With the recent addition of Aaron Lottes (BME PhD ’06) to the faculty after a number of years immersed in the medical device industry we have increased our focus in this area. BME now offers regulatory-centric courses every semester with a course in medical device design and non-clinical and clinical testing in the Fall, regulatory submissions for medical devices in the Spring, and quality systems and compliance in the Summer. Pending final approvals, we are prepared to launch a new Graduate Certificate in Regulatory Affairs and Regulatory Science for Medical Devices in 2022. The certificate will consist of at least two of the three regulatory courses with an option to select all three regulatory courses or a course in engineering ethics or biostatistics depending on individual student interest and career goals; the certificate can be completed in-person on campus, remotely online, or as a hybrid approach.

An integral part of these courses is learning from the practical experience of industry, regulatory agency (e.g., US FDA), and clinical professionals. During the past year we have engaged with over 50 experts from across these groups, and spanning geographically from Europe to America to Asia, who have generously shared their expertise and diverse real-world experiences by helping develop course content and teach material that they live daily in their careers. This practical approach has resonated with students, many of whom are planning a future career in industry. Moving forward we are actively working to increase engagement and partnership with these stakeholders to continually improve course content as well as to develop new opportunities for mentoring and career development for students. Building on the thriving medical products industry in Indiana and the Midwest region, Purdue BME is aiming to be a leader in regulatory education to help meet this critical training need for the medical device field.

An exciting new medical device regulatory training opportunity for BME students, as well as students in other health-related disciplines across campus, is the launch of a short-term study abroad program focusing on medical device development, testing, and regulation in Japan. Students will have the opportunity to spend two weeks in Japan meeting with academic regulatory and engineering experts, industry leaders, and government regulators to learn about and discuss the medical device development process and consider how processes in the US and Japan, including regulatory pathways, can be optimized to contribute to improving global health.

Regulatory courses help prepare Professional Master's Program students

The regulatory courses are an important component of our vibrant and growing Professional Master's Program and help differentiate our students when entering the job market. Regulatory “know-how” is essential in the highly regulated field of medical devices and is a critical skill that engineering managers are seeking. Students in this program have the choice of two paths; one which allows them to complete the coursework quickly (in as little as a year) or one that allows up to a one-year internship. The one-year internship pathway helps students further develop their skillsets while tackling more in-depth projects than a traditional 3-month summer internship. Our industry partners seek the higher experience level of a graduate student and benefit from the opportunity to hand off more complex projects. Some of the industries who have taken advantage of this program's internship requirement are: Cook Biotech, Cook Medical, Cook Research, Abbott, Zwift, Regeneron, BD, Zimmer Biomet, Nevro and several start-up companies just to name a few. The program started with one student in Fall 2016 and has slowly picked up the pace to nearly 35 students presently. We look to see this program gain even more momentum in the upcoming years.

In addition to the on-campus program, we are in the process of developing a fully online as well as hybrid option to offer increased flexibility for students interested in a non-thesis MS in BME. This may be particularly relevant for working professionals who are interested in advancing their education, but need a more convenient and part-time schedule. Online classes will be the same material offered to students on-campus and the program will leverage Purdue’s well-regarded expertise in online engineering graduate education.