Ethical Engineering of Medical Devices
The medical device industry may be on the brink of a crisis. While innovations in lifesaving new technologies are transforming medical practice, the rapid pace at which these developments are emerging and the intense pressures of the competitive industry is challenging the ethical training of the engineers involved. In addition, the regulatory environment for medical device development has been changing dramatically, leaving companies with more questions than answers on how to best practice safe and effective medical device development. These changes are creating opportunities for ethical problems to arise--and they have. Recent documentaries, such as The Bleeding Edge and Bleed Out highlights some of the concerns over the state of the industry. In this course we will examine many of these ethical and regulatory concerns from multiple frameworks and perspectives including industry, government, and society. We will practice ethical analysis and develop empathic and decision=making skills designed to prepare engineers to deal productively and ethically with these issues in their professional practice. Guest speakers will include thought leaders from clinical medicine, engineering innovation, and the healthcare products industry who will offer their professional insights. The final project of the course will be a paper analyzing the ethical development of an emerging medical product. This course is designed for graduate students and upper-level students in all engineering disciplines.
Spring 2019 Syllabus
Applied / Theory:50 / 50
Projects:Each of the three projects will be addressing a real case involving the design and development of an emerging medical device technology. Details of the projects will be forthcoming in a handout.
- A reflection paper based on a team analysis of the ethical issues
- A stakeholder report based on a team analysis of the varying stakeholder perspectives
- A journal article based on full ethical analysis of the emerging medical technology