Course syllabus

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Course-PM

EEN040 Development of medical devices lp2 HT21 (7.5 hp)

Course is offered by the department of Electrical Engineering

Contact details

Faculty

Teaching assistants (TAs)

Student representatives:

1

2

3

4

5

 

Course purpose

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

Schedule

TimeEdit

Course literature

Durfee and Laizzo, Medical Device Innovation Handbook, University of Minnesota, 2017. Available to download as a PDF from the course modules section

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 4 people. Registration of the groups is done in Canvas.

There are 3 lectures per week. New concepts will be introduced in the first 2 lectures (Tuesdays and Wednesdays), and students will present the application of such concepts to their project in the 3rd lecture (Fridays). Observe the following requirements for student presentations:

  • All students should present equally (distributed over all presentations)
  • A student can only miss 1 presentation sessions or 2 in very exceptional circumstances to pass this course
  • All students must participate in the final presentation of their project (December 13th) 

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 (December 13th)
  • 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 flow of the presentation made sense from start to finish
  • The presenters demonstrated an understanding of the lecture material 
  • The presenters demonstrated critical thinking skills in the implementation of the material

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:

  • The quality of the report
  • Being clear in your communication 
  • Being concise in delivering information (and avoid repetition)
  • Employ good grammar and spelling (use the functionalities in word)
  • Use of standard refencing sources

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

Course summary:

Date Details Due