[Image courtesy of WuXi AppTec]
You can learn a lot about a potential medical device testing partner by asking about experience, capacity, testing approaches, communication and pre-submission meetings.
By Sandi Schaible, WuXi AppTec Medical Device Testing
Selecting a laboratory testing partner can be tricky — it goes well beyond mere technical capabilities.
Knowing the right questions to ask when choosing a testing partner will help device manufacturers build strong relationships, protect timelines, and deliver safe, effective medical devices.
1. What experience do you have in medical device testing, specifically in the areas of biocompatibility, chemical characterization and toxicological risk assessment?
Asking about a potential partner’s experience in the fundamental areas of preclinical medical device testing allows manufacturers to quickly determine if the potential partner can handle a project effectively.
Requesting case studies or examples of successful projects also helps manufacturers determine whether the potential partner has demonstrated success in delivering high-quality results and meeting a program’s unique requirements.
2. How experienced is your staff and what is your capacity to handle our project?
Understanding the qualifications and experience of the people working on a manufacturer’s project is crucial, as this expertise directly impacts the quality and accuracy of the testing and analysis performed. It also helps the manufacturer determine the potential partner’s competence and comfort with various technologies and methodologies.
Asking about a potential partner’s capacity and availability helps manufacturers determine whether the testing partner can deliver on time. Manufacturers will also need to know how workloads are managed and when they can expect test results.
3. Can you describe your approach to testing and how you tailor these services to meet medical device manufacturers’ needs?
Learning about a potential partner’s approach to testing and how they tailor it to meet manufacturers’ needs demonstrates their flexibility and adaptability. It also gives manufacturers a clear look at the lengths to which the potential partner will go to ensure full characterization, compound identification and a thorough toxicological risk assessment.
Chemical characterization is perhaps the most variable capability among lab testing facilities. ISO 10993-1:2018 states clearly that chemical information is a necessary first step in any risk assessment. Moreover, ISO 10993-18:2020 provides extensive guidance on identifying and quantifying chemical constituents present; and the proposed ISO/FDIS 10993-17 promises cutting-edge approaches to assess the toxicological risk of those constituents. Despite overwhelming regulatory support for complete chemical identification and characterization in medical devices, not all laboratories are fully committed to it.
Gap analyses identify missing information prior to preclinical testing. Experts from your quality, project management and engineering departments should be involved to provide cross-functional perspectives. Once a gap analysis is complete, the study design process can begin. E/L testing can include leachables, simulated use, exhaustive, and exaggerated studies. Exaggerated and exhaustive studies test how a product will react when exposed to extreme temperatures or solvents; simulated-use and leachables testing uncovers compounds that are expected to be released (i.e., leached) during standard clinical use.
Complete compound identification is then used to compare analytical data against commercially available databases. If that is insufficient, scientists turn to their own proprietary databases. If that doesn’t help, expert chemists are called upon to perform compound elucidation. The whole point is to identify everything. Any unidentified chemicals in a medical device must be assumed to be carcinogenic or genotoxic, leading to additional chemistry or biological testing. Unidentified compounds also can lead to an unfavorable risk assessment, which could send you to the back of the line for another round of testing.
A potential partner’s approach to testing provides critical information about its commitment to safe medical devices.
4. How do you communicate with clients throughout the duration of the project?
Any good laboratory testing partner will make experts available to answer any questions related to process, results or regulatory next steps. Manufacturers should also ask about post-testing and even post-submission support.
Whether it’s innovative products, regulatory requests for additional information or evolving standards, a quality lab partner should be able to take any new developments in stride. Experienced lab partners can also anticipate new questions and interpret regulatory expectations proactively.
Fostering open communication and ensuring that any challenges or uncertainty are addressed promptly and effectively are vital in building a strong working relationship with a lab.
5. Should we request a pre-submission meeting with our local regulatory body?
Pre-submission meetings are used exclusively when submitting a device to the FDA, but the EU’s MDR, China’s NMPA and Japan’s PMDA use variations of these touchpoints between regulators and device manufacturers. A great testing partner will recognize the value of pre-submission meetings. Often the lab will offer to attend pre-submission meetings to serve as expert counsel.
Manufacturers should also know their device’s intended use, features, function, testing strategies and similarity to predicate devices. Pre-submission meetings are a chance to receive direct (but unofficial) feedback and guidance on a device’s test plan. These meetings can reduce the time and money spent preparing formal submissions and prevent regulatory rejection.
Experienced testing partners may also employ technical and/or regulatory experts who serve or hold leadership positions on international regulatory committees. This helps them stay on top of emerging trends and anticipate new requirements and expectations, such as complete chemical characterization of medical devices or compound elucidation of drug components.
Sandi Schaible is the senior director of analytical chemistry and regulatory toxicology at WuXi AppTec Medical Device Testing. [Photo courtesy of WuXi AppTec]
Sandi Schaible is the senior director of analytical chemistry and regulatory toxicology at WuXi AppTec Medical Device Testing, located in St. Paul, Minn., specializing in extractables and leachables studies. She is a U.S. delegate and international delegate for ISO 10993 part 18 in chemical characterization, and also a U.S. delegate for ISO 10993 part 13 and the particulates committee (TIR42).
How to submit a contribution to MDO
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design & Outsourcing or its employees.
