Courses

This course is designed to introduce medical students to the biomedical engineering design, development and deployment of medical and assistive technologies and their translation into clinical practice. Prior coursework or training in engineering is not necessary. A universal, human-centered design approach is essential to developing medical devices and assistive technologies that are ethical, innovative, and socially responsible. Developing an awareness of the ethical, regulatory, and commercial issues that influence the development of medical and assistive devices is critical for effective collaboration between clinicians and engineers and is essential to the process of identifying and translating new technologies into clinical practice. Medical students will be informed about key issues surrounding engineering design, development, and deployment from multiple perspectives including clinical, industry, governmental, entrepreneurial and societal. Students will also engage in facilitated learning experiences to develop their skills, and apply these skills to analyzing design, development, and translation of new and emerging medical technologies. Active learning is organized around content, practice, and discussion with case study analysis as a key outcome.

Course Director: Andrew O. Brightman, PhD
Email: aob@purdue.edu
Phone: (765) 496-3537
Primary contact for Adds/Drops: Cynthia L. Holderbaum, cholderb@purdue.edu
Home campus: West Lafayette
Type of course: On-site

Learning objectives:

1. By the end of this course, a student will be able to:
   Recognize and be able to analyze ethical, regulatory, and entrepreneurial issues
   and challenges in the design of medical devices (PBLI1, SBP4, P3)
2. Be able to independently engage in observational and reflective activities to
   enhance their abilities to identify unmet medical needs (PBLI1, SBP5)
3. Be able to effectively collaborate with engineers to evaluate potential design
   solutions that value the perspectives of a wide range of stakeholders (SBP1, P2)

Course activities:
The course is delivered through a series of online multimedia content, online learning
modules and interactive group sessions to discuss the online content and practice
ethical literacy in the context of designing, developing and deploying medical
technologies. Course topics include: identifying unmet medical needs, human-centered
design; analyzing stakeholder perspectives; establishing design specifications; market
evaluation and reimbursement strategies; intellectual property development; verification
and validation testing; preclinical and clinical study design; regulatory basics and
pathways for FDA approval; and licensing and commercialization.
Students will be mentored as they analyze recent and historic cases of medical devices
development and emerging technologies; participate in debates about new cases; and
hear from thought leaders from clinical medicine, engineering innovation, and the
healthcare products industry who will offer their professional insights. They will also
engage with engineers to practice identifying unmet medical needs and evaluating
potential solutions.

Estimated time distribution: Small group sessions meet for 2-3 hours per month for 9 months during the fall and
spring semesters.

In-class lecture/presentation/discussion: 80%

Online learning: 20%

Assessments: Participation in group sessions as demonstrated by active participation and contribution to oral discussion, as assessed by faculty observation, including attendance at >80% of recitation sessions: 50%

Completion of all online modules and written assessments (interviews, analyses, and case reports); the student must receive a score of 75% or greater on each
assessment including quizzes (delivered through online modules) or written submissions: 50%

Prerequisites: Scholarly Concentration enrollment
Interprofessional collaboration: None at this time

Introduction to Customer Discovery (ICD) is based on the Innovation Corps (I-Corps) curriculum that helps learners discover the commercial potential of medical technologies. During the course, students will learn how to build a business model, talk to customers and gain insight from experienced leaders in the field of medical devices/technologies. This is an experiential learning opportunity; teams will be engaged by “getting out of the building” and interviewing customers to discover the value of their idea each week for four weeks. Along the way, ICD instructors will guide the teams through the course, but the bulk of the work comes from engaging with real customers. Updates will be made weekly, with the course culminating in a final presentation of findings and learnings. Startups often communicate in a very direct and urgent style. This can feel brusque and impersonal, but in reality is focused and oriented to create immediate action in time- and cash- constrained environments. Students have limited time and the program leaders will push, challenge, and question participants in the hope they will quickly learn the most critical elements of their business model. ICD leaders will be direct, open, and tough to help students identify clear, next-step questions to address. This approach may seem intense, but it is all intended to help challenge quickly and objectively, and to appreciate that as entrepreneurs it’s critical to learn and evolve faster than ever imagined. Students will be expected to question, challenge, disagree and engage in real dialogue with the course leaders.

Course Director: Andrew O. Brightman, PhD
Email: aob@purdue.edu
Phone: (765) 496-3537
Primary contact for Adds/Drops: Cynthia L. Holderbaum, cholderb@purdue.edu
Home campus: West Lafayette
Type of course: On-site

Online modules and team work may be done remotely and workshops via Zoom, pending project locations and agreement by leadership. Email access to instructors required.

Learning objectives:

1. Use a Business Model Canvas to collect information from customers and key
   stakeholders to validate an idea(s) before beginning development (SBP1, PBLI1, ICS5)
2. Identify approaches that can be used to reduce stakeholder risk (PBLI2, ICS1, ICS5,
   SBP1)
3. Generate presentations capable of demonstrating the commercial potential of
   innovative medical technologies. (ICS5)

Course activities:
The pre-course work consists of approximately 15 hours of online modules, readings and a pre-survey that provide a foundation in the courses methodology. For approximately 15-20 hours a week for four weeks (~60-75 hours), students will engage in course learning, customer interviews and update and improve a Business Model Canvas for presentation.

Estimated time distribution:
55% Laboratory or Scholarly Research
15% Lecture/Seminar
10% Library/Research
20% Online

Assessments:
Completion of pre-course work (readings, videos and pre-survey): 20%

Participation in customer interviews as demonstrated by active participation and contribution to weekly oral presentations, as assessed by faculty observation: 45%, Final Canvas and oral presentation, as assessed by a standardized rubric: 35%

Prerequisites: Scholarly Concentration enrollment
Interprofessional collaboration: None at this time