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About Utah bioInnovate

‣ The Department of Engineering and School of Medicine have partnered with Tech Ventures to provide both technical and commercialization education to the students in the graduate bioInnovate track. The courses include instructors from both the clinical and industrial side of medical device development. Guest lecturers from the medical device sector including clinicians, entrepreneurs, designers, engineers and business executives who will provide case studies of successful new products. The core teaching team is comprised of Bioengineering and School of Medicine faculty.

‣ As part of the curriculum we require our student teams to adhere to FDA mandated standard operating procedures (SOPs) that were developed for relevant areas of the bioInnovate design process. By establishing our own internal procedures for this course, we mirror the approach that is taken by industry, thereby exposing our students to current best practices. In addition, the SOPs provide all student design teams with a common interpretation of design control as contained in the Code of Federal Regulations. Utah bioIinnovate takes advantage of key collaborative resources at the University, provides an avenue for the development of new medical products and trains our students in medical device innovation, design and development. In addition to regulatory compliance training, the bioInnovate track aims to train students in business development and clinical needs identification and concept generation. This will provide a rounded professional training experience allowing students to identify unmet needs, generate conceptual solutions, develop and design medical products under the regulatory framework of the FDA, develop business plans and identify funding sources for company startup.