The Challenges of Mobility in Life Science Risk Management
In 2016, the global market for mobile medical apps was valued at nearly $1.5 billion. However, this market is expanding so quickly—just over 20 percent per year—that by 2025, its value may increase eight-fold to over $11 billion. This massive growth, encouraged by the rapid pace of technological development, is already changing healthcare as we know it.
With such a wide market projected for mobile medical apps, one thing is clear—mobility is going to become a key user need for life science products. And even with products that, by design, must remain immobile (such as CT scanners), remote access to the data they generate and retain is a necessity. The world is mobile, and our life science products must shift to meet that world.
Mobility can be a great benefit to life science organizations and their products, but it also presents several challenges, particularly in regard to risk management. Identifying them earlier in the development process makes it easier to evaluate and control them.
With the advent of mobile technologies, life science organizations are forced to rethink what use environments look like. With certain life science products (like surgical implements, ultrasounds, some drugs/biotherapeutics, and so on), their use environments are still limited. However, many diagnostics and therapies are moving into the mobile medical app market, changing traditional care settings. As the Apple Watch and the AliveCor KardiaBand demonstrate, healthcare functions like monitoring and detecting health issues can be done anywhere, at any time.
These technological breakthroughs are altering the definition of the use environment; users can essentially engage with your product anywhere around the globe. How can your organization possibly manage the whole world for risk—especially when so many factors can influence human-product interaction in one given use environment?
Unfortunately, there’s no good answer to this question at the present moment. There are some approaches your risk management teams can take in evaluating use environments for risk, however. First, uniformity is key; identifying the key aspects of your life science product and how to make a user’s experience the same across different use environments can be productive. In addition, prioritizing product features already identified as high risk for evaluation in context of the use environment can optimize time and effort. Likewise, focusing on the most common use environments in your risk evaluation can have greater benefits than trying to scope out all the possible ones out there.
Even for life science products that aren’t capable of moving between use environments, mobility still impacts them. Rather than the physical product moving, its data moves instead. With technological advances like the Internet of Things (IoT), artificial intelligence (AI), big data analytics, and others, data is going everywhere, all at once. Innovative telehealth devices allow for remote monitoring of patient health; likewise, IoT-connected products can send diagnostic information to healthcare professionals remotely, as well as maintenance information to servicing personnel.
All of this data moving back and forth can ultimately present risks to users and patients. Data integrity and cybersecurity are two major concerns in our mobile world, and as incidents like the WannaCry cyberattack have proven, interconnected life science products are not free from these issues. Ensuring data is accurate and has limited exposure to cybersecurity vulnerabilities needs to be a major concern for your life science organization when addressing mobility in your products.
Evaluating the risks of cybersecurity and data integrity are not easy tasks, but they’re necessary as more life science products become mobile or remotely accessible. Usability is a major factor to consider, as well as process risks. Maximizing use of tools and methodologies like preliminary hazard analysis is valuable too; by identifying known hazards, hazardous situations, and harms related to cybersecurity and data integrity, your team can come up with more robust controls and mitigations that more effectively handle mobility risks.
Whatever steps your life science organization takes in managing the risks associated with mobility, taking them sooner rather than later is critical. The rate of technological change today is outpacing advancements, and consumers are demanding more from their healthcare products as a result. Being able to meet these demands can be difficult, but robust, risk-based approaches mean your organization can send out products that deliver—for both today and the future.
About Nick Schofield
Nick Schofield is a content creator for Cognition Corporation. A graduate of the University of Massachusetts Lowell, he has written for newspapers, the IT industry, and cybersecurity firms. In his spare time, he is writing, hanging out with his girlfriend and his cats, or geeking out over craft beer. He can be reached at firstname.lastname@example.org.