The Swiss engineering master's degree

The course provides an in-depth overview on necessary aspects for implementing a medical device into the market. You will work on real products and improve the device by reviewing the clinical need and update the concept. For this you will be guided through the first steps of the Stanford biodesign principle. Besides concept improvement you will learn how to go through the mandatory regulatory aspects. In addition, you will get insights into market analysis techniques and fundamentals of the health care system.

Requisiti

This course requires knowledge about

• technical design methods
• mathematical statistics/data analysis
• basic knowledge about standardization

Obiettivi di apprendimento

Aims:

The aim of this module is to:

• Know and apply the first steps of the Stanford Biodesign principle to develop a 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 basic aspects of the health care system and know the relevant market aspects.

Contenuti del modulo

• 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 improvement
  • Knowledge of the classification of medical devices and the corresponding regulatory pathway within EU-MDR and US-FDA
  • Overview of the legal requirements on the design and construction of medical products. This includes the requirement engineering as well as the general safety and performance requirements.
  • 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 usability engineering according EN 62366 and the validation of usability
  • Understanding the risk management according to ISO 14971 and having insights into the risk analysis.
  • Knowledge in market evaluation, current health care systems and developing a reimbursement strategy.
  • Introduction into the clinical testing of medical devices and basic knowledge of "good clinical practice".

Metodologie di insegnamento e apprendimento

During the course you will directly apply the theoretical aspects of the module by working with your colleagues on real medical devices. The provided documents will help you to navigate through the regulatory approval process.

Bibliografia

• 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