"The challenge that is facing manufacturers of any orthopaedic device or medical device is that the landscape of the requirements is potentially on a living, breathing document, so it could change at a moment’s notice," says Lissy. “Generally, the way that regulatory agencies let manufacturers know of changes in requirements is through their response letter to a submission. FDA has guidance documents for different types of devices for testing and all the general requirements, but those documents aren’t the most current.”

At the OrthoTec Europe conference, Lissy educated attendees about not just the importance of mechanical testing but also understanding how and where it fits into the entire product development cycle. “If you don’t plan ahead and have strategies in place, you could potentially blow up your entire pipeline and project,” says Lissy.

Understanding current testing and regulatory requirements are the keys to success when conducting mechanical testing. Having an awareness of the potential testing pathways—which range from conservative to cavalier—are critical too. “[With] most devices, as you push the envelope, there is no clear and defined checklist,” says Lissy. “Understanding those paths and what your company’s risk-reward assessment is with time, money, return on investment to market is going to be crucial to understanding your total product development timeline and being successful at it.”

Lissy offers an example of the conservative versus the cavalier route in mechanical testing. “In spinal implants, for example, there is a vertebral body replacement device, and then there’s an intervertebral body fusion device—both of those devices [can be tested using the] part [ASTM] F2077 [method], she says. “Depending on the level, material, and indication, you may do only parts of [F]2077.”  The conservative route for either device would be to conduct all of the tests under ASTM F2077, which consist of three static tests and three dynamic tests. The most cavalier route would be rationalizing out five of the six tests and perform only one or two of the tests. These testing choices must be made on a case-by-case basis. It’s important for manufacturers to consider time, cost, and the number of specifications needed when making a decision.

“Because there isn’t a current documents that encompasses all the current requirements, you have to look at your device and decide what makes sense for your device,” says Lissy. “It’s the manufacturer’s responsibility to prove safety and efficacy—[so], are you doing that with the testing that you propose? It’s our responsibility to answer all of those questions from a mechanical evaluation for safety and efficacy when you submit to FDA.”