The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: May 21, 2015 at 8am to May 22, 2015 at 4pm
Location: Boston, MA
Street: Boston, MA
City/Town: Boston, MA
Website or Map: https://www.globalcompliancep…
Event Type: food, fda, medical, device, defence, and, navy, aerospace, mining
Organized By: GlobalCompliancePanel
Latest Activity: Feb 24, 2015
Why companies are prone to having past problems in new devices? One of the main reasons seems to be the �weak cognition.� It is usually the result of short term memory, inattention to details, insufficient vigilance, or multitasking. This unsafe work propagates unknowingly because of not engaged or disengaged employees, insufficient understanding of customer needs, splitting design among several designers, and ineffective risk analysis. Another big reason is that ineffective device management procedures often touted as �best practices�, are like a bad virus with long incubation period and no early warning, resulting into sudden catastrophic malfunction of the device. Most companies still hold individuals responsible for mistakes instead of fixing the management process.
Marketing has the advantage of helping prevent past mistakes and improve efficiency of the device design. They have records of customer complaints for years. They even have knowledge of what problems exist on similar devices because they hear them from customers during marketing efforts. They need to be involved throughout the life cycle starting with the concept design.
The goal is to develop and implement risk balance throughout the design, manufacturing, installation and device use process. It includes FDA guidance on Incorporating human factors into risk and FDA guidance on premarketing risk assessment. The important areas include assessing resources requires, a good policy, good methods for assessing the effectiveness including the effectiveness of the management policy, qualifications of personnel.
You have to do risk analysis using the tools in ISO 14971. It is one of the first things FDA will ask for! It is required by law (21 CFR Section 820) and appears on regulatory submission checklists. In addition, it will help define testing that should be done to prove the safety of your device. You can also eliminate costs associated with recalls lawsuits.
Dev Raheja, MS,CSP, author of the books Preventing Medical Device Recalls and Safer Hospital Care, is an international risk management, patient safety and quality assurance consultant for medical device, healthcare and aerospace industry for over 25 years. Prior to becoming a consultant in 1982 he worked at GE Healthcare as Supervisor of Quality Assurance/Manager of Manufacturing Engineering, at Cooper Industries as Chief Engineer, and at Booz-Allen & Hamilton as Risk Management consultant for variety of industries. His clients include Johnson & Johnson, Siemens Medical Systems, Medtronic, Carl Zeiss, Warner-Lambert, Zimmer Holdings, and DuPont.
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