39473 - Bioengeneering and Development of Artificial Organs and Prosthesis

Learning outcomes

By the end of the module, students will have acquired the knowledge and skills required for the design, fabrication, and management of limb prostheses. In particular, they will understand the main types of upper and lower limb prostheses and the biomechanical principles underlying their function. Students will also acquire knowledge of prosthetic classification systems, fabrication methods, and the classification of prosthetic devices within the national reimbursement and coding system.

Course contents

The course introduces the fundamental principles of bioengineering applied to medical devices, with particular emphasis on biomaterials, biocompatibility, and 3D printing technologies. It covers the basic concepts of intellectual property and patents, the definition and classification of medical devices, custom-made medical devices, CE marking, general safety and performance requirements, technical documentation, and traceability. The course also provides an introduction to the international regulatory framework for medical devices, with particular reference to the role of the U.S. Food and Drug Administration (FDA) in the United States.

Course Outline

Introduction to Bioengineering
Definition of bioengineering. Main application areas. The role of bioengineering in the development of medical devices.

Biomaterials and Biocompatibility
Definition of biomaterials. Main classes of biomaterials, including metals, polymers, ceramics, and composites. Fundamental material properties. Biocompatibility and interactions between biomaterials and the human body.

3D Printing and Digital Manufacturing Technologies
Principles of additive manufacturing. Main 3D printing technologies. Materials used in 3D printing. General workflow of the manufacturing process and its main application limitations.

Patents and Intellectual Property
Definition of a patent. Patentability requirements. Duration, territorial scope, and exclusive rights. Differences between patents, trademarks, industrial designs, and copyright.

Medical Devices, CE Marking, and International Regulation
Definition and classification of medical devices. Custom-made medical devices. CE marking. General safety and performance requirements. Technical documentation and traceability. Introduction to the role of the U.S. Food and Drug Administration (FDA) in the regulation of medical devices in the United States.

Readings/Bibliography

Course notes provided by the professor. The course notes will be made available on the Virtuale learning platform.

Teaching methods

The course consists of in-person lectures delivered in the classroom.

Assessment methods

Student learning is assessed through a one-hour final written examination consisting of multiple-choice questions. The use of books, notes, and electronic devices is not permitted during the examination. The written examination is designed to assess the knowledge and competencies acquired throughout the course.

The final grade for the integrated course is calculated as the arithmetic mean of the grades obtained in the three component courses.

With regard to assessment, the use of artificial intelligence (AI) is prohibited. Any use of AI constitutes a violation of academic integrity.

Students with learning disorders and\or temporary or permanent disabilities: please, contact the office responsible (https://site.unibo.it/studenti-con-disabilita-e-dsa/en/for-students) as soon as possible so that they can propose acceptable adjustments. The request for adaptation must be submitted in advance (15 days before the exam date) to the lecturer, who will assess the appropriateness of the adjustments, taking into account the teaching objectives.

Teaching tools

Computer and digital projector.

Office hours

See the website of Emanuela Marcelli

See the website of Davide Maria Donati

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