CASE STUDIES
A Global Leader in Cardiovascular Care
A global leader in cardiovascular care reduced business risk in critical care device packaging and labeling with Drishti.
Client Overview
This Just Company Award winner is nothing if not responsible. When their inspection activities uncover an abnormality, this major medical device manufacturer will deploy quality engineers at their 3PL operations to exhaustively investigate. These investigations are painstaking and time-consuming.
If an abnormality is discovered in the field, they'll take on a number of expensive or time-consuming actions, including recalling entire batches to inspect and validate them. Government regulators could be involved, and a range of further actions or fines may be imposed.
The challenge: reduce the risk of nonconformance and customer complaints
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 big deal. The obvious risk is patient health, of course. Beyond that, the risks include the threat of fines, recalls, and damage to brand reputation caused by regulatory action.
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 this medical device manufacturer had two imperatives: zero defects and complete traceability.
To achieve this goal, the medical device manufacturer typically relies on overlapping, redundant layers of manual inspection. This creates high labor costs and reduces throughput.
They brought on Drishti to automate and facilitate the inspection process.
The solution: complete video traceability for speedy investigations with concrete results
This leading medical device manufacturer deployed Drishti's solutions on a set of packing stations. They provided complete video traceability for station activities, while measuring the cycle time of each unit at each station. Together, these two Drishti products created a number of problem-solving opportunities:
- Radically faster investigation of abnormalities. Drishti’s video feeds were browsed by line, station, day and time, or searched by unit serial number; this let the engineer quickly review video of packaging operations to determine the point of failure. The engineer then annotated the video using Drishti’s software and shared it as a report to the team. The engineer’s job was significantly faster, and resulted 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 reviewed video of line activities well after the fact, and adjusted the scope of their response accordingly. It was a lot easier to watch videos of units than to recall units that have already shipped.
- Proactively monitoring throughput variance for abnormalities. Drishti's AI automatically measures cycle times at each station, for each product. When cycle time is significantly shorter or longer than expected, it may have meant the line associate deviated from standardized work. With one click, a supervisor watched video to validate the operation.
The results: lower costs and higher quality
Drishti helped 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 provided another layer of defect detection, so risks could be managed before defects escaped.
The manufacturer now has assurances that packing operations are safe and can prove customers are shipped the right devices with the right documentation in every package.
In short, Drishti helped:
- Reduce time in nonconformance investigations
- Increase traceability
- Reduce risks of defects in the field