As manufacturers continue to work hard bringing medical devices and supplies to market, they are facing not only the challenges of pressing regulatory timelines but also disrupted operations due to the pandemic. The recent EU Medical Device Regulation (MDR) extension may feel like a relief to project timelines but be aware of congestion and capacity constraints across the board — from production to approval. Industry experts are urging manufacturers to complete testing as soon as possible to avoid costly and time-consuming barriers.
Manufacturers are looking for ways to streamline processes and keep their testing on track. Some opt to collaborate with outside lab partners, while others are focusing efforts on internal testing capabilities, and an increasing number elect for a hybrid of the two.
Now is the time to determine whether it makes sense to outsource medical device testing to save on time, money, resources and, most importantly, lead to regulatory approval.
Understanding the Regulatory Landscape
The MDR’s extended deadline to 2021 is a relief to manufacturers that were scrambling to meet the stricter requirements in time. However, this extension shouldn’t equate to relaxing timelines but rather ramping up the submission process to ensure that your medical device will make it to the EU market. Even with the delay, other factors, such as limited capacity with notified bodies (NBs), still pose a level of risk.
Additionally, there are numerous regulatory changes that manufacturers may find challenging to keep up with that could lead to surprising setbacks and progress delays. One example is the increased expectations for chemistry and toxicological risk assessment. ISO 10993-18:2020 requires chemical characterization for all materials to a specific concentration and also introduces the analytical evaluation threshold (AET). Understanding the AET is essential for compliance. Lack of awareness of regulatory changes, such as the AET, can set a testing plan back months and lead to plan adjustments and retesting.1 The regulatory landscape continues to evolve rapidly, and it’s not always easy to keep up. Outsourcing to lab partners can offer some relief and peace of mind to those with limited capacity.
When Outsourcing Is the Right Step
Weighing your testing options is imperative to submission success. When appropriate, outsourcing can keep your medical device moving forward without overloading your staff and resources. It’s crucial to know when to bring in a partner.
If you relate to any or all of the following six indicators, outsourcing may be the right solution to support your medical device testing needs.
Lack of resources. Some manufacturers don’t have direct access to a qualified lab to conduct the proper tests on their devices. Additionally, manufacturers that have their own in-house testing capabilities may experience overflow. Prevent delays by identifying whether an in-house lab is at, or near, capacity and quickly relaying this work to your lab partner.
Ease internal resources. Effective partnerships often alleviate pressure on internal workloads and help manufacturers meet crucial deadlines. This is where a lab partner steps in. Testing is an integral part of the process and partnering with a contract research organization can free up internal resources while meeting all biological endpoints.
Necessary expertise. Building a team of testing experts is a daunting task that takes time to perfect. A lab partner can help fill any experience and industry knowledge gaps as you continue to build the team. Labs employ specific toxicology and chemistry experts that have experience working with a variety of devices. These experts must have experience with extractables and leachables (E/L) and the necessary skills to write a comprehensive risk assessment. Deficiency or knowledge gaps in any of these areas put your device at risk for regulatory setbacks.
Regulatory knowledge. Testing experts and organizations should be up to date or ahead on regulatory modifications and variations. If your team does not have a thorough and current understanding of all relevant regulatory requirements, outsourcing to those who do can save money and time in lab education. Lab partners help ensure that all the boxes are checked before submission and can catch mistakes or gaps that a regulatory body will deem unacceptable. Furthermore, labs communicate frequently with regulatory agencies to give their clients the best chance at submission success.
Expansive chemical databases. After the publication of ISO 10993-18, chemical characterization standards have increased identification expectations dramatically. Submissions may be at risk for those who did not plan for this level of testing and don’t have the supporting technology to achieve this. Some outsourced lab partners dedicate resources to building out extensive chemical database libraries, which can take years to build. Outsourcing your device to a lab partner that has this database already built out can significantly support your submission.
Credibility. Having a third party test your medical device can provide a level of integrity and potentially mitigate bias that may be more prevalent for in-house testing facilities. Credibility in the eye of the regulatory body can further support your submission. Additionally, contract research organizations are cognizant of their testing reputations, which motivates them to provide thorough and accurate results. Regulatory bodies are often familiar with lab partners and may anticipate quality related to reputation.
If outsourcing seems to be the right option for you to stay on track with both timelines and budgets, the next step is to find the partner to best meet your needs.
When vetting a lab partner, it’s essential to keep in mind that not all partnerships are equally effective, and you shouldn’t take the decision lightly. Having a productive, trusting relationship with your lab partner will only make the process easier and more efficient.
Transparent and frequent communication from the onset is critical. Providing existing data, even the files that may not seem applicable, can help build a thorough device background for effective study design. This data may include everything from accurate device dimensions to patient contact time, materials, polymers, and the intended purpose of the device. The more data you can provide, the better. Your lab partner will thank you.
Productive partnerships truly depend on both parties working together. Keeping an open mind about suggested tests can set your submission up for regulatory approval. When lab partners recommend identifying the compounds in your device, consider the advantages that chemical characterization may provide. Lab partners want to be an integral part of your team by delivering quality study designs and valuable results. Taking the time to foster this relationship could pay dividends in the long run.
MDR compliance has manufacturers looking at their testing options, and there are many elements to consider when outsourcing medical device testing to a lab partner. No matter the scope of your testing needs, it’s critical to choose a partner that will save you time, money, and resources, as well as prepare your device for regulatory success. If you have any questions regarding potential outsourcing needs, contact your lab partner.
- S. Schaible , “Preparing for MDR? Don’t Overlook the Analytical Evaluation Threshold,” Medical Design Briefs, Vol. 10 , No. 2 , February 2020.
This article was written by Sandi Schaible, Senior Director of Analytical Chemistry and Regulatory Toxicology, WuXi AppTec, St. Paul, MN. For more information, visit here .