Medical Device Quality Systems Demystified: Why Companies Need Best-Of-Breed ERP, PLM And EQMS

By Sparta Systems, Inc.

Intense global pressures, such as more stringent regulatory scrutiny, tax increases and reimbursement challenges are causing stalled top-line growth for medical device organizations and prompting them to find ways to increase operational efficiencies. One way that companies look to reduce costs is by rationalizing Information Technology spend. Although this practice works in theory, it often leads to users struggling with ineffective processes and potentially opens the company to compliance risks. Rather than settle for suboptimal processes and systems, organizations should learn how investing in best-of-breed ERP, PLM and EQMS systems can save the organization money while increasing compliance at the same time.

Time and time again organizations follow a familiar path when evaluating new software purchases. The quality organization identifies a need and a short-list of vendors that they would like to evaluate. The quality department's primary concern is finding a solution that will meet their needs –i.e., help them maintain compliance, now and in the future as the organization and regulations evolve. IT, on the other hand, has a different perspective. They want to identify vendors that fulfill the identified requirements at the lowest total cost of ownership (TCO). Frequently low TCO is associated with leveraging existing systems rather than buying new, with the incremental support and infrastructure costs, so IT is always on the lookout for ways to extend existing systems.