Each module contains 3 ECTS. You choose a total of 10 modules/30 ECTS in the following module categories:
- 12-15 ECTS in technical scientific modules (TSM)
TSM modules teach profile-specific specialist skills and supplement the decentralised specialisation modules.
- 9-12 ECTS in fundamental theoretical principles modules (FTP)
FTP modules deal with theoretical fundamentals such as higher mathematics, physics, information theory, chemistry, etc. They will teach more detailed, abstract scientific knowledge and help you to bridge the gap between abstraction and application that is so important for innovation.
- 6-9 ECTS in context modules (CM)
CM modules will impart additional skills in areas such as technology management, business administration, communication, project management, patent law, contract law, etc.
In the module description (download pdf) you find the entire language information per module divided into the following categories:
The course provides an in-depth overview on all relevant aspects for successfully introducing a medical device into the market. It will make use of the Stanford biodesign principle to evaluate the clinical need and concept development with respect to regulation and the specific medical device market restrictions. The corresponding topics include the important tasks during the development of a medical device (prior market access) as well as after its placement on the market.
This course requires knowledge about
- technical design methods
- mathematical statistics/data analysis
- basic knowledge about standardization
The aim of this lecture is to
- Know the important medical device design principle
- Know all relevant aspects for the development of a medical device
- Know and apply the Stanford biodesign principle to design and develop a commercially successful medical device
- Understand the regulatory aspects within EU (MDR) and US (FDA)
- Know the current standards used for designing and developing medical devices according to MDR
- Understand the relevant aspects of the health system and business aspects within medical device market sector
Contents of Module
Stage 1: Defining the clinical need
- From bench to bed side. Understand the clinical need and make use of knowledge about disease fundamentals and observation/clinical problem identification.
- Understanding the scientific language of medicine, the research culture as well as the ethical aspects in the context of medical devices.
- Introduction into the medical device regulation
Stage 2: Screening and concept development
- Knowledge of the classification of medical devices and the corresponding regulatory pathway within EU-MDR and US-FDA
- Prototyping, concept screening and generating a MVP.
- Overview on the legal requirements on the design and construction of medical products. This includes the requirement management as well as the verification and validation of development results including the Software Life Cycle (ISO 62304).
- Insights into the quality management system EN ISO 13485:2016 including testing, verification, and validation principles.
Stage 3: Product concept and business strategy
- Understanding the basics in the usability according EN 62366, validation of the usability
- Understanding the risk management according to ISO 14971 and having insights into the risk analysis.
- Understanding biological safety according to ISO 10993 and some technical safety aspects (ISO 60601)
- Knowledge of the CE-labelling in Europe and registration procedure in the USA. Product labelling (ISO 15233) and UDI.
- Knowledge in current health systems and developing a reimbursement strategy.
- Introduction into the clinical testing of medical devices and basic knowledge of "good clinical practice".
Teaching and Learning Methods
lectures combined with group-work
- Medical device design: Innovation from concept to market, Peter Ogrodik, Academic Press (2020). ISBN 978-0-12-814962-1
- Biodesign – The Process of Innovating Medical Technologies, Paul Yock, Stefanos Zenios, Josh Makower, Todd Brinton, Uday Kumar, Cambridge Academic (2015). ISBN 978-1-107-08735-4
- EU-MDR, US-FDA
- Various standards