Participating Units

Degree Programs

  • Bachelor of Science (BS)
  • Master of Science (MS)
  • Doctor of Philosophy (PhD)
  • BS/MS
  • MS/MBA
  • MD/PhD

Partner faculty

The Biomedical Device Innovation Program at the University of Utah

The Department of Biomedical Engineering (BME) at the University of Utah established a hands-on, project-based educational program to address urgent industry demand for biomedical engineering specialists. The program fosters innovation, emphasizes the commercialization of medical products, and provides practical product design and development experience for future biomedical engineers. Since its introduction in 2005, the Program has established successful collaboration with physicians and scientists at the University of Utah Spencer Fox Eccles School of Medicine, offering educational and research opportunities that accelerate the development of impactful healthcare solutions at the intersection of engineering and medicine.

The Program equips students with comprehensive training in medical device development through a project-based curriculum, including clinical immersion, hands-on prototyping, regulatory affairs, business development, risk management, and intellectual property analysis. Additionally, clinicians, researchers, and healthcare professionals contribute project ideas, direct device development, and mentor student teams to effectively address real-world healthcare challenges.

Notable successes from the program include competition-winning projects, award-winning startup companies founded by collaborative teams of students and clinicians, and alumni advancing into leadership positions within prominent biomedical companies around the world.

Participants in the Biomedical Device Innovation Program have unique access to unparalleled teaching and research facilities in the Intermountain West. As projects mature, teams can leverage extensive biomedical device expertise and advanced manufacturing capabilities available throughout Utah.

Program Highlights

Prospective Students

Clinical Collaborators
Students receive comprehensive training through classroom instruction, clinical immersion, and hands-on device development. Clinical Collaborators identify unmet clinical needs and partner with student teams to develop innovative solutions.
Students collaborate with clinicians, researchers, and engineers to address real-world clinical issues. Clinical Collaborators guide the creation and testing of prototypes, providing valuable clinical and research perspectives. IP protection and commercialization are coordinated with the University’s Technology Licensing Office.
Students develop proof-of-concept devices with potential for patents and startups. Clinical Collaborators engage in projects with commercialization potential, including opportunities for patent filings and startup formation.
Students gain critical skills in regulatory affairs, business development, risk management, and intellectual property analysis. Clinical Collaborators enhance their professional knowledge through involvement in device development, regulatory compliance, and commercialization processes.
Students build valuable networks by engaging with peers, medical professionals, and industry mentors. Clinical Collaborators expand their networks by connecting with academic innovators, industry leaders, and peers experienced in medical device commercialization.

For Prospective Students

This program is offered at the undergraduate and graduate levels. Undergraduate students engage through the bioDesign capstone course series, a rigorous two-semester, project-based medical device design experience. In bioDesign, student teams collaborate closely with clinicians, researchers, and healthcare professionals to identify clinical needs, define design inputs, develop prototypes, and conduct verification testing, following FDA design control.

Graduate students participate in the bioInnovate graduate track, which builds upon the bioDesign foundation and offers advanced training in business model development, startup investment strategies, detailed planning for clinical validation studies, and deeper clinical immersion, such as shadowing or surgical observations.

Join Us

Undergraduates participate through the BME Bachelor of Science (BS) degree, completing mandatory courses such as Digital Design and Fabrication, bioDesign I, and bioDesign II, typically taken in their junior and senior years.

Graduate students participate through the bioInnovate graduate track within the BME Master of Science (MS) or Doctor of Philosophy (PhD) degrees, completing core courses such as bioInnovate I and II and Clinical Problem Solving I and II.

Students at both levels can further enhance their regulatory training through Regulatory Affairs I and II courses and earn credentials such as the undergraduate-level Regulatory Affairs in Healthcare Certificate and the graduate-level Regulatory Affairs in Medical Devices Certificate.

Please refer to the latest Undergraduate and Graduate Handbooks for detailed admission requirements and program information.

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 collaborate with student teams in the Biomedical Device Innovation Program, actively shaping the development of innovative medical device solutions.

Why Collaborate?

  • Demonstrate Feasibility: Prototype and test potential clinical solutions through student-led teams.
  • Toward Clinical Impact: Collaborate on projects that directly address the clinical needs you identify, with potential for commercialization, patent opportunities, and startup formation.
  • Professional Growth: Gain firsthand experience in device development, regulatory procedures, and commercialization pathways.
  • Network Expansion: Connect with academic innovators, industry leaders, and peers who have successfully navigated the medical device commercialization process.
  • Impactful Mentorship: Guide the next generation of innovators to make a lasting impact in your field.

Your Role

Your role includes defining clinically relevant problems, evaluating the clinical relevance of engineering solutions, guiding and/or performing validation studies, and mentoring student teams by providing clinical insights, particularly regarding user needs and the intended use environment. We encourage regular engagement with student teams, including participation in design reviews held four times over two semesters. Historically, teams with greater mentor-student engagement have achieved better outcomes, including higher-quality prototypes, enhanced student learning experiences, greater project advancement, stronger performance in competitions, and increased potential for commercialization.

Get Involved

We invite project submissions year-round. Graduate projects start each fall, undergraduate projects each spring. To propose a project or learn more, please contact our program faculty today.

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

Jason Pope, Senior Scientist (Nelson Laboratories)

Dr. Adam Dubis, Professor of Ophthalmology & Visual Sciences (University of Utah)

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 Casucci, Science & Engineering Librarian (University of Utah)

Parker Tyler, Director of Clinical Development (Edwards Lifesciences)

Alpa Patel, Director of Lab Operations (Nelson Laboratories)

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

Dr. Tyler McCabe, Co-Founder & Chief Operating Officer (J3 Bioscience)

Dr. Helin Räägel, Principal Biocompatibility Specialist (Arthrex)

Dr. Jocelyn Todd, Senior Manager, Data Science (bioMérieux)

Randy Parry, Regulatory Affairs Specialist (Consultant / embecta)

Nolan Ingersoll, Senior Quality Engineer (Epitel)

John Stringham, Shareholder (Workman Nydegger)

Logan Christenson, Shareholder and 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 Sciences (University of Utah)

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