Eagle Medical Launches Novel Pre-Validated Packaging Solution

Eagle Medical Packaging, Sterilization Inc., headquartered in Paso Robles, California, has introduced a fully pre-validated packaging solution to the medical device industry in the U.S.
 
Pre-validated packaging has been available for a number of years, helping OEM’s shave a few weeks off of a typical 9 to 12 month development schedule. In contrast, Eagle Medical says its Packaging Accelerated Timeline Help (PATH) solution is capable of garnering a device submission in as little as three weeks.
 
According to CEO Roy Morgan, “our True-Validated packaging system has the potential to transform the industry. Pre-validated packaging has proven to be valuable to OEMs with tight launch schedules and our solution takes that concept to its logical conclusion. We’ve pre-validated every step of the packaging and sterilization process and we include a complete, submission-ready document set.”
 
The only task left to the OEM is to write the adoption rationale and submit to the FDA.
 
According to the company, the key to PATH is the ‘worst-case’ proxy device that was designed and manufactured by Eagle Medical, and contains many of the materials and characteristics of common orthopedic devices. This allows the OEM to utilize the substantial equivalence adoption rationale in their submission.
 
According to Morgan, “the predicate device that we designed, truly is the worst-case device that we’ve ever seen. We deliberately pushed packaging systems beyond their limits, then established maximums to achieve validation. But the end result is that a wide variety of medical devices will be compatible with our True-Validated packaging system”.
 
Startup and early-stage orthopedic device manufacturers requiring expedited development timelines are prime candidates for PATH, Morgan said.
 
“Startup device companies frequently fail to consider packaging until it’s too late and they burn through capital as their device goes through months of testing. And one failed test along the way can reset the development clock. PATH mitigates that risk and ensures commercialization in the shortest timeframe possible.”
 
Eagle Medical has submitted an application for a Master File which is currently being evaluated by the FDA.