The following is an interview with John McCloy, the Founder and President of Engineered Assurance. He is a member of the American Society of Testing Materials (ASTM), the American Society of Metals (ASM), the American Welding Society (AWS) and maintains numerous industry and scholastic licenses and certifications including PE, CWI, and MBA.
Q: In your experience what is the main driver today in medical implant product development?
McCloy: It’s no secret that medical implant failure represents the most litigated cases in the courtroom today. The consequences of implant failure are obviously huge to say the least. Not only in terms of settlements, legal fees, insurance premiums and recalls; but lost market share must also be considered. Implant quality and longevity continue to be near the top of the list for medical implant manufacturers of all types and sizes.
Q: What can we expect to see in the near term – what’s a realistic expectation?
McCloy: Many implant manufacturers have a twenty-year lifespan goal. When you think of it that’s quite an accomplishment. Not long ago a patient receiving an artificial hip might have to endure two or more replacements of that implant during his or her lifetime. Now consider the wide range of expenses associated with all that’s involved; from surgery, and insurance to fees, rehab, and so on. Reaching this twenty-year goal will save costs significantly. In the cases where implants are under less stress a permanent one-time installation is becoming more and more common.
Q: What steps are manufacturers taking to get there?
McCloy: Simply put they are making more informed and better decisions about designs, materials, and manufacturing processes. Look, everything breaks. It’s that simple. At some point that artificial hip, knee, or spinal stabilizer is going to wear out. With the help of testing however, manufacturers can have a better understanding of which designs, materials, and manufacturing processes work best and how to extend the life cycle of any implant or fastener. Physical testing remains the best way to provide real-world data that serves as the basis for next-generation medical implants.
Q: What are some of the more commonly used tests?
McCloy: Depending on the end requirements there are several. For example explant testing involves analyzing an actual failed implant that has been removed from the patient. Think of it as detective work. We perform visual inspection and apply laboratory tests to work backward to determine why a specific implant failed. Was it poorly designed? Were inferior materials used? Can the problem be traced to how the implant was secured or installed by the surgeon? This information is valuable to all parties involved, from manufacturers and insurance companies to evidence in the courtroom. Other tests are performed on physical prototypes to validate new designs before that product goes into production.
Q: These types of tests are obviously different since there is no failed part. So how do you determine structural integrity in these instances?
McCloy: We utilize two different, but related types of tests: static and dynamic. Both are required to validate a new implant design. Static Testing is a single cycle process whereas a steady force is exerted on a given part, assembly or system to determine in a short time when and where breakage will occur. Because this is a relatively quick test, it can be used to indicate a pass/fail for a new design and draw some good assumptions about designs and material strength.
Dynamic testing is a multi-cycle testing process. In this type of test a series of steady impulses are applied over a longer duration. In this way we can measure wear and durability to understand the expected life of an implant based on actual data rather than guestimates. All of this information — be it from explant, static, or dynamic testing — is fed back to the manufacturer helping them to create better and longer-lasting implants.
More information about Engineered Assurance can be found by visiting the company’s web site www.engineeredassurance.com. John McCloy can be reached at 513.543.8146 or via e-mail at firstname.lastname@example.org