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Challenges with medical device supply chain quality

Over the last few years, the medical device industry has evolved to incorporate emerging technologies. Moving forward, integrating mobility, cloud, big data and the Internet of Things (IoT) presents new challenges for your company. But if you work in medical device manufacturing, your principle task remains the same: Ensure patient safety by prioritizing people over profits. As such, improving medical device supply chain quality is critical to your company’s success.Challenges with medical device supply chain quality_IQS

Supply chain quality in the medical device industry

When it comes to supply chain quality, your company’s ability to collaborate efficiently is a business-critical asset. To enable a mutually beneficial commitment to quality, your company may have implemented web portals for suppliers to view and input their own quality data. Ideally, web portals help to eliminate quality failures that originate from down-line contractors.

With respect to supplier collaboration, however, there is still much room for improvement in today’s global manufacturing industry. Medical device manufacturers must ensure that their quality standards align tightly with their supplier’s quality capabilities. Otherwise, your company may make all-too-common mistakes, such as inadequate testing or performance.

In a recent article published by the journal Medical Device and Diagnostic Industry, Amy Heintz delves into the risk of poor materials as a major source of quality failures. “Analysis of data from recent medical device recalls suggests that materials performance is a primary cause of failure in at least 20 to 30 percent of recent recalls,” she writes. “When we add cases where materials are a secondary factor, materials may be implicated in 50 percent or more of medical device failures.”

The high cost of failure

The impact of supply chain failures and the cost of poor quality can be substantial. A recent report by McKinsey and Company indicated that adverse quality events cost the medical device industry between $2.5 billion and $5 billion per year. As you can see, this statistic coincides with the high number of materials failures that can originate from any point in the supply chain.

Along those lines, “28 percent of medical device companies experienced more than one recall, and one company had 23 recalls during the third quarter of 2015 alone,” according to an article written by Kevin Pollack and published by the online magazine Medical Design Technology. Clearly, quality management in the medical device industry has room for improvement when you consider these figures.

Furthermore, as medical uses for Internet of Things technologies come to market, you can add yet another risk factor to the equation: Information security. With respect to cybersecurity, “hacking” medical devices themselves is not necessarily the biggest risk factor. In a cybersecurity context, a patient’s private information is most at risk since cyber criminals can monetize the data to perpetrate insurance fraud or identity theft.

As a quality professional, your task is to implement quality systems you need to do your job right the first time. Enterprise quality management software provides your company with the ability to improve visibility across all manufacturing operations, especially among suppliers. Ensuring that your quality system has clearly defined requirements is key to collaborating with a global supply chain.

Medical device supply chain quality has its challenges, but these hurdles are not insurmountable. With EQMS in place, however, you can help your company mitigate longstanding supply chain issues.

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