The Impact of a Medical Device Recall (Infographic)

THE IMPACT OF A MEDIGAL DE ICE RECALL Over 50% of the world's largest medical device companies are based in the United States. The US is widely acknowledged as a leading manufacturer of medical devices. The industry employs over 400,000 Americans. The industry is responsible for over $33 billion in annual exports. Medical device manufacturing is an important segment of the rebounding U.S. economy. Medical devices run on complex software code, which ensures that insulin pumps make injections at necessary intervals, ventilators provide requisite amounts of oxygen, and so on. 0100101110 1001000110 Ensuring software quality and security is critical not only for the continued welfare of the U.S. health care industry, but also for the people that rely on these devices to keep healthy! $300 MILLION Average cost for FULL development cycle of medical devices The full development cycle, from concept-to-product launch takes about 4-10 years. These skyrocketing costs are largely due to regulatory mandates posed by government agencies to ensure products are safe. DEVELOPMENT COSTS Device failures can result in costly litigation or, even worse, a product recall due to device malfunction; these failures can be the result of software errors. <ERROR> 2012DEVICE RECALLS QUARTER 1 QUARTER 2 QUARTER 3 QUARTER 4 277 242 407 314 DEVICES RECALLED DEVICES RECALLED DEVICES RECALLED DEVICES RECALLED 82M UNITS TOTAL 123.5M UNITS TOTAL 26.5M UNITS TOTAL 10M UNITS TOTAL 2012 TOTALS 242 MILLION DEVICE UNITS 1240 DEVICE RECALLS Sorry ..... .... The cost of these recalls can be crippling WE'RE CLOSED In the fourth quarter of 2011, the largest medical device company in the U.S reported a 12% decline in profits that was primarily due to a major recall of a hip replacement device. It ended up costing more than $900 MILLION The cost of these recalls can be crippling to companies, given the high initial costs required to develop these products. Given the high financial stakes involved, it has become increasingly critical for companies to find and fix critical software bugs </> earlier in the device development lifecycle. Learn more about how Coverity helps organizations ensure quality code and minimize security vulnerabilities at: Coverity.com O coverity" This infographic is brought to you by: SOURCES: http://www.mddionline.com/article/medtech-2012-SWOT medcitynews.com - http://bit.ly/YASPBZ http://www.mannfbe.org/commercialize/approval-process.htm http://www.fda.gov/MedicalDevices/Safety/default.htm ncbiomed.org - http://bit.ly/10FON08 http://www.expertrecall.com/recallindex/