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.
As an anesthesiologist, my goal is to make the hospital a better, more efficient place to work so that I may provide the best possible care to my patients from the moment they come under my supervision. As part of this, improving a patient’s health record – and our access to it – by using effective mobile technology is an important step to providing holistic care. With nearly half of a physician’s day devoted to administrative tasks, it feels as though the time we clinicians can spend with our patients is getting slimmer and slimmer. Consequently, we want the precious time we have with our patients to be valuable and ensure them that their concerns are being heard and addressed in an efficient manner.
Over the last few years, the healthcare industry has undergone an incredible revolution. Mobility solutions deployed across the care continuum are providing higher quality patient care. The shift from fee-for-service to fee-for-value – no matter how the political environment affects the market – is prevailing. Beyond that, innovation and digital tools are supporting this shift. In the U.S. alone, there are more than 6,000 medical device companies. Around 80 percent of them have fewer than 50 employees. Creative solutions to longstanding problems abound.
A healthcare game changer and warrior is no longer with us. Neal Patterson has been an icon and mentor in the industry and will always be remembered.
I have been in this challenging arena of healthcare IT for almost two and a half decades. I call it challenging because of the constant changes that forced all of us to adapt and re-invent ourselves. I have faced some of these challenges as an ally to Neal and some on the other side as a competitor. We won some battles and lost others, but the challenge is what made it fun, and Neal’s brilliance pushed us to think harder to stay in the game. The most important thing is that we were always driven by our shared mission and passion to do the right thing for our customers and the healthcare industry. Ultimately, the customers and the industry always won!
The role of a nurse is a complex one. Not only is this individual responsible for the physical bedside care of multiple patients, but may also be called upon to offer emotional support for patients and their families. While this is an absolute honor and a privilege, it can also be emotionally draining and lead to burnout syndrome or compassion fatigue. In order to ensure that patients receive the highest quality care, we must make sure that nurses have support for their own emotional well-being.