Article by Maiken Hedegaard, Life Science Consultant, NNIT
When looking at the current global use of smartphones, approximately 1.7 billion people use a smartphone on a daily basis1. Not only has the individual acquisition of mobile devices increased, so has the individual need for mobility services. As a result, the public expectation is that any kind of data can be generated and exchanged anytime, anywhere. In particular, the life science industry has adapted to mobility at a much faster pace than predicted by experts and is currently facing a growing demand for personal data exchange2. The spectrum of life science end-user profiles has broadened, and on top of that, the number of end-users has exploded. Life science data is no longer confined to healthcare professionals, but is now shared between patients, competent authorities and healthcare professionals. We have all become life science end-users. This article will focus on why end-users should be the centre of attention in life science mobility strategies.
Most mobility solutions and apps serve to improve end-users’ productivity by allowing faster and easier information-sharing, but despite that, usability testing is often neglected during the development phase or when pitching a mobility project. However, a successful mobility venture requires that all end-users understand, and are motivated for, a constant push and pull of data. If end-users do not engage with the solution immediately, it is most likely that the end-users will continue to work as they did previously, leaving the mobility initiative unproductive.
The majority of leading life science companies has already established various mobility initiatives, but surprisingly, many of these have come to a halt after the devices have been purchased. Mobility, however, is not about buying a device. Mobility means that people are able to access, communicate and share information via a mobile device. Another common mistake is that companies often start with a single department and await a certain outcome, although preferably two collaborating departments should be involved to get an actual feel for the mobility solution. Caution is understandable, but in terms of mobility, the toe-dipping approach can, in fact, be riskier
As mobility initiatives in life science typically involve highly sensitive data, such as medical or personal data, it is crucial that the IT supplier has created a mobility strategy beforehand. In theory, the ideal life science mobility strategy would start with a workflow assessment performed by the IT supplier in collaboration with line of business. The assessment would map how each life science segment in the entire mobility solution is related and how all end-users collaborate, think, act and breathe. Of course, this is not feasible in real life, but the message is clear: Mobility has placed IT suppliers in a more participatory role in life science industry. In general, IT suppliers have become more and more ethical and politically involved during the past decade. Presently, IT suppliers in the life science industry must be in compliance with the competent authorities (EMA, FDA). Herein lies the responsibility of ensuring that the implemented mobility solution does not jeopardise patient lives in any aspect of the relevant solution. Thus, downprioritising of usability testing in life science is very risky. Preferably, all relevant end-users should be involved from the very start in life science mobility projects. Unfortunately, this is rarely the case.
The consequence of overlooking end-users in life science was illustrated by a recent study of diabetes patients using smartphone apps for blood glucose self-management. The study identified 80 diabetes self-management apps available on the Android platform. Forty-two were classified as eligible for the study, and finally only four of these achieved a usability score above 20 on a scale of 1-30. Disturbingly, none of these apps offered direct data exchange to glucometers (blood sugar monitors), indicating that none of the diabetes apps were able to provide reliable diabetes management in practice3. Publishing inadequate and non-validated apps will lead to serious problems when patients use these apps in good faith as if they were medical devices, subject to regulation by competent authorities.
Mobility has grown popular, because it has enabled us, potentially, to share all kinds of information immediately. Obviously, the increased information flow has also given rise to new risks, and data has become more vulnerable, i.e. the impact of false information is greater than ever before, due to the extended volume of end-users. Bearing this in mind, experts have estimated that by 2015, 500 million people will be using medical apps, and that 76% of these medical apps will profit from healthcare services1. Within just a few years, most mobility end-users in life science will fall into the patient category, and therefore, mobility guidelines for the life science industry are urgently needed.
In the summer of 2011, the FDA and the Center for Devices and Radiological Health (CDRH) published Draft Guidance for the Industry and Food and Drug Administration Staff – Mobile Medical Applications4. Currently, the life science industry and the U.S. Congress are reviewing the draft, and once completed, this guidance will undoubtedly have a significant impact on how medical apps and medical devices will be made and regulated in the future.
The FDA guideline draft intends to divide medical apps into two high-level categories, ‘mobile apps that are used as an accessory to a regulated medical device’ and ‘mobile apps that transform a mobile platform into a regulated medical device’. Hopefully, the uncontrolled life science apps and poorly tested medical devices will be phased out as authoritative guidelines are brought into effect. Moreover, the FDA has made a rule proposal for implementation of Unique Device Identifiers (UDIs) for the medical device industry5. The UDI is intended to improve patient safety while using medical devices. The UDI will enable tracking of adverse events related to each specific medical device purchased.
However, in a field as wide-ranging as life science, where all individuals can be regarded as patients, where all life science stakeholders need to agree, one could speculate that an elegant solution to this problem is going to be multi-purpose applications. This approach has been successful in the public healthcare segment, where all types of life science end-users are using the same life science application. Also, the multi-purpose applications could possibly ease tough decision making in regard to where and how to set the regulatory bar in life science mobility matters. Yet, at this stage, many regulatory legislative initiatives are still waiting to be written. Nevertheless, attention has certainly been drawn to this matter.