship courses, taken at either UNC or NC State, which teach technology valuation, new venture analysis and business plan development.
“The coursework gives a strong foundation for real-world work and prepares you on many levels. From manufacturing and prototyping, to working in interdisciplinary teams and commercialization, the entire product life cycle is demonstrated through coursework and projects.”
— Maggie Walker, Class of 2025