There is a diverse array of explanations for the rise in medical device recalls in the past decade. A few of these reasons include the increasing complexity of these devices, the globalization of the supply chain, and a frenzied race to get new products to market.

Many devices incorporate technology – utilizing mobile, Internet, and/or other software, which evolves rapidly. This can cause issues with technical glitches and frequent advances that affect the efficiency of devices.

Another issue can arise as a result of the complex worldwide network of suppliers and sub-suppliers who are manufacturing different aspects of these products. There are many logistical trials in working with an international supply chain, which could potentially mean that upon completion, the pieces assembled from multiple manufactures may have resulting issues.

Lastly, the makers of medical devices are under incredible pressure by both shareholders and consumers to come to market before the competition with innovative, advanced devices. Unfortunately, this rush to get products into the marketplace can result in manufacturers taking quality shortcuts. (1)

EngiLifeSciences unique approach of “Optimizing Product Realization” recognizes the co-dependencies between Quality and Business Performance. At EngiLifeSciences, we take a strategic perspective that recognizes the end-to-end value chain must be properly aligned to deliver on customer and shareholder expectations. Quality cannot be separated from the final product, it must continually be considered in all enterprise activities.

Please contact us today for more information on how we can assist you with this process.