Going Beyond the Regulations to Evaluate Relevant Medical Device Risk

Many companies are working overtime to ensure lifesaving medical devices get and stay on the market. While efficiency is key, important steps can slip through the cracks when speed is the priority. If companies feel pressure to rush and focus solely on satisfying standards, there’s a chance their device’s success could be limited to the short-term in our fast-paced industry and regulatory environment. Going the extra mile can help prevent minor changes from snowballing into bigger issues.

Companies need to review their testing plan so it supports a successful submission, saves time on the back end, and ensures the long-term success of their product. To avoid potential setbacks, they should use the following steps to identify and evaluate the relevant risks for each device, instead of simply meeting what regulators require.

Do: Start with a clean portfolio. Whether these preparations already started for the Medical Device Regulation (MDR) or capacity constraints have forced prioritization, now is the ideal time to prioritize product portfolios and pull devices from the market that aren’t delivering necessary value. Many companies have already pulled devices from the European market where it doesn’t make sense to update the files and registration under the MDR. It may be time to extend this process to other markets, or with non-critical devices. While these decisions may lead to a predicted reduction in the total number of available devices, they also allow companies to focus on more pressing needs.

Don’t: Depend on device class. Another lesson learned from the transition to the MDR is how quickly device classifications can change—the implications of which can be frustrating and time-consuming. Staying ahead of classification changes takes diligence and proactive research. The necessary chemical characterization and toxicological risk assessment requirements vary depending on the risk level and regulatory body. These discrepancies can lead to gaps in technical files when a device changes classifications and testing results no longer meet appropriate standards.

When approaching testing to satisfy regulatory needs, it’s important to look not only at the current device classification but consider its future potential throughout the product lifecycle. Those going beyond what regulators currently require are typically better prepared to meet future needs.

Taking steps to go further when it makes sense could also help meet product standards across multiple regulatory bodies. For example, while the FDA and MDR closely align in many of their criteria for high-risk devices, lower-risk devices may see greater inconsistencies in various standards and/or their implementation. Preparing to meet FDA and MDR requirements can grant greater flexibility in entering new markets and globalization of standards.

Do: Keep post-market performance in mind. Thinking about a device’s long-term success means evaluating how a testing partner will impact a device post-market. When resolving issues after a device has launched, such as bypassing resubmission after minor device changes or addressing unexpected device observations, a partner who produces high-quality results and offers post-market strategy can support information gathering and issue resolution.

Choosing a good testing partner is worth the investment to protect a device’s post-market success and gather high-quality data. For example, if a company wants to run a chemical equivalency study to identify a potential contamination source, the original lab needs to have complete chemical identification and quantification to allow an accurate comparison. Additionally, most testing lab partners have greater exposure to the industry than most device companies, and this broader perspective can help inform strategy when post-market issues arise.

Don’t: Overlook documentation. Thorough documentation that supports relevant data and testing details, as well as regulatory strategies, is useful for answering questions. Leaving information gaps for legacy knowledge to fill can create room for error when team members move to different positions or simply when memory fails.

Even when facing a tight deadline, companies need to take the necessary time to document foundational knowledge and any reasoning to support decisions during submission, testing, and manufacturing. In the future, should a product team require any background on the reasons for performing specific tests or the thinking behind a manufacturing decision, this documentation can answer any questions easily, whether the team has changed or not. Fortunately, some testing facilities can offer support in documentation. They can create formal documentation and strategies independently to ease the workload of meeting standards.

Do: Critically assess historical data. This industry moves at a rapid pace—even the testing technology has improved leaps and bounds in just the last five years. When preparing device submissions, before using historical data, reviewing it with a critical eye is a vital first step. Advancements in regulatory expectations may challenge the status quo or technology that was available for the medical device initial testing, meaning that the tests need to be updated in order to comply with submission requirements.

Long-term devices are an excellent example. Just a few years ago, it was not routine to perform exhaustive extraction studies. After requirements became more stringent, the practice changed and left many devices with testing gaps. With the rate of change in technology and regulatory requirements, companies must prepare for the possibility of a rise in testing gaps. Providing historical data may not be enough.

Piecemealing testing for technical files can impact how long a submission satisfies standards. If a device has already been through the submission process and sees a minor change, it is tempting to limit testing to an extractables/leachables study, and in some cases that may be adequate. However, there still may be gaps in addressing relevant risks, and there may be long-term value for the cost of running full assessments. Satisfy the most up-to-date standards across biocompatibility, chemical characterization, and toxicology while evaluating the file for gaps.

Don’t: Forget packaging and labeling. It’s easy to overlook the implications packaging and labeling can have on a device, but this can lead to roadblocks closer to final submission. While packaging and labeling considerations are often seen as marketing responsibilities, both can have a significant impact that must be considered by product development and quality teams. The effects of packaging and labeling on a device range from contributing leachable chemicals revealed during testing to hold-ups in regulatory submission reviews due to discrepancies with intended clinical uses. Leaving packaging and labeling responsibility solely to the marketing team can lead to cross-functional gaps and set back commercialization.

It’s prudent that marketing is brought into the process early on. Marketing plays a critical role in labeling and the instructions for use, but they can’t provide perspective if they aren’t involved in the conversation. The marketing team helps determine any accommodations for the latest use scenarios; identifies intended patient populations, like pediatrics, when performing testing; and can clarify packaging implications on the device.

While it can be easy to put packaging and labeling on the back burner when the focus is testing, regulatory submissions, and other demanding processes, letting these details slip can be devastating. Small intended-user details from the label can completely change testing needs and put a project behind schedule. It is also critical to perform testing on devices out of their final packaging to identify any leachable chemicals.

Communication with the internal regulatory team should also be a priority. If the regulatory team is not involved soon enough, it will be difficult to understand what standards must be satisfied and how to coordinate timelines to achieve this. No company wants to push back a launch date because of submission setbacks. Coming together to give as much information to the testing lab as early as possible will help support a successful submission.

Do: Vendor credentialing. Companies commonly fail to gather sufficient details from their suppliers and manufacturers. Requesting specific details and available data on materials, additives, etc., at the beginning of the process helps with planning and conducting appropriate testing and supports quality assurance. Not all material suppliers and manufacturers are created equally. Auditing vendors thoroughly can lead to a deeper understanding of their capabilities and responsiveness. By establishing these processes, companies can enhance vendor accountability and reduce quality issues in case an additive makes its way into the production process or a material changes without warning.

Safeguarding Against Speed
The urgency many in the industry feel likely won’t subside any time soon, so taking these extra steps is important for future preparedness and efficiency. Patient safety is always the top priority, and when taking a hasty approach to meeting regulatory requirements, risks can arise. Companies can’t let these become surprises and create setbacks in progress.

With the amount of stress and work that goes into a successful product submission, looking for reliable support can offer relief and beef up areas that might not be a company’s strong suit. Testing facilities across the industry are here to provide partnerships. 

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Sherry Parker, Ph.D., is senior director of Regulatory Toxicology at Wuxi AppTec Medical Device Testing. 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. As an innovation-driven and customer-focused company, WuXi AppTec helps partners improve the productivity of advancing healthcare products through cost-effective and efficient solutions. With 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 3,700 collaborators from over 30 countries to improve the health of those in need.