Leading Manufacturer of Sleep Equipment Maintenance Devices, creator of the #1 device for sleep equipment maintenance
Refreshing the design of a market-leading device for sleep equipment maintenance to stay ahead of competitors. The new device needed to meet rigorous home healthcare medical standards to ensure safety and reliability, integrate advanced anti-counterfeit measures to protect disposable elements and maintain trust, and support a scalable product range to address evolving market demands.
Our client’s existing product was highly successful but required updates to:
Comply with stringent home healthcare medical standards.
Prevent counterfeiting of disposable elements, a significant shortcoming in the previous design.
Support a scalable product range with varying capabilities.
Ensure seamless transition to production while maintaining high-quality performance.
Recognizing Impact ES–Rhode Island’s proven track record in designing and delivering compliant electronics for class II medical devices, the client entrusted us with this critical redesign.
Impact ES–Rhode Island leveraged its experience in the medical design space to deliver a comprehensive solution, including high-level design, regulatory compliance, and production support:
Standards Definition: Collaborated with the client to identify global medical standards required for shipment and compliance.
Risk Analysis: Conducted electrical and firmware components of the risk analysis and developed subsystem requirements for electronics and software.
Counterfeit Prevention: Designed an anti-counterfeit system leveraging Impact ES–Rhode Island’s expertise in RFID and cryptographic technologies to authenticate disposable elements effectively.
Designed a scalable architecture to support a product range with varying capabilities while minimizing production costs.
Integrated features to ensure the device’s safe and intuitive use, including enhanced durability and consistent performance.
FCC and IEC60601-1 Testing: Oversaw submission to the FCC and a full suite of electrical testing for IEC60601-1 compliance, ensuring the device met global standards.
Regulatory Approval: Facilitated a smooth regulatory approval process with comprehensive documentation.
Developed software tools for board- level and functional unit testing to streamline manufacturing.
Provided remote debugging support to address and resolve production issues efficiently.
Ensured seamless communication and collaboration with the client’s manufacturing partner to maintain production quality.
The redesigned sleep equipment maintenance device achieved compliance with home healthcare medical standards and successfully transitioned to production. Impact ES–Rhode Island’s enhancements included:
Anti-Counterfeit Technology: A robust system to protect disposable elements from counterfeiting, ensuring product integrity.
Scalable Design: Flexibility to support a range of products with varying capabilities, future- proofing the client’s product line.
Regulatory Success: Achieved FCC and IEC60601-1 compliance with thorough documentation for FDA de novo submission.
Efficient Manufacturing: Streamlined production processes with customized testing tools and responsive support.
Collaboration and clear communication with the client and manufacturing teams ensured seamless execution from design to production.
Impact ES–Rhode Island’s expertise in medical device design and compliance enabled the client to maintain their market-leading position.
The refreshed design reflects Impact ES–Rhode Island’s commitment to innovation, quality, and customer success.
