Learning Outcomes:
On completion of the module, students will:
(a) Demonstrate an ability to derive, analyse and apply potential design solutions within the medical device design process
(b) Demonstrate an understanding of the core requirements and of legal and ethical issues, including the circular economy, within regulatory frameworks
(c) Be able to define core user needs for a given medical device application area
(d) Be able to capture and define core issues relating to intellectual property within a device design
(e) Be able to identify and rank clinical needs and potential medical device design solutions
(f) Development project management skills related to medical device development
(g) Be cognisant of the commercial challenges in clinical translation of medical device technology
Indicative Module Content:
The module follows a condensed version of the Biodesign Approach to Medical Device Development through team-based projects aimed at identifying and addressing real clinical needs:
(1) Clinical Need Identification - Figure out strategic focus, learn how to observe and identify clinical problems, construct and rank clinical need statements
(2) Invent Device Solutions - Ideation & Brainstorming, Prototyping and concept development
(3) Implementation Plan - Developing IP, Regulatory and Clinical Strategies, Stakeholder Analysis and Business Development Plan