Advanced Medical Product Engineering and Development (AMPED) program
AMPED is a professional Master’s degree (MEng) for engineers who want to make an impact in the medical technology industry. The design and development of medical devices and systems is a complex and highly structured process. Engineers play key roles at all stages of medical product development, including needs finding, concept generation, mechanical design, prototyping, testing, fabrication, and commercialization. The goal of the AMPED program is to provide students with the practical knowledge and skills needed to bring new and improved medical devices to the clinic in the context of the current healthcare environment.
Key features of the program include:
• A design-build-test practicum, in which student teams form around clinical problems and work together to create new product concepts.
• Core content in quality systems, risk management, and regulatory structures, which are foundational to medical product development.
• Preparation in advanced concepts of current importance in the medical technology industry, including telehealth, cybersecurity, AI/ML in healthcare, value-based care, inclusive design, and sustainable product development.
• Professional development and leadership training to enhance self-awareness and cross-functional teamwork.
Link to AMPED website: AMPED.BME.UMICH.EDU
Other courses taught by Jan Stegemann in previous terms:
Biomedical Product Design and Development
This class was developed based on my experience in the medical device industry, and the need I saw to train graduating engineers in the basics of product development and commercialization. In particular, biomedical products are subject to important regulatory, legal and ethical constraints that affect their design and development. This class gives an overview of the product development process, as well as the context in which it must be carried out. Classroom sessions are highly interactive and use case studies as well as guest speakers from industry, in addition to lectures by the instructor. By the end of the semester, students should be able to:
- describe the U.S. medical device industry in general and identify the key stakeholders, technologies and driving forces in the industry
- describe the regulatory structures in the U.S. for medical devices, and provide examples of possible regulatory paths for different devices
- outline important features of the product design and development processes, and explain how regulatory, intellectual property and commercialization issues impact these processes
- use and understand the appropriate vocabulary when discussing design, development and commercialization issues in the medical device industry
Graduate Innovative Design in Biomedical Engineering
This is a two semester course that stimulates students to explore their own solutions to biomedical challenges. Students experience the entire spectrum of innovative design, from concept generation through design validation to prototype fabrication. The course challenges students to learn about the current state of the art, explore the technical needs and current challenges, and brainstorm new solutions with members of the medical community. The first semester is dedicated to needs assessment through a series of lectures by practicing physicians who describe challenges they face in the clinic. Students formulate a set of possible solutions, evaluate each solution, and then assemble into design teams to work on selected solutions. The focus of the second semester is on product prototyping, validation, and commercialization strategy. Each team participates in a series of design reviews that highlight key aspects of product development. Guest lecturers in key areas of medical technology commercialization provide guidance. Students are encouraged to participate in national and local design and business competitions throughout the year. Successful designs compete to represent the University of Michigan in a national design competition at the end of the second semester.
Biology and Engineering of the Extracellular Matrix
This class is for senior undergraduates and graduate students and focuses on the structure and function of the extracellular matrix in a variety of tissues. In each segment of the course we discuss both the scientific (biological) aspects as well as the applied (engineering) aspects of the material. We rely largely on the current primary literature as reference material, which provides the opportunity to teach students how to read the literature in preparation for lifelong learning. The main topics in this class are:
- cell function as related to interaction with the cellular microenvironment
- the general structure of a variety of tissues
- the specific contribution of major ECM components to tissue structure
- cell signaling, especially as related to the ECM
- the contribution of ECM components to tissue mechanical properties
- diseases and conditions associated with ECM dysfunction
- the current state of the art in ECM research and its application
Tissue-Biomaterial Interactions
This class covers relationships between structure and properties of synthetic implant materials, including metals, polymers, ceramics and composites. Examination of the molecular and cellular level events that lead to biological and physiological consequences of medical device implantation. Detailed review of blood-material interactions, inflammation, infection, wound healing and the immune response. An introduction to biocompatibility and case studies of implant materials to illustrate biomaterials selection as a key part of implant design.