OD9110 – Development of Implantable Medical Devices
Course content
Students will acquire insight on the development process for implantable medical devices, including technical and clinical considerations, as well as insights into the factors contributing to implant failure and approaches for addressing them.?
Learning outcome
This course builds on the principles of biomedical engineering and materials science underlying the design and development of implantable medical devices.?
Knowledge
?The learning objectives and outcomes will primarily?
Provide insight into the techniques to critically assess the performance, safety, and efficacy of existing implantable medical devices through case studies and clinical examples.??
Introduce the principles of design thinking and human factors engineering to optimize user interaction, patient comfort, and device functionality in implantable medical device development.??
Introduce the common modes of implant failure, including mechanical, biological, and material related factors, and strategies to mitigate failure risks through improved design, material selection, and surgical techniques.??
Skills
The learning objectives and outcomes will primarily?
Analyze the anatomical, physiological, and biomechanical considerations influencing the selection of materials and design features for implantable devices.??
Evaluate the biocompatibility, mechanical properties, and degradation kinetics of materials commonly used in implantable medical devices, including examples from all classes of biomaterials, i.e., metals, polymers, ceramics, and composites.?
Explore emerging trends and innovations in implantable medical device technology, such as wireless connectivity, miniaturization, and smart sensing capabilities.??
Address the lifecycle of implantable medical devices, including preclinical testing, clinical trials, post-market surveillance, and regulatory compliance.??
Introduce the regulatory landscape and standards governing the development, manufacturing, and commercialization of implantable medical devices.?
Admission to the course
The course is open to all registered PhD students.
Special admission requirements
No special admission requirements.
Formal prerequisite knowledge
No mandatory prerequisites.
Recommended previous knowledge
Participants should have a basic understanding of biomaterials science (including properties of implantable polymers, metals, and ceramics), human physiology (such as adverse effects and tissue responses to biomaterials). Familiarity with regulatory standards (e.g., ISO 13485, FDA requirements) and lab techniques (e.g., sterilization methods) will be beneficial but not required. While the course accommodates interdisciplinary learners, those without prior exposure to these topics should review the provided introductory materials on core concepts. A basic awareness of clinical challenges (e.g., long-term biocompatibility) will enhance engagement with case studies.
Teaching
Mandatory attendance includes 3 2-hour lectures and 2 hands-on workshops with absences requiring prior approval.
Examination
Week 1: Lecture 1?
Week 2: Lecture 2?
Week 3: Workshop: Essay topic discussion and approval?
Week 4: Independent Research ?
Week 5: Outline, online submission?
Week 6: Independent Work: Drafting ?
Week 7: Submit 1,500-word draft for feedback?
Week 8: Peer Review (evaluation of the essay of one peer) and Workshop 2 with group feedback session?
Week 9: Lecture 3 / participants prepare 10-minute talk??
Week 10: Final Presentations: 10-min talk and 5-min Q&A?
Participants finalize and submit 3,000-word essay (±20%), revised slides and reflection statement?
Examination support material
To be announced.
Language of examination
All work submitted must adhere to formal academic English standards, including, discipline-appropriate terminology and flawless citation management of all sources.
Grading scale
A-F
Resit an examination
Late submissions follow standard penalty protocols.
More about examinations at UiO
- Use of sources and citations
- How to use AI as a student
- Special exam arrangements due to individual needs
- Withdrawal from an exam
- Illness at exams / postponed exams
- Explanation of grades and appeals
- Resitting an exam
- Cheating/attempted cheating
You will find further guides and resources at the web page on examinations at UiO.