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Safe & Compliant: Mitigating Risks After Device Modifications

May 4, 2021 | Biocompatibility, Manufacturing, Medical Device Testing, Technical Expertise

The medical device regulatory environment is continuously evolving. As regulatory body expectations become more demanding, manufacturers need to evaluate the safety implications of changes to their devices and processes.

Manufacturing modifications are one example that can affect a medical device’s compliance and possibly end-user safety. Changes to supply chains and manufacturing processes may pose more than just logistical challenges—they can potentially alter a product’s chemical makeup, impact toxicological risk assessments (TRAs) and even put a device’s regulatory approval at risk.

Whether changes to a manufacturing process are planned or reactive, it is critical to understand the implications they may have on a medical device’s material composition and what that means for evaluating biological safety concerns. When modifications to the device or the process occur, ensure your team takes the right steps to protect the end-user and meet or maintain regulatory approval.

Keeping an Eye on Potential Pitfalls

The manufacturer is responsible for identifying, addressing and eliminating potential risks before implementing modifications to the device design or a manufacturing process. There is always the possibility that adjustments may go wrong and cause obstacles or delays. Companies must be intentional in identifying challenges that can affect a device’s chemical makeup at all stages of the product lifecycle.

When design changes occur, there may also be new materials or processes at play. These changes can affect the outcome of chemical characterization and toxicological risk assessments – and could potentially lead to retesting a device altogether. Evaluating device toxicity is critical to gauging potential patient safety risks and assists in gaining regulatory approval. 

It is essential to consider the various regulations that device or material modifications could fail to satisfy – as well as new standard updates that may soon come into effect. For example, the updates to ISO 10993  should always be considered when making changes to a device or process.

Even when no red flags from the manufacturing process arise, a modified device may contain new unknown risks. Ensure your team assesses new device risks that could be associated with the changes and undergo further testing when necessary to protect end-user safety. Your testing partner can help you determine when additional testing is needed.

Recognizing the Common Link

For many established products, one variable that sticks out as the most volatile to change is material choice. When an element in your device makeup changes, differences in raw material composition and quality can falter when it’s time to evaluate toxicity.

When proven safe through testing and risk assessment, a device’s material and chemical composition allow it to function accurately and consistently. But, even altering just one component can put the compatibility of these selections in flux, and the impact on your end-user may be unclear. Laboratory testing partners are more than willing to provide their perspective in determining the necessary next steps when there are material changes in a device. They may suggest additional testing such as material characterization, validation testing, biocompatibility and risk assessments to prove the device is still safe and meets regulatory standards.

Innovate While Playing It Safe

Protecting patient safety and maintaining regulatory compliance is the top priority, so it is essential to consider the risks associated with manufacturing and chemical changes and take the necessary precautions to minimize potential hurdles. Addressing obstacles before they arise can support safer products and successful regulatory submission. Modifications aren’t just manageable—they’re an opportunity to strengthen your understanding of a medical device’s chemical composition through purposeful planning and connection with the right partners.

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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, socially responsible and sustainable 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 4,200 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.”

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