Jul 13, 2020 | Medical Device, Medical Device Testing, Technical Expertise
If your organization is planning for a submission under the Medical Device Regulation (MDR), it’s important to consider outsourcing your testing needs to a testing lab. Working with an experienced partner that is well-versed in the latest standards can save you time, money and manpower.
When selecting a testing partner, it’s important to keep in mind that not all labs are created equal. The quality of your results depends largely upon the skills and expertise of the chemists and toxicologists who carry out the testing, which is why the selection process demands thoughtful consideration. Here are five questions to ask to help you find the right partner for your MDR testing needs.
- Do you have the capabilities to conduct chemical characterization, toxicological risk assessments and biocompatibility testing in-house?
The MDR requires that medical devices undergo a complete biological risk assessment to evaluate chemical, toxicological and biocompatibility conditions before they are approved for market. When developing a test plan, look for a partner that offers all three analytical tests under one roof. A lab that is skilled in all areas and uses highly sensitive analytical methods increases efficiency and helps address all biological endpoints, while minimizing room for error between tests. Working with a partner that doesn’t have all of these capabilities may leave you with no choice but to piecemeal your testing, which could risk miscommunication between parties, loss of information altogether, increased costs and longer timelines.
- What is your track record for complete identification?
The MDR places increased emphasis on the importance of chemistry and toxicology. For this reason, working with a lab that specializes in complete chemical characterization will yield the best results. Ask how long they have been conducting extractable/leachable (E/L) studies and how sensitive their analytical methods are. It may be a red flag if their test methods can’t detect chemicals above the analytical evaluation threshold (AET). If a lab doesn’t use proper methods or equipment, they may not be able to provide the right data for a toxicologist to fully assess risks. Unidentified chemicals or incomplete risk assessments will endanger your entire submission package. You should look for a lab testing partner staffed with experts who can demonstrate a track record of regulatory success.
- What is your approach to reporting unknown chemicals? How often do you report unknowns?
Complete chemical characterization requires identification of every chemical compound in your device found above the AET. While there are commercially available libraries that can help identify some chemicals present in extracts, they are not necessarily reliable in every circumstance. Reporting unidentified compounds can result in an unfavorable risk assessment, which could send you to the back of the line for another round of testing. Having to retest products increases cost and lead times. Ensure your partner has the ability to identify every compound the first time around.
- Do you offer follow-up support once a submission is ready for regulatory approval?
While the testing process is of the utmost importance, seeking out a partner that also provides post-submission support ensures everything runs smoothly from start to finish. If regulators have questions or ask for additional information, your partner should be available to provide guidance. Even after an MDR submission, partnerships should continue on through the lifecycle of the product.
- How does your staff stay up-to-speed on the changing regulatory expectations?
You will want to work with a lab testing partner that is staffed with experts who sit on regulatory committees, are in-the-know with the evolving regulatory landscape and have been doing chemistry, toxicology and biocompatibility on medical devices for several years. Do your due diligence in learning about a lab or CRO’s involvement with regulatory bodies before inking any agreements, so that you can be confident in your submission package.
These questions will put you on the right path to gauge whether a potential testing partner is capable of meeting your needs. To learn more about how to get the most out of your testing services, read “How to maximize your lab partnership: Details pay dividends.”
WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. As an innovation-driven and customer-focused company, WuXi AppTec helps our partners improve the productivity of advancing healthcare products through cost-effective and efficient solutions. With industry-leading capabilities such as R&D and manufacturing for small molecule drugs, cell and gene therapies, and testing for medical devices, WuXi AppTec’s open-access platform is enabling more than 3,900 collaborators from over 30 countries to improve the health of those in need – and to realize our vision that “every drug can be made and every disease can be treated.
Sep 3, 2019 | MDR, Regulatory, Technical Expertise
Medical device manufacturers are under serious pressure to get in gear and conduct their pre-clinical device testing—and fast. Europe’s Medical Device Regulation (MDR) will require submissions to be approved by May 26, 2020 to maintain a presence in the EU medical device market. If an extension was granted, Medical Devices Directive (MDD) and Active Implantable Medical Device Directive (AIMDD) certificates will be void as of May 27, 2024.
The changes introduced by ISO 10993-1 in the United States and Europe’s MDR aim to close regulatory gaps across markets and establish a globalized set of safety requirements. Every medical device, including legacy products that have been on the market for years, needs to be supplemented with new data and updated evaluations. It is estimated that more than half a million different devices currently CE marked under Europe’s medical device directive (MDD) will need to be recertified under the new MDR. Given the amount of work to be done and a shrinking number of notified bodies to review submissions, time is of the essence. Device manufacturers can’t afford to put off MDR preparation efforts any longer.
Failure to comply by the deadline will result in costly consequences, including having to retest devices or pull products from the market altogether; but thoughtful planning and partnership can help avoid challenges and delays. The following are some critical questions for your internal team to consider while preparing product portfolios and selecting a contract research organization (CRO) to carry out pre-clinical device safety testing.
Internal Responsibilities: Role of the Recruitment Committee
Before partnering with a CRO or laboratory testing facility, it is important to assemble a multi-disciplinary team of specialists from across your organization. This internal team will focus on MDR preparation efforts and regulatory education. Since MDR is multifaceted, your team should include experts from quality, product, regulatory affairs and engineering departments to ensure that nothing is overlooked or forgotten. Together, they can conduct a gap analysis on your product lines and identify any missing or outdated information in the technical files. To comply with the new requirements, notified bodies will not accept historic product data or performance reviews alone, which is why it is important to do this work before approaching a CRO. The following are some guiding questions to help kick off internal efforts and the gap analysis.
- How old is the device?
From a timing standpoint, begin with legacy devices that have been on the market longer is wise. The pre-existing data for these devices will likely be more outdated and may require more legwork than newer products that have undergone testing more recently.
- When was the device tested last? What were the results?
Even products that were tested three years ago may need to be retested to fully comply with the latest standards. However, it will still be beneficial to include all historical data in your technical file. Providing a track record of regulatory success will show regulators that you are dedicated to positive outcomes and patient safety. A comprehensive device history will also help your CRO develop and drive your test plan forward.
- Have changes been made to the device since the last time it was tested?
Not only is it important to note any alterations that have been made to the device itself since it was last tested, but you must also account for any changes in suppliers or manufacturing and sterilization processes. Device changes could impact chemical makeup or potential risk outcomes, and regulators will be looking for data that supports the safety of all individual material components.
- Have there been any patient safety issues linked to the device?
Any evidence of past performance problems that have put patients at risk will be an automatic issue for regulators, if you are unable to show that the issues have been sufficiently rectified. In these situations, investing in robust testing is the best course of action.
- Is the design history file complete and ready for the lab or CRO?
Your internal team should compile existing data on all of the materials and processes that go into making your devices before selecting a testing partner. A complete design history file includes information on any adhesives, additives, colorants, polymers and manufacturing aids used on or in the product, as well as the procedures used in the manufacturing and sterilization of the device. Having all of this data in one place will help you and your testing partner evaluate what tests are necessary to verify safety as efficiently as possible.
Evaluating the Pool of Candidates: Questions to Vet Testing Partners
Once your team has gathered all of the necessary product information and technical file data, it is time to develop a pre-clinical device safety test plan. Many manufacturers opt to outsource their regulatory testing needs to a CRO as a way to accelerate the process and get devices in front of regulators before their competitors. CROs are instrumental resources, but they’re not all created equally. Here are some questions and considerations that will help you decide who to trust with your testing needs.
- What are your in-house testing capabilities?
Under MDR, a complete risk assessment evaluates chemical, toxicological and biocompatibility results. CROs that are able to complete all three analytical test methods in-house are preferable, as doing all testing in one place increases efficiency, allows all endpoints to be addressed and decreases the risk of information gaps. If a CRO cannot do all three under one roof, you may have to piecemeal your testing, which can lead to miscommunication between parties, loss of information altogether, increased costs and longer timelines.
- How do you ensure complete identification?
MDR will place increased emphasis on the importance of chemistry and toxicology, so working with a CRO that is skilled in complete chemical characterization is critical. Ask the CRO how long they have been doing extractable/leachable (E/L) studies and what the sensitivities of their analytical methods are. If their test methods are unable to detect chemicals above the analytical evaluation threshold (AET), the toxicologist may not be able to accurately assess risk, putting your whole submission in danger.
- Do you report unknowns? If so, how often?
Complete chemical characterization requires that every chemical constituent contained in your device is identified. Although commercially available libraries can help identify some chemicals present in extracts, they are not reliable in every circumstance, and reporting unidentified compounds or unknown chemical concentrations may result in an unfavorable risk assessment.
- Do you offer follow-up support?
It is in your organization’s best interest to work with a testing partner that provides post-submission support. In the event that regulators have questions or requests for additional information, your CRO should be available to provide guidance and consultation.
- How do you stay current on regulatory changes?
You will want to work with a CRO that is staffed with experts who sit on regulatory committees, are in-the-know with the evolving regulatory landscape and have been doing chemistry, toxicology and biocompatibility for several years. Do your research, insist on transparency and set expectations early on to put your organization in a position for long-term success.
Making the Hire
At the end of the day, investment in high-quality, robust pre-clinical device safety testing is an investment in your organization and overall business objectives. The survival of your product lines and revenue streams is reliant upon teamwork, thorough planning and establishing partnerships built on trust and transparency in the face of MDR. Making MDR preparation a priority now and hiring a testing partner that can demonstrate a track record of success will help get you on the path to achieving regulatory approval by the deadlines.
