Product Design: Dale Medical – ACE Connector
Engineering to Meet New ISO Regulations for Medical Devices
Dale Medical faced the challenge of maintaining an existing patent and meeting the new ISO regulation 80369-3. Their new ACE connector supports a closed enteral system and reduces misconnections. It helps protect both the clinician and patient with straightforward in-line feeding, irrigation, gastric residuals and medication delivery without the need to disconnect. Our team worked with Dale on a tight timeline to ensure standards were met. Our process took advantage of our in-house prototyping to build and test the design repeatedly until meeting the final objectives and releasing the product to production.
A Closer Look At The Project
“We are proud of our partnership with Helix to update the ACE Connector system for enteral feeding. They developed a new design that was both compliant with the new ISO 80369-3 standard and offers an excellent solution for our customers. The new design is easy to use and effective for clinician and patient use.”
— Sharon Steeves
Product Development Manager, Dale® Medical
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Dale 485 In Use
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Project Objectives:
- Review the new ISO 80369-3 regulation and the current Dale ACE patent
- Explore design options to meet the new ISO requirements
- Prototype to evaluate and verify
- Develop documentation package for production
Helix’s Approach:
- Brainstorm with design and engineering teams
- Prepare preliminary engineering CAD concepts
- Generate mock-ups and test models
- Prototype concepts and identify areas of opportunity for refinement
- Produce production CAD assembly, BOM, and 3D database
Product Solutions:
- ISO 80369-3 ENFit compatible reduces misconnections
- Designed to physically prevent administration of enteral formula in any line other than 80369-3 ENFit compliant enteral tubing systems
- Works with all ENFit type small-bore feeding tubes, PEG/PEJ tubes, most G/J tubes, and enteral feeding sets
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