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THE BUSINESS PROBLEM
Imagine this scenario: While prepping for surgery, an attendant realizes that the heart valve they were preparing to implant was the wrong size for the patient. The manufacturer had labeled it incorrectly.
In other industries, it’s not a crisis if a package has a labeling mistake, or if the Spanish documentation is accidentally inserted into a Germany-bound product.
But in medical device manufacturing, it’s a really big deal. The obvious risk is patient health, of course. Beyond that, the risks include the threat of fines, recalls and brand damage from government regulators.
The costs of complying with FDA-ordered mitigation, even for “simple” packaging mistakes, can range into the tens of millions of dollars. That’s why medical device manufacturers have two imperatives: Zero defects and complete traceability.
This is a story about one medical device manufacturer who turned to Drishti to help achieve both aims.
WHAT’S THE CURRENT METHODOLOGY?
This medical device manufacturer typically relies on overlapping, redundant layers of manual inspection. This creates high labor costs and reduces throughput.
When inspection activities uncover an abnormality, this manufacturer will deploy quality engineers to exhaustively investigate following prescribed methodologies. These investigations are painstaking and time-consuming.
If an abnormality is discovered in the field, the manufacturer will take on a number of expensive or time-consuming actions, including recalling entire batches to inspect and validate them. Government regulators will be involved, and a range of further actions or fines may be imposed.
HOW DRISHTI HELPS
This manufacturer is deploying Drishti solutions on a set of packaging stations. Drishti can provide complete video traceability for station activities and measures the cycle time of each unit at each station. These capabilities create a number of problem-solving opportunities:
KPIs AND SUCCESS METRICS
Drishti will help this customer radially reduce the time required to investigate abnormalities, and provide traceability to reduce the risk of high-cost fallout in the event that a defect is caught in the field. In addition, Drishti’s AI provides another layer of defect detection.
Read more about Drishti's solutions.
