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. Doutor Tiago Bilhim
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
Evaluation of learning and student evaluation.
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.
Due to the COVID-19 constraints, classes may be available in 2 possible formats:
1. Physical presence.
2. Through e-learning where live interactive videoconferences will be organized.
Subject matter
|
Date |
Time* 30 min break between sessions |
Place |
Tema |
Docente |
|
25/2 |
14.30 16.30 |
FCM|NMS /Online FCM|NMS /Online |
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 |
Tiago Bilhim Tiago Bilhim Eduardo Rodrigues |
|
4/3 |
14.30 16.30 |
FCM|NMS /Online |
The life cycle of medical devices and regulatory aspects. Evaluation of quality, efficacy, safety. Specificities of clinical studies Innovation in medical devices. Examples of physician collaboration with patients and other professionals in the development of innovation: patient innovation and 3D printing and augmented reality |
Catarina Madeira Salomé Azevedo Diogo Casal Philips |
|
11/3 |
14.30 16.30 |
Hospital Curry Cabral |
Innovation in Diferent Medical Specialities: - Robotics and laparoscopic surgery - Interventional Radiology |
Luís Campos Pinheiro Hugo Pinto Marques Tiago Bilhim |
|
18/3 |
14.30 |
Hospital São José |
Innovation in Diferent Medical Specialities: - Anesthesiology - Neurorradiology |
Rafael Marques Pires Isabel Fragata |
|
25/3 |
14.30 16.30 |
FCM|NMS /Online |
Innovation in Diferent Medical Specialities: - Orthopedics: Implants (60 min) - Ortopedics: Arthrometres (30min) Medical Devices in Diabetes |
Paulo Felicíssimo Francisco Guerra Pinto João Raposo |
|
8/4 |
14.30 17.00 |
CUF Tejo |
Innovation in Diferent Medical Specialities: - Neurosurgery- Gamma knife - Othorrynolaryngology (Implantes cocleares) - Simulators |
Begoña Cattoni |
|
15/4 |
14.30 |
Hospital Santa Marta (25 students) Hospital Santa Cruz (25 students) |
Innovation in Diferent Medical Specialities: - Cardiology - Vascular Surgery
Programs where the course is taught:
|