In the ten years since John McCloy founded Accutek Testing Laboratory, he has built a nimble company that employs more than 40 people and serves medical device manufacturers out of a 50,000 square foot facility.
The company has grown by learning how to develop relationships with startups and major players in the industry, as well as creating a customer service-oriented culture and diversified staff that has led Accutek to work with clients on every continent except Antarctica.
BONEZONE spoke to McCloy about the regulatory and economic environment, as well as future trends in orthopaedic devices.
BONEZONE: How has the economic and regulatory environment affected your business?
John McCloy: In the U.S., FDA is the law of the land. It’s difficult in some regards, because when we invest in equipment and run a test through a particular standard and FDA changes the standard or requirements, then we’re stuck with a very expensive paperweight. The upside to that is that FDA is requiring additional testing all the time.
BONEZONE: So, FDA will continue to add more testing?
McCloy: Yes, I do believe that they’ll require more as the medical community and the standards and development folks are influenced by the automotive and aerospace folks. I know there has been a lot of failure with materials—biocompatibility is a big issue—but I can predict that there will be a bionic man down the road. In the meantime, the hips, knees, spine and bone plates we have now are just scratching the surface of where we’ll be in ten years. There will be new materials, mostly composites.
BONEZONE: During your experience, what have you observed from an economic standpoint?
McCloy: From an economic standpoint, the big guys are tightening their belts and outsourcing more testing. Maintaining a test lab is expensive, and it’s often more efficient to outsource. As an independent lab, we’re seeing an increase in inquiries.
BONEZONE: Have price pressures affected Accutek?
McCloy: Oh yes. There’s constant pressure on keeping our cost and prices down, which is very tough to do.
BONEZONE: How has Accutek adapted to meet customers’ needs in the face of the regulatory and economic environment?
McCloy: We’ve had to be more nimble and add to our capacity. The OEMs will ask for a battery of tests that will normally take eight to 12 months, and we’ll get it done in three to four. To do that, we design, develop and build our own test equipment, which enables us to provide the service at a lower cost and not carry the huge overhead burden on a piece of equipment. At the same time, it affords us the option to hire qualified team members.
BONEZONE: How has testing evolved in recent years?
McCloy: It has evolved to a more biomechanical application. There is more work being done on pressures and cycles. A lot of the testing we’re doing is performed at a higher load and a faster rate than it was ten years ago. Half of it may be that the client wants to show their improved performance; the other half may be that they want the test done quicker. Time is of the essence.
BONEZONE: What advice do you have for OEMs based on your unique experiences?
McCloy: It sounds self-serving, but test early, test often, watch for over-testing—you don’t want to get lost in the detail. Catching a design flaw early can save a lot in the long run. I’ve seen a lot of money thrown at projects with the wrong leadership and millions of dollars go down the drain. The toughest client we have is the one that doesn’t know what they want.
For the leaders, trust your instinct and frequently review what your team is doing on price, delivery and quality. One of the things I like to do is I like to invest in the training of our young professionals. The way I train them is I tell them stories. I tell them good stories and I tell them horror stories. Maybe teach some high school or college on the side. It’s amazing what young professionals are up to today and how they operate—it’s at the speed of light, and I’m very impressed.