Medical device software is a segment of the software industry expected to grow by double digits year-over-year. Companies all over the world want to get in on the action, and justifiably so—not only is there money to be made, but so are breakthroughs in public health, longevity, and quality of life. When you can help that many people, what risk isn’t justified?
Of course, with technology geared toward public health comes scrutiny from regulators—in the case of the United States, the Food and Drug Administration (FDA). The FDA’s basic mandate is to prevent breakthroughs targeted at aiding public health from harming public health—like, for example, a COVID-19 treatment that could kill more people than it saves if touted or distributed without testing.
For a software company convinced that it stands on the precipice of greatness, FDA approval can smack of burdensome regulation. In truth, it’s all a balancing act, especially as the technological breakthroughs begin to organize around software instead of hardware, as was traditionally the case for medical devices.
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Here are three things companies need to know about medical device software and the FDA.
1. There’s a Big Difference Between “Software as a Medical Device” and “Software in a Medical Device.”
In 2019, the FDA released the much-noted paper “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback.” This paper got a lot of attention in the medical device software industry by focusing attention on the differences between “Software as a Medical Device” (SaMD) and “Software in a Medical Device.” (SiMD)
The distinction between SaMD and SiMD is about exactly how the software functions. According to Orthogonal, SiMD (in a medical device) is dependent on the device it is in. For example, software is needed to guide the magnet in an MRI machine or the arms of a robot that performs surgeries. If you drop either of these softwares into a computer or smartphone, it won’t be able to do anything.
SaMD (as a medical device), by contrast, does not necessarily depend on the device in which it is sitting. SaMD might consist of an app that reads a Bluetooth signal from a pacemaker or blood glucose monitor to provide the patient or his/her doctor with actionable medical info. In cases like these, the software is the medical device, even if it works in concert with other medical devices.
The International Medical Device Regulators Forum (IMDRF) defines SaMD 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 software needs to be in a device, but could potentially be in a variety of devices—like different kinds of phones, for example, or in tablets.
2. The FDA Holds “Software as a Medical Device” to Different Standards.
Software companies that want in on the booming SaMD space need to understand that they will face stringent and evolving regulatory burdens in the approval of their software.
This is because of the more widespread availability of SaMD to lay people, compared to SiMD. After all, many SiMD-medical devices never leave the hospital or clinic. They are calibrated for the device that they sit in, and will only be accessed by doctors, nurses, and medical lab techs.
SaMD, by contrast, will probably live as an app on a smartphone, tablet, or desktop computer. Developers will put a lot of thought and effort into the Business-to-Consumer user interface, but the FDA will be looking over their shoulders to make sure that the medical science is sound and reliable. Peoples’ lives may be at stake—a unique situation for a smartphone app to face.
3. Expect Ongoing Scrutiny of Software with Artificial Intelligence.
Maybe regulators saw Terminator too many times. Maybe we all have. Suffice it to say, the FDA takes a special approach to medical device software that leverages one of the guiding lights of next-gen software development—artificial intelligence (AI).
AI stands to revolutionize the medical device industry like few others technologies. The key feature of AI software is the development of machine intelligence—computing power that can aggregate vast sums of data and make judgements about it, the way a human brain can.
In time, artificially intelligent medical device software could recommend treatments, perform complex diagnoses, track epidemics, identify risk factors from medical histories, implement preventative medicine, and much more.
So are we on the road to being nuked by Skynet? That’s probably a long way off. In a sense, AI is just a new plateau for computer software. Early computers could independently determine what 2 + 2 equaled, which before then was only something a human brain could do. AI computers can simply do much more complicated tasks that previously only a human brain could do. Is that the same thing as self-awareness (or a murderous vendetta against its creators)? Hardly.
What it does mean is that the software as it stands today could be very different from the software as it might grow in its machine learning over time.
In their 2019 “Proposed Regulatory Framework,” the FDA envisions an expectation of extra commitments from manufacturers of AI medical device software that goes far beyond the usual pre-market tests. After all, pre-market tests can’t tell you what an AI software will ultimately become. If you work with AI SaMD or SiMD, expect to make a commitment to ongoing transparency and real-world performance monitoring, as a function of ongoing FDA scrutiny.
Ultimately, it’s an exciting time to be involved in medical device software development. With an increasing demand for public health aids in the face of pandemics and epidemics, the public wants solutions, and software developers are in a prime position to provide those solutions.
FDA approval may seem like a formidable obstacle to that opportunity, but every great opportunity is couched in obstacles. Understanding and overcoming them is the only road to the kind of breakthroughs that alter the destinies of entrepreneurs, nations, even the whole human race.
