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376-1308-00L 3 Credits MSC , NDS D-HEST , D-MAVT , D-PHYS , D-ITET
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Development Strategies for Medical Implants

Lecturers & Examiners: Dr. Jörg Mayer-Spetzler, Dr. Marina Rubert, Dr. Johannes Früh, Dr. Anil Kumar Rajak, Felix Albert Kraeft, Alice Della Casa
VVZ CR n/a

Last Updated: 2026-06-01 11:33:04

Abstract

The lecture guides through the entire implant development process from concept to market. It illustrates how mitigation of risks during the development of patient-centered implants catalyzes innovations while simultaneously meeting user needs, socio-economic requirements, and economic targets. Discussions include real-world case studies and trends in orthopedics and cardiovascular surgery.

Objective

- Understanding patient-centered implant development processes within the regulatory framework as a never-ending improvement cycle. - Relevance of safety and efficacy in a risk-minimizing approach for a commercially successful implant development process - Understand the critical role of risk analysis in the design process of medical implants. - Learn how to apply “Design for” strategies to address specific risks in biocompatibility, manufacturability, functionality, and bioactivity. - Gain insights from practical examples, such as surgical implants and their real-world testing scenarios. - Discussion of state-of-the-art and actual trends in implant development in sports medicine, cardiovascular surgery, and soft tissue reconstruction and repair

Content

- Introduction to human-centered implant design. Key drivers of innovation such as clinical needs, economic and socio-economic criteria, and the role of risk mitigation in these processes. - Additive manufacturing as a typical lead innovation impacting core design and development processes. - Risk-based Design: Overview of the risks that medical implants typically face (e.g., biocompatibility, contamination, mechanical failure) and how these shape design choices. Basic introduction to Risk Analysis. - Regulatory considerations (e.g., FDA) that guide the risk management process in medical device development. - Design for Biocompatibility and Safety: Introduction to biocompatibility and sterility concept and considerations. Basics of tissue reactions, implant-body interactions, materials, and design principles aimed at minimizing adverse reactions. Introduction to biocompatibility standards and test planning - Design for Manufacturing and Validation: How manufacturing processes (e.g., additive manufacturing) introduce risks like contamination and how these can be mitigated through design. - Design for Functionality: How to address clinical needs. Verification and validation processes to prove performance and usability. - Design for Bioactivity: Introduction to surface modifications, test methods and biological response - Discussion of state-of-the-art and actual trends in implant development in sports medicine, cardiovascular surgery, and soft tissue reconstruction and repair. Commented movies from surgeries will further illustrate selected topics. Seminar: - Group seminars on selected controversial topics in implant development. Participation is mandatory. - Guest lectures on “how to market innovative implants”, “Risk analysis according to ISO 14971 incl. practical training”, and “Robotics and Virtual Reality in Thorax Surgery”. (titles are tentative; to be confirmed) Planned excursions (limited availability, not mandatory, to be confirmed): Participation (as a visitor) in a life surgery (travel at own expense)

Resources

Lecture Notes

Script (electronically available):- presented slides- selected scientific papers for further reading

Literature

Reference to key papers will be provided during the lectures.

General Information

Language
English
Levels
MSC , NDS
Frequency
Yearly recurring

Examination

Type
session examination
Mode
oral 30 minutes
The exam will be in English

Registration & Places

Limited places (Special selection)
Signup End
03.02.2025

Course Components

Type Title Time & Place Hours
lecture Development Strategies for Medical Implants
Permission from lecturers required for all students. Admission to the lecture is based on a letter of motivation to the lecturer J. Mayer ( ). The number of participants in the course is limited to 30 students in total.
  • Thu 10:15-12:00 (HG E 33.1)
2 h weekly
exercise Development Strategies for Medical Implants
Permission from lecturers required for all students.
  • Thu 13:15-14:00 (ML H 41.1)
1 h weekly

Offered In