Case Study
ZipThaw®
About the Work
FreMon Scientific, a venture-funded start-up, is a leading developer of biomedical devices intended to provide safe and efficient thawing of lifesaving blood, plasma, and tissue products. The team at FreMon Scientific turned to Build by Boyd to support the process design and development, validation, and scale-up of long-term manufacturing for the ZipThaw® consumable called the ZipSleeve®.
Process Development & Validation
Product DesignPackaging Design
Process Design
Process Validation
Test Method Design
Manufacturing
Automated ManufacturingComplex Assembly
Packaging
Inspection
Supply Chain Management
Material SourcingSupplier Qualification
Supply Chain Management
Process Development & Validation
The ZipThaw® product launch required the team at Build by Boyd to develop new manufacturing and assembly processes, complete process validation, and establish new test method procedures. The ZipSleeve® consumable incorporates an RFID sensor to manage temperature during thawing and monitor device usage cycles. Incorporating the sensor into the ZipSleeve® consumable required close collaboration between the team at Build by Boyd, the sensor manufacturer, and the software development team. We also created a new packaging design to ensure the product's shelf life and maximize production efficiency.
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Manufacturing
After our Process Development & Validation work, the team at Build by Boyd successfully started commercial manufacturing of the ZipSleeve®. We scaled up manufacturing to produce an inventory build necessary to support the product launch. After a successful product launch, our operations team transitioned the manufacturing operation into regular production campaigns. At scale, the team has completed process optimization programs focused on material yields, productivity, and our inspection and testing procedures. The team at Build by Boyd was able to support the launch of ZipThaw® and allow the team at FreMon Scientific to focus on product adoption and long-term growth.
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Supply Chain Management
The ZipSleeve® consumable is assembled with a variety of flexible materials, rigid plastics, metals, and electronic components. Our supply chain management team was engaged early in the program to identify and source the bill of materials and then assume the supply chain management responsibilities alongside commercial production. The team at Build by Boyd works closely with suppliers and the FreMon Scientific team to build demand forecasts and align our raw materials pipeline to ongoing commercial production. This is an international supply chain that includes several long lead-time items that require proactive supply chain management from our team.
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Outcomes
FreMon Scientific successfully launched the ZipThaw® and ZipSleeve® consumable and introduced a new standard of thawing for blood, plasma, and tissue products. The new manufacturing operation captured both the efficiency of automated manufacturing and the flexibility of custom assembly. The successful launch has propelled FreMon Scientific into the forefront of growth and innovation for these lifesaving technologies.
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Manufacturing Transfer
New Product Launch
Manufacturing Scale-up
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