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

Teacher assistants (TAs)

Student representatives:

MPBME   benblo@student.chalmers.se - Benjamin Blomqvist
MPBME   ludvig.hovland@hotmail.com - Ludvig Hovland
MPBME   jackiej@student.chalmers.se - Jackie Johansson
MPBME   friol@student.chalmers.se - Frida Olsson
MPBME   shivani.ravichandran@studentmails.com - Shivani Ravichandran

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 at https://sites.google.com/a/umn.edu/mdih/

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 (December 14th & 15th) 

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 14th & 15th)
  • 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 were conducted via Zoom in 2020. This year's lectures will be in person with some exceptions when needed.

Course summary:

Date Details Due