Best Practices for Independent Testing, by Cynthia Rancourt
Frequently, medical plastics processors do not have the budget to purchase the range of equipment and analytical instruments necessary to perform the many tests needed to successfully bring a new medical device to market, let alone the funds and time to hire and train employees to use them. Outsourcing testing to an independent laboratory can be a project-saving move in the medical world and serve as a force multiplier of a processor’s own staff. There are recommended practices when seeking out an independent testing lab to ensure success for you and your company collectively.
1. You’re only as good as your suppliers
Ultimately, it is the responsibility of the OEM (original equipment manufacturer) to ensure vendors meet the rigorous standards set by medical device regulatory bodies.However, CMOs (contract manufacturing organisations), CROs (contract research organisations) and plastics processors all need to conduct due diligence in researching analytical labs. This can involve extensive supplier questionnaires and some online research. However, if an OEM is working towards a medical device submission an on-site audit is a must. Seeing a facility and meeting the personnel gives more accurate information on capabilities, quality system maturity and capacity—more so than just internet or questionnaire research.
2. You get what you pay for
Much like everything in life, you get what you pay for. Many labs offer inexpensive test results and sometimes boast of those low prices. Make sure when requesting quotes from testing labs that you are clear on what you are getting. For example, what is the quality infrastructure that supports the lab? For a robust and GMP quality system truly committed to continuous improvement, you can expect that the lab will have substantial overhead costs. Those high overhead costs will transfer into higher prices when compared to labs lacking such infrastructure. Also, seek clarity as to what the lab considers to be test results. Are their results more than just data? Often it is possible to have inexpensive testing done but should a question arise about the testing there is no expert to interpret results, explain results, or offer recommendations. The ultimate goal should be a testing lab with a quality infrastructure to support reliable results, in addition to expert interpretation of those results. Ask yourself: what are you sacrificing in your quest to achieve a smaller invoice? The answer may be penny wise and pound foolish—as the saying goes.
3. Expertise matters
When in search of the perfect outsourcing partner for independent analysis, considering expertise from a variety of angles is a must. Not only do you want a testing lab that has expertise in analytical science, you must find a testing lab that has expertise with the rigorous requirements regulatory bodies expect and enforce. You need a test lab that thoroughly grasps instrument qualifications, method validations, and the ins and outs of data requirements for submissions. Some labs have a regulatory consultant in place to supplement any area where they may lack expertise. This is a common and acceptable practice assuming the consultant has the required education and experience. Either way, it is necessary that the testing lab is an expert both in science and regulatory matters to meet the needs of a client within the medical device or medical product industry.
4. Ensure you have found an outsourcing partner
The independent testing lab selected should serve as an extension of the OEM, CMO, CRO, or plastics processing company. Acquiring data for medical device submissions or to demonstrate compliance is a long and sometimes windy road. Ensure from the very start that the chosen vendor is one you enjoy working with and that the communication channels flow freely in both directions. The work of the independent lab can be more productive and cost effective for the client when a good working relationship is in place between a lab liaison and a client liaison. Often the client doesn’t know what information might be critical to the materials science aspect of the issues, and the scientists do not fully understand the business implications and actions that may need to occur based on the test results. The more relevant information that is provided to the laboratory, the better information the scientists will have with which to develop relevant testing protocols within the timelines set forth by the business side of the organisation.
5. Determine the testing lab’s “back-up plan”
Well thought out procedures for data protection, equipment redundancy, and cross-training of scientists are three critical areas that a well-established testing laboratory should be able to articulate to a client or potential client. The testing lab should have contingency plans in place for both personnel issues as well as in case of large-scale disasters. This should include a discussion about redundancy of trained personnel. Determine if scientists are cross-training from one laboratory to another in case of an illness or surge in work load. Certainly an OEM would not want their submission timeline altered because the only scientist equipped to operate an instrument was out on maternity leave. Life is full of uncertainty. For an OEM with a strict submission timeline uncertainty must be mitigated! When considering multiple independent testing labs it is imperative to explore exactly how the lab can minimise risk as it pertains to your submission timeline.
When it comes to choosing the right lab based on expertise, robust quality systems, and capacity, spending time and money on the best practices listed above can be the best way to ensure the success of the project and protect its deadlines. Choosing the right independent testing lab can save time. And…in the medical device world, time is money!
Cynthia Rancourt is director of business operations at independent chemical analysisl physical testing and materials analysis company Polymer Solutions in Virginia, USA.