On August 6, 2020, we are hosting a live interview where Rick Stockton will share a story about how he helped one of his clients conduct a design FMEA.
When most people think of risk analysis, the first tool they think of is the failure modes and effects analysis (FMEA). For medical device design, most people use a variant of this tool called a design FMEA or dFMEA. Despite the ubiquity of this tool, most design teams struggle greatly with the creation of a design FMEA. The process often requires many meetings, long in duration, and the end result is often of little value to the design team. Design FMEAs are valuable tools, but you need to know how to manage this risk management activity if you want to have it be a value-added design activity.
Last week I was talking with Rick Stockton and he told me a story about one of his medical device clients that were struggling to complete their design FMEA. Therefore, the company asked Rick to facilitate their next meeting. I thought his story sounded very similar to what I have heard from Medical Device Academy’s clients, and I thought his advice might be helpful to most companies that are struggling with performing risk analysis. If you are interested in listening to Rick’s story, please register for our live interview on August 6, 2020, at 1:30 pm EDT.
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This week we had 500+ registrants for the live webinar with Leo Eisner and not everyone was able to login to the meeting. Fortunately, we recorded the event and you can watch the replay on our YouTube channel. We will also be uploading Rick’s interview to our YouTube channel.
What you will learn in this interview with Rick:
- What is a design FMEA (dFMEA)
- Steps involved in creating a design FMEA
- How you can avoid stalling of this process
Rob Packard, the host of this interview, has been performing risk management activities since 1990 as a chemical engineer working in the biotech and pharmaceutical industry. He was taught how to use the FMEA in 1999 by a fuel systems company where every malfunction leads to an explosion.
FMEAs are a great risk management tool, but only one tool. If you want to learn more about risk management, you might be interested in our training bundle.
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About Rick Stockton
Rick Stockton is President and Product Designer at J.R. Stockton Consulting, LLC. He is an experienced mechanical engineer that specializes in helping medical device companies translate their design concepts into reality. He provides mechanical design when manufacturability is important. Rick is a SolidWorks expert that provides the following design services to medical device companies: Design for Manufacture (DFM), analysis, planning, invention, ideation, creative design, with an extensive network of available engineers, technicians, and designers. He provides remote and on-site assistance. If you need help with supplier acquisition, design tolerance and fit analysis, or complete product design, contact him by email or phone at (210) 608-1907.