Medical Devices 2015 - Designing Medical Devices for Long Life at Lower Costs

Overview:
The number of medical device recalls was up 28% in 2013 and estimated to be even higher in 2014. Learning to design for durability using risk analysis tools the right way at right time can eliminate many life cycle costs such as production rejects, rework, warranty costs, safety litigation costs, and maintenance and repair costs to customers. Learn how to design it right the first time for not only long life design but understand that no safety related failures should occur during the long life.
Why should you Attend: A critical and sometimes overlooked aspect of designing medical devices is the inability to implement systems thinking. Usually the specifications are flawed, designs are flawed, manufacturing requirements for defect-free production are flawed, and integration among users, suppliers, and interfaces is flawed.
Systems thinking is not a panacea that can prevent every mistake, but it a best known tool that helps us design for zero failures for a long time and help us see many robust solutions to eliminate risks including warranty costs. Unlike the limited single focused cause-and-effect approach, the systems thinking is about relatedness of individual causes to system causes, interdependencies on the knowledge of cross functional teams, interdependencies on the knowledge of manufacturers and device users, and understanding what you don’t know about device durability.
Areas Covered in the Session:
Introduction to medical device quality requirements
Writing specifications for long life free of failures
Correctly using risk assessment
Risk mitigation for long life
Avoiding mistakes during early design
Using system functions fmea
Fault tree analysis to prevent adverse events
Verifications during the detail design
Preventing manufacturing defects by designusing design validation for long life
Post production monitoring the risk to patients
Who Will Benefit:
R & D Managers
Engineering managers and developers
Software specialists
System engineers
Regulatory staff
Quality Engineers
Quality Auditors
Marketing staff
Maintenance and servicing staff
Device Users
Speaker Profile
Dev Raheja PE, CSP, is a system safety practitioner, consultant and trainer for over 25 years. He is a Fellow and former Vice President of the System Safety Society and received its Scientific Achievement Award and Educator of the Year Award. He is the author of the text Assurance Technologies Principles and Practices: A System, Process and Safety Perspective. He has conducted System Safety training at Johnson Space Center, Kennedy Space Center, Boeing, US Navy, US Army, Lockheed Martin, and at several universities such as UCLA, George Washington University, University of Maryland, and University of Alabama. He served as Adjunct Professor at University of Maryland during 1994-99, where he taught graduate courses on system safety. He is also the member of the G-48 Committee for the Government-Industry standards and is Associate Editor of the Journal of System Safety.
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