Course content

Design of Orthopaedic Medical Devices

1. Fundamentals

Biomaterials: metallic, ceramic, polymeric, and composite materials for orthopaedics
Biocompatibility: biological response, corrosion, wear, degradation
Body–Implant Interaction: osseointegration, tissue healing, immune response

2. Orthopaedic Devices

Hip Prosthesis: design principles, fixation methods, bearing surfaces
Knee Prosthesis: types (unicompartmental, total, revision), kinematics, constraints
Ankle Prosthesis: mobility restoration, challenges in small joints
Spine Devices: fusion vs motion-preserving devices, instrumentation
Shoulder Prosthesis: anatomical vs reverse design
Devices for Traumatology: plates, screws, nails, external fixators
Patient-Specific Implants: additive manufacturing, imaging-based design, case studies

3. Regulatory and Clinical Aspects

Certification of Medical Devices: EU MDR, FDA regulations, ISO standards
Testing on Medical Devices: mechanical tests, fatigue, wear, tribology, ISO/ASTM standards
Patient Follow-Up: clinical evaluation, registries, radiographic assessment, outcome measures

4. Design & Engineering Tools

Drawing of Medical Devices: technical drawing, CAD tools, tolerances
Finite Element Modelling (FEM) of Medical Devices: modelling strategies, boundary conditions, validation with experiments
Quality in Medical Devices: risk management (ISO 14971), quality systems (ISO 13485), traceability

5. Manufacturing

Manufacturing of Medical Devices: conventional methods (casting, forging, machining) and advanced methods (3D printing, surface treatments, coatings)
Case studies: from design to production

Objectives (and/or specific learning outcomes)

Course Objectives and Learning Outcomes

The course is a continuation of Orthopaedic Biomechanics and focuses on the analysis and design of medical devices, with particular attention to orthopaedic and traumatologic implants used to restore function when the human body is damaged. Students will develop an understanding of the materials, design principles, and manufacturing processes involved in orthopaedic devices, as well as the biological and mechanical interactions between implants and the human body. In addition, the course will address essential aspects of regulation, certification, testing, and clinical follow-up of medical devices, providing a complete overview of the path from design to clinical application.

At the end of the course, students will be able to:

Identify and describe the main biomaterials used in orthopaedic applications and evaluate their biocompatibility.
Analyse the mechanical and biological interaction between body tissues and implants.
Understand the design rationale of the main orthopaedic devices (hip, knee, ankle, spine, shoulder prostheses; trauma devices; patient-specific implants).
Apply engineering tools (CAD, FEM) to the analysis and design of medical devices.
Interpret and apply the main regulations and standards concerning the certification and quality of medical devices.
Explain testing protocols and interpret results from mechanical and in vitro tests.
Understand the principles of patient follow-up and clinical evaluation of implanted devices.
Recognize conventional and advanced manufacturing technologies for medical devices and evaluate their impact on quality and performance.

Prerequisites and Corequisites

Required and Corequired knowledge and skills

Required Knowledge

Students are expected to have prior knowledge in the following areas:

The contents of the Orthopaedic Biomechanics course.
Functional anatomy of the main joints of the human body.
Fundamentals of physics and mechanics.
General concepts of applied mechanics, including:
- Friction
- Wear
- Fatigue
- Contact
- (and related topics)

Teaching methods and learning activities

36h lectures and 12h of project work, in which the students will work on the development of an orthopaedic medical device

References, bibliography, and recommended reading

Human Orthopaedic Biomechanics: Fundamentals, Devices and Applications

Innocenti, Galbusera, Academic Press, 1st Edition – February 24, 2022

Contribution to the teaching profile

Contribution to the Teaching Profile

This teaching unit contributes to the development of competences required for the realistic design of an orthopaedic medical devices. Starting from the anatomical, morphological, and biomechanical constraints of the human body, students will learn how to design and finalize a mechanical device intended for clinical use. They will acquire an understanding of the full design process, encompassing mechanical aspects, sterilization requirements, regulatory and quality considerations, and post-market activities such as clinical studies and patient follow-up. Working in small groups, students will apply this knowledge to develop a prototype implant, for example a total hip prosthetic stem, thereby gaining hands-on experience in translating engineering concepts into practical biomedical solutions.

Other information

Contacts

Prof. Bernardo Innocenti, PhD

BEAMS Department (Bio Electro and Mechanical Systems)

Local: UB3-169 - Campus Solbosch

e-mail: bernardo.innocenti@ulb.be

Campus

Solbosch

Evaluation

Method(s) of evaluation

Oral examination
Oral presentation
Group work

Oral examination

Oral presentation

Group work

Oral examination. The oral will be divided into a general presentation of the project (one per group), followed by an individual examination on the topics covered in the course.

Mark calculation method (including weighting of intermediary marks)

During the course, students will acquire the knowledge and skills necessary to develop a medical device.

Students will work in small groups to design a real orthopaedic implant, such as a shoulder or hip implant.

Each student must also produce a technical report integrating all the main aspects of the design process.

Language(s) of evaluation

english

Design of Orthopaedic Medical Devices : biomechanics, design and regulation

Course teacher(s)

ECTS credits

Language(s) of instruction