Medical Device Design and Regulation

Code

MMME4042

School

Mechanical, Materials & Manufacturing Engineering

Level

4

Credits

20

Semesters

Full Year UK

Summary

This module covers the design and manufacture of medical devices and the regulations covering marketing sale and use of medical devices within the UK and the European Union.
There are three key themes to the module: 1. Selection of appropriate materials for medical devices, taking into account clinical use, performance in vivo, and design for manufacture. 2. The design of medical devices, taking into account the clinical need, functional requirements, relevant national and international standards, and regulations regarding design and construction. 3. The manufacture and marketing of medical devices, including processing, sterilisation, marketing, and after-market surveillance of medical devices. This will include aspects of risk management, quality control, remuneration, and after-market surveillance.
The module will include project-based learning, where students are tasked with designing a medical device and presenting their embodiment designs to an assessor in a preliminary design review meeting.

Target Students

Students registered for full-time MSc Bioengineering degree. NOTE: Erasmus/Socretes/Visiting students MUST take any relevant examinations for this module in Nottingham at the appropriate time with all other students in the cohort.

Classes

• One 2-hour tutorial each week for 8 weeks
• One 2-hour lecture each week for 16 weeks

Assessment

• 40% Coursework 1
• 10% Coursework 2: Individual Project Report
• 10% Exam 1 (2-hour): 2 hour exam
• 40% Exam 2 (2-hour): 2 hour exam

Educational Aims

Learning Outcomes

 LO1 – Analyse the critical functions to be achieved in an implantable or
extracorporeal medical device and select viable design solutions to fulfil these
functions, as part of an overall systems solution (Knowledge, comprehension,
application, evaluation).

 LO2 – Describe appropriate manufacturing routes for individual components of
a medical device, with regard to material selection, processing route, sterilisation
and packaging (Knowledge, comprehension, application).

 LO3 – Describe the processes by which manufacturers minimise harm to
patients, healthcare professionals, and members of the public. (Knowledge,
comprehension and application).

 LO4 – Describe the roles played by National and International Standards and
Regulations in ensuring patient safety and adequate performance of medical
devices (Application and evaluation).

 LO5 – Demonstrate an understanding of commercial viability and appropriate
pricing for medical devices,

Conveners

• Dr Alastair Campbell Ritchie