Course syllabus

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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:

MPBME karthikb@chalmers.se Karthik Babu
MPPDE davijay1997@gmail.com Vijaya Kumar Dasappa Ashoka
MPPDE ajayvg009@gmail.com Ajay Vivek Gokhale
MPBME emigusjo@gmail.com Emil Johansson

 

Course purpose

This course aims to provide specific knowledge in the ideation, creation, and certification of medical devices including product development procedures. This course will be taught and examined 100% in English language

 

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. You will take an idea for a medical device through the process of developing it into a potential product., however you will not be making or building the device or any part of it. You are encouraged to explore your own ideas for a medical device. If the you do not have your own idea, case studies/projects will be provided.  

Please form groups of 4 and register your group in Canvas.

There will be 3 lectures per week. New concepts will be introduced by guest lecturers from industry in the first 2 lectures (Tuesdays and Wednesdays), and you will present the application of such concepts to your project in the 3rd lecture (Fridays). Observe the following requirements for your presentations:

  • All students should present equally (distributed over all presentations)
  • You can only miss 1 presentation session 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 with regard to relevant scientific, social and ethical aspects ;
  • 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 and demonstrate awareness of ethical aspects in research and development;
  • 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 by critically examining ethical, legal, and social aspects including equal treatment and gender equality;
  • 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;
  • understand the concepts and measurement of equity in healthcare.

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 you must:

  • Complete the project report
  • Complete all laboratories
  • Participate in the final presentation of your project (December 13th)
  • Be present in your project presentations. (You can only miss 1 presentation session or 2 in very exceptional 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

Bonus points are available to those who upload their presentations before the 9am deadline each day of presentation.

Bonus points are available to groups whose presentations are </= 10 minutes.

There will be 5 weekly presentations (totalling 30 points), making 30% of your final grade.

The final presentation will be graded using the same criteria and will make up 30% of your final grade.

 

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
  • The report will make up 40% of your final grade

Course summary:

Date Details Due