Ethical Engineering of Medical Tech

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.

BME56400

Credit Hours:

Learning Objective:

Students who successfully complete this course will be able to:
1) recognize and analyze personal and systemic challenges to the design and development of medical devices or assistive technologies that are innovative, ethical and socially responsible.
2) independently engage in empathy-building activities based on somatic awareness and cognitive neuroscience to enhance their abilities to understand and value the perspectives of other stakeholders when designing and developing medical devices or assistive technologies that are innovative, ethical, and socially responsible.
3) effectively use a structured, iterative decision-making process that considers the perspectives of multiple stakeholders in optimizing a design or development decision about medical devices or assistive technologies that are innovative, ethical and socially responsible.

Description:

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

Topics Covered:

Prerequisites:

Applied / Theory:

50 / 50

Web Address:

https://mycourses.purdue.edu/

Web Content:

Syllabus, Grades, Homework, Message Board

Homework:

There are multiple readings, watchings (videos), and reflective writing assignments due during the course that facilitate discussions and learning.

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

Exams:

There are no exams in this course.

Textbooks:

Official textbook information is now listed in the Schedule of Classes. NOTE: Textbook information is subject to be changed at any time at the discretion of the faculty member. If you have questions or concerns please contact the academic department.No Textbook is required. Course readings from published papers will be provided in Blackboard Learn.

Computer Requirements:

Proed Minimum Requirements

ProEd Minimum Requirements:

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