Testing is an essential function for most all medical device companies looking to introduce a product to market. Many medical device manufacturers, however, struggle to understand what they need to do to test and certify their packages and/or products when working with a third-party testing laboratory. Here are some suggested tips from DDL for manufacturers to adopt to help make medical device testing projects go more smoothly.
Define your objectives
What do you want to achieve from your medical device package or product testing? For instance, do you want to recreate damage or do you want to simulate the actual transportation and storage environment for compliance to regulatory requirements such as ISO 11607?
Define criteria and key deliverables
An important key to completing a successful testing project is to define the acceptance criteria. The ASTM Test Standard D 4169, “Standard Practice for Performance Testing of Shipping Containers and Systems,” which is a performance test or validation test, devotes a section on defining “acceptance criteria” and indicates the importance it has on test results. For each project or product, there should be some detail that indicates where the test failed. For medical device packages, the ultimate indicator of acceptance is if the package integrity is maintained and the product remains sterile at the point of end use.
Match lab’s capabilities to your testing needs
During your search for a test lab it is important to match your objectives with the laboratory’s capabilities and expertise. You also will want to evaluate its credibility by the accreditations, registrations, and certifications it holds as well as the participation of its staff in technical activities such as AAMI, ASTM, and other professional associations. You should also check to find out if the lab is ISO 9001 or 17025 registered.
Witness testing in person
On-site viewing of testing is always more valuable than just reviewing the details of test results described in a test report. When on-site observation is not possible, viewing of the testing via a webcam is another good option most test labs now offer. Another option for customers who are not able to be on-site is the use of digital photography or video that can be easily e-mailed for observation of test procedures and results.
Be prepared to make on-the-spot decisions and use advanced techniques
Because packaging development is often part of the critical path to product approval and introduction into the marketplace, timely validation of the packaging process is critical and must stay on track and on schedule. In order to keep the project and approval process on track, be prepared to make fast and sometimes instantaneous decisions regarding your packaging problems or failures.
Documenting the details and events that occur during testing is critical to the entire project. Data can be recorded on pre-designed worksheets for each test type, or data can be recorded in standard laboratory notebooks. There must be approval of the data by a project manager after testing is completed. There also must be pre-approval of the worksheet to ensure that the test plan matches the protocol.
Read and analyze the report as soon as it’s received
While most of the vital tasks for creating a successful testing project have been performed by this point, testing is not complete until proper analysis of the data and decisions based on that data are made. The testing laboratory should help summarize the data to make it easier to see what the results may portend for the project, be it a solution to a problem, a reduction in packaging costs, or a successful process validation.
Clarify and revise as required
When all objectives are met, a final test report will be provided that details all test results, procedures, and events that took place during testing. This test report should be concise and professional and include photos where possible to demonstrate test procedures and results.
Authorize additional testing if indicated
Sometimes the original objectives of the project are not met by the testing protocol developed or sometimes something unexpected happens during testing that causes a change in the objectives. Consequently, a new series of tests may be required to glean more information about the product or package design, or you may need to make design changes to the package or product and then re-validate.