MedLaunch: Extending Shelf-Life from 6 Months to 5 Years for a Medical Startup's Innovative Device
In an ambitious move to enter the market swiftly, a medical device startup launched a groundbreaking product with a conservative initial shelf-life of six months.
However, this strategy led to an unforeseen challenge: a significant portion of the inventory was at risk of expiring before use. MedLaunch was brought in to address this critical issue and extend the product’s shelf-life, ensuring a continuous supply to patients.
Client Background
The client, an innovative medical device startup, had successfully developed and launched a novel medical device. The initial short shelf-life was a strategic decision to facilitate rapid market entry, but it posed risks to inventory management and product availability.
Challenge
The startup faced the possibility of substantial product waste due to the impending expiration of their inventory. This not only represented a financial loss but also threatened the continuity of supply to patients who relied on this novel device.
Solution by MedLaunch
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Accelerated Aging Study: MedLaunch conducted an accelerated aging study, a process that simulates the aging of products in real-time, to predict the device's longevity accurately.
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Standard Compliance and Testing: Utilizing several industry standards, including ASTM F1886/F1886M (Test Method for Integrity of Seals), ASTM F1929 (Standard Test Method for Detecting Seal Leaks), ASTM F1980 (Standard Guide for Accelerated Aging of Sterile Medical Device Packages), and ASTM F88/F88M (Standard Test Method for Seal Strength of Flexible Barrier Materials), as well as FDA guidance documents, MedLaunch performed comprehensive testing.
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Validation of Extended Shelf-Life: The results from these tests were meticulously analyzed to validate an extended shelf-life of five years, significantly more than the initial six months.
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Regulatory Compliance and Documentation: Ensuring regulatory compliance, MedLaunch updated all relevant documentation required by regulatory bodies.
Results
MedLaunch’s intervention and strategic application of industry standards led to a significant extension of the product's shelf-life from six months to five years. This not only prevented inventory waste but also ensured an uninterrupted supply of the safe and effective device to patients, thereby supporting the startup's reputation and financial stability.
Conclusion and Learnings
This case illustrates MedLaunch's expertise in employing advanced testing methodologies and industry standards to solve complex challenges in medical device manufacturing. The success of this project underscores the importance of proactive shelf-life testing and its potential to significantly impact supply chain efficiency and product reliability.
Come work with us.
MedLaunch is committed to helping medical device companies navigate the challenges of product development and market sustainability. If your organization faces similar challenges or seeks expert guidance in the medical device field, contact MedLaunch for innovative and reliable solutions.