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When to Contract Your Device Testing

Confidentiality

Another drawback to outsourcing is the possibility of leaked proprietary information. Vilendrer points out that some labs do not have measures in place to keep your data private.

“Confidentiality is a big consideration. Your intellectual property is a significant component of your competitive advantage,” he says. “The device design, test protocol and data generated need to be kept confidential. Does the test lab you are considering have a quality policy that deals directly with confidentiality?”

Lab wide crop

Metcalf echoed those sentiments, adding that when you share information on your device’s acceptance criteria, you may be unintentionally sharing that with the entire device testing community. Non-disclosure agreements (NDA) are of paramount importance; you should be sure that your contract testing partner either provides an NDA or is willing to sign one.

Cost

Many OEMs that stay in-house believe there is a benefit of cost savings. That may be true, but the amount of savings depends upon myriad factors. Direct comparisons between in-house testing costs and contracting to an external firm can be complicated. The cost of performing an outside test is easily obtained by requesting a quote, but be mindful that in-house testing costs have more parameters to consider:

  • Will you need to purchase equipment and accessories (such as fixtures, sensors, etc.)?
  • Will you need to design and fabricate parts, such as fixtures?
  • What are the costs of using your own facilities and equipment?
  • What are the costs of technicians’ and engineers’ time spent training on and calibrating the equipment, setting up and performing the test, then performing data analysis and writing reports?

In addition to these more obvious costs, other factors need to be considered, such as schedule delays and their financial impact. There is also the possibility of testing errors and repeat tests.

Startups and OEMs that don’t have testing capabilities save on the cost of investing in equipment, as well as personnel and training to run and maintain the equipment, when they contract out. It may make financial sense to invest in testing equipment later, as your company grows.

Expertise-On-Demand

“Complexity of the test is usually a key reason to select a contract test lab,” Vilendrer says. “Tests can range from basic materials characterization and feasibility for proof of concept, to full device fatigue-to-success for FDA submissions or supplementary data needed based on device performance in patients.”

As an example, Vilendrer says that if your device includes metal ions that may be released post-op, your device may require metal ion analysis. If your device includes an additively-manufactured coating, and runs the risk of shedding particles post-implantation, it may require a particle capture and analysis. If your internal lab does not have experience with those tests, it makes sense to contact test labs.

“Labs are generally set up to run specific standardized tests, quickly and efficiently, with validated methods,” Metcalf says. “You, on the other hand, may want to focus on manufacturing validations, suppliers and second-tier suppliers. Having the assurance that your device is being tested as quickly and efficiently as possible should set you at ease.”

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