This book provides caregivers and administrators with high-quality support for strategic decision making in the selection and use of medical devices so as to ensure value optimization. Medical treatment is increasingly complex, with wide application of medical devices and corresponding involvement of physics and engineering. A multidisciplinary methodology that brings together expertise from key disciplines in a holistic, system-oriented approach is essential in controlling this complexity and further improving health care. This book will help readers to understand the design, validation, and application of medical devices and the standards and regulations that apply to them across the world. In addition, it provides technical, operational, and economic perspectives on their use. The relevance of concepts such as expenditure optimization and sustainability to medical device technology is explained and healthcare reimbursement systems are discussed from different points of view. Readers will gain a clear appreciation of the managerial and economic implications of the use of medical devices and how to get the most out of them. Academic research, industrial experiences, and case studies are presented as appropriate.
Author(s): Carlo Boccato, Sergio Cerutti, Joerg Vienken
Series: Research for Development
Publisher: Springer
Year: 2022
Language: English
Pages: 283
City: Cham
Foreword
Introduction
Contents
Contributors
Abbreviations
Part I: Opening Thoughts
Chapter 1: The Medical Devices Promise to the Healthcare System
1.1 The Medical Devices Technology: A Preliminary Definition
1.2 The Main Challenge
1.3 A Possible Answer
1.4 The System Thinking
References
Chapter 2: The Role of the Engineer and Technology in Healthcare
2.1 Medical Devices, Experiences Skills, Customer Needs and Ethical Impacts
2.2 Challenging Issues for Engineers: Reliability of Medical Device Testing
2.2.1 The Problem
2.2.2 Reasons and Explanations
2.2.3 Boundary Conditions for Optimal Testing
2.2.4 Conclusion on Testing
2.3 Challenging Issues for Engineers: Medical Devices and Extractables
2.3.1 How are Extractables Defined?
2.3.2 Case Report on an Artificial Hip
2.3.3 Observations from Experiences on Haemodialysis Treatments
2.3.4 Examples for Adverse Clinical Effects in Patients
2.3.5 Conclusion on Extractables
2.4 Challenging Issues for Engineers: Medical Devices and Biocompatibility
2.4.1 Thrombogenicity and Blood Coagulation
2.4.2 Stimulation of the Immune System (Complement- and Cell-Activation)
2.4.3 Hypersensitivity Reactions
2.4.4 Haemodynamic and Vasoactive Effects
2.4.5 Conclusion on Biocompatibility
References
Chapter 3: Essentials of Innovation Theory for Medical Devices
3.1 Healthcare Innovation
3.1.1 Presentation of the Problem
3.1.2 Innovation Management as an Approach to Solution
3.2 Model of Innovation Adoption
3.2.1 Overview
3.2.2 Example of Application: Implant Technology
Product Idea
Development
Certification and Market Approval
Reimbursement
Market Introduction and Idoption
Feedback Loops
Basic Innovations vs. Adaptions
References
Sources of Law
Part II: Definitions and Regulations
Chapter 4: Definition and International Regulations for Medical Devices
4.1 The Medical Device Concept and Classification
4.1.1 Definition of Medical Device in Europe
4.1.2 Definition of Medical Device in the United States
4.1.3 Definition of Medical Device in Japan
4.2 Regulations (EU, USA, Japan)
4.2.1 European Regulatory Framework: CE-Mark
4.2.2 CE-Mark Device Classification
4.2.3 Major Changes Introduced by the MDR
4.2.4 CE-Mark Certification and Declaration of Conformity
4.3 US Regulatory Framework: FDA Notification and Approval
4.3.1 FDA Device Classification
4.3.2 FDA Premarket Approval and Premarket Notification Process
4.4 Japanese PMDA
4.4.1 Japan Medical Device Classification
4.4.2 PMDA Process
4.5 International Technical Standards
4.5.1 Harmonized Standards in Europe
4.5.2 Harmonized Standards in the USA
References
Chapter 5: Lifecycle of Medical Devices
5.1 Medical Devices Lifecycle: WHO Definition, Main Phases, and Stakeholders
5.1.1 Phase 1: Conception and Development
5.1.2 Phase 2: Manufacturing
5.1.3 Phase 3: Packaging and Labelling
5.1.4 Phase 4: Advertising
5.1.5 Phase 5: Sale
5.1.6 Phase 6: Use
5.1.7 Phase 7: Disposal
5.2 Regulatory Requirements
5.2.1 Conception and Development: Harmonized/Consensus Standards
5.2.2 Manufacturing: Good Manufacturing Practice and Quality Management System
5.2.3 Packaging and Labelling: Information to Report and Symbols to Use
5.2.4 Advertising: Local Laws and Truthful Statements
5.2.5 Sales: Responsibility of Manufacturers, Distributors, and Importers
5.2.6 Use: Correct Information to the User and Post-market Surveillance
5.3 A Case-Study: Development of a Device for Cardiac Arrhythmia Detection, for Personal Use
5.3.1 Conception and Development: From the Idea to the First Prototype
The Clinical Need Unmet
The Idea of the Device
The Context
The Competitors
The Requirements
The Prototyping
5.3.2 Manufacturing: Choice of Suppliers and Mass Production
5.3.3 Packaging and Labelling: A Compromise between Regulatory Restriction and Brand Message
5.3.4 Advertising: The Target is the Patient
5.3.5 Sale: Distribution Network and Personnel Training
5.3.6 Use: Attention to Possible Misuses and Customers Reviews
References
Part III: Engineering and Operations
Chapter 6: The Medical Devices in Healthcare Provider Organisations
6.1 Setting the Issue
6.1.1 Healthcare Technology and Medical Devices
6.1.2 The Quality in HPO
6.2 The Role of the Infrastructure
6.2.1 Acquisition
6.2.2 Utilisation
6.2.3 Reprocessing
6.3 Impact on the Healthcare Processes
6.3.1 The Concept of Risk in Medical Devices
A Risk Is Not a Disease
6.3.2 The Risk Management Activity in HPO
6.4 A Possible Paradigm: The Case of Blood Purification with Haemodialysis
6.4.1 Short Intro
6.4.2 Operations
6.4.3 Infrastructure
6.5 Additional Considerations for Low-Income Countries
References
Chapter 7: Information and Communication Technology: Implications on Patient´s Privacy and Security
7.1 The Present Status
7.2 EU: The General Data Protection Regulation (GDPR)
7.2.1 Pseudonymization and Encryption
7.2.2 The Right to be Forgotten
7.3 EU: Information Security and IT for Medical Devices
7.4 The USA: The Health Information Portability and Accountability Act
References
Part IV: Apply Economics in Medicine
Chapter 8: Economic Perspectives: An Overview
8.1 Systems Approach
8.2 Costs
8.3 Outputs, Outcomes, and Impacts
8.4 Performance
8.5 Period
References
Chapter 9: Assessment of Medical Technologies: Methods and Challenges
9.1 The Concept of ``Value´´ in Healthcare
9.1.1 Value-based Healthcare and Technology Assessment
9.1.2 Health Technology Assessment
9.1.3 Economic Assessment of Technology in Healthcare
9.1.4 Cost-Utility Analysis
9.1.5 Multi-criteria Decision Analysis
Equation (9.1): Determination of Value According to MCDA
9.1.6 Social Return on Investment (SROI) in Healthcare
9.2 Disinvesting for Investing in Healthcare
9.3 Technology Assessment in Hospitals
9.3.1 The Linkage Between Technology Assessment and Hospital Strategy
9.3.2 The Organizational Arrangements for Technology Assessment in Hospitals
9.3.3 Frameworks for Technology Assessment in Hospitals
9.3.4 Acceptance of Innovation in Hospitals
9.3.5 Government of Technology Assessment in Hospitals
References
Chapter 10: Reimbursement Systems for Healthcare: Considerations on ``Pay for Performance´´
10.1 Pay-for Performance and Clinical Therapies
10.1.1 Pay-for-Performance (P4P) Programs
10.1.2 Determining Factors for the Introduction of P4P Programs
10.1.3 Motivation of Involved Stakeholders and Their Possible Conflict of Interest
Patients as Stakeholders
Physicians as Stakeholders
Hospital Management as a Stakeholder
Health Insurance Funds as Stakeholders
10.1.4 Case Report: The P4P System in the United Kingdom
10.1.5 Results: General Observations
10.1.6 Results: Improvements in Clinical Quality Indicators
10.1.7 Lessons Learned from QOF Daily Practice
10.2 Performance and Compensations for Medical Devices
10.2.1 Trends and Observations in the Global Medical Device Market
10.2.2 Innovative Products for the Reduction of Total Cost of Care
10.2.3 Adaptation to Different Requirements of International Healthcare Systems by Innovative Processes
References
Part V: Problems and Opportunities
Chapter 11: The Role of Medical Devices in Healthcare Sustainability
11.1 The Healthcare System Sustainability and Its Enemies
11.2 Health Care Systems Sustainability and the Impact of Medical Devices
11.2.1 Pollution Control and Resources Saving
11.2.2 Active Contribution of Medical Devices to Sustainability
References
Chapter 12: Medical Devices in Low- and Middle-Income Countries
12.1 Many Worlds of Health
12.1.1 Classification
12.1.2 Characteristics of Health and Healthcare in Low- and Middle-Income Countries
12.2 Applied Technology
12.3 Emerging Markets: Markets of the Future
12.3.1 Economic Growth: The New Tigers
12.3.2 Social Insurance
12.3.3 Aging Population and Urbanization
References
Chapter 13: Ethical Aspects in Medical Devices and Ethical Committees in Clinical Trials and Regulations
13.1 Clinical Trials for Medicinal Products (Pharmaceutical Drugs)
13.2 Clinical Trials on Medical Devices and In Vitro Diagnostics Medical Devices
13.2.1 The New Regulations on MD in a Nutshell
13.3 Regulation (EU) No. 2017/745
13.3.1 Classification of Devices and Conformity Assessment Procedures
13.4 Key Aspects of the New Medical Device Regulation (MDR)
13.4.1 Quality Management System (QMS)
13.5 Ethical Aspects and Ethical Committees
13.5.1 Ethical, Scientific and Methodological Evaluation of Clinical Studies
13.5.2 European Regulation on Clinical Trials: Towards the Harmonisation of Standards on Clinical Trials
References
Chapter 14: Medical Devices in Healthcare: Where We Are and Where We Are Going
14.1 The Questions
14.2 The Role of Technology
14.3 System Approach
References
