Medical Device Design Innovation Project

Module code: MEP56BM1 · Semester: Full year

Resources

• Module descriptor (TCD)

How it's assessed

No end-of-semester exam. It's assessed through project work.

Teams work with clinicians to uncover a real clinical need and develop a new medical device, alongside a separate medical device testing project.

Assessment	Weight
Innovation project: background presentation, progress updates, final presentation, final report and an individual component	60%
Medical device testing project: background presentation, testing protocol report, final report with results	40%

• Attendance is mandatory.

Summarised from the TCD module descriptor, checked 2026-11-09. Details can change from year to year, so check this year's descriptor and Blackboard.

From students who've done it

No write-ups yet.

Questions by Year

This module has no end-of-semester exam, so there are no past papers. See How it's assessed above.

Topics

• Clinical need finding and the needs-led design process LO5
• US and EU medical device regulation LO1
• Intellectual property and patents LO3
• Legal and ethical aspects LO4
• Business case and engineering plan for a device LO5
• Device testing: test rigs and protocols; why devices succeed or fail LO2

Learning outcomes

1. Understand medical device regulation in the US and EU
2. Use engineering principles to explain why devices succeeded or failed
3. Understand patents in medical device design
4. Understand legal and ethical aspects of device development
5. Understand the needs-driven approach to new devices

Summarised from the module descriptor, checked November 2026.