BMT-62356 Product Development of Biomedical Devices, 5 cr
Additional information
Prerequisites: Students should have finished their BSc degree studies AND have obtained 50 credit units of MSc studies. Students must show that they have 30 credits from the field of biomaterials, biotechnology, biomedical engineering, medicine and related subjects. The course is intended for the students in their last study year for MSc (DI) degree (or for PhD students). It is most useful for the students at that stage. If you are unsure, contact responsible teacher for your qualifications.
Recommendations: It is recommended that all participating students have studied the BMT-62237 Introduction to Quality and Regulation for Medical Product Development couse before taking this Product Development course.
Suitable for postgraduate studies.
Person responsible
Timo Allinniemi, Minna Kellomäki
Lessons
| Implementation | Period | Person responsible | Requirements |
| BMT-62356 2019-01 | 1 - 2 |
Timo Allinniemi |
All the lectures, assignments, project group meetings and seminars are compulsory. Accepted written reports and accepted oral and written final reports requested. |
Learning Outcomes
Student has collected, combined and explained the planning process stages of a medical device from an idea to a final product including regulatory aspects and risk analysis. Student has collected data and compiled review reports in groups which include patent and market surveys and survey requirements for the application and the biomedical device. Student has critically overviewed scientific articles and different databases for the information retrieval. As a part of a group student has planned and prepared schedule, budget, and workflow for the project. Student has presented group work as written document and as an oral presentation in seminar. Student has also assessed the work of other groups and received criticism.
Content
| Content | Core content | Complementary knowledge | Specialist knowledge |
| 1. | Process and design stages of a medical device from an idea to a final product | ||
| 2. | Literature review: patent survey, marketing survey, setting up the requirements of the application, properties of the components of the device studied | ||
| 3. | Influence of regulatory aspects to medical device R&D chain | ||
| 4. | Risk analysis | ||
| 5. | Setting up the schedule, work flow and budget for the project | ||
| 6. | Written and oral presentations of the work stages |
Instructions for students on how to achieve the learning outcomes
The final grade of the course is determined based on the assessment of all part of the course. The weighting factor of each part is given at the beginning of the course. Grades 1-2: Learning outcomes have been achieved. Satisfactory command in core content of the course. Grades 3-4: Some learning outcomes have been exceeded qualitatively or quantitatively. Good command in core content and complementary knowledge of the course. Good or very good marks from all parts of the course. Grade 5: Most of the learning outcomes have been exceeded. Deep command in the whole content of the course. Almost maximum performance in all parts of the course.
Assessment scale:
Numerical evaluation scale (0-5)
Partial passing:
Additional information about prerequisites
Prerequisites: Students should have finished their BSc degree studies AND have obtained 50 credit units of MSc studies. Students must show that they have 30 credits from the field of biomaterials, biotechnology, biomedical engineering, medicine and related subjects. The course is intended for the students in their last study year for MSc (DI) degree (or for PhD students). It is most useful for the students at that stage. If you are unsure, contact responsible teacher for your qualifications.
Recommendations: It is recommended that all participating students have studied the BMT-62236 Medical Device Research and Productization couse before taking this Product Development course.
Correspondence of content
| Course | Corresponds course | Description |
| BMT-62356 Product Development of Biomedical Devices, 5 cr | ELT-62356 Product Development of Biomedical Devices, 5 cr |