Successful technology transfer from R&D partner
Sourced all specified materials from domestic suppliers
Designed and fabricated equipment for application of label sensor to product
Blood, Plasma, and Tissue Warming
Existing market solutions for blood, plasma, and tissue warming and thawing devices are slow, heavy, wasteful, inaccurate, and require costly labor and maintenance.
Commercially available devices need roughly half an hour to warm up to operating temperature, which leads clinicians to leave them plugged in, thereby increasing energy consumption. When devices are ready to work, the actual thawing and warming can take up to half an hour. The longer than necessary wait times spur another problem: to ensure there is enough thawed blood, plasma, or tissue for the procedure, excess product is processed and becomes waste.
Current devices rely on 3 to 5 gallons of heated water, making them bulky and requiring permanent lab bench space with access to wet sinks. If moved, they require extensive calibration, sanitization, and maintenance. Additionally, they lack the ability to track lot numbers and are unable to monitor the actual temperature of the media – measuring only the ambient temperature, which delivers inconsistent results.
FreMon Scientific Platform
Recognizing the need for a better option, FreMon Scientific solved the existing challenges by designing a portable, dry, quiet device with a small footprint that requires very little maintenance. Their product, ZipThaw™, features a touch screen with a user-friendly interface, integrated barcode reader, and software for easy blood product tracking and data capture of the entire thawing process. The device plugs into a standard outlet, costs less to operate, and requires far less energy than other commercially available devices.
Understanding that portability is a crucial function lacking from existing devices, FreMon designed their device to be extremely transportable, thereby expanding the ease of use not only in operating rooms and other hospital settings, but to also provide rapid treatment at a patient’s bedside or trauma location. ZipThaw utilizes a disposable yet durable, leakproof sleeve that contains warming technology, producing a final product with uniform temperature, and eliminating the risk of contamination caused by bursting bags.
A Disposable Electronic Warming Pocket
The ZipSleeve™ disposable is a critical component of the FreMon Scientific platform. The patented sleeve enables rapid thawing and real-time temperature monitoring. It provides consistent, repeatable transfer of heat to standard units of blood or tissue product. To assure cleanliness, and to eliminate the possibility of cross-contamination, it is replaced after 8 uses. Each ZipSleeve has a sensor that records the number of uses in addition to tracking the temperature and lot number of the thawing media. In the event of a specimen bag rupture, the sleeve is disposed of, thereby protecting the ZipThaw from contamination.
Building the Solution
FreMon Scientific engaged with Aran R&D, an Israeli product design and development firm, to usher the ZipThaw from concept to device. In addition to product development, Aran supported FreMon Scientific in securing a patent, CE mark, and FDA 510K clearance but was unable to sustain the volume of commercial manufacturing of the ZipThaw and the ZipSleeve. Furthermore, FreMon Scientific wanted to relocate the production of the devices to the US, choosing to partner with Minnetronix for the production of ZipThaw and with Boyd Technologies for ZipSleeve.
As Aran had come up with the design of both devices, it was necessary to impart their knowledge of the design to allow for a smooth flow of information. Maintaining open lines of communication is important throughout the entire transfer process to ensure timelines are kept and to guarantee a robust information exchange. Highly effective program management and planning are equally important to make sure information is being disseminated to the appropriate team members as the project progresses.
A successful technology transfer also requires an understanding of the current manufacturing process. Even if the original process is different from the commercialized process, it gives an understanding of which attributes are important to process versus those that are critical to function. This way, when an issue arises, such as tolerances that don’t work at production volumes, engineers are able to determine if they can be revised without impacting the performance of the device. Additionally, if failures occur in the final device, understanding the original manufacturing process helps diagnose whether issues are arising from a result of the current process and if a new process would mitigate the underlying problem.
Working in conjunction, FreMon Scientific’s team of Aran, Minnetronix, and Boyd Technologies were able to complete a successful technology transfer of the design, materials, and performance for ZipSleeve and ZipThaw devices.
Aran provided a list of the raw materials and suppliers used in the proof of principle parts. With the exception of the sensor, the materials were all nearshored by sourcing 100% of the bill of materials domestically using industry best practices. In order to build a robust supply chain, it is of the utmost importance to properly vet suppliers. Suppliers must be selected that have the appropriate quality controls in place to meet the specifications and regulatory requirements for the medical device industry. Ideally, a supplier would be ISO 13485 certified, have a significant portion of business within the medical device industry already, and submit to an onsite audit. Having identified an approved list of suppliers, FreMon Scientific was presented with options for final approval.
The sensor is a critical component to the ZipThaw, as it monitors the temperature of the thawing media, keeps track of lot numbers, and the usage count of the ZipSleeve. However, the incoming orientation of the sensor was 90° off from its final position. In part, this challenge cropped up because the product was not initially designed to be produced on an inline, rotary process, and thus, the requirements sent to the supplier were not with rotary process parameters in mind. This speaks to design for manufacturing. Due to product launch timeline constraints, reengaging with the supplier to change the incoming sensor orientation wasn’t an option that could be pursued at the time.
Instead, engineers designed a custom tooling solution that would pick the sensor off its release liner, rotate it, and correctly place it on the ZipSleeve. What makes this process more complicated is the sensor and the thermal barrier are attached to a plain white film (what becomes the back of the ZipSleeve) but registered to a position on the printed front layer that is sealed together in a later process. With this completed, the ZipSleeve manufacturing process could be validated to run efficiently and effectively at a commercial scale.