MSE Master of Science in Engineering

The Swiss engineering master's degree


Ogni modulo equivale a 3 crediti ECTS. È possibile scegliere un totale di 10 moduli/30 ECTS nelle seguenti categorie: 

  • 12-15 crediti ECTS in moduli tecnico-scientifici (TSM)
    I moduli TSM trasmettono competenze tecniche specifiche del profilo e si integrano ai moduli di approfondimento decentralizzati.
  • 9-12 crediti ECTS in basi teoriche ampliate (FTP)
    I moduli FTP trattano principalmente basi teoriche come la matematica, la fisica, la teoria dell’informazione, la chimica ecc. I moduli ampliano la competenza scientifica dello studente e contribuiscono a creare un importante sinergia tra i concetti astratti e l’applicazione fondamentale per l’innovazione 
  • 6-9 crediti ECTS in moduli di contesto (CM)
    I moduli CM trasmettono competenze supplementari in settori quali gestione delle tecnologie, economia aziendale, comunicazione, gestione dei progetti, diritto dei brevetti, diritto contrattuale ecc.

La descrizione del modulo (scarica il pdf)riporta le informazioni linguistiche per ogni modulo, suddivise nelle seguenti categorie:

  • Insegnamento
  • Documentazione
  • Esame
Medical Device Market Access (TSM_MedDMA)

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.

Requisiti

This course requires knowledge about

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

Obiettivi di apprendimento

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

Categoria 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 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".

 

 

 

 

 

 


Metodologie di insegnamento e apprendimento

Theoretical

lectures combined with group-work

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

 

 

 

Scarica il descrittivo completo del modulo

Indietro