Case Study: Vision Screening Medical Device

Helping Fulfill a Vision for Pediatric Ophthalmic Health

Product Highlights
  • Ground-breaking portable digital vision screening device
  • Allows pediatricians to accurately screen for vision abnormalities in children, even those too young to take conventional vision tests
  • Contains embedded computer, keyboard, color display, digital camera, flash, battery & charging circuit, and focusing LEDs
  • User data collection and upload of data for analysis via the built-in Ethernet port
Market
  • Class 2 Medical Device
Lifecycle Stages
  • From final design, prototyping, to full volume manufacturing, direct fulfillment and service depot support
Key Challenges
  • Needed to be far more mobile, lightweight than previous design (4.5 vs. 30 lbs)
  • Design to meet IEC-60601 standards for safety and emissions
  • Device needed to increase processing power and functionality from original design
  • Easy-to-use, portable
  • Economical
Enercon Solutions
  • Enercon took concept, then identified and corrected issues with product
  • Modified design to solve safety, electromagnetic emissions, & static discharge issues
  • Supported IEC-60601 re-testing of product
  • Helped customer secure 510K approval
Enercon Services
  • Product design and programming (Linux-based)
  • Supply chain management
  • Regulatory testing management & coordination
  • Manufacturing and quality control
Results
  • Seamless, direct fulfillment to end-users (pediatricians)
  • Customer does not need to maintain or manage inventory
  • Enercon maintains a supply of back-up product for ready fulfillment
  • Service depot support

"The success of our product results from our listening to our customers, and Enercon in turn listening to us. Their experienced team worked closely with us, and were absolutely essential to getting our product to the market."

-President & CEO


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