1. Introduction (CB, SC, JV)
1.1 How the medical devices can add value and support the health systems worldwide for present and future challenges
2. Role of technology in Health Care (CB, JV)
Historical background: summary of the different approaches to medicine along the times
The technology in medicine: from the stethoscope, to the WWI innovation, to the present
The meaning of innovation in technology and medicine
3. Definition and international classification of Medical Devices (SC, JV, GC)
3.1 The medical device concept
Medical devices and pharmaceuticals: an important difference
The rationale behind the definition
3.2 Standards and regulations (ISO, AAMI (USA), MHW (Japan), MDD (Europe))
Description and comparison among the different standards
The rationale behind the classification
Evaluation of risks and benefits
Focus on EU MDR
The impacts of classification on design and operation of medical devices
Remarks on in-vitro diagnostics and combination products
3.3 ICT and patient's privacy
3.4 Ethical aspects
4. Technical and operational perspective (CB, JV)
4.1 Typical lifecycle of a medical device
4.2 The impact of Medical Devices in the healthcare institution
4.3 The need for a systemic approach
5. Economic Perspective (EL, SF, MdV)
5.1 Overview
5.2 Value in medicine
5.3 Reimbursement systems
6. Further challenges (CB, SC, JV, SF)
6.1 Healthcare sustainability and consequences on medical devices technology
6.2 Medical devices in Developing Countries
7. Future outlook and conclusions (CB, SC, JV).