Medical device manufacturer
A specification library for more than 200 carton SKUs
The manufacturer had more than 200 carton SKUs, many with no current artwork files or packaging specifications, which made reorders, incoming inspection, and any change of supplier slow and risky.
- Built a structural dieline for every SKU from production samples.
- Recreated print-ready artwork for each SKU that had none on file.
- Drafted a Packaging Parts Specification (PPS) for every SKU.
- Produced an acetate overlay for each carton for the customer's incoming receiving inspection.
- Delivered all specifications in an organized binder, with every artwork file on an external drive and an offsite server link.
Result: Every carton SKU now has a dieline, artwork, specification, and inspection overlay on file, under the customer's control.
Pharmaceutical company
A warning-letter recall, and back in the field in 60 days
After an FDA warning letter from the Office of Prescription Drug Promotion (OPDP) over a promotional claim, the company had to pull every printed piece carrying that claim from the field, identify who had received it, and replace it with approved materials.
- Day zero: ordering was shut down within minutes, queued orders halted, and all shipping stopped. Inventory reports identified every affected item in the field.
- Day one: return shipping labels went to every field representative. Warehouse stock was audited and moved to quarantine.
- Days two to eight: every returned box was counted, recorded, and quarantined. Verified reports were prepared for submission to OPDP.
- Days nine to thirty: corrected materials were designed, regulatory print samples produced for the company's OPDP submission, and all recalled material destroyed with certificates of destruction issued.
- After approval, the new materials were printed, stocked, and shipped to the full field force in one coordinated release.
Result: The sales force was back in the field within 60 days of the warning letter.
Mid-sized pharmaceutical company
Insert copy that disappeared in the fold
After weeks of back-and-forth with its existing printer, the company still had a package insert where required copy was hidden once the insert was folded.
- We reworked the panel layout and fold so the required copy stayed visible after folding.
Result: Print-ready files were back to the customer within 24 hours.
Healthcare products company
A new healthcare product without tooling costs
The customer needed a sheeted paper filtration product converted to custom sizes for distribution to healthcare facilities, without investing in dedicated tooling.
- After research, procedure reviews, and effectiveness evaluations, we developed a conversion process using existing equipment.
Result: The customer launched a new branded product without expensive tooling, setup, or peripheral charges.
Global medical device manufacturer
A labeling process built from scratch
The manufacturer's R&D team needed a new label, equipment to apply it, and a way to teach the application procedure consistently across sites.
- We developed the label, located suitable application equipment, and produced a training video with foreign-language subtitles for international teams.
Result: All three objectives were met, giving the customer a documented, repeatable labeling process.