Medical Devices

Objectives

Medical devices have an increasing impact on diagnosis and therapy and costs far more than drugs. Unlike drugs, devices are not yet covered in an integrated way during medical school. The benefit-risk assessment of devices is in deep structuring, approaching drug standards and necessarily involving physicians. The overall objective is to sensitize the future generation of physicians to the importance of medical device evaluation and clinical research in this area. The course will also stimulate interdisciplinary work and the participation of physicians in device innovation.

 

At the end of the UC students should know:

1. Define health technologies

2. Classify the devices

3. Explain the innovative nature and challenges of medical devices in specific areas

4. Give examples of the need for disciplinary exchange (computer science, physics, engineering, etc.) for the development and implementation of devices in medical practice

5. List the stakeholders and describe the process of development and implementation of the different groups of devices

6. Describe the circuit in the health units of the most relevant devices for diagnosis and therapy

7. Discuss the perspectives of industry and regulatory agencies in approving a medical device

8. Identify future professional opportunities in the area

General characterization

Code

11232

Credits

3

Responsible teacher

Prof.ª Doutora Emília Monteiro

Hours

Weekly - Available soon

Total - Available soon

Teaching language

Portuguese

Prerequisites

 

Bibliography

 

Teaching method

The sessions held in the NMS | FCM are essentially expository, followed by application to a specific case. The remaining ones include demonstration with "hands-on" of some components of the devices.

The seminar (session 15) will have a theoretical framework guided by questions posed by the moderator followed by a discussion with the students

Evaluation method

At the end of each session, each student will be asked to identify in writing 3 aspects that he / she learned in that session. This information and the active participation in the classes will correspond to 20% of the final evaluation

 Presentation and discussion of a final study that will deal with a medical device at the student's choice (80% of the final evaluation). The work should address the classification of the DM, the justification of its innovative nature, the steps that followed to be approved, the clinical investigation to assess its efficacy and risks and the limitations that the device has. The choice of device must be previously approved by the UC chair.

The final classification will be the weighted average of the 2 components (there is no mandatory minimum classification in any of the components).

The evaluation in alternative periods is based on the same components of the regular evaluation.

Subject matter

Organizational aspects of  the UC.
Health technologies and medical devices: concepts and classification.
Contextualization of the evolution of medical devices in the practice of Medicine
New perspectives in doctors' careers. Digital Health and adherence to protocols: the UpHill case
Innovation in medical devices. Examples of physician collaboration with patients and other professionals in the development of innovation: patient innovation and 3D printing
The life cycle of medical devices and regulatory aspects. Evaluation of quality, efficacy, safety. Specificities of clinical studies
Artificial intelligence applied to diagnosis: the SkinSoul case
Devices that might have to be drugs: example of hyaluronic acid
Innovation and challenges applied to various specialties:
General anesthesia (monitoring, drug administration, airway, robotics, etc)
Medical devices for distance monitoring (e-health)
Medical devices in nephrology
Medical devices in orthopedics:
Implants (60 min)
Innovation in arthrometers (30min)
Medical Devices in Diabetes
Interventional medical devices
Abdomino-pelvic (CHULC) (26 students)
Neuroradiology (CHULC) (12 students)
Neurosurgery- Gamma knife (CUF Infante Santo) (12 students)
Devices in cardiology (Hospital da Luz, 15 students)
The robotics applied to urology (Hospital da Luz, 15 students)
Devices in cardiology (Hospital Sta Marta, 20 students)
Selection criteria and device circuits in health units
Seminar - Approval and reimbursement of medical devices
The perspective of the regulatory authority
The perspective of the medical device industry
Discussion of students’ work

Programs

Programs where the course is taught: