Terumo Medical Corporation
Validating Radial Compression Devices Through Iterative Cold-Chain Distribution Testing
Challenge
Terumo Medical Corporation manufactures a finished good used in vascular access procedures that is stored and handled at room temperature. Cold exposure falls outside the device’s normal handling environment, so Terumo needed to confirm whether the packaging and device could withstand the physical conditions of frozen distribution, including temperature extremes, shock, and vibration encountered during parcel shipment. The engagement was a deliberate stress test of the packaging system rather than a routine shipping qualification.
Objectives
The engagement was structured as a staged testing process to characterize failure modes and confirm whether design changes resolved them.
- Characterize the effect of frozen shipping hazards on the finished goods packaging and device functionality
Conduct testing according to ASTM D4169-23e1, applying temperature extremes, shock, and vibration as concurrent hazards rather than isolated conditions - Establish a pre-test and post-test visual inspection protocol to document the physical condition of the packaging and devices at each stage
- Provide Terumo with defensible data to evaluate whether design and material changes resolved damage observed in earlier testing
Results
Modality Solutions executed three rounds of distribution testing across two versions of the packaging design in its Transport Simulation Laboratory. The first study, conducted at negative 35 degrees Celsius and negative 20 degrees Celsius on the original finished goods configuration, documented torn thermoformed trays and a broken connection tube on one device tested at the lower temperature. This gave Terumo the information needed to update the packaging adhesive.
Two follow-on studies tested the updated configuration under the same ASTM D4169 protocol and inspection discipline. No damage was observed during pre-test inspection in any of the three studies, confirming a consistent baseline condition before hazard exposure. The updated adhesive resolved the tray tearing seen in the original design, confirmed across both follow-on studies. The second study also identified a narrower failure mode: connection tube breakage at the tab weld on two of the regular devices under combined cold, shock, and vibration exposure, a finding that isolated temperature testing would not have revealed.
Terumo now has a documented, staged testing record across three studies showing where the original design failed, what was changed, and what specific vulnerability in the regular device configuration remains to be addressed.
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