Perspectives on Looking Back and What's Ahead Part II
Over the course of 2008, we saw the medtech industry continue on with further innovations, greater consolidation, and slimmer margins. In the upcoming year, medical device manufacturers will continue to strive to minimize the complexity of regulated business processes while reducing the costs associated with production, design, and customer service.
We also expect to see greater FDA scrutiny to guarantee consumer safety. Tough economic times, coupled with a greater scrutiny on quality will push medical device manufacturers to further innovate and streamline critical business processes in 2009. With greater FDA oversight, including the forthcoming electronic medical device reporting (eMDR) mandate, and a sharper focus on economic issues resulting in tighter margins, enterprise-wide quality management and compliance will have significant importance on the medtech industry in 2009.
Combining tighter systems integration, consolidated practices, streamlined business processes, and far-reaching global initiatives, Sparta Systems predicts that medical device companies will need a centralized and holistic view of their compliance and quality activities across the global organization. Without this centralized, enterprise-wide view of activities, organizations will be unable to streamline processes, drive organizational efficiencies and ensure competitive success with greater regulatory pressures in a tougher economic climate.
Gabe Gurman
VP of R&D, Sparta Systems
About Sparta Systems
Sparta Systems’ global quality management solutions enable high-value organizations to safely and efficiently deliver products and services to market. Its TrackWise® Enterprise Quality Management Software, a trusted standard among highly regulated industries, is used by quality, manufacturing and regulatory affairs professionals to manage compliance, reduce risk and improve safety across the global enterprise. Headquartered in Holmdel, N.J. and with locations across Europe and Asia, Sparta Systems maintains an extensive install base in the pharmaceutical and biotechnology, medical device, electronics manufacturing and consumer packaged goods markets. Read more about Sparta Systems and TrackWise software on the corporate website and blog: blog.spartasystems.com.