Safety, evaluation, and economic development of medical devices
Download in PDF- Lecturer: Ludovic Saint-Bauzel (saintbauzel@isir.upmc.fr)
- Course code: UM5RBM31
- Student workload: 24 h of lectures
- Credits: 3 ECTS
- Specialization tracks: ROBOT SI MeDH
- Semester offered: S1 S2 S3 S4
- Language of instruction: French English
- Targeted audience: Eng. Sc. department Other :
- Localization : PMC Campus Other :
Course Overview
The objective of this course is to give an overview of the societal and economic constraints of medical devices. It examines several central aspects with respect to the safety and the acceptability of assistive and rehabilitation technologies. It also presents risk management concepts and techniques for the development of medical robots, more specifically of rehabilitation robots. Study of the economic viability of a project. Medical economic development: study of the various stages of the development of a device with medical use, the proof of concept in the launch on the market.
Mots-clés : TRL, Ergonomics, UX design, Clinical trial, Medical devices, Risk plan
Prerequisites
Students should have previously acquired the following prerequisites to follow this course:
- None
Intended Learning Outcomes
By the end of this course, students will be able to:
- Definition and application of basic concepts for risk management: risk, harm, safety, hazard, hazardous situation, safety integrity, safety integrity level, etc.
- Risk analysis methods based on system modeling. Risk reduction techniques for medical devices (Hardware and software fault avoidance techniques, fault tolerance mechanisms, etc.)
- Acceptability and ergonomics of the assistive technologies. Relationship between Assistive Technology and Inclusive Design.
- Clinical trials methodology and protocol design.
- Engineers, designers and technicians collaboration methodology / Evaluation of a medical product / Certification principles and regulations
Indicative Teaching Sequence and Methods
| Week | C/TD/TP* | Content | Preparation | Learn.\ outc. |
|---|---|---|---|---|
| S1 | 3/0/0 | Definition basic concepts of risk | AAV1 | |
| S2 | 3/0/0 | Acceptability and ergonomics | AAV2 | |
| S3 | 3/0/0 | Clinical trials methodology and | AAV3 | |
| S4 | 3/0/0 | Certification principle and regulation | AAV4 | |
| S5 | 3/0/0 | Medtech seminaries | AAV1,2,3,4,5 | |
| S6 | 3/0/0 | Medtech seminaries | AAV1,2,3,4,5 | |
| S7 | 3/0/0 | Medtech seminaries | AAV1,2,3,4,5 | |
| S8 | 3/0/0 | Medtech seminaries | AAV1,2,3,4,5 |
- C/TD/TP respectively corresponds to lectures, tutorials and lab sessions.
Indicative Assessment of Intended Learning Outcomes (1st session)
| Week | Individ./group | In-person/remote | Type of exam | Evaluated outcomes | Scale % |
|---|---|---|---|---|---|
| S6 | Group | In-person | Other | AAV1-7 | 50% |
| S8 | Individual | In-person | Other | AAV1-7 | 50% |
2nde session
| Session | Individ./group | In-person/remote | Type of exam | Evaluated outcomes | Scale % |
|---|---|---|---|---|---|
Date of generation of this unit description: 06/10/2026
