Dawn A. Lissy, Founder & President, Empirical06.01.22
As an amateur potter and eternal optimist, I am intrigued by the concept of kintsugi, the Japanese art of reassembling shattered pottery with a lacquer mixed with precious metals. Rather than covering up the flaws in the piece, the cracks are highlighted. The idea is that there’s no shame in past mistakes—when we learn from them, they make us stronger, better, and more beautiful.
That’s how I see my work. When people ask me about my profession, I tell them I break things for a living. It’s a cheeky oversimplification but it rolls more lightly off the tongue than “mechanical testing of medical devices and regulatory consulting.” I explain that by knowing how something breaks, we learn how to improve it and ensure better outcomes for patients.
That’s why failure analysis is such a critical step in the development of medical devices. It’s a vital part of the process of developing medical devices that function safely and efficiently. Failure prevention starts with failure analysis of the components that failed either during use or initial testing.
Burak Akyuz is vice president of Lab Services and principal metallurgist for Applied Technical Services LLC, a partner of Empirical Technologies. Like me, he’s built a career on finding the breaking point to build back better.
“Failure analysis is a very complex process, but we can define it basically as a set of procedures to determine why a component failed,” Akyuz said. “We get the background information, the information about the component, then start the actual analysis. That includes but is not limited to the visual inspection, determining fracture mode and verifying the material property, and comparing the results against the design criteria and the specifications.”
When a device comes in for failure analysis, his team starts with a thorough external review.
“Visual inspection is used to observe several features such as dents, scores, cracks, fractures, evidence of corrosion, and wear,” he said. “That’s a really important first step. This will give you a very good idea of what the scope will be, which properties you need to check, what kind of research you need to do, and determine where to go from there.”
Next comes material testing to ensure the source material is up to the specifications of the device.
“That’ll include a lot of different testing/analysis such as chemical analysis, microstructure, strength testing stress analysis,” Akyuz said. “There’s really no limits depending on the failure mode. When we do that, then we can put all these pieces of the puzzle together and come up with the cause of the failure. That tells you how you can use those results to improve your product and prevent future failures.”
Akyuz and I both recommend failure analysis on the front end of testing to find those failure points before the device is implanted in a human body.
“It is more cost-effective to test ahead of time than to wait for it to fail in a body,” he said.
It also prevents damage to a company’s reputation, which can be priceless cost savings. But post-op failure testing is a crucial process to salvage that reputation. It’s a slightly different approach that also factors in the effects of something a lab can’t always simulate: patient compliance and what happens on the operating table.
“The patient is a big part of it, and that’s not something we can control,” he said. If they’re not following the doctor’s instructions or have other body problems [that can affect the device]. Even smoking and weight loss sometimes can affect materials.”
So we encourage a wide range of testing simulating different forms of wear and tear in the human body that can reveal an equally wide range of issues before they cause discomfort or harm to a patient.
“If you test the material and components for those environments and you see a premature failure, you realize you need to improve your product and how to do that,” Akyuz said.
Independent labs are critical resources for smaller companies and individuals who don’t have the resources in-house to run the depth and range of tests to find failure. But they’re also a good option for larger developers with in-house testing. Independent labs conducting failure analysis have a broader knowledge of failure modes and material properties of different types of materials and components, Akyuz said. It’s a specialty that takes into account all of the stages of device development: engineering, design, prototyping, regulatory, manufacturing, and other points of the product development cycle.
“With an independent testing lab, you’ll have all these testing capabilities,” Akyuz said. “You don’t have to send it anywhere else. Also, these labs have additional qualifications and expertise.”
Outsourcing failure analysis offers a fresh set of eyes from experts dedicated to asking the right questions.
“Do I need to change materials, change the design? Was the right material supplied? Did something happen during the manufacturing process?” Akyuz said. “They don’t have any type of bias. They’ll tell you the exact story of what’s going on where.”
In learning the story of the “cracks” in a product, device developers discover critical data to improve materials, chemistry, design, structure, and/or processes. By highlighting points of failure, we learn how to make it better and offer the very best patient care.
And that’s the ultimate success.
Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, Empirical Technologies Corp. has operated under Lissy’s direction. Empirical offers the full range of regulatory and quality systems consulting, testing, small batch and prototype manufacturing, and validations services to bring a medical device to market. Empirical is very active within standards development organization ASTM International and has one of the widest scopes of test methods of any accredited independent lab in the United States. Because Lissy was a member of the U.S. Food and Drug Administration’s Entrepreneur-in-Residence program, she has first-hand, in-depth knowledge of the regulatory landscape. Lissy holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. Her M.S. in biomedical engineering is from The University of Akron, Ohio.
That’s how I see my work. When people ask me about my profession, I tell them I break things for a living. It’s a cheeky oversimplification but it rolls more lightly off the tongue than “mechanical testing of medical devices and regulatory consulting.” I explain that by knowing how something breaks, we learn how to improve it and ensure better outcomes for patients.
That’s why failure analysis is such a critical step in the development of medical devices. It’s a vital part of the process of developing medical devices that function safely and efficiently. Failure prevention starts with failure analysis of the components that failed either during use or initial testing.
Burak Akyuz is vice president of Lab Services and principal metallurgist for Applied Technical Services LLC, a partner of Empirical Technologies. Like me, he’s built a career on finding the breaking point to build back better.
“Failure analysis is a very complex process, but we can define it basically as a set of procedures to determine why a component failed,” Akyuz said. “We get the background information, the information about the component, then start the actual analysis. That includes but is not limited to the visual inspection, determining fracture mode and verifying the material property, and comparing the results against the design criteria and the specifications.”
When a device comes in for failure analysis, his team starts with a thorough external review.
“Visual inspection is used to observe several features such as dents, scores, cracks, fractures, evidence of corrosion, and wear,” he said. “That’s a really important first step. This will give you a very good idea of what the scope will be, which properties you need to check, what kind of research you need to do, and determine where to go from there.”
Next comes material testing to ensure the source material is up to the specifications of the device.
“That’ll include a lot of different testing/analysis such as chemical analysis, microstructure, strength testing stress analysis,” Akyuz said. “There’s really no limits depending on the failure mode. When we do that, then we can put all these pieces of the puzzle together and come up with the cause of the failure. That tells you how you can use those results to improve your product and prevent future failures.”
Akyuz and I both recommend failure analysis on the front end of testing to find those failure points before the device is implanted in a human body.
“It is more cost-effective to test ahead of time than to wait for it to fail in a body,” he said.
It also prevents damage to a company’s reputation, which can be priceless cost savings. But post-op failure testing is a crucial process to salvage that reputation. It’s a slightly different approach that also factors in the effects of something a lab can’t always simulate: patient compliance and what happens on the operating table.
“The patient is a big part of it, and that’s not something we can control,” he said. If they’re not following the doctor’s instructions or have other body problems [that can affect the device]. Even smoking and weight loss sometimes can affect materials.”
So we encourage a wide range of testing simulating different forms of wear and tear in the human body that can reveal an equally wide range of issues before they cause discomfort or harm to a patient.
“If you test the material and components for those environments and you see a premature failure, you realize you need to improve your product and how to do that,” Akyuz said.
Independent labs are critical resources for smaller companies and individuals who don’t have the resources in-house to run the depth and range of tests to find failure. But they’re also a good option for larger developers with in-house testing. Independent labs conducting failure analysis have a broader knowledge of failure modes and material properties of different types of materials and components, Akyuz said. It’s a specialty that takes into account all of the stages of device development: engineering, design, prototyping, regulatory, manufacturing, and other points of the product development cycle.
“With an independent testing lab, you’ll have all these testing capabilities,” Akyuz said. “You don’t have to send it anywhere else. Also, these labs have additional qualifications and expertise.”
Outsourcing failure analysis offers a fresh set of eyes from experts dedicated to asking the right questions.
“Do I need to change materials, change the design? Was the right material supplied? Did something happen during the manufacturing process?” Akyuz said. “They don’t have any type of bias. They’ll tell you the exact story of what’s going on where.”
In learning the story of the “cracks” in a product, device developers discover critical data to improve materials, chemistry, design, structure, and/or processes. By highlighting points of failure, we learn how to make it better and offer the very best patient care.
And that’s the ultimate success.
Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, Empirical Technologies Corp. has operated under Lissy’s direction. Empirical offers the full range of regulatory and quality systems consulting, testing, small batch and prototype manufacturing, and validations services to bring a medical device to market. Empirical is very active within standards development organization ASTM International and has one of the widest scopes of test methods of any accredited independent lab in the United States. Because Lissy was a member of the U.S. Food and Drug Administration’s Entrepreneur-in-Residence program, she has first-hand, in-depth knowledge of the regulatory landscape. Lissy holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. Her M.S. in biomedical engineering is from The University of Akron, Ohio.
