Software and Medical Devices? It’s Complicated
April 12, 2012 – 3:54 pmAs more and more healthcare apps enter the marketplace, manufacturers increasingly will wrestle with complex regulatory issues that don’t always have a clear path to compliance. For example, as functionality is added to software used in a healthcare setting, it can become a medical device in legal terms, writes life sciences and IP lawyer Erik Vollebregt on the Eucomed blog.
“Traditional device manufacturers will be faced with this as they provide additional software to make their devices more user friendly or effective,” writes Vollebregt, citing potential iPad apps that can remotely control or monitor a group of infusion pumps as one example. “The same will happen with IVD products, where expert system functionality becomes more and more important as the amount and complexity of raw data produced by IVDs keeps growing. Furthermore, the way stand-alone software is delivered to the end user is often radically different from the traditional model, so manufacturers must start to adopt a ‘device as service’ strategy,” writes Vollebregt in “Standalone software: objects in the regulatory mirror may appear simpler than they are.”
The theme of Vollebregt’s article, as you may have gathered, is complexity. If you are looking for clarity, by all means read his post on the Eucomed blog. You may also be interested to know that Vollebregt will be participating in a webcast on stand-alone medical software sponsored, as it happens, by medtechinsider and emdt.co.uk. To learn more about that, go to the registration page.
Norbert Sparrow
2 Responses to “Software and Medical Devices? It’s Complicated”
Also there is the question of medical software localization into the different languages the company plans to market the app in. If a certain piece of software is considered a “medical device” all its GUI and help structure MUST be translated and localized into the official language of the countries it is going to be sold. As a medical software localization expert can confirm that some middle-size medical companies try to elude the enforcement of this law…but they are not seriously taking into consideration the risks for users and patients at all! Hope this tendency among middle size companies could be finally left aside!
By Jose Montero on Apr 13, 2012
With the evolution to intelligent Medical Devices & Diagnostics would it not further improve patient’s lives if device manufacturers could also provide a software solution to quickly correlate patient test results from the devices in real time with the product type they use? In addition to this it could also allow instant feedback to manufacturing through blogging directly from the patient highlighting possible quality issues or satisfaction in using their product and give GP’s the capability to trend their patients test results with a few clicks of their mouse?
Typically the challenges around new software systems are not only in their development and management but also the quality of the data being driven from them (data rich information poor scenario) however if this could be a single platform that was tested and deployed once, then ran as a service for manufacturers and patients it could take the data obtained from the device further extending its capability and provide this information to a wider user group. This in effect would provide the ability to correlate quality data and create meaningful collaboration between manufacturers, patients and the health services that support them.
What could a service like this mean to the patient, manufacturer, GP’s or hospitals?
By Steve McCluskey on Apr 16, 2012