There is an interesting debate going on in Washington right now over a report by the Institute of Medicine released last Friday – July 29th, 2011. The Institute of Medicine, a group consisting of physicians, academics and lawyers is making an argument for a tougher approval process through the Food and Drug Administration (FDA) for a wide variety of medical devices including defibrillators and hospital pumps. This comes at the heels of several recalls of devices that failed and caused patient injuries in recent years.
On the other side of the fence are the device manufacturers who argue that the suggestion of introducing new regulations would stifle innovation, increase costs and slow down the process of bringing valuable devices to the market.
It’s an age old debate and the FDA, has in the past, done their part in sorting this out. For medical device software, the FDA introduced the guidelines in the form of General Principles of Software Validation (created in 1997, updated in 2002). Such guidelines serve to help the device manufacturers put in processes and take specific actions to validate software embedded within medical devices. These guidelines have taken on a significant role in recent years since - similar to most other industries - the amount of software in medical devices is doubling every two years. For example, modern infusion pumps can contain more than 100,000 lines of code while proton beam therapy machines may contain in excess of 10,000,000 lines of code. In fact, by identifying the recent growth in the use of mobile device applications for improving and facilitating patient care, the FDA has started work on drafting a guidance for Mobile Medical Applications.
However, it’s obvious there is an issue. For example, in the first half of 2010, the FDA issued 23 recalls of defective devices, all of which were categorized as Class I, meaning “there is reasonable probability that use of these products will cause serious adverse health consequences or death.” At least six of the recalls were likely caused by software defects. So, what’s missing?
Software development technologies that allow medical device manufacturers to innovate, solve critical patient health problems through new devices, and do so in a cost-effective manner fail to make a clear link between the FDA guidelines and the development process. Sometimes it is unclear how to implement guidelines into the development and validation process. Then there is the challenge of building the process so that it ties in the daily activities of the developers to the goals of the business which is typically to speed up the FDA approval and bring new devices to the market quickly.
The good news is that such debates bring to light many underlying issues that have not been addressed, such as software development and the difficulty of translating guidelines into actionable processes within the software development lifecycle of medical devices. Going forward, development solutions can only play a more important role in creating and bringing to market life-enhancing and life-saving medical devices.