THE CHALLENGE OF DEVELOPING INTELLIGENT, CONNECTED MEDICAL SYSTEMS
Connected Health represents a big shift. No longer do companies develop and launch products solely for use by experts in medical settings. They are launching connected medical solutions that are fundamentally different; firstly because these devices’ uses include the need to work with the unpredictable behavior of non-experts in everyday settings, and secondly because they must be continually managed and updated remotely. To effectively build, launch, and manage intelligent medical solutions, life science and medtech companies must evolve to become much more like software companies. They must develop products that not only carry out regulated medical functions, but that also have the software and backend IT systems to collect, share, store, analyze, and visualize sensitive medical data.
These products must be designed to work outside of the safe walls (and firewalls) of health institutions, with some SaMD products running on users’ own mobile devices and using internet connectivity. They must deal with messy real-world data on user behavior, and protect themselves from cyber threats. They must be backed by systems that manage connected devices on the market, across multiple countries with different regulatory requirements.They must be designed to integrate with and adapt to multiple third-party mobile sub-systems and connected platforms, each with its own lifecycle, beyond the control of the medical device manufacturer. But – despite all this complexity – companies must innovate rapidly, as both traditional competitors and tech startups move into this space, looking to eat their lunch.
To innovate at speed, companies must move away from the linear product development process still common in biotech and pharma, and set themselves up to launch products that exist in a continuously evolving environment. They must embrace the agile approach of tech companies, within the context of the medical world’s strict adherence to legal requirements around safety and medical data.Yet these are still medical devices that inform serious health decisions. So, in all of this, devices must meet a plethora of complex and evolving regulations, both around the device itself, and on data, software, and cybersecurity.