While options may be limited overall, selecting the right package testing laboratory can still be critical for a medical device manufacturer to ensure a timely and on-budget product launch. Therefore, keeping the following five considerations in mind when going through the selection process can make a significant impact on a company’s success.

As medical device package testing is somewhat of a niche, there are relatively few laboratories that offer these types of services. Regardless, size, experience, and the scope of services offered certainly differentiate the good laboratories from the below average ones. These specialty labs may not be as numerous as coffee shops, making the selection process a bit easier; however, taking the time to select the right lab can pay off in the long run, especially when deadlines are quickly approaching. Following are five considerations every medical device OEM should take into account when selecting a package testing laboratory.

1. The scope of the testing services offered
The scope of the services being offered should cover all current and projected testing needs. Packaging validations and evaluations often require multiple test components: temperature/humidity cycling, transportation simulation, accelerated aging, fragility testing, sterile package integrity testing (bubble leak/dye penetration), substrate material testing, microbial testing, etc. Having all of a company’s testing needs met under one roof can save time, money, and frustration. It should also be noted that conducting various test intervals at different labs opens the door to uncontrolled variables affecting test results. A prime example would be conducting a transportation simulation on a package/product and then sending these samples to a separate lab for subsequent testing; if failures occurred, it would be impossible to determine whether they were created in the controlled laboratory environment or during shipment to the second lab. In some cases, this cannot be avoided, but these risks should be mitigated when possible. Evaluating the laboratory’s equipment and testing abilities is necessary to determine if it will be able to efficiently meet a company’s testing objectives.

2. Ensure that the third-party testing laboratories are assuredly considered ‘critical vendors’ by other medical device OEMs.
With this comes audits and heavy scrutiny of the lab’s systems and facility.  Seeking out a laboratory that is ISO-9001 or ISO-17025 ensures that many of their systems are well designed and functioning properly. Many labs will claim “compliance” with ISO standards. While this is a positive, a lab should have an ISO registration number from a “notified body.” This guarantees that they are subjected to the rigorous annual audits required for certification. A lab being ISO certified is a great sign, though an on-site audit will allow a potential medical device OEM client to delve deeper into their systems, making certain the lab meets with the organization’s standards and expectations. Potential areas of interest during an audit may include:

  • Quality controls (quality program, statistical process controls, validations program)
  • Calibration/preventative maintenance program
  • Receiving/storage/shipping controls
  • Adherence to GDP/GLP standards
  • Employee training/records controls

3. Evaluate the cost vs. value
Cost versus value is somewhat cliché, but this relationship should not be overlooked. Consider what value-added services the prospective lab offers.  A good lab will provide guidance in the form of test protocol development, explanation of the test standards and methods, and assistance with failure analysis. This can be especially helpful for smaller organizations or start-ups lacking the resources to develop their own test plans, or the experience to evaluate failures. If a company is having an issue with a specific package or material, chances are that the folks at the test laboratory have seen identical or similar issues; they should be willing and able to help.

The personnel employed should also be taken into account as well. Does the lab have packaging or materials engineers on staff? What level of experience do they have? Keeping abreast of changes within a dynamic, tightly regulated industry requires involvement in technical committees and organizations, such as AAMI, ASTM, IoPP, and ISTA. The lab should be have involvement with these, or similar, organizations.

4. The location of the lab
The proximity of the lab, in relation to the medical device OEM’s manufacturing or R&D facility, should be considered. The logistics of working with a local lab can be easier and more cost efficient. Getting samples to and from the lab using a courier service is often less expensive and faster than typical FedEx/UPS delivery. And many of the environmental hazards that samples would be exposed to during shipping can be eliminated when using a local courier service. Being near the test lab will make vendor audits easier to schedule and perform, and will allow for lab visits to observe critical testing. While important, locality should not be the only deciding factor in choosing a lab. Many medical device OEMs do not have a lab that will meet their requirements within their metro area. If working with a lab out-of-state or across the country, make sure to send samples in protective packaging in an effort to minimize the stresses seen during shipping.

5. Vendor lead times
The lead times of vendors will always be important when bringing a product to market on time. Labs often experience fluctuations in the volume of testing, but should be able to provide a reasonable lead time. Does the lab have the facilities and staff necessary to meet the company’s demands? In pinch situations, the lab should be able to work with an OEM to provide priority testing services. With certain large-scale projects, some deviation from the standard lead time may be necessary; the staff should be willing to develop a test schedule in advance of the project’s initiation.

In addition to these considerations, soliciting recommendations from peers in the medical device industry could be beneficial. Due to non-disclosure agreements, the lab itself may not be able to provide references, but it can’t hurt to ask.

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