Software as a medical device (SaMD) is defined by the International Medical Device Regulators Forum as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” SaMD is developed at a much faster pace than traditional medical devices, and may require frequent updates, as opposed to hardware devices that typically are updated every few years. While SaMD and medical devices are clearly different and evolve at completely different paces, the same regulatory approval process currently applies to both types of technology. Using the same process for both is akin to forcing a square peg into a round hole – it is not going to work because one size does not fit all, especially in healthcare.
Over the past couple of years, there have been around 200 merger and acquisition (M&A) deals in the healthcare IT space, driven by high enterprise value and the sheer size of the industry. 49 deals came together in the first quarter of this year alone. These numbers make health IT the highest performing industry in terms of M&A activity in the consumer and retail space, and the second highest in the infrastructure/industrial space.
Between 2018 and 2019, we will see an insatiable need for increased health IT interoperability, with providers putting increased pressure on health IT vendors to deliver. This pressure – combined with the shift brought on by new regulations like MACRA around performance, measurement and outcomes – will drive one of the biggest M&A pushes we’ve seen in the health IT industry.
This is a watershed moment in healthcare. New technologies are constantly in development to help treat and prevent previously incurable conditions, and improve current processes. From leadless pacemakers to mobile applications that advance telehealth access, digital innovation is at an all-time high. The problem is that our current speed of regulatory approval for these innovations simply cannot keep up.
While many groundbreaking technologies are being created, their full promise is not being realized because they are not being approved quickly enough to be implemented and adopted by health systems. The FDA regulatory process has long been a matter of contention. However, now that the rate of innovation is increasing, things need to change accordingly. By working together to streamline this regulatory process, technology will arrive to the market faster and propel the healthcare industry forward.
We are currently experiencing the biggest transformation in healthcare ever. Technology plays a significant role as an enabler of this transformation, but will not drive it alone. Improving patient care and driving toward patient engagement are crucial goals in this next phase of the healthcare industry. To make adoption ubiquitous and implementation effective, there are several things we should focus on as we dive into 2015: