People’s Choice for Innovation Excellence
Product: PATH™ (Packaging Accelerated Timeline Help)
Company: Eagle Medical Packaging, Sterilization, Inc.

Product Description:
“Pre-validated” packaging has been developed in recent years as a way to shorten packaging development timelines; unfortunately, the pre-validated solutions currently available to the medical industry are insufficient. Pre-validations were performed with empty packaging material, which offers no guarantee that the sterile barrier will survive the distribution and delivery process with anything other than air inside. Perhaps the empty package meets all specifications, but it certainly behaves differently with an actual device inside, which could result in a puncture or tear that renders the contents useless due to sterility compromise. Furthermore, when creating and testing a new package, it could fail validation at any point in the process. A project could be 20 weeks into a 26 week process when testing reveals that the packaging fails after aging, which sadly resets the development clock, representing an existential threat to many start-ups.

Eagle Medical is proud to announce the Packaging Accelerated Timeline Help (PATH) system. PATH True-Validated® packaging is completely validated in accordance with ISO 11607-1:2015 and medical industry standards. True-Validated packaging compresses timelines by eliminating the need to design and build packaging, source materials, validate processes, and test the packaging. The True-Validated system includes both inner and outer sterile barrier (suitable for implants) along with a single pack product box and labeling. Additionally, PATH participants receive a complete representative data set backed by reports, charts, and protocols based on actual distribution testing after sterilization, that allows easy adoption of the packaging and process into any QMS. The sole remaining task is to write up the adoption rationale and submit to the FDA. The resulting contraction in launch schedule equates to $250,000 to $1 million in average burn-rate savings, and can provide the competitive edge required to win the race to market.

Partnering with Eagle Medical
Eagle Medical provides FDA-compliant assembly, packaging, sterilization, and validation services to the medical device industry. Eagle’s Quality System is ISO 13485:2016 certified, and assembly and packaging is performed in cleanrooms compliant with ISO 14644-1 CLASS 7 (Class 10,000). By leveraging key strategic industrial partnerships along with 30 years of experience serving a wide variety of device manufacturers, Eagle has the unique tools in place to reduce project timelines and costs and to efficiently execute any medical device packaging plan.

https://eaglemed.com/
https://eaglemed.com/path
https://www.youtube.com/watch?v=XuMYDVqdn1Q&t=11s

Additional Information: https://drive.google.com/file/d/1iwUVEzH_gyfqa3nVtIUUcCeGtOBSF8nA/view?usp=drive_link