By Dave Durfee, Chief Scientist
Medical-Grade Polymer Company
A company specializing in medical-grade light-curable polymers required a compliant light source for their bone stabilization system. An appropriate medically approved illuminator was not available on the market, necessitating a custom solution.
The client faced a significant challenge in finding a medical-grade light source that met compliance standards for use with their photodynamic polymer. Time to market was a critical factor, requiring a solution that could be implemented swiftly while adhering to medical regulations.
To accelerate development, Impact ES–Rhode Island partnered with a vendor that had an existing commercial illuminator and guided modifications to meet medical compliance requirements. Key steps included:
Conducting a thorough review of the commercial device and providing detailed feedback to ensure compliance.
Advising the vendor, who had no prior experience in the medical industry, on necessary regulatory and technical modifications.
Developing additional custom electronics to enhance the user interface and mitigate risks, ensuring full compliance with the IEC60601 standard.
The completed illumination product enabled the client to bring their medical-grade polymer system to market efficiently. The device successfully obtained CE mark approval, allowing distribution in Europe. The collaboration resulted in a compliant, effective, and commercially viable medical light source.
Partnering with existing vendors can significantly reduce development time while achieving compliance.
Expert engineering guidance is crucial when adapting non-medical devices for medical applications.
Custom electronic enhancements improve both usability and compliance with medical standards.
Strategic modifications enabled the client to secure CE mark approval and successfully enter the European market.
Time-to-market pressures can be managed effectively through collaborative problem-solving and regulatory expertise.
