Medical device manufacturing offers unique challenges compared to typical manufacturing environments. Strict regulations requiring products and processes to be validated and documented, coupled with high reliability requirements, create an environment that presents challenges for process changes and upgrades. Legacy processes include many manual assembly steps. Equipment is heavily siloed, and the generated data is work-cell-specific. Batch records, device history records, testing logs, and calibration sheets are often managed on paper or in separate digital records, which complicates audit-readiness. Processes remain untouched for years because organizations want to avoid process changes that require revalidation.
In the current environment, medical device manufacturers need to scale to meet increases in demand while also tightly controlling costs to stay competitive. User-specific requirements for specific devices require agile manufacturing to meet customer demands. Devices are increasingly complex, driving up the cost of manual processes. Trying to scale to meet demand amid increasing complexity, the need to manage costs, and the necessity of staying compliant is challenging.
Automation is providing manufacturers with an avenue to control costs, standardize and streamline compliance documentation, and dynamically scale to fill increasing market needs.
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