A Fortune 500 medical device manufacturer, designing regulated products under ISO 13485 and FDA 21 CFR 820, put bananaz into production across its design, sustaining and NPD engineering teams. Over 16 weeks, from February to June , usage data and the engineers themselves told the same story:
In medical devices, every drawing revision carries regulatory weight. For this manufacturer’s engineering team, that meant comparing each new revision against the last dimension by dimension, sheet by sheet, which took one to two hours per drawing. Drawing standards were enforced entirely by reviewers, and first article inspection ballooning lived in a separate, single-purpose tool outside the design workflow, adding another one to three hours per SKU.
The result was a review process that depended on a few senior engineers and repeated itself. Drawings were routinely kicked back four or five times before they cleared review, and any error that slipped through compounded into scrap, rework, release delays, deviations and audit risk.
“The old way, I’d have two PDFs open and literally highlight every single dimension on every single sheet to make sure nothing was missing or changed,” said a sustaining engineer on the team.
bananaz connected to the team’s native CAD and drawings and took over the manual comparison work. Every new revision is now compared against the last automatically, with every changed, added or removed dimension highlighted for the engineer, so reviewers start from a complete list of differences instead of hunting for them.
Because issues are surfaced before a drawing ever reaches review, engineers now catch their own mistakes earlier. “Where the senior reviewer used to kick drawings back four or five times, the issues are now front and center,” said the team’s Engineering Lead. “Engineers catch their own mistakes before it ever reaches review.”
Within 16 weeks in production, bananaz changed how the team reviews and releases drawings:
“bananaz reduced 65% of my daily review tasks,” said one of the team’s mechanical engineers. “What took me most of the day, now takes an hour or two.”
With change analysis now part of the daily workflow, the team is expanding bananaz into automated design checks against its drawing standards, and into generating redline and inspection reports directly from validated designs. At full adoption of 250 drawings a month, the team projects 10,000 hours of review work automated each year, worth about $800K in engineering time and equal to adding roughly five engineers of review capacity.
“Probably the best news I’ll hear all week,” said another engineer on the team, after seeing where bananaz is headed. “The painstaking hours in weeks and months and years that could be saved here, I think that’s fantastic.”
Ready to see what bananaz can do for your engineering team? Book a demo today.
Schedule a demo and discover how bananaz can accelerate your product development from concept to delivery
