Course syllabus

Medicinteknisk design
Biomedical Design

EEMA01, 9 credits, G1 (First Cycle)

Valid for: 2020/21
Decided by: PLED BME
Date of Decision: 2020-03-24

General Information

Main field: Technology.
Compulsory for: BME2
Language of instruction: The course will be given in Swedish

Aim

The purpose of the course is that the student shall develop an understanding of innovation and development processes of particular relevance to medical devices. This includes creating an understanding that medical devices often have a critical function and must be safe for patients, users and third parties. Also, the student needs to understand that, apart from demands from professionals and patients on safety, science and proven experience, there are also legal demands that make it necessary for the engineer to have deep knowledge about quality and government demands related to the development and management of medical devices.

Learning outcomes

Knowledge and understanding
For a passing grade the student must

 

Competences and skills
For a passing grade the student must

 

 

Judgement and approach
For a passing grade the student must

 

Contents

The course deals with innovation and development processes for medical devices in both lecture form and project form. The project starts at the course start, and will be performed in parallell with the lectures. The topics discussed at lectures shall be applied within the projects.

Medical devices play a crucial part in the diagnosis and treatment of patients in modern healthcare. An engineer working with medical technology and medical devices face particular demands, regardless if the person is an entrepreneur, works within research and development, service and maintenance, adminstration or law, in a small or large company, within the private or publi ector; she/he needs to have patient safety as the number one priority – a safety mindset that is matched only in the aerospace sector.

Medical devices often have a critical function and must be safe for patients, users and third parties, and apart from demands from professionals and patients on safety, science and proven experience, there are also legal demands that make it necessary for the engineer to have deep knowledge about quality and government demands related to the development and management of medical devices.

The course will deal with needs analysis, trend and technology watch, concept and prototype generation, requirement specifications, patent issues, how a product is brought to market within (CE marking) and outside of Europe, laws and regulations, medical devices directive (MDD), standards, Notified Bodies, quality systems, risk analysis, clinical evaluation, and environmental management systems.

Examination details

Grading scale: TH - (U,3,4,5) - (Fail, Three, Four, Five)
Assessment: Written assignment, written exam (individual assessment), written project report (team assessment) and indivdual written reflection.

The examiner, in consultation with Disability Support Services, may deviate from the regular form of examination in order to provide a permanently disabled student with a form of examination equivalent to that of a student without a disability.

Parts
Code: 0118. Name: Assignments.
Credits: 1,5. Grading scale: UG. Assessment: Written assignments.
Code: 0218. Name: Written Examination.
Credits: 3,5. Grading scale: TH. Assessment: Written test (individual assessment).
Code: 0318. Name: Project.
Credits: 3,5. Grading scale: TH. Assessment: Written project report (team assessment). Verbal presentation of the project (team assessment). Contents: The project is assessed by a written report.
Code: 0418. Name: Personal Reflection of Group Work .
Credits: 0,5. Grading scale: TH. Assessment: Individual written reflection.

Admission

The number of participants is limited to: No

Reading list

Contact and other information

Course coordinator: Universitetslektor Magnus Cinthio, magnus.cinthio@bme.lth.se
Course coordinator: Professor Anders Warell, anders.warell@design.lth.se
Course homepage: http://bme.lth.se/course-pages/medicinteknisk-design/medicinteknisk-design/
Further information: The course is given by the Departments of Biomedical Engineering and Design Sciences in collaboration.