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 Trace and Drishti Flow on a set of packaging stations. Drishti Trace provides complete video traceability for station activities, while Drishti Flow measures the cycle time of each unit at each station. Together, these two Drishti products create a number of problem-solving opportunities:
- Radically faster investigation of abnormalities. When an abnormality is discovered, a quality engineer has a simpler alternative to the standard forensics-style investigation. Drishti Trace’s video feeds can be browsed by line, station, day and time, or searched by unit serial number; this lets the engineer quickly review video of packaging operations to determine the point of failure. The engineer can then annotate the video using Drishti’s software and share it as part of reporting. All told, the engineer’s job is significantly faster, and typically results in countermeasures that are more targeted in scope.
- Risk reduction in the event of escaped defects. One of the biggest challenges of escaped defects is the uncertainty: do you have one bad unit in the world or 1,000? Without any certainty, you assume the worst and plan your response (recalls, inspections, and other costly activities) accordingly. With Drishti, this manufacturer will be able to review video of line activities well after the fact, and adjust the scope of their response accordingly. It’s a lot easier to watch videos of units than to recall units that have already shipped.
- Proactively monitoring throughput variance for abnormalities. Drishti Flow’s AI automatically measures cycle times at each station, for each product. When cycle time is significantly shorter or longer than expected, it may mean the operator deviated from standardized work. With one click, a supervisor can watch video to validate the operation.
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.