Adhesives are a foundational element in wearable medical devices, yet they come with their own set of challenges — from regulatory approval to patient comfort. During a recent interview with UC Liu, Head of Regulatory Affairs atBioIntelliSense, we explored the essential considerations when developing adhesives for medical devices, including the 510(k) process and post-market surveillance.
The Importance of Adhesives in Medical Devices:
Adhesives in wearables need to balance strong adhesion with skin safety.BioIntelliSense, a leader in wearable sensor technology, uses adhesives to attach their devices to patients for continuous monitoring of vital signs. But getting these adhesives approved by the FDA isn’t as simple as it sounds. UC Liu shared that one of the biggest challenges is biocompatibility testing, which ensures that adhesives do not irritate or harm the skin.
Navigating the 510(k) Process for Adhesives:
The FDA’s 510(k) submission process requires extensive validation of adhesives, particularly around performance and biocompatibility. As UC explained, adhesives must undergo cytotoxicity, sensitization, and irritation testing to ensure they are safe for prolonged use. These tests often take months, but working with accredited labs can streamline the process.
Common Regulatory Pitfalls and How to Avoid Them:
UC stressed the importance of choosing the right predicate device when submitting your adhesive for approval. If the FDA perceives an adhesive to be too novel, they may require more extensive testing, moving your submission out of the 510(k) pathway into a more complex approval process. Pre-submission meetings with the FDA can help mitigate these risks.
Post-Market Surveillance: What to Watch For:
Even after FDA approval, adhesives often face post-market challenges. Complaints about skin irritation or adhesion failure are common, making up about 20% of all reported issues. UC recommends setting up a robust post-market surveillance system to monitor these complaints and report them to the FDA if necessary.
Conclusion:
Developing adhesives for medical devices is a complex process that requires careful planning, testing, and ongoing monitoring. By involving adhesive experts early in the process, companies can avoid many of the common pitfalls and ensure their products are safe, effective, and compliant with regulatory standards.