Medical device makers need to be more proactive

November 6, 2013 1:27 pm Published by

There’s room for improvement in any organization or industry. That appears to be the case in the world of medical devices.

According to a whitepaper based on a survey sponsored by Camstar Systems, device makers are spending too much time reacting to defects rather than being proactive about improving their processes.

“As long as defects remain the primary focus, then clearly many companies will never get to the real efficiencies, cost saving and ‘leaning’ of their processes,” the whitepaper says. Unfortunately, the root of this is blamed in part on “the narrow focus on quarterly results seen at many device companies. With companies putting perhaps too much stock in short-term financial results, process improvement initiatives that require steady, long-term commitment and support have not taken hold.” These include Six Sigma, lean, value-stream mapping and Kaisen.

According to the survey, defects make up 88 percent of the waste impacting medical tech organizations. And when asked about their primary drivers for process improvement initiatives, the overwhelming majority of respondents (76 percent) said it is to reduce these defects.

So it only makes sense for this industry to continue to adopt ISO 13485:2003, Medical Device Management System. This standard assists an organization to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

After all, when you’re making devices that help to save lives, you only have one chance to get it right. Beth is our go-to expert on ISO 13485. She can fill you in more on how this standard can really make a difference.

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This post was written by Roy D'Ardenne