Clinical Technology Assessment and Risk Management

BMG 540 explores the critical aspects of managing clinical technology from acquisition to disposal. Students will delve into systematic approaches for evaluating new technologies, understanding their clinical utility, and ensuring patient safety through robust risk management processes. The course emphasizes practical application of international standards for medical device risk management, exploring methodologies for risk identification, analysis, evaluation, control, and post-market surveillance. Additionally, it covers financial planning elements like total cost of ownership, budgeting, and resource allocation for healthcare technology, preparing professionals to make informed decisions that align technological advancements with institutional goals and regulatory compliance. Through case studies and hands-on exercises, participants will develop skills essential for effective healthcare technology management.

Prerequisites

BMG 501

Course outline

Lectures, virtual labs, and graded assignments — completed in your browser.

01Lesson 1: Introduction to Clinical Technology Assessmentlecture

02Lesson 2: Regulatory Landscape and Quality Management Systemslecture

03Lesson 3: Foundations of Risk Management for Clinical Technologylecture

04Hands-on Lab: Risk Identification and Analysis Techniqueslab

05Lesson 5: Risk Evaluation and Acceptability Criterialecture

06Lesson 6: Risk Control Measures and Implementationlecture

07Lesson 7: Post-Market Surveillance and Risk Management Reviewlecture

08Hands-on Lab: Developing a Risk Management Planlab

09Lesson 9: Strategic Technology Planning and Needs Assessmentlecture

10Lesson 10: Life-Cycle Cost Analysis for Clinical Systemslecture

11Hands-on Lab: Financial Modeling for Technology Acquisitionlab

12Lesson 12: Technology Performance Monitoring and Optimizationlecture

13Lesson 13: Ethical and Societal Implications of Clinical Technologylecture

14Capstone Service Project: Comprehensive Technology Assessment and Risk Management Planassignment

Syllabus

["Week 1: Lesson 1: Introduction to Clinical Technology Assessment","Week 2: Lesson 2: Regulatory Landscape and Quality Management Systems","Week 3: Lesson 3: Foundations of Risk Management for Clinical Technology","Week 4: Hands-on Lab: Risk Identification and Analysis Techniques","Week 5: Lesson 5: Risk Evaluation and Acceptability Criteria","Week 6: Lesson 6: Risk Control Measures and Implementation","Week 7: Lesson 7: Post-Market Surveillance and Risk Management Review","Week 8: Hands-on Lab: Developing a Risk Management Plan","Week 9: Lesson 9: Strategic Technology Planning and Needs Assessment","Week 10: Lesson 10: Life-Cycle Cost Analysis for Clinical Systems","Week 11: Hands-on Lab: Financial Modeling for Technology Acquisition","Week 12: Lesson 12: Technology Performance Monitoring and Optimization","Week 13: Lesson 13: Ethical and Societal Implications of Clinical Technology","Week 14: Capstone Service Project: Comprehensive Technology Assessment and Risk Management Plan"]