93924 - Context Sensitive Design of Medical Devices

Academic Year 2022/2023

  • Docente: Stefano Severi
  • Credits:: 9
  • SSD: ING-INF/06
  • Language: English
  • Moduli: Stefano Severi (Modulo 1) Johannes De Bie (Modulo 2)
  • Teaching Mode: Traditional lectures (Modulo 1) Traditional lectures (Modulo 2)
  • Campus: Cesena
  • Corso: Second cycle degree programme (LM) in Biomedical Engineering (cod. 9266)

Learning outcomes

The course aims to offer the students: i) an overview of the process and the basic skills necessary for the design of a medical device, starting from what already learned in the first year courses; ii) an alternative look and approach to the problems and applications of biomedical engineering, starting from the point of view of low-resource settings. In particular, in the second part of the course, the student is introduced to the development and application of appropriate technologies in these settings. By the end of the course the student has acquired the basic elements on: - Global Health, UN Sustainable Development Goals, and the concept of Reverse Innovation. - Definition of the design specifications for a medical device, starting from the clinical needs and the constraints imposed by socio-economic low resources settings. - Regulatory aspects concerning the design of a medical device and its placing on the international markets. - Risk analysis and risk mitigation in the design of a medical device. - Low cost, electronic and 3D printing prototyping.

Course contents

  • Introduction on Global Health. Current state of health services offered / available in the world. Which are and how are characterized the low-resource settings.
  • Outline on International Health Cooperation: Role and Perspectives.
  • Use of biomedical technologies in low-resource settings and role / presence of biomedical engineers.
  • The concept of appropriate technology. Bioengineering examples.
  • The concepts of Reverse Innovation and Frugal Innovation. Examples.
  • Case study: re-designing a dialysis machine.
  • Tools for the realization of low-cost biomedical devices.
  • Main critical aspects for the management / maintenance of medical devices in low-resource settings.
  • Outline of regulatory aspects for medical devices in non-European countries.
  • Examples of international cooperation in biomedical engineering.
  • Work in small groups: design / implementation of a simple medical device.


  • Yock, Zenios, Makower, Brinton,Kumar, Watkins and Denend, Biodesign - The process of Innovating Medical Technologies. Cambridge University Press, 2015
  • Missoni E. e Pacileo G., Elementi di salute globale. Globalizzazione, politiche sanitarie e salute umana. Franco Angeli, 2016
  • Stefanini A., Salute e mercato. EMI, 1997
  • Falcitelli G., Tecnologie sanitarie per lo sviluppo umano. Linee guida per la cooperazione allo sviluppo nel settore delle tecnologie biomediche e della ingegneria clinica. Il Pensiero Scientifico, 2009
  • Richards-Kortum R., Biomedical engineering for global health. Cambridge University Press, 2010
  • C. Wicklein R.C., Appropriate Technology for Sustainable Living. The University of Georgia, 2001
  • Hazeltine B. and Bull C., Field Guide to Appropriate Technology. Elsevier, 2003
  • Platt A., Making Health Care Equipment. Practical Action, 1990
  • England R., How to Make Basic Hospital Equipment. Intermediate Technology Publications, 1979
  • Govindarajan V & Trimble C., Reverse Innovation. Create Far from Home, Win Everywhere. Harvard University Press, 2012
  • WHO, Compendium of innovative health technologies for low-resource settings. World Health Organization, 2015

Teaching methods

Lectures in the classroom, seminars, laboratory activity to be carried out in small groups.

Assessment methods

Written test. Once the written exam has been passed, oral exam during which the presentation of the project / prototype developed within the small group will be requested

Teaching tools

Biomedical Engineering Lab

Office hours

See the website of Stefano Severi

See the website of Johannes De Bie


No poverty Good health and well-being

This teaching activity contributes to the achievement of the Sustainable Development Goals of the UN 2030 Agenda.