The medical device industry is no stranger to costly recalls with serious impact on a company’s stock price, bottom line, and most importantly their reputation.
In 2010, Baxter was ordered by FDA to recall AND destroy all Colleague volumetric infusion pumps that had been sold in the market. This recall occurred after FDA received more than 56,000 complaints associated with infusion pumps. By some estimates, there were “serious injuries and 500 deaths.” Unfortunately these recalls were ordered after repeat efforts to correct the device flaws. Baxter had estimated that the recall will create a pre-tax “special charge” of $400 million to $600 million.
A European supplier of high-tech equipment faced quite a few major quality challenges that included quality costs above competitor levels, a focus on problem resolution after customer delivery rather than problem prevention in development and production, and low-quality performance of suppliers.
Addressing low-quality concerns for medical device companies is really about transforming the start-to-finish production life cycle, including but not limited to:
- Reorganization of the quality function
- Design for reliability
- Supplier quality oversight
- Manufacturing process changes
- In-market product performance monitoring
- Most importantly, developing a proactive quality mind-set
This might sound simple, but in reality it is very time and resource consuming. All in all, the desire to build a quality driven device starts from conceptualization and it does not end once the device is released into the market. Rather, there should be a mechanism to collect and analyze feedback from all countries where the device is released.
One of EPIC Translations‘ clients conducts an annual survey from the entire value chain ranging from end users, retailers, distributors, suppliers, and employees. This feedback is conducted in several different languages. Once all of the feedback is translated into English it is normalized and prepared in a report format that the C level management religiously studies. It then implements and monitors improvements in the ENTIRE life cycle from design to manufacturing to marketing to technical support.
In another example, a small capital device manufacturer faced significant issues with rising product failures in the field, customer complaints, and slowing growth. Senior leadership concluded that revamping the approach to quality from end-to-end across the value chain was necessary to turn the business around. They undertook a major program to overhaul and tightly integrate product development, sourcing, and manufacturing while bolstering their ability to use customer and field sales-force feedback as a core listening device to monitor and improve product performance.
Providing quality driven and contextually correct translations of your manuals and instruction sheets are JUST AS IMPORTANT to medical device consumers as the device itself. If you are spending $millions in manufacturing the device, why would you short change yourself and your customers by releasing inaccurate and contextually incorrect translations? Settling for a cheap document translation service might actually end up costing you LOT MORE in the long run.