Navigating Organizational Tensions in Medical Device Companies' Digital Health Initiatives

The evolution of medical devices from the earliest days of medicine many thousands of years ago through the late 1990’s has moved from things you can hold in your hand, like a primitive scalpel, to a standalone box that measures body functions, or emits energy or mechanical force to provide diagnostic insight or therapeutical treatment.  Something more dramatic has happened since then. 

The internet took hold and over the last 20 years, we have seen a rapid progression toward all medical devices and information systems being connected.  Irrespective of its first connection point, such as a watch, a phone app, or a box that sits on your bedside table, it is rare that the collected data ends its journey there.  Data is moving inexorably to a slew of cloud or enterprise-hosted databases. 

We think of this broadly as digital health, and it encompasses large webs of devices and applications, ranging from bedside in a hospital to a variety of patient and provider mobile apps.  Beyond the medical applications, there are a wide variety of applications for device manufacturer’s service technicians, informing them when a given device may need repair or even a software update.  

This rise of connectivity creates the need for a more complex suite of software solutions; solutions that require a much greater diversity of skills to conceptualize, realize, operate, and maintain.  To the degree these connected systems are utilized as medical systems or interact or store Patient Health Information (PHI) they still require the traditional medical systems development processes, regulatory compliance, and, when there is a physical device, hardware development and manufacturing expertise.  Additionally, they now need skills more traditionally found in an IT department.

Skills related to the development of hosted environments, proprietary enterprise applications, non-regulated application development and integration, and the cloud and enterprise DevOps tool kit.  Not to mention deployment and 24/7 support of these distributed cloud-based systems.

This shift in technology is driving many new opportunities and collaborations, but like all change, it comes with challenges.  Traditionally, the R&D and IT groups haven’t needed to collaborate to such a significant degree.  Aligning these two groups, when their decisions are often driven by different processes, priorities, contexts, timelines, and areas of expertise is creating significant stress within many device organizations. Some of this stress can be positive – pushing both organizations to better think through areas of competency to more clearly define areas of responsibility. But much of it can be counter-productive – appearing to outsiders to be more of a turf war than a collaboration.

The crux of the matter lies in the fact that, from a customer-centric perspective, the end-user does not discern between services provided by IT or R&D. The once clear-cut boundaries between these domains have blurred. Consider the simple act of ordering supplies, which has become intricately linked to the product itself. This interconnectedness emphasizes the urgency for a cohesive collaboration between IT and R&D, where the product, its digital interface, and the support systems coalesce seamlessly, providing an integrated experience for the end user.

To navigate the complexities of digital health initiatives, it is crucial to comprehend the technical strengths of IT and R&D, where they differ and where they may overlap. IT traditionally excels in solution development, managing hardware infrastructure, and implementing enterprise systems. Conversely, R&D is skilled at developing medical devices and increasingly adept at software-centric solutions. Modern digital health initiatives necessitate a fusion of these competencies. For instance, both groups might vie for the task of developing a React mobile application. While IT might lack expertise in FDA regulations, R&D might not possess robust cloud operations capabilities. Bridging this gap demands a holistic strategy that acknowledges the strengths and weaknesses of each group.

The journey towards a unified digital health initiative involves several critical actions.  Getting to a clear and mutually understood definition of roles is an important one.  Each of IT and R&D must recognize their own limitations as well as their capabilities and understand those of the other group as well. Defined roles and responsibilities are foundational. This collaborative effort should encompass assessing skill sets, available assets, existing responsibilities, and service level agreements (SLAs).  

Beyond an understanding of roles, is the understanding of potentially differing architectural viewpoints.  The systems need to be architected in a way that accommodates the initial and longer term vision of the system in a manner that maximizes utilization and minimizes costs. IT and R&D need to apportion the work to meet these goals and this requires a nuanced understanding of viewpoints, especially the organizational viewpoint, ensuring that the digital infrastructure mirrors the collaborative efforts of both departments.

Using formalized architecture design techniques, such as ATAM will allow for impartial high-level system design that proper insulates medical functionality from system support functions, thereby minimizing effort, time and costs associated with regulatory overhead. Relying on robust systems engineering skills to properly manage risk and allocate functions across the system will ensure a solid underpinning for a complex system with a long expected usable life.

As in all human efforts, there needs to be an effective way of working.  Clear communication protocols are vital. Adopting agile methodologies, such as the 'scrum of scrums' approach, fosters consistent communication, ensuring a shared understanding of project objectives, timelines, and challenges, particularly when there are changes to requirements along the way.  Part of this is determining the release cadence.  Balancing any differing or changing requirements is essential and, furthermore, clear protocols for issue resolution and escalation mechanisms need to be established.

Particularly in a regulated system, comprehensive testing and documentation is critical. Integration testing must be thorough, defining test systems that follow detailed interface documentation. Establishing a common backlog for joint planning ensures that both IT and R&D concerns are addressed, fostering a sense of unity in the development process.

New innovations, with all of their promise, always come with new challenges.  Technology is not the only area that requires innovation in order to be successful in this market.  Companies need to innovate how they construct their organizations in order to develop solutions leveraging best of breed patterns and methods specific to the risk, function and environment of that component of the solutions.  At the same time, program leaders need to have a big-picture, systems view of the solution that considers clear definition at points of interface and the impact that various system components will have on other components as well as overall system performance. 

The relevance of digital health initiatives in medical device companies is indisputable in today's healthcare landscape. However, the successful execution of these initiatives requires more forethought of the challenges that can arise from an interdepartmental collaboration such as : a common vision of the solution at a systems level, a detailed understanding of organizational strengths and how they map to the various components of the system, and innovation of thinking and planning to match the technical innovations found in the rapidly evolving digital health market.  That forethought will pay dividends when it comes to establishing role clarity between IT and R&D.