The main aim of this 18h module, divided into 6 sessions, is to understand and apprehend the development of a medical device through the regulatory pathway that structures the entire process of validating this health product. We review the main phases of product research and development, while analyzing the main steps to be taken, which are put into perspective through real-life feedback. The mix of theory and practice that makes up the content of each session helps to give students a faithful picture of the industrial reality of companies in the healthcare sector, which should enable them to better project themselves in this business sector later on. This anticipated knowledge of the overall development of a medical device should be useful both to students wishing to join a company in the healthcare sector, particularly as R&D engineers, and to those same companies looking for qualified profiles who will be sensitive to the knowledge acquired by these engineers. Translated with DeepL.com (free version)
| On completion of the unit, the student will be capable of: | Classification level | Priority |
|---|---|---|
| Understand and precisely define a medical device | 4. Analyse | Essential |
| Understand the regulatory requirements applicable to a medical device | 2. Understand | Important |
| Understand the different phases in the development of a medical device, culminating in marketing authorization (CE). | 3. Apply | Essential |
| Percentage ratio of individual assessment | Percentage ratio of group assessment | ||||
|---|---|---|---|---|---|
| Written exam: | % | Project submission: | 0 | % | |
| Individual oral exam: | 0 | % | Group presentation: | 60 | % |
| Individual presentation: | 0 | % | Group practical exercise: | 20 | % |
| Individual practical exercise: | 0 | % | Group report: | 20 | % |
| Individual report: | 0 | % | |||
| Other(s): 0 % | |||||
| Type of teaching activity | Content, sequencing and organisation |
|---|---|
| Course 1 | Introduction to medical device development Overview Presenters: William WIECEK & Gérard PELISSON -Duration: 3h Objectives : - Regulatory framework: main principles of regulatory requirements - Anticipating legal and normative requirements - The main stages in the development of a medical device - Definitions and specificities of a medical device Part 1: Definition and examples of DM and the first steps in the regulations: overview and principles Part 2: Discussions and exercises on the requirements and annexes of regulation 2017/745 |
| Course 2 | Product Development From R&D to functional prototypeFrom R&D to functional prototype Speaker: Benoit DACLIN Benoit DACLIN - Duration : 3h Objectives : - Design control: principle and method - Defining proof of concept (POC) - Intellectual property and freedom to operate - Prototype feasibility Part 1: Design control - Feasibility - Design - POC Part 2: Feedback |
| Course 3 | Design & Process Freeze / Risk analysis How risk analysis guides development and consolidates strategy Speakers : Sandra THOLOT & William WIECEK Duration: 3h Objectives: - Risk analysis for DM development - Learn how to adapt the method through case studies and avoid pitfalls - Notion of product life cycle and sustainable development Part 1: Design control - Design & Process Freeze Part 2: Product risk analysis |
| Course 4 |
Usability & validation Industrialization Speaker : Laure OLIVER & Sandra THOLOT Duration: 3h Objectives: - Understand and manipulate the concept of fitness for use and industrialization. Part 1 : Fitness for use Part 2: Validation of manufacturing processes |
| Course 5 | Clinical Evaluation Pre-clinical, clinical and post-marketing evaluation Speaker : NEXIALIST Duration: 3h Objectives : - Principles of clinical and pre-clinical evaluation - Ethics and legal framework for clinical trials Part 1: Biocompatibility, clinical evaluation and post-marketing follow-up Part 2: Feedback |
| Course 6 | Putting things into perspective Visit and evaluation of acquired skills Speaker : Nathalie COHET & William WIECEK Duration: 3h Objectives : - From theory to practice: visit to a local medical device company: DTF Diffusion Technique Française, rue de la presse, Saint Etienne. Part 1: Regulatory interactions and design control Part 2: Visit to a manufacturer (in small groups) Part 3: Assessment of skills acquired: group pitch (in parallel with the visit) sis). State of the art of tissue engineering research (in France and in the world). |