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.
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.
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.
In healthcare, we constantly seek new ways to deliver and improve care. Countless ideas have already been tried and tested, and people often think that coming up with the next great innovation requires thinking ‘outside of the box.’ This notion has been instilled in most of us from a young age, and those in all industries – not just healthcare – often strive to show their creativity through this approach. However, in my experience, thinking outside of the box doesn’t always lead to the best new ideas. Sometimes, we need to focus on thinking better inside the box.
Across the country, health care organizations are re-envisioning how to deliver care. Major health systems like Lahey Health are seeking out new solutions that allow us to transition from episodic care to wellness – minimizing the impact of disease and managing the health of populations more effectively. At the same time, patients continue to demand more from their care providers. We now must bring care to patients at the time and location of their choosing, and this is the beginning of the consumerization of healthcare. These shifts require technology that can provide more comprehensive and context-aware views of patients’ data, support for collaborative care across the continuum, and allow health systems to scale their delivery of care in new ways. Consequently, CIOs face constant challenges to seek out the most effective technologies that will ensure an organization’s vision can come to fruition.
Healthcare is constantly evolving, and healthcare IT in particular is undergoing more change now than at any other point in history. Health systems trying to ‘ride the wave’ of change may often feel like they are implementing updates, only to face a new regulation, technology, or best suggested practice that shakes up the process yet again. While it is challenging to stay current, health systems looking to stay relevant need to constantly re-evaluate their processes and whether they are as efficient as possible. While these organizations can’t always predict what comes next, the triple aim of reducing costs, improving outcomes, and enhancing patient satisfaction, provides a solid framework for thinking ahead.
So how do you know where you are on the healthcare wave?
Any market that experiences a boom of innovation and creates transformative start-ups has a typical lifecycle. It often starts with deregulation, followed by start-ups popping up and creating a market of many competitors with novel but often similar products who find short-term success. At some point, however, the competition becomes too fierce, and not everyone can survive. Some business strategies, products, and operations will find long-term success, while others will not.
This week, I had the privilege to present at the Energy and Commerce Subcommittee on Commerce, Manufacturing and Trade Hearing that took place in Washington, DC. As part of the “Disrupter Series: Health Care Apps” hearing, leaders in the healthcare industry discussed how mobile applications are disrupting the ways in which doctors and patients engage in the health care system and impact the affordability, accessibility, and delivery of care.
As the chief innovation officer of Carle Foundation Hospital, my primary responsibility is to find the best cutting-edge technology to help alleviate our physicians’ biggest pain points. This can seem like a daunting task considering the sheer quantity of technologies being produced by innovative vendors to improve the healthcare industry. I often get asked to define the ‘magic’ behind making the right decision. Ultimately, you simply have to start somewhere. With the trust of leadership and the direct involvement of our system’s physicians, I’ve determined my own process to cut through the noise and find success.
Much has changed in the years since HIPAA was first passed into law, not the least of which is the use of mobile technology in healthcare. As a physician, patient, and healthcare technology business leader, I have experienced numerous frustrations and inefficiencies resulting from practices struggling to adhere to the letter of the HIPAA law rather than embracing its spirit.