Medical Device Refurbishment Program

When it comes to critical life-saving care for animals, veterinarians rely on accurate, timely blood analysis to help them make treatment decisions. Thanks to groundbreaking new developments in medical equipment and software, physicians no longer have to wait three to five days for lab results. Now, specially designed compact laser flow cytometers (blood analyzers) can conveniently sit on a countertop in the veterinarian’s office and analyze blood samples in less than 15 minutes. This technology breakthrough is quickly becoming the new standard for providing onsite, real time feedback to pet owners and their veterinarians— and is increasingly being used for human blood analysis.

THE CHALLENGE

Uncovering the Failure

In the spring of 2008, a formidable medical device manufacturer discovered that a large supply of their laser flow cytometers had multiple failures that could not be specifically identified by the company’s internal design team. With thousands of unusable units sitting on the shelf, the manufacturer was faced with the tough decision of scrapping the units and starting over, or determining whether they could be appropriately refurbished at a favorable cost.

The devices were brought to LightWorks Optics for analysis. This provided a unique opportunity for design engineers to “reverse engineer” the device to identify existing failures, and to also make recommendations for a re-design that would virtually eliminate any future end use performance failures. Equally challenging would be whether the re-designed device could be produced to meet the manufacturer’s stringent production throughput, acceptance and budget parameters.

THE SOLUTION

Turning Lemons into Lemonade

Over the next few months, LightWorks Optics’ design engineers identified multiple optical alignment failures in the existing devices and alerted the customer that refurbishment was possible. In addition to several structural modifications, a new laser assembly prototype was developed to allow the machine to accurately focus, count, and measure the blood cells being analyzed with the assurance of long-term alignment stability, regardless of temperature variables. By fall of 2008, the prototype verification and validation process was completed and the unit was transferred from the design engineering operation in Tustin, CA, to LightWorks Optics’ new High-Volume Production (HVP) facility located approximately 60 miles south, in Vista. The manufacturer stipulated that 50 quality-tested devices be produced each week—leaving very little room for error. The HVP management team set up a dedicated assembly and testing line utilizing LEAN manufacturing techniques to help save on labor costs, reduce potential failures and ensure predictable throughput. Further cost savings were achieved by hiring qualified technicians at a lower hourly rate, who then underwent intensive hands-on training by the product engineering team.

Within six weeks of production setup, 10 units per day were being successfully produced, with target costs achieved in the first two months of production and throughout 2009. As a result of well-coordinated design engineering and advanced high-volume production capabilities, LightWorks Optics was not only able to demonstrate to the customer what the device failures were, but ultimately provided a 90% acceptance rate for the refurbished devices at about one-third of the original cost.

For more information about how LightWorks Optics can help meet your optical design and production challenges, please call 714.247.7180 or email info@lwoptics.com.

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