Designing biomedical products requires a specific methodical design process, because of the diversity of the stakeholders, the different background of the project participants, the limitation of the amount of background information, and the complexity of the working environment.
General course aim: in this course, students learn all aspects of a methodical design process specifically required for designing biomedical products and they apply these aspects of methodical design by performing a biomedical design project.
After the course, the student is able to:
- analyze his team and demonstrate how to work optimally in a team
- apply project management theory
- identify the differences in working habit of medical and technical experts
- identify the specific difficulties in designing biomedical products
- apply the methodical design process for solving medical problems
- apply the principles of medical technology assessment to increase the chance of successful market introduction
- apply the rules that ergonomics state on a design
- apply the steps necessary for CE-certification
- apply all steps necessary for a MET c-application
- integrate all aspects of methodical design, including project management and teamwork on designing biomedical products
During this course strategies are presented as an addition to the methodical design process. Subjects that will be discussed are project management, teamwork, communication methods for a good co-operation between medical and technical experts, application of selection processes, specific design aspects of implants, test of prototypes, including FMEA-analysis, METC-protocol and CE-certification. During the course an project assignment will be worked out by a multidisciplinary group of students.