The past decade has seen a significant shift in consumer behaviour. In healthcare and life sciences, patients now expect technology enablement to help them better manage their medications, long-term treatment and overall health. It is the development of apps and technologies that add value, effectively integrating data across silos, and keeping pace with a changing tech landscape.
Pharmaceutical companies have responded to the demand. Over the past ten years, these companies have launched thousands of apps, transforming consumers’ smartphones into one of the most hotly contested arenas in healthcare. For instance, the number of apps developed by pharma companies more than tripled from 305 in 2013 to 988 in 2016, according to research from Deloitte.
Yet engagement on a handheld touchscreen, built on millions of lines of ones and zeros, is a competitive arena drastically different to pharmaceuticals’ traditional bread and butter. Most companies have yet to develop breakthrough apps that their patients just can’t live without. Pharma apps generated 5.6 million downloads out of 3.2 billion downloads generated overall by mHealth apps in 2016, the Deloitte research found.
Part of the challenge stems from the fact that pharma companies are very different to tech companies. In drug and medical device development, innovation occurs up front over a ten to fifteen year product lifecycle, and once a product is launched in the market, it’s locked. In the digital world, however, iteration is constant. In fact, the first app or software product a tech company launches is usually its worst product, and then using analytics and other tools the product is improved over time. Beyond the differences in product development, there are significant cultural differences as well. Pharma and medtech companies are traditionally very conservative – and for good reason. They’re developing highly regulated life-saving drugs and devices. Tech companies, on the other hand, operate in a less regulated environment and operate in a more agile manner.
Is big data a help or hindrance?
At its heart, each application hinges on data: information on patient behaviour and lifestyle, biometrics, genomic and medical history. There’s more data available today than at any point in medical history, presenting immense new opportunities for innovation. New applications can better manage treatment, catch unwanted interactions between drugs or genomic predispositions, and prevent issues before they occur.
Yet data in healthcare and life sciences is not readily available. Most are segmented amongst significant silos, spanning electronic medical records, disease management programs, payers, clinical trial systems and more. Despite attempts to incentivise interoperability, major health IT players continue to make it challenging to share data across systems. To maximise the value of digital health applications, interoperability and open systems are critical.
And access to data is only half the battle. The more information that lives within a digital health platform, the greater the regulatory burden. With new regulations like the European Union’s General Data Protection Regulation (GDPR), the stakes for appropriately categorising, managing and protecting data have never been higher.
On the security front, with enormous sets of patient data required for technology innovation, new apps and connected medical devices now face the same threats hospitals and health insurance companies struggle to defend against. According to Cylance’s 2017 Threat Report, ransomware attacks tripled in prevalence in 2017, and healthcare companies were targeted more than any other industry, a striking 34 per cent of all reported incidences. Verizon’s 2018 Data Breach Investigations Report found medical data was the target of two-thirds of all healthcare data breaches, with the remaining third targeting personal information.
Beyond the stringent privacy and security requirements, there are also regulatory hurdles. The typical product lifecycle of a molecule is ten to fifteen years. Software regulated as a medical device, in stark contrast to a pharma company’s bread and butter, must be updated every few months. From a regulatory compliance perspective, it is challenging to create harmony across these varied development and regulatory submission timelines, including details on requirements, design, testing, processes and articles used in the development, every time an update takes place.
The changing CIO
The responsibilities of the healthcare CIO, and the consequences for non-compliance, are arguably more significant than at any point in medical history. While technology innovation is critical to remain competitive in a fast-evolving healthcare landscape, failure to adequately protect data can now result in fines up to 4 per cent of an organisation’s annual global revenue under GDPR legislation.
For CIOs inside and beyond the healthcare industry, these are new trends. According to a 2016 Gartner report, less than 40 per cent of CIOs believed their role involved leading digital transformation. Today, 84 per cent of CIOs hold responsibilities beyond traditional IT, spanning well into innovation and digital transformation.
Today, the role of the CIO is to lead digital strategy and efforts in addition to the traditional IT support services. These leaders must steward digital innovation that will define the competitive footprint of global organisations as we enter this digital era, and understand where it makes sense to partner externally versus build systems internally.
The critical significance of the role also requires that CIOs have a direct line to the CEO. A seat at the leadership table, and a tangible, consequential role shaping company strategy.
Is collaboration the way forward?
The challenges faced by CIOs are significant. Despite the tremendous potential of digital health, and the thousands of applications already inundating the marketplace, the field remains in its early days. With a few exceptions, pharmaceutical and medical technology companies have so far failed to scale beyond niche, siloed applications.
In attempting to establish a digital beachhead, companies are feeling the sheer scale of the regulatory burdens required to develop and maintain an app or connected combination product, let alone integrate with relevant data sets across platforms. The costs to build the underlying connectivity infrastructure to support digital health apps, devices and algorithms can be eye-wateringly high, and that’s not accounting for the large number of specialised digital health engineers required to build and maintain a platform. As a nascent field, teams of 85 digital health experts aren’t exactly floating around the industry.
For organisations choosing to develop their own digital health platform to support their apps, devices and more, they must factor in the time and resources needed to find, recruit and retain such a large team, before development can commence. The risk of losing competitive advantage while building the connectivity infrastructure is very real.
Through a collaborative approach, companies can save tens of millions, shave years off a launch roadmap, open integrated data sets, and hand off immense regulatory burdens in ongoing iteration and data protection. For the CIO and their teams, resources can shift away from building the connectivity infrastructure or “plumbing” and towards developing differentiated digital health offerings, such as unique algorithms or Software as a Medical Device solutions.
In the new frontier of digital transformation, collaboration is healthcare’s most viable path forward.
Learn more about the evolving role of the pharma and medtech CIO and how to overcome challenges with digitisation in our latest white paper.
Dr. Kal Patel, SVP of Digital Health, Flex
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