Artificial organs

This teaching unit links all previously acquired knowledge in active medical devices (e.g., bioelectronics, bioinstrumentation, stimulation of excitable tissues, neurology, etc.) to propose to the students a concrete and project-oriented way to design an artificial organ aiming to replace/improve a specific function of an organ.

Students will design, implement, manufacture and assess an artificial organ through two group projects (see teaching methods below). A few lectures will give students practical and project-oriented skills to support them in their design:

• Introduction
• Implant Manufacturing and Encapsulation
• Wireless Implant Powering
• Implanted Recording and Stimulation
• Placing a medical device on the EU market

Particular attention is paid to the normative and regulatory aspects of the biomedical field (a recurrent request from the professional field): through a role play, students set up a quality system (inspired by ISO 13485 and MDR 2017/745) and build up the documentation (product file, risk analysis) needed to obtain a — fictitious — CE marking.

At the end of this course, the student will be able to:

• to design, implement, manufacture, and assess an artificial organ aiming to replace/improve a specific function of an organ
• to design a quality system and place a medical device on the EU market

The lectures are oriented to give students the skills required to design and implement an artificial organ. Most of the learning takes place through two group projects.

1. The first project is carried out together, in class ("do it yourself" project): in groups and under continuous supervision, students design and build a pedagogical "implantable" device. These devices share the same general structure for all groups — a remotely rechargeable, encapsulated electronic device — but the application differs from one group to another. The project follows a fixed schedule, in 2-hour sessions, and students receive a single assignment covering the whole project from its very beginning. Each session has a specific objective: system design, schematic, layout, PCB implementation, encapsulation of the device, etc. One or two teaching assistants/researchers are permanently present to answer questions, and concise information is given at key moments in the laboratory (for example about the design of the inductive link or the use of SolidWorks). Students, for instance, encapsulate their device in a clean room and test the inductive powering in aqueous conditions. Attendance at the sessions of this first project (cf. course schedule) is mandatory.
2. The second project is also carried out in groups (typically of three students), but mainly in autonomy: supervision is provided at periodic follow-up meetings. These projects are technically more advanced and include, for example, the design and implementation of parts of implantable devices (e.g., shielding for an active implantable device, firmware and communication of an implant, capacitive strain sensor, low-power communication for implantable devices, etc.) and the understanding of the interaction of implantable systems with the human body (modelling of a nerve for the study of electrical stimulation, changes in the optical properties of a nerve during stimulation, etc.).

Normative and regulatory aspects are addressed transversally through a role play. After a lecture on regulatory aspects, students progressively complete, as their design moves forward, a product file and a risk analysis; they also set up a quality system (inspired by ISO 13485 and MDR 2017/745) covering the R&D, the production and the distribution of the developed medical device. This is also an opportunity to address the ethical dimension of their approach (what is necessary/desired/permitted, who is the sponsor/beneficiary/responsible, etc.). The laboratory ends with an "external audit" of the quality system and of the product file, carried out by the teaching team.

Support(s) de cours

• Université virtuelle

Contacts

antoine.nonclercq@ulb.be

Campus

Solbosch

Méthode(s) d'évaluation

• Autre

Autre

The students will present their projects and explain their approach. An audit related to their project (i.e., a specific oral exam) will allow them to go deeper into the methodology and course content.

Construction de la note (en ce compris, la pondération des notes partielles)

The mark will be based on the proposed projects, the quality system, and the product file.

Langue(s) d'évaluation

• anglais
• (éventuellement français )