Diagnostic Device Experience

ECG

Andrews-Cooper has extensive experience across the ECG space.  A number of our engineers are noted experts in the space.  Recent project work has involved a 12 lead ECG monitor and a 1 lead ECG/Holter monitor.

Vision System

This client developed an idea (and a prototype) for a vision system used to diagnose neurological issues.  Andrews-Cooper was originally tasked with the electrical design.  Our involvement grew to include assistance with Project Leadership, Project Planning and Documentation to assist with regulatory requirements for a medical device.

Breath Analysis Device

This client had developed science toward diagnosing general health from measurement of aldehyde levels in patient’s breath.  Andrews-Cooper engaged to provide product development and FDA compliance experience to allow the client to continue to focus on the specific science of their device.

Mechanical Design: Based on some very aggressive requirements, Andrews-Cooper created an innovative mechanical design that enabled the mechanism to use one motor to both rotate and actuate the product consumable (breath cartridge).  In addition to the breath cartridge, the rotational portion of the device was required to house the optical components including two PCAs, two lenses, two filters, and a light-tight enclosure.  Andrews-Cooper designed the handle which contained a pressure transducer calibrated to measure air flow for obtaining a 3 Liter breath sample. (Note: the breath cartridge, not designed by Andrews-Cooper, obtains a sample by installing it into a handle from which a breath sample is extracted).

Electrical Design: Andrews-Cooper designed all the electronics in the handle and the device.  This included all the motion electronics (motor control), a touch screen display, USB, battery power, and optics control and processing.

Firmware Design: Andrews-Cooper did all of the firmware associated with the parent device.  This firmware also interfaced with a web portal for data storage. A-C created screen images and did the touch screen software.




Radiology Device – Ultrasound

Evaluation

  • Evaluate the shielding needs of the device (emissions and susceptibility)
  • Recommend the specific geometry and technologies needed to achieve a reliable, manufacturable shield design
  • Create a production strategy that will allow a repeatable, reliable device:
    • Shielding method and technology
    • Potting methods and materials
    • Assembly steps
    • Assembly aids and fixturing requirements
    • Assess the amount of design margin (spacing variations, potting variations, etc.) that is maintained in the proposed strategy

Design internal flex cables

Analyze/Document

Help with creation of risk analysis and updates to Device Specification. Write verification test plan and test procedures, these tests were to ensure the device will meet 60601-1 safety requirements.  

Test

Create test fixtures for verification testing. Execute verification tests (safety testing, EMC testing, performance testing). Implement changes as needed to ensure device passed verification tests.

Medical Product Case Studies