In the wake of rising cases of medical device software defects and malfunctions, software quality assurance and compliance with regulation has come to the forefront of discussion among industry experts. Leading medical device manufacturers at Pharma IQ’s 14th Annual Software Design for Medical Devices are to discuss the top concerns and challenges of this industry. The conference will be attended by Thuy Cook, sr. software quality engineer for Covidien, the US Food & Drug Administration (USFDA), Abbott, St. Jude Medical, GE Healthcare, Boston Scientific, the Medical Device Division of Intel Corporation and other leading medical device manufacturers.
The event, being held May 23-25, 2011 at the Hilton San Diego Resort and Spa in San Diego, CA will assist medical device manufacturers decrease their medical device development cycle time, while ensuring product safety and integrity. For the first time ever the event will present a second track with new exclusive view from hardware engineers. These sessions will address major challenges and the latest developments in the industry and how they relate to software design and development. A series of workshops have been designed to translate winning strategies from leading experts and develop them into tangible benefits.
According to a survey by the USFDA, which inspects, approves and sets safety standards for drugs, chemicals, and medical devices, 8 percent of device failures was due to software glitch- 39 medical device recalls in 2010 and 500 total recalls over the past 7 years were reported to be related to software defects. The US medical device market is the world’s largest and highly regulated. As medical devices have become more complex and interconnected, the USFDA has intensified the verification and validation process with a strong focus on software quality in order to ensure a quality device and fully comply with regulations.
IEC 62304, a standard for software design of medical products, includes safety classification for software, testing and analysis, new requirements for software risk management, and updated requirements for “SOUP” product components. The standard, recently adopted by the European Union and the United States, harmonizes both European and American medical standards. ISO 14971 specifies a process for a manufacturer to identify the hazards associated with medical devices, to estimate and evaluate the associated risks to control these risks, and to monitor the effectiveness of the controls.
In a recent interview, Cook discussed how to implement these risk management processes for safety critical software using the guidance and best practices from IEC 62304 and ISO 14971.
As technology is advancing, competition is getting tough, and regulations are getting more stringent. Companies need to get their products to market first, while at the same time maintaining the integrity and safety of their products. Medical device manufacturers now find themselves trying to maintain compliance and high quality standards, while dealing with evolving technologies and reducing time-to-market cycles.
Neelam Malkani is a HealthTechZone contributor. To read more of her articles, please visit her columnist page.Edited by
Jennifer Russell
