案例分析

Biomaterial Product Manufacturer Enhances Patient Safety

How did a leading biomaterial product manufacturer enhance patient safety?

A leading manufacturer that develops, produces and markets instruments, implants and biomaterials for the surgical fixation, correction and regeneration of human skeleton and its soft tissues market, sought a thin film technology partner to help them enhance patient safety through color-coding of their product line.

Instrument manufacturers can often reduce mistakes and risk for error by color-coding their products. While color-coding can make such surgical implants as screws more easily recognized and discernible with respect to the implant’s desired characteristics such as type (for easily matching the size of the screws with the corresponding instruments, for example) or overall size and strength, in this instance, the color-coding would be applied to enhance instrument visibility under specific surgical lighting.

The instrument manufacturer’s system requirements included a thin film deposition tool that could color-code for identification but also required a precision deposition system designed to meet difficult-to-attain coverage and uniformity of deposition, together with high-production yields per run.

Denton Vacuum’s unique solution comprised a designed, engineered and manufactured solution that enabled this customer to achieve the desired coverage and yields in two distinct manners:

(1) endpoint detection for deposition coverage and uniformity; and
(2) proprietary fixturing mechanism for high-yields per production runs

Denton Vacuum provides a flexible sputtering platform engineered for high-volume deposition of biocompatible films for medical implants. FDA-regulated manufacturing facilities face special challenges, too. To be compliant with Current Good Manufacturing Practices (CGMPs), production equipment must be thoroughly tested and documented, all software, data logging and diagnostics verified and validated, and capable of real-time monitoring and reporting. Denton Vacuum’s solution is the only PVD system of its kind designed to support medical implant coatings in FDA-regulated facilities.

Denton Vacuum provides thin film technology solutions for such applications as cardiac lead electrodes, color-coding, wear coatings and, medical electronics, among others.

Denton Vacuum provides thin film technology solutions for biocompatible films for medical implants using such capabilities and features as DC, DC-pulse, and/or RF sputtering, 3-dimensional coating, load lock material transfer, data logging, remote access (diagnostic and operations management), endpoint detection, globally supported control system platform, software verification for FDA regulatory support and customer workstation support, among others.