The Biomedical Device Innovation Program at the University of Utah

The University of Utah Department of Biomedical Engineering (BME) and the University of Utah Health collaborate at the interface of BME and clinical medicine to develop and commercialize biomedical products and related technologies. Leveraging Salt Lake Valley’s renowned expertise in biomedical device design and production, this partnership paves the way for innovative advancements and future growth.

Initiated in 2005, the Biomedical Device Innovation program creates educational and research opportunities that capitalize on the engineering/medicine interface to enhance product development within the University and the Utah medical device industry.

The program, through its biomedical device design (bioDesign) undergraduate courses and biomedical device innovation (bioInnovate) graduate track, offers students a unique opportunity to gain hands-on experience in developing groundbreaking medical devices from conception to prototype within the U.S. Food and Drug Administration (FDA) Design Control regulatory framework.

Program Highlights

      • – Promotes Hands-On Learning: Engage in a comprehensive biomedical device design training program that combines classroom learning, collaboration with clinicians, and laboratory work.
      • – Fosters Collaboration with Clinicians: Work directly with clinicians and physician-scientists who identify critical unmet needs in their practice, providing real-world problems for you to solve.
      • – Encourages Development of Innovative Solutions: Learn how to develop proof-of-concept prototypes and Design History Files that could lead to patentable devices and startup opportunities.
      • – Teaches Essential Industry Skills: Understand the medical device development process within the context of FDA Design Control regulations, build business models for medical device startups, and gain insights into risk management and intellectual property evaluation.
      • – Facilitates Collaboration and Networking: Work as part of a multidisciplinary team and connect with professionals, mentors, and peers in the biomedical device industry.

For Prospective Students

The foundational knowledge acquired from this program enables our alumni to thrive in the biomedical device industry and make life-changing impacts through innovation. Students in the program have a strong track record of success in competitions like Bench 2 Bedside, where they can secure funding to advance their projects beyond the program.

Join Us

At the undergraduate level, the Biomedical Device Innovation program is an integral part of the BME Bachelor of Science (BS) degree. Key courses include Digital Design and Fabrication and bioDesign I and II. At the graduate level, the program is offered through the bioInnovate graduate track specialization, either as part of a BME Master of Science (MS) or Doctor of Philosophy (PhD) degree. Key courses include bioInnovate I and II, Clinical Problem Solving I and II, and Regulatory Affairs I and II. For detailed admission requirements and program structure, please refer to the latest Undergraduate and Graduate Handbook.

For Clinicians, Researchers, and Healthcare Professionals

Every day, you encounter unique challenges and unmet needs in your clinical practice and research. We invite you to leverage your insights by mentoring student teams in the Biomedical Device Innovation Program.

Why Participate?
– Drive Innovation:Collaborate with passionate engineering students to transform your clinical insights into innovative solutions.
– Professional Growth:Gain exposure to the engineering design process and FDA Design Control requirements.
– Impactful Mentorship:Guide the next generation of innovators and contribute to developing new medical devices and products.
– Networking Opportunities:Meet engineering students passionate about solving healthcare problems and participate in groundbreaking medical innovations.

Your Role:
As a clinician, researcher, or healthcare professional, you can uniquely identify clinical needs and challenges. Your practice and research can form the basis of impactful project ideas, driving real-world medical innovations.

Get Involved:
Contact our program faculty! We welcome submissions throughout the year for two-semester project periods. Graduate projects start each fall semester, with undergraduate projects beginning each spring semester.

Program Faculty:

Dr. Kelly Broadhead, Director of Undergraduate Operations
Email: kelly.broadhead@utah.edu

Dr. Alphonsus Ng, bioInnovate Track Chair
Email: alphonsus.ng@utah.edu

Dr. Tomasz Petelenz, Biomedical device innovation and regulatory affairs specialist
Email: tomasz.petelenz@utah.edu

Guest Lecturers:

Shawn Fojtik, CEO and Co-Founder (Control Medical Technology and Distal Access)

Dr. Raymond Price, Endowed Professor of Global Surgery (University of Utah)

Paul Taylor, Shareholder (Ray Quinney & Nebeker)

Alfred Mowdood, Head of Faculty Services (University of Utah)

Tallie Casuccim, Science & Engineering Librarian (University of Utah)

Parker Tyler, Director of Reliability Engineering (Edwards Lifesciences)

Alpa Patel, Director of Scientific Improvement (Nelson Laboratories)

Dr. Bryan McRae, Otolaryngology Surgeon (University of Utah)

Dr. Tyler McCabe, President and CEO (J3 Bioscience)

Dr. Helin Räägel, Principal Biocompatibility Expert (Nelson Laboratories)

Dr. Jocelyn Todd, Senior Software Analytics Project Manager (bioMérieux)

Randy Parry, Staff Regulatory Affairs Specialist (embecta)

Nolan Ingersoll, Senior Qualify Engineer (Epitel)

John Stringham, Shareholder (Workman Nydegger)

Logan Christenson, Associate Patent Attorney (Workman Nydegger)

Dr. Jim Agutter, Associate Professor of Multi-Disciplinary Design (University of Utah)

Martell Winters, Director of Scientific Competency (Nelson Laboratories)

Dr. Roger Altizer, Associate Professor of Population Health Science (University of Utah)

Troy D’Ambrosio, Vice President for Innovation (University of Utah)