Chapter
1 - Medical Device Development and Regulatory Overview
1 - Reframing Product Life Cycle for Medical Devices
1.2 FDA TOTAL PRODUCT LIFE CYCLE
1.2.3 PRECLINICAL INVESTIGATION
1.2.4 ADVANCED CLINICAL/POSTMARKETING STUDIES
1.3 EUROPEAN COMMISSION PRODUCT LIFE CYCLE
RECOMMENDATIONS FOR ADDITIONAL READING
2 - Overview of Medical Device Clinical Trials
2.2 MEDICAL DEVICE SUBMISSIONS OVERVIEW
2.3 MEDICAL DEVICE CLINICAL TRIALS
2.3.1 INVESTIGATIONAL DEVICE EXEMPTION
2.3.3 MANUFACTURING AND ADDITIONAL STANDARDS
2.4 REGULATORY PROFILE OF THE US MEDICAL DEVICE BY CLASSIFICATION TYPE
2.4.1 CLASS I MEDICAL DEVICES
2.4.2 CLASS II MEDICAL DEVICES
2.4.3 CLASS III MEDICAL DEVICES
2.5 REGULATORY PROFILE OF THE EU MEDICAL DEVICE BY CLASSIFICATION TYPE
RECOMMENDATIONS FOR ADDITIONAL READING
3 - Review Regulatory Guidelines by Device Classification Type
3.2 BASIC OVERVIEW OF THE PREMARKET NOTIFICATION 510(K)
3.2.2 PRIMARY 510(K) SUBMISSION STEPS
3.2.3 SUBSTANTIAL EQUIVALENCE
3.3 PREMARKET APPROVAL APPLICATION REGULATORY PATH
3.3.2 PRESUBMISSION INTERACTION
3.3.3 PMA FOOD AND DRUG ADMINISTRATION REVIEWS
3.3.4 PRE-INVESTIGATIONAL DEVICE EXEMPTION SUBMISSION
3.4 Medical Device Class I
3.5 MEDICAL DEVICE CLASS II
3.6 MEDICAL DEVICE CLASS III
3.6.1 CLINICAL EVALUATION AND IDE SUBMISSION
RECOMMENDATIONS FOR ADDITIONAL READING
4 - Manufacturing/Distribution Considerations
4.2.1 PRODUCT LIFE CYCLE MANAGEMENT
4.2.2 CURRENT GOOD MANUFACTURING PRACTICES
4.3.1 ADVERSE EVENT MEDICAL DEVICE REPORTING
4.3.2 POSTMARKETING 522 STUDIES
4.4 EUROPEAN UNION CE MARKING: PREMARKETING STAGE
4.4.2 NOTIFIED BODY BEST PRACTICES
4.5.1 ADVERSE EVENT MEDICAL DEVICE REPORTING
4.5.2 POSTMARKETING STUDIES
RECOMMENDATIONS FOR ADDITIONAL READING
2 - Defining and Meeting Regulatory Challenges in Clinical Engineering
5 - Defining and Meeting Regulatory Challenges in Clinical Engineering
5.2.1 ISO AND OTHER RESOURCE GUIDANCE
5.2.2 CROSS-FUNCTIONAL KNOWLEDGE BASE REPOSITORIES
5.2.2.1 The Front End of Medical Device Development in the Product Life Cycle
5.2.2.2 The Back End of Medical Device Development in the Product Life Cycle
5.2.2.3 Opportunities in the Center of Medical Device Development Product Life Cycle
5.2.3 PROFESSIONAL INTEGRATION
5.3.1 MEDICAL DEVICE MANUFACTURERS AND MEANINGFUL USE
5.3.2 CONNECTING PROFESSIONALS TO ACHIEVE IMPROVEMENTS IN RISK MANAGEMENT
5.4 STERILITY AND REUSABILITY
RECOMMENDATIONS FOR ADDITIONAL READING
6 - Role of Biocompatibility
6.2.3 CONTACT, DURATION, AND TISSUE TYPES
6.3 US MAJOR BIOCOMPATIBILITY GUIDANCE
6.4 DISCUSSION AND RECOMMENDATIONS
RECOMMENDATIONS FOR FURTHER READING
7.2 THE UPSIDE OF INTERDISCIPLINARY COLLABORATIVE PARTNERSHIPS
7.2.1 CLINICAL ENGINEERING
7.2.2 THE DOWNSIDE OF INTERDISCIPLINARY PARTNERSHIPS
7.3 MANAGING RISK IN HEALTHCARE TECHNOLOGY
7.3.1 EXISTING POINT-OF-CARE PROTOCOLS
7.3.2 ENGINEERING ASSESSMENT OF MEDICAL DEVICE FAILURES OVERVIEW
7.3.2.1 Root Cause Analysis
7.3.2.2 Healthcare Failure Mode and Effect Analysis Overview
7.3.3 WORKPLACE SAFETY PRACTICES
7.3.3.3 Hazardous Materials
7.4 HEALTH INFORMATION TECHNOLOGY MANAGEMENT IN ACTION
RECOMMENDATIONS FOR ADDITIONAL READING
8 - Sterility and Reusability
8.1.1 SPAULDING’S CLASSIFICATION SYSTEM
8.1.2 STERILITY, STERILIZATION, AND REUSABILITY
8.2 STERILIZATION GUIDANCE AND LEGISLATION FOR MEDICAL DEVICE DEVELOPERS
8.3 STERILIZATION GUIDANCE AND LEGISLATION FOR MANUFACTURING
8.4 STERILIZATION GUIDANCE AND LEGISLATION FOR HOSPITALS
8.5 DISCUSSION AND SUMMARY
RECOMMENDATIONS FOR ADDITIONAL READING
9 - European Union National Differences and Potential Impact on CE Marking
9.2.1 HEALTH SYSTEM OVERVIEW
9.2.2 HEALTH SYSTEM ORGANIZATION AND REIMBURSEMENT
9.3.1 HEALTH SYSTEM OVERVIEW
9.3.2 HEALTH SYSTEM ORGANIZATION AND REIMBURSEMENT
9.4.1 HEALTH SYSTEM OVERVIEW
9.4.2 HEALTH SYSTEM ORGANIZATION AND REIMBURSEMENT
9.5.1 HEALTH SYSTEMS OVERVIEW
9.5.2 HEALTH SYSTEM ORGANIZATION AND REIMBURSEMENTS
9.6 DISCUSSION AND CONCLUSIONS
RECOMMENDATIONS FOR ADDITIONAL READING
10 - Understanding the Transitioning Regulatory EU Market
10.2 CLINICAL TRIAL REGULATION
10.2.2 TWO-PART CLINICAL TRIAL DOSSIER APPLICATION
10.2.3 RISK-BASED INTERVENTIONS
RECOMMENDATIONS FOR ADDITIONAL READING
4 - Equipment Acquisition,Integration and Maintenance
11 - Evaluating New Medical Devices Purchases
11.2 MEDICAL DEVICE REGULATION GENERAL OVERVIEW
11.3 EVIDENCE-BASED MEDICINE
11.4 END USER PURCHASING STAKEHOLDERS
11.4.1 OPERATIONAL ASSET MANAGEMENT
11.5 CLINICAL EVIDENCE STRATEGIES
11.5.1 COMPARATIVE EFFECTIVENESS RESEARCH IN THE US
11.5.1.1 Early Assessment and Market Introduction
11.5.1.2 Eliciting Protocols
11.6 COMPARATIVE TECHNOLOGIES
11.7 MEDICAL DEVICE INTEGRATION INTO EXISTING WORKFLOWS
11.7.1 INFORMATION TECHNOLOGY INTEGRATION AND WORKFLOW
RECOMMENDATIONS FOR ADDITIONAL READING
12 - Evaluating Reimbursement Strategies in the US
12.1.1 DEFINITIONS AND OVERARCHING REGULATION
12.1.2 PROCEDURE AND DISEASE CLASSIFICATION OVERVIEW
12.2 BUSINESS OF MEDICAL TECHNOLOGY
12.2.1 NATIONAL COST OF MEDICAL TECHNOLOGY RESEARCH AND HEALTH EXPENDITURE
12.2.2 OVERCOMING OBSTACLES TO MEDICAL TECHNOLOGY INNOVATION
12.2.2.3 Product Utilization
12.3 MEDICAL DEVICE IDENTIFICATION AND REGULATORY OVERVIEW
12.4 THREE TYPES OF USER PAYMENT METHODS
12.4.1 PRIVATE INSURANCE REIMBURSEMENT
12.4.2 PUBLIC PAYER REIMBURSEMENT PROGRAMS
12.4.3 DIRECT PAYER REIMBURSEMENT
RECOMMENDATIONS FOR ADDITIONAL READING
13 - Healthcare Facility Users’ Legal Responsibilities and Risks
13.2 PREMARKET APPROVAL IN THE US
13.2.1 MEDICAL DEVICE REGULATION BACKGROUND
13.2.2 THE FDA DEVICE CLASSIFICATION SYSTEM
13.2.3 DEFINING DEVICE CLASS
13.2.4 THE ROLE OF THE 510(K) PREMARKET NOTIFICATION
13.2.5 THE SALE OR THE “LENDING” OF A 510(K)
13.3 POSTMARKET SURVEILLANCE: GOOD MANUFACTURING PRACTICES
13.3.1 GOOD MANUFACTURING PRACTICES DEFINED
13.3.1.1 Determining if Good Manufacturing Practices Apply
13.3.1.2 Exemptions to Good Manufacturing Processes
13.3.1.3 Overview of Best Practices
13.4 DEVICE USER FACILITIES: POSTMARKETING REGULATORY OBLIGATIONS
13.4.1 ADVERSE EVENT REPORTING, LITIGATION, AND CONFLICTS OF INTEREST
13.5 SPECIAL REGULATORY APPLICATION FOR DEVICE USER FACILITIES
13.5.1 OFF-LABEL USE AND MODIFICATIONS
Regardless of the market entered
13.6 COMPARISON AND DISCUSSION OF OBLIGATORY REGULATION IN THE US AND EU
13.6.1 COMPARISON OF POSTMARKET SURVEILLANCE IN THE US AND THE EU
RECOMMENDATIONS FOR ADDITIONAL READING
5 - Data Management, Patient Safety, and Efficacy
14 - Clinical and Biomedical Engineering Evidence Strategy
14.2 IMPORTANT OVERVIEW FOR MEDICAL DEVICE MANUFACTURERS: COMPLAINTS AND RISK
14.3 HEALTH TECHNOLOGY BASICS
14.3.1 DEFINING HEALTH TECHNOLOGY CHARACTERISTICS
14.3.2 STAGES OF NEW TECHNOLOGY INTRODUCTION DECISION-MAKING OVERVIEW
14.3.3 CLINICAL ENGINEERING AND OEM PERSPECTIVE DURING THE TOTAL PRODUCT LIFE CYCLE
14.4 CLINICAL DEVELOPMENT OF MEDICAL DEVICES
RECOMMENDATIONS FOR ADDITIONAL READING
15 - Device Failure Tracking and Response to Manufacturing Recalls
15.2 REGULATION DEFINITIONS AND OVERVIEW
15.2.3 DEVICE FAILURE TRACKING AND INVESTIGATIONS OVERVIEW
15.2.3.1 Medical Device Reporting and Investigations
15.2.3.2 OEM Recall Communication to Customers
15.2.3.3 Typical Device End User Recall Activity
RECOMMENDATIONS FOR ADDITIONAL READING
16 - Health Economics Outcomes Research and Evidence Strategies
16.2 HEALTH ECONOMICS FOR MEDICAL DEVICES
16.3 VALUE ASSESSMENT PROCESS
16.4 CLINICAL AND OUTCOMES DATA
16.5 TYPES OF ECONOMIC EVALUATION
16.5.1 ADMINISTRATIVE CLAIMS DATA STUDY, EXAMPLE, AND IMPLICATIONS
16.5.2 BURDEN OF ILLNESS STUDY, EXAMPLE, AND IMPLICATIONS
16.5.3 BUDGET IMPACT ANALYSIS, EXAMPLE, AND IMPLICATIONS
16.5.4 COST-EFFECTIVENESS ANALYSIS/COST–UTILITY ANALYSIS, EXAMPLE, AND IMPLICATIONS
16.5.5 MARKOV MODELING, EXAMPLE, AND IMPLICATIONS
16.5.6 TIME–MOTION STUDY, EXAMPLE, AND IMPLICATIONS
16.6 OTHER HEALTH ECONOMICS PROXY MEASURES
16.7 DISSEMINATION STRATEGIES AND TOOLS FOR HEALTH ECONOMIC EVIDENCE
RECOMMENDATIONS FOR ADDITIONAL READING
17 - The Future of Health Technology Management
17.2 EMERGING TECHNOLOGIES: SEEING THE FUTURE NOW
17.2.1 REMOTE PATIENT MONITORING
17.2.2 APPLICATION-BASED INFORMATION ECONOMY
17.2.3 BIOMATERIAL DEVELOPMENT
17.3 PLANNING MEDICAL DEVICE DEVELOPMENT
17.3.1 DESIGN METHODS TO IMPROVE CLINICAL OUTCOMES
17.3.2 INCREASING ACCESS TO FEDERAL FUNDING AND REIMBURSEMENT PATHS
RECOMMENDATION FOR FURTHER READING
18 - Challenges of New Technology: Securing Medical Devices and Their Software for HIPPA Compliance
18.2.1 PREMARKET/POSTMARKET VALIDATION GUIDANCE
18.3 CHALLENGES OF SECURING NEW TECHNOLOGY
18.3.1 DEVICE USER FACILITIES
18.3.2 ORIGINAL EQUIPMENT MANUFACTURERS
18.3.3 MOBILE TECHNOLOGY AND APPLICATIONS
18.4 ALERT MECHANISMS AND AGENCY RESOURCES
18.5 COMPLIANCE SOLUTIONS
18.5.1 INDUSTRY AND ORGANIZATIONAL SUPPORT SERVICES
18.5.2 US GOVERNMENT RISK-BASED FRAMEWORK
18.5.3 ACADEMIC CYBERSECURITY RESEARCH MODELS
RECOMMENDATIONS FOR ADDITIONAL READING
19 - Managing Smartphone and Tablet Applications
19.2.1 THE CLEARANCE “WORTHINESS” OF MOBILE MEDICAL APPS
19.3 MANAGING DIGITAL TECHNOLOGY: THE DEVICE IS RIGHT
19.3.1 DIGITAL IMPACT ON THE INTERNAL HEALTH IT ENVIRONMENT
19.3.1.2 Norway/Netherlands: Chronic Disease Alternative Care Options
19.3.1.3 US: Wireless Technology Basics for Medical Devices in the Hospital
19.3.1.4 Italy: Smart Hospital Infrastructure
19.3.2 DIGITAL IMPACT ON THE EXTERNAL HEALTH IT ENVIRONMENT
19.3.2.1 HIPAA Manufacturing Adherence
19.3.2.2 Patient Self-Management Data Access, Integration, and Business Intelligence
19.3.2.3 Hospital Reimbursement and Cost-Effectiveness
19.3.2.4 Physician Data Storage Policy and Capacity
RECOMMENDATIONS FOR ADDITIONAL READING
Managing Medical Devices within a Regulatory Framework
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