Course syllabus


EEN040 Development of medical devices lp2 HT20 (7.5 hp)

Course offered by the department of Electrical Engineering

Lectures online

Lectures will be online using Zoom. Links and passwords to the lectures can be found below.

We aim at keeping the quality of this course despite the restrictions we are facing, so please observe the  following etiquette online: 

  • Have your camera on as much as possible.
  • Keep your microphone muted if you are not speaking.
  • Please ask questions, and use the "Raise Hand" button when you want to do so, or use the chat.


Lectures Topic Date Time Link Password
L1 Intro + Needs & Market 3-Nov 10:00-11:45 331721
L2 Ideation 4-Nov 08:00-09:45 398462
P Case study - Integrum 6-Nov 10:00-11:45 093078
L3 Regulatory affairs 10-Nov 10:00-11:45 538796
L4 Regulatory affairs 11-Nov 08:00-09:45 878177
SP1 Student presentations 13-Nov 10:00-11:55 792956
L5 Testing - Animals 17-Nov 10:00-12:00 844234
L6 Testing - Humans 18-Nov 08:00-09:45 455312
SP2 Student presentations 20-Nov 10:00-11:55 895478
L7 Testing - Bench 24-Nov 10:00-11:45 462259
L8 Intellectual property (IP) 25-Nov 08:00-09:45 025411
SP3 Student presentations 27-Nov 10:00-11:55 646042
L9 Product development 1-Dec 10:00-11:45 802687
L10 Product development 2-Dec-20 08:00-09:45 180200
SP4 Student presentations 4-Dec 10:00-12:00 817106
L11 Business / Communication 8-Dec 10:00-11:45 009894
L12 Business / Communication 9-Dec 08:00-09:45 813683
P Case study - Coapt (USA) 9-Dec 17:00-17:50 631690
SP5 Student presentations 11-Dec 10:00-12:00 099599
FP1 Final Presentations 15-Dec 10:00-11:45 741102
FP2 Final Presentations 16-Dec 08:00-11:45 306795


Contact details


Teacher assistants (TAs)

Student representatives:

MPBME                 Shahrzad Damercheli
MPBME             Veronika Knudsen
MPBME               Ida Moberg
MPBME   Vignesh Nandagopal
MPBME             Simon Nordenström

Course purpose

This course aims to provide specific knowledge in the ideation, creation, and certification of medical devices including product development procedures.



Course literature

Durfee and Laizzo, Medical Device Innovation Handbook, University of Minnesota, 2017. Available at

Course design

This is a project-based course. Students will take an idea for a medical device through the process of developing it into a potential product. Students are encouraged to explore their own ideas for a medical device. If the students do not have their own idea, case studies/projects will be provided.  

Students must form groups of 3 people (2 people in special circumstances). Registration of the groups is done in Canvas.

There are three lectures per week. New concepts will be introduced in the first two lectures (Tuesdays and Wednesdays), and students will present the application of such concepts to their project in the third lecture (Fridays). Observe the following requirements for student presentations:

  • All students should present equally (distributed over all presentations)
  • A student can only miss two presentation sessions to pass this course
  • All students must participate in the final presentation of their project (Dec, 14-18) 

Learning objectives and syllabus

Learning objectives:

  • explore the implementation of technologies within the field of medicine;
  • classify a medical device according to European and USA regulations;
  • implement a verification and validation plan for a medical device;
  • judge which type of tests that are needed for verification and validation of a medical device;
  • perform risk assessments of medical devices;
  • implement projects which meet the technical and safety requirements of medical devices;
  • confront criteria in the decision-making process, and make judgements from information which may be incomplete or limited within the field of biomedical engineering;
  • apply previously developed knowledge and skills to work with engineering solutions in medicine;
  • identify value creation for external stakeholders;
  • seek and acquire information from relevant scientific publications when working in a project team;
  • in oral presentations and written report in English, describe a medical device development process; and
  • reflect on own and other's abilities and roles in relation to project work.

Link to the syllabus on Studieportalen.

Study plan

Examination form

The grading of this course is divided as follow:

  • Project - 6.0 p
  • Laboratories - 1.5 p

To approve this course students must:

  • Complete the project report
  • Complete all laboratories
  • Participate in the final presentation of their project (Dec, 14-18 - 2020)
  • Be present in their project presentations. A maximum of two sessions can be missed under special circumstances.

Grading of the presentations

0, 1, or 2 points will be given for each of the following criteria during the presentations

  • The presentation had logical coherence (organization)
  • The presenters demonstrated an understanding of the material
  • The presenters demonstrated critical thinking skills in the implementation of the concepts
  • Time was managed appropriately
  • The presenters successfully addressed questions

There will be 5 weekly presentations allowing for a total of 50 points, which would be equivalent to 20% of the final grade (points*20/50).

The final presentation will be graded using the same criteria and will amount to 30% of the grade (points*30/10).

Grading of the project report

The final report will be graded considering the application of the concepts learned in this course, and not the potential impact of the medical device. In addition, the following will be considered:

  • Quality over quantity
  • Clarity
  • Concise (repetition will be penalized)
  • Misspellings will be penalized
  • Use of dubious sources will be penalized

Additional information:

  • Maximum 20 pages without the title page and references. Annexes are allowed and do not count for the 20-page limit.
  • Provide sources and cited them properly (tip. Use Mendeley as a source management system). 
  • Include a table of contents
  • Illustrations are encouraged


Changes made since the last occasion

Lectures will be done via zoom