The cost of getting it wrong in medical device design

A new report by the US Food and Drug Administration shows a 97% increase in recalls of medical devices since 2003. Emergo

Value of human factors testing in medical device design

There are several explanations for the dramatic jump in recalls, including; the increasing complexity of devices, a global supply chain and an ever demanding race to the market. The medical devices market is growing every day, and now with a growing number of sophisticated products available. These devices will often incorporate technology advances that impact the way a device is designed, built and how people interact with it.

Medical device manufacturers are under growing pressure from consumers and shareholders alike to beat competitors to market with new more advanced devices. This race can lead to cutting corners on quality. While transformational growth and innovation propel the medical device industry forward, new burdens are created that impact quality systems and result in an ever-increasing number of recalls.

The financial costs of recalls for medical device companies can be huge. However, the financial implication is only part of the overall picture. News spreads fast now thanks to the internet and social media, and companies can quickly develop an unwanted reputation. Global manufacturers who have experienced recalls can manage the situation given their influence on the market, but smaller manufacturers, operating with tighter margins, will suffer far more, especially given the level of scrutiny and culpability associated to a poor performing medical device.

Recalls require companies to invest resources in litigation, communication, logistics and product disposal. These resources might be better utilised in the research and development of new products. The high costs associated with recalls coupled with the damage done to a company’s brand might mean the lost opportunities are never recouped. The bigger issue for the medical device industry will be balancing the benefits and rewards of bringing new products to market with the risks and pitfalls of not being quite ready for patient use.

At CCD we aim to be involved in a new product development cycle as early as possible. Test early and test often, gaining invaluable feedback on the product design and a real insight into user needs. Formative studies, with smaller pools of participants are relatively inexpensive compared with failing a late summative study with roughly double the participants involved.

Dan is a Senior Human Factors Consultant at CCD.




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