Software as a Medical Device Drives Innovation in the HealthTech
Introducing Software as a Medical Device (SaMD)
The goal of software as a medical device (SaMD) is simple: SaMD performs medical functions. But it’s crucial to know the difference between SaMD and software that’s used to make medical hardware function.
The International Medical Device Regulators Forum (IMDRF)—a global group of medical device regulators with a goal of harmonizing international medical device regulations—have defined 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.” Crucially, SaMD can run on general-purpose computer platforms and does not require a hardware medical device to run but can interface with other medical devices—like hardware— or other SaMD or general-purpose software. Mobile apps that meet this definition are also considered SaMD.
In the last few decades, the volume of software in the medical device field has increased dramatically—particularly over the previous two decades. The Internet of Things (IoT) and its subsequent developments (smartphones, wireless connectivity, and cloud computing, to name a few) have upended the way healthcare is delivered to the public.
SaMD has become even more popular in the last few years. Because SaMD doesn’t require hardware to function, the utility constraints are limited, and improvement happens quickly. According to Orthogonal, a boutique software development firm, the growth of artificial intelligence (AI) and machine learning in medical devices can be used to measure the explosive growth of SaMD.
The SaMD Industry: Where Are We?
SaMD is an “increasingly critical tool” in a doctor’s toolbox, providing data-powered insights to improve health outcomes and driving innovation through quick and inexpensive updates and solutions. And the market is booming: by 2027, the SaMD market is expected to reach $86.56B—up from $18.49B in 2019—with an estimated compound annual growth rate of 21.9%.
In 2020, an npj Digital Medicine article identified 64 AI or machine learning-based medical devices approved for use by the FDA. A 2021 piece in The Lancet Digital Health reviewed approval trends in both the US and Europe between 2015 and 2020, identifying 222 approved devices in the US and 240 in Europe by the European Medicines Agency (EMA).
Medical software definitions differ slightly between the FDA and the EMA. The FDA defines SaMD as medical software that is, by itself, a medical device—and not a “component, part, or accessory” of a medical device. In the EU, SaMD is referred to as medical device software (MDSW) and “must have a medical purpose on its own” to qualify as MDSW. It also must meet the EU MDR definition of a medical device, software, or in vitro diagnostic medical device.
MDSW is also classified based on the risks inherent to the intended use. The four categories of devices—low, medium, medium/high, and high risk—in conjunction with the user’s healthcare status (critical condition, serious condition, or nonserious condition), help the agency determine the MDSW class.
In response to the high volume of SaMD products seeking approval, the FDA launched the Software Precertification (Pre-Cert) Pilot Program, intended to guide future regulatory model development to create a “streamlined and efficient regulatory oversight of software-based medical devices.” The Pre-Cert Pilot Program first evaluates the software or HealthTech developer—instead of the product—and acknowledges that because software is adaptable, any adverse events or safety concerns can be quickly addressed.
Key Players in the SaMD Field
Google is preparing to launch their first SaMD in the form of Derm Assist, a web-based application that patients can use to triage skin complaints. This AI-powered tool uses the same techniques that detect conditions like diabetic eye disease and lung cancer, powered by the camera on a patient’s phone.
According to Google, there are nearly ten billion searches each year for skin, hair, and nail issues and a global shortage of dermatology specialists. Users can take pictures of skin, hair, or nail concerns, then respond to questions about skin type and other symptoms. The AI analyzes this information and draws from a database of 288 conditions to provide a list of matching conditions, complete with dermatologist-reviewed information and FAQs.
Google’s Derm Assist will be launching as a pilot later in 2021.
Pear Therapeutics is a leader in the prescription digital therapeutics space, operating “at the intersection of biology and software technology.” According to the company, Pear’s goal is to discover, develop, and deliver software that’s been clinically validated to provide better patient outcomes, smarter engagement with tools, and better tracking for clinicians—all while being cost-effective.
Pear’s key product is reSET, a 90-day prescription digital therapeutic for substance use disorder that provides cognitive behavioral therapy adjunct to a contingency management system for those in clinically supervised outpatient treatment. reSET-O was the first FDA-approved 84-day prescription digital therapeutic to receive a breakthrough authorization and is used to increase patient retention in outpatient opioid use disorder treatments.
Mobile apps also fall under the category of SaMD—Eli Lilly’s insulin dose calculator app Go Dose is one such example. Although it was approved in 2017, Lilly Diabetes opted not to launch the app; but in that time, the field of mobile insulin dosing apps has grown competitive. AmalgamRx’s iSage app was approved in 2017 for use with all basal insulin brands, as well as Sanofi’s My Dose Coach. Glytec’s Glucommander app provides users with basal and bolus dose adjustment recommendations via their healthcare provider. And Hygieia was approved in early 2019 for the d-Nav Insulin Guidance Service that’s billed as a “diabetes GPS”: a mobile titration app for all type 2 diabetes basal and bolus insulin regimens.
For patients with asthma or chronic obstructive pulmonary disease (COPD), Propeller is a mobile app that helps patients stick to treatment plans and track flare-ups. Propellor sensors are compatible with any inhaler and track “where, when, and how often” patients use medication. Over time, the companion mobile app learns about medication use and flare-ups and helps patients both identify triggers and manage symptoms.
These are just a sampling of the many approved SaMDs available on the market today.
Addressing SaMD Challenges and Concerns
Despite its popularity, there are, of course, challenges associated with SaMD use. A 2020 study from Harvard’s T.H. Chan School of Public Health highlighted concerns about data, including transparency, quality, and validation.
In the US, the FDA is addressing this by developing machine learning best practices to evaluate and improve the algorithms used to manage data interpretability and documentation. The agency is also looking to “stay current” with developments in the AI/machine learning field, which can be challenging given the fast pace of software innovation. Agencies like the EMA have also introduced regulatory pathways for MDSWs, recognizing the importance of staying on top of this constantly changing technology.
The IMDRF has also recognized challenges associated with SaMD regulation, including that many so-called nontraditional medical device manufacturers—like Google, for example—are now being confronted with the realities of the medical regulatory landscape. Conversely, regulators find themselves needing to keep up with software that is frequently updated, potentially—as one article in the DIA Global Forum put it—“changing [the] safety and/or effectiveness” of the software.
Global agreement and implementation on SaMD device identification and coding standards will help with some of these challenges, allowing both regulators and the industry to track and identify SaMD across its life.
And as with any medical device that connects to the internet, cybersecurity should be front-of-mind for developers—especially where personal health information is concerned.
The Future of SaMD
The future is bright for SaMD technology. Digital healthcare and HealthTech are driving innovation in the healthcare industry, incentivized in part by the industry-wide changes brought on by the COVID-19 pandemic. One trend to watch out for is cross-collaboration between multiple companies that lead to new and innovative product offerings. According to Medical Design Briefs, “the lines are blurring between hardware and software vendors” as customers look towards multiple, not single, vendors to provide the best solutions.
About the Author
Miguel Costa, President, leads TMG360 Media’s technology initiatives both for the company and its clientele. He supervises emerging technologies and assesses their application to a company’s business strategies and solutions. DM me to learn more on how I can help you leverage digital media and stay up to date on the latest SaMD developments.