Yes, I say it with tongue firmly in cheek. That’s a gross oversimplification of a business I’ve been in for almost 20 years: mechanical testing for medical devices and regulatory consulting to get those products to market. We do test devices to find their failure points, but it’s a much more complicated and nuanced process than simply breaking things. It involves a learning curve I’ve been on most of my adult life, and always seems to be arcing up.
From my perspective, this isn’t an industry easy to understand or stay on top of. But thanks to a supremely talented team, Empirical Testing Corp. has managed to grow and improve its depth of knowledge over its 18-year history.
The majority of clients for the Empirical family of companies are small businesses. They have unlimited talent and potential, but often have tight budgets and limited lab resources. Like any other business, they’re looking for the best value for their money.
When it comes to regulatory testing, at first glance that best value may appear to be buying test frames and keeping those tests in-house. If they look strictly at dollars in and out, some small businesses believe they might benefit from paying for test frames—particularly if they’re in the early years of development with a business plan that allows for capital investments in equipment.
However, it’s not just about dollars and cents. The bigger picture includes productivity, capacity, best use of the company’s time and talent, and a significant learning curve.
Dennis Buchanan, engineering manager for Empirical Testing Corp., understands that small business dilemma. Buchanan has worked for major international biomedical corporations as well as small, independent labs over the course of his 30-year career.
“For smaller companies, should they survive five to 10 years, for what they spend on testing in that five to 10 years, at first glance it’s easy to justify the capital [expense on equipment],” he said. “But financial costs are only one of many considerations. You also have to hire the right people, and you have to know enough about testing to know if you’re hiring the right people.”
That may be outside the knowledge bank of a small company. Further, there’s also the consideration of infrastructure, maintenance on equipment, and how employees spend their time.
Based on Buchanan’s experience in smaller companies, he said if such a company has a lab in-house, that lab is typically best suited for developmental testing. That enables the company to focus on getting the prototype right. Once the design is frozen, that device can be outsourced for regulatory testing and the in-house lab and staff is freed up for more device development and other responsibilities to get the product to market.
When the product development clock is ticking, you’re already under pressure to get to market and start seeing a return on investment. There are so many other aspects to consider in addition to testing—instruments must be designed, surgical technique needs to be written up, reimbursement has to get a green light—most of those concerns are best handled in-house by those who best understand the device.
“Running fatigue and other regulatory testing is like watching grass grow,” Buchanan said. “If they’re running regulatory testing in half their lab, now maybe they have a queue with a dozen engineers waiting to develop products. But if product development testing stays in-house and regulatory testing is outsourced, then product development is always moving forward.”
With that focus on product development, clients often reach a design they know well enough to predict how that device will test out. There’s also the issue of capacity; outside vendors typically have many more test frames than a smaller, in-house setup.
“We have multiple machines where we can efficiently get the regulatory testing done,” Buchanan explained. “They can continue their product development and not waste time and resources on regulatory testing that can be outsourced more efficiently.”
Ideally, clients reach out to us a few weeks before actually needing us to run tests. They give us a heads-up on when we can expect parts from them, then we work with them to cut the timeline as much as possible.
“Call me up and say, ‘In six to eight weeks, our design will be frozen. We need a full battery of regulatory tests—give me an estimate,’” Buchanan said. “I know within that time frame we’ll be ready to go. We’ll have everything in place so when your parts get here, we’ll get it on a machine.”
And we don’t just “get it on a machine.” When outsourcing, you receive more than a spot in a queue; you expand your base of experts to support the product’s journey to market. When regulatory testing is kept in-house, you may very well run into roadblocks like no existing predicates or test protocols—another point at which outside expertise may be a benefit.
“If there’s no existing protocol, do you know if you have the right fixture and can you do the setups?” Buchanan asked. “For every test method out there, you’re going to have to develop fixturing for it. If you don’t already have it, it’s going be expensive. If you don’t have the experience, it can bite you later on.”
Which is another important point to consider: do you understand testing requirements well enough to realize what you don’t know?
“Sometimes that’s a tough thing to recognize,” Buchanan said. “We can lend that expertise and professional advice. Clients are always welcome to call us with questions. Whether we do the testing or you do it yourself, you can leverage our expertise to do it better. We’re gonna help you out.”
Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, the Empirical family of companies (Empirical Testing Corp., Empirical Consulting, LLC, and Empirical Machine, LLC) 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.