by Hannah Buckelew
The Translation of Biomedical Innovations to Clinical Practice Certificate Program completed its first successful cycle in 2024. The program is a non-degree graduate certificate that provides both non-engineering and engineering graduate students with opportunities to gain the knowledge, skills, and competencies required to translate basic science discoveries and new biomedical technologies into products in the clinical setting.
"Participating in the Biomedical Innovations to Clinical Practice Certificate Program has been a truly edifying experience, offering me a unique opportunity to collaborate with a diverse team of engineering and MBA students,” says Stéphanie Marie Aguilera, graduate student. Together, we tackled real-world healthcare challenges, including a project aimed at reducing complications for diabetic patients undergoing AV fistula hemodialysis and developing innovative thermoregulating activewear, always prioritizing efficacy and safety in our designs. The program's comprehensive biodesign approach included deep dives into legal considerations and regulatory pathways, enhancing our understanding of bringing medical innovations to market. The most memorable part was pitching our team ideas in front of three successful startup veterans who served as judges, an experience that brought together our technical knowledge, business acumen, and newly acquired insights into healthcare and legal regulations. This interdisciplinary journey has equipped me with a holistic understanding of translating biomedical innovations from concept to market-ready solutions, bridging the gap between engineering principles and clinical practice."
Program participants gain an understanding of specific biomedical technologies and learn to identify and describe commercialization concepts, such as value proposition, intellectual property, and FDA regulation. Students define an unmet clinical need and determine the desired clinical performance necessary to meet this need.
"As a fourth year Ph.D. student in the Department of Biomedical Engineering, gaining perspective on translational work has been important to my future career prospects,” says Vaishala Bala, graduate research assistant. “The Biomedical Innovations to Clinical Practice Certificate Program has provided an excellent framework for understanding how biomedical discoveries can be transitioned into clinical settings. The interdisciplinary approach, especially working with MBA students and various graduate students from different engineering departments, has deepened my understanding of the challenges and rewards of translating science into practical solutions for patient care. One of the important takeaways was addressing a need that would do well for a substantial population and was a necessity. We had the opportunity to interact with people from the startup industry and ask them questions about how they could make their move and be successful. It’s been a transformative experience, giving me the skills and confidence to contribute meaningfully to the field of medicine."
Next steps include becoming familiar with innovation and entrepreneurship skills, including customer discovery, market evaluation, regulatory approval, development planning and communication. Ultimately, program participants design a pathway from ideation to a commercial clinical product.
“The BME Certificate in Clinical Translation was designed to provide individuals with the background and knowledge to transform nascent ideas into clinical products. This involved several challenges including developing three new core courses and two new electives. We were pleasantly surprised with the reception and enthusiasm, especially from BME graduate students who felt that this certificate could add significant value to their graduate degree. The first cohort included ten students and the feedback we received was overwhelmingly positive,” says Palaniappan Sethu, Ph.D., certificate director and associate professor. “We look forward to continuing to build on what we accomplished in the first year and build additional curriculum around our core courses. We are extremely thankful to our Chair Dr. Jay Zhang for his continued support, and core course directors Drs. Dale Feldman and Ian Berg and elective course instructors Drs. Yang Zhou and Jianli Zhao for doing an excellent job developing and delivering new courses as part of this certificate”
Learn more and apply for the Certificate in Translation of Biomedical Innovations to Clinical Practice here.