Keeping Compliance on Track Through Testing

The beginning of 2020 has left the industry strained and delayed implementation of the Medical Device Regulation (MDR) by one year (May 2021). Regardless of where a manufacturer’s product portfolio currently stands, challenges such as fewer notified bodies (NB) than anticipated and industry-wide capacity issues are prompting companies to push forward with their remaining compliance efforts. While much is out of the manufacturer’s hands, one factor they can control is re-evaluating their testing plans. Now is the time to ensure these plans are as efficient as possible.

Testing Plan Evaluation
Committing time to review testing plans can help companies increase efficiencies and identify potential risks that could eventually delay approval. There are several factors medtech firms should consider when evaluating their current and future testing efforts, from the internal team and risk management to lab partnerships. Reviewing these areas can help ensure the timely success of testing plans.

Step 1: Assemble a capable team. Eliminating any room for error in a testing plan requires the support of the best possible team. The internal team needs to know every detail about the product(s). A team with cross-functional knowledge spanning marketing, R&D, operations, and quality helps to ensure each testing plan is comprehensive and considers all angles. A strong team can also confirm all information is provided to the lab accurately and promptly.

A team with detailed product knowledge can support submission success from start to finish. For example, if a test returns with the device reporting higher levels of ethylene oxide residue than deemed acceptable for pediatric use, an informed product manager can provide necessary insight on the next steps. For a product not intended for pediatric use, these results would not be relevant. Without someone on the team to support this, further measures may have been taken, or even additional, unnecessary testing could occur, setting the timeline back and wasting money. The right team can streamline the testing plan with detailed knowledge of significant product markets and more.

Additional roles to involve in the planning process include design engineers who can speak to product design and functionality, manufacturing engineers, and a production manager with expert knowledge of the manufacturing process and any additives that may have contacted the product. Other topic areas that require knowledgeable representation include sterilization, packaging, and labeling. Review the team supporting the testing plans, because now, more than ever, there is no room for error.

Step 2: Be aware of obstacles and risks. Each testing plan is unique and obstacles may vary, but the two common pain points facing most manufacturers are keeping up with regulatory knowledge and issues with legacy devices. Staying up to date with regulation changes continues to be a challenge for manufacturers because expectations are still evolving. As NBs gain experience enforcing these standards, they will likely continue to ask even tougher submission questions as time passes.

On top of regulators gaining confidence in enforcing the MDR, other governing bodies continue to release standards to elevate compliance requirements for manufacturers. This has been evident in early 2020 with the release of ISO 10993-18, requiring manufacturers to uphold a more rigorous identification standard for chemical characterization. Being unaware of the critical information in this standard can lead to significant setbacks in testing plans. Companies must ensure their teams have the resources to gain a deeper understanding of the standard’s expectations internally. This action allows them to understand their role in holding testing labs accountable for meeting the latest regulations. Continue to monitor vigilantly for regulation changes, even after the MDR deadline, to avoid backlogs.

Issues arising from legacy devices also pose a challenge for manufacturers. These products likely require supplemental testing to fill submission gaps, running the risk of setbacks. The testing needed to move forward under the MDR typically demands additional information not previously required of legacy devices. Medtech firms that are unable to provide that information may find their testing plans stuck in place.

One commonly missed piece of documentation for legacy products is the device surface area. Surface area was not previously required, but with regulation changes, manufacturers must deliver this information going forward. Without surface area data on-hand, manufacturers may face delays, having to take the time for engineers to retrieve these details. Prioritizing legacy devices is critical to avoid additional setbacks.

Step 3: Practice proactive partnership. A testing plan is only as strong as the testing partnership—and that relationship goes two ways. To get the most out of their testing partners, companies must realize that they have a significant role to play, too. Testing labs need their partners not only to collect and provide as much relevant information as is available but also to be proactive and willing to share it with their team. Manufacturers can never offer too much information to their testing partners. While labs may seem like they are requesting excessive detail, the data is critical for successful execution.

Avoid potential information gaps by preparing the following device details:

• Existing data: Providing any previously recorded data, which exists in the majority of cases, can expedite the test design process. Turning this over helps the lab team better understand device capabilities and restrictions.
• Parts and composition: The number of components within a device ranges drastically from product to product. Detailing the total number of parts and how they come together allows labs to determine the correct test specifications.
• Materials, colorants, pigments, adhesives, additives, polymers and manufacturing aids: Labs require this information to select the correct equipment, solvents, temperatures and extraction times.
• Size, thickness and surface area of the entire device, and the portions that come into patient contact: The extraction ratio is dependent on wall thickness, making detailed dimensions especially important. Additionally, understanding the surface area helps labs request the appropriate number of samples for testing. At this point labs also need to know whether the device can be cut into pieces for testing.
• Purpose, category and patient contact time: Communicating where products contact the patient, the duration of exposure, the temperatures and fluids it will come into contact with and other factors all help inform test design.

While providing the necessary information, companies should be aware of partnership pitfalls that could slow any testing progress. These pitfalls include providing outdated information, improper notification of device changes, using test articles that don’t correctly represent the final device, and resisting chemical characterization testing. Reduce risk in the testing plan by proactively approaching the lab with transparency into forecasts, intervals and timelines.

Resetting the Course
Testing teams are not alone in their struggles. The transition to the MDR has been a resource strain to most, especially considering the unprecedented challenges that have arisen recently (namely, COVID-19). At this point, success comes down to companies accepting the current state of their efforts while keeping their feet on the gas.

Reassessing testing plans is the first step to stay on track and ensure medical devices are compliant as quickly as possible. Companies can take control of what they can by building a well-rounded and knowledgeable team, ensuring they are an excellent partner to testing labs, and taking necessary measures to mitigate challenges and support a successful submission. 

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Sandi Schaible is the senior director of Analytical Chemistry and Regulatory Toxicology at WuXi Medical Device Testing, a part of WuXi AppTec. She specializes in extractables and leachables studies. Sandi is a U.S. delegate and international delegate for ISO 10993 part 18 in chemical characterization. She is also a U.S. delegate for ISO 10993 part 13 and the particulates committee (TIR42). WuXi AppTec provides a 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.