Originally Published MX January/February 2006
INFORMATION TECHNOLOGIES
A Pricetag for Quality?|
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When it comes to establishing their company's quality systems, medical device executives bear heavy responsibilities that start with the requirements imposed by FDA's quality system regulation (QSR) and continue through the investor expectations of a company's entire life cycle.
Such divergent responsibilities can sometimes result in a serious dilemma, as when executives must decide how much to spend to establish their company's quality systems. If they spend too little, the company runs the risk of having an underpowered system that cannot ensure compliance with the QSR and may result in significant regulatory consequences. If they overspend, the company may wind up with a complex and expensive system that is more than its current product pipeline demands.
As outlined in the adjacent article, the costs of implementing an automated electronic manufacturing compliance platform (MCP) can be significant. Nevertheless, many device companies have come to believe that the benefits of having an MCP far outweigh the costs for such a system. The typical cost of implementing an MPC for a single manufacturing site starts at approximately $600,000. The initial, upfront costs are consistently larger, but as organizations develop a baseline solution, build internal competency, and develop their validation approach, subsequent costs per site can be a fraction (30–60%) of initial costs.
Fortunately, the process of implementing an MCP is usually rather painless and the return on investment is relatively quick. Because an MCP is built on the foundation of a company's existing manufacturing execution system, it can be put in place with minimal disruption to a company's other systems. Return on investment analyses performed by various manufacturers, analysts, and consultants have shown that a typical MCP implementation has a payback period of anywhere from six to 18 months. These factors may not make the executive's decision to implement an MCP any easier, but they can at least help investors understand how their funds are supporting the company's commitment to quality in both manufacturing and business practices.
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