Systems thinking and designerly tools for medical device design in engineering curricula

Area of Science:

• Industrial Design Engineering (IDE)
• Medical Device Development (MDD)

Background:

• Focus on medical device development (MDD) within Industrial Design Engineering (IDE) academia.
• Analysis of current methods used by MDD students.
• Identification of guidance shortcomings and areas of added value.

Purpose of the Study:

• To evaluate the methods employed by MDD students in their academic projects.
• To pinpoint deficiencies in current academic guidance for MDD.
• To determine the added value of existing guidance in MDD education.

Main Methods:

• Analysis of 19 master and 3 doctoral theses in the IDE curriculum.
• Evaluation focused on four key themes: regulatory, testing, patient-centricity, and systemic design.

Main Results:

• Frequent disregard for regulatory aspects and medical testing procedures, attributed to lack of experience and short thesis timelines.
• Application of medical-oriented systemic tools enhancing multiperspectivism.
• Shortcomings in translating systemic approaches to the List of Specifications and business models.
• Challenges in implementing participatory techniques within an evidence-based medicine framework.

Conclusions:

• MDD education needs to better integrate regulatory and testing requirements.
• Enhancing the translation of systemic design principles into practical business and specification outputs is crucial.
• Further development is needed to effectively incorporate patient-centric and evidence-based approaches in MDD projects.