Manufacturers should get started by examining their process on paper. Of course, having a consistent process across groups is helpful for management to understand what is happening. But is this process truly the one being followed? Companies should be honest with themselves to determine if their departures from the stated process occur across all products, or only some. Try to determine where software tools are most helpful — where the integrations are strong and consistent across the entire organization — and identify the areas for improvement as well.

If a manufacturer determines it isn’t meeting its paper process, it could simply be that the process is good in theory but difficult in practice. Compare both to what the IEC 62304 standard requires. Does it follow all the phases the standard says are needed? Is there traceability between the phases as required? Most of the time manufacturers can step through this comparison the first time by themselves. If necessary, they can then bring in a third party to review the whole process and obtain recommendations for closing any gaps discovered. A third party may recommend changes in the process (even simplifications) as well as specific tools that: (a) offer strong collaboration across the software development lifecycle, and (b) are specifically geared to support software and systems delivery.

Of course, it is up to each individual organization to decide what works best, and changes should be carefully considered both in light of the IEC 62304 specification as well as the product delivery culture and history of success. The best tool solutions will be those that allow incremental adoption of new capabilities, allowing companies to avoid wholesale process changes and massive new infrastructure investments.

This article was written by Martin Bakal, Electronics Industry Leader for IBM Rational, Westford, MA. For more information, Click Here 

Medical Design Briefs Magazine

This article first appeared in the May, 2011 issue of Medical Design Briefs Magazine.

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