Are apps medical devices? Part one: what is the impact on pharma as the first app is registered as medical device with the MHRA?
Paul Dixey and Sam Walmsley offer some points to consider when developing an app.
The Mersey Burns app has just been launched on the iTunes Store and this is the first in the UK to be registered with the MHRA as a Class I medical device as per the EU Medical Device Directive. Should pharmaceutical companies now register their own apps as medical devices?
As the recent studies from d4 and EPG Health Media have shown, the use of smart phones by healthcare professionals in the EU and the UK is ubiquitous. In addition the appetite for smart phones in the UK amongst the wider public continues unabated although the choice of operating system amongst the public differs from, for the moment, the predominant use of the Apple iOS by HCPs.
So, not to be left behind, the last couple of years have seen a number of pharmaceutical companies launch apps for HCPs, patients and the wider public. These have ranged from HCP professional educational content and brand information, to the development of attachments such as pocket ultrasounds and diabetes management. However within pharma there is a wide range of knowledge and experience on how to compliantly develop these apps from a process, liability, and regulatory perspective. Last year saw several high profile pharma company apps removed from the iTunes store.
“Try to avoid the “shiny toy” syndrome and ask instead how does this app benefit HCPs their patients or public health?”
At most digital pharma meetings when the question is asked, “Is your app a medical device?” there is a shuffling of feet and nervous glances. Some internal discussions on this matter can range from, “how can we check the review section on iTunes for adverse events” to, bizarrely, if the app is hosted on a server in the USA “is an export licence needed to download it to an iPhone in the EU”?
Historically pharma companies have developed expertise in the prescription pharmaceutical rules, regulations and codes when it comes to providing a service to HCPs or the public to go alongside their product or provide a disease or healthcare resource. Consequently, many med / legal / compliance departments may not have an expertise in medical devices or a relationship with that section of the national competent authority, in the UK’s case the MHRA, so here are a few hopefully useful tips and questions to consider when developing an app.
How does developing and launching an app help achieve your strategy? ‘Because a competitor has an app’ or ‘it seemed a good idea in the agency pitch’ are not good enough reasons. Try to avoid the “shiny toy” syndrome and ask instead how does this app benefit HCPs their patients or public health? Is it better than what else is out there?
How will you be measuring how the app is performing? Not just downloads but also engagement as nearly 30% of downloaded apps are only used once (Localytics, January 2011) and <, 5% of free apps are still in use a month after first usage (Pinch media)
“…if it wasn’t a medical device when it was a couple of cardboard cycles with a cut out window, why is it a device when I do the same thing with an app?”
How will you promote it and how will you maintain it?
How will you manage access? In the UK for an HCP app featuring brand information it may be sufficient to add a disclaimer before download and a reminder in the app with alternative content for the public but not all med legal departments will be comfortable with this and this will differ across countries.
Seek expert advice – if it wasn’t a medical device when it was a couple of cardboard cycles with a cut out window, why is it a device when I do the same thing with an app? Engage with the MHRA – ask their advice.
Do you have a trusted developer? Do you have your own account with Apple? Who does the app belong to? What if the developer or agency is no longer available if you want to take the app down or amend it?
When you develop the app do you have a documented process in place to manage quality assurance? This will be required for your own internal compliance and as documentation if you are registering the app as a medical device.
Who is liable for the app? Does your company policy cover provision of software or devices as opposed to medical products?
“…the more the app contributes to making a clinical decision the more likely it is to be classed as a medical device”
Do you have the internal resource to review both from a med / legal / compliance and technical perspective, how will you test it, do you have the in-house kit to review how it works? Consider that many pharma people still don’t have access to iPad / iPhones or android devices.
Essentially, the more the app contributes to making a clinical decision the more likely it is to be classed as a medical device and the more potential there is for patient harm the higher the medical device class and therefore the greater the need for robust processes, quality assurance and documentation (to be covered in part 2 of this series).
In short it is better to consider all of these before lusting after that shiny toy otherwise it will only end in tears when someone takes it away from you!
Part 2 of this article can be viewed here
About the authors:
Paul Dixey firstname.lastname@example.org @pauldixey
Sam Walmsley email@example.com @sammielw
Paul Dixey and Sam Walmsley are Managing Partners at Bluelight Partners, which is an independent experienced digital and mobile consultancy focusing on the healthcare and pharmaceutical industry. We develop innovative and integrated strategies, so that digital, social media or mobile can be an integral and compliant part of pharmaceutical marketing and communication mix.
Should pharmaceutical companies now register their own apps as medical devices?