According to Insider Intelligence, the digital therapeutics (DTx) market is forecast to be a $56 billion global industry by 2025. Much of this dynamic growth will be spurred by software, most of which will be software as a medical device (SaMD).
SaMD are software functions that help prevent, manage, or treat medical conditions, without being part of medical device hardware−in other words, the software works independently from another device. If the software is a feature of the hardware and helps it to function, that’s Software in a Medical Device (or SiMD) and an integrated component of the medical device. For example, software that enables a surgical robot to perform a procedure is SiMD.
Conversely, an example of SaMD can be software used to analyze medical images, or an app for diabetics that uses a person’s blood sugar levels to calculate insulin doses. SaMD can generate a large amount of data in real time and is usually connected to the internet. Also, SaMD runs on portable devices, such as smartphones, laptops, or smartwatches.
All SaMD are DTx, but SaMD must be cleared or approved before they’re brought to market. Statista estimates that 1 billion people will be supported by DTx in 2026. This is a fast-moving industry with multiple benefits to pharma. Integrating SaMD into traditional pharmaceutical treatments will eventually become standard practice, and making the right decisions now will make companies stand apart from their competitors. Importantly, regulators around the world are taking notice of this evolution in healthcare and are bringing the regulatory environment up to speed.
SaMD Solutions: Quality Healthcare in the Digital Age
High-impact SaMD uses the latest technologies, propelled by artificial intelligence (AI) and machine learning (ML). AI/ML systems can increase software performance by self-learning, which is based on designing software algorithms to adapt over time according to data collected from portable devices, such as smartphones. This is why SaMD is the frontier of new treatment solutions for patients and healthcare providers (HCPs) alike.
SaMD aims to improve therapy outcomes by treating, monitoring, preventing or mitigating health conditions. Key issues where SaMD can expand current therapy impact are patient adherence to treatment, including compliance with treatment guidelines, delayed responses to deteriorating health issues, such as side effects to medication, and monitoring treatment progress of patients with limited access to healthcare facilities.
The innovations provided by SaMD integrate the patient into the treatment plan, which makes it both more accessible and personalized.
This is particularly important for patients with chronic diseases, where lifestyle changes can greatly improve treatment outcomes.
Ongoing feedback from the SaMD provides the opportunity to fine-tune the details of the software, making it more user-friendly and also fueling more innovation.
The benefits of SaMD to HCPs are far-reaching, as data are easily shared across various platforms, keeping HCPs updated in real-time on patients’ current health status. Software can also provide a patient’s medical history, helping doctors and nurses make improved decisions on patient care.
New Types of Therapeutics for Pharma
SaMD allows pharma to further their research on diseases by capturing standardized, real-world data across regions. The more data is fed into SaMD algorithms, i.e. generated from a smartphone app or from detectors on wearables, such as smartwatches, the better the performance of the algorithm—it self-creates tailored solutions to the problem, becoming “smarter” with each user.
Improved data quality has the potential to bring new insights to clinical trials. SaMD can circumvent current challenges of clinical trials, such as low clinical trial participation, due to, for example, mobility issues and additional time required for travel to clinical trial centers. The use of AI-driven digital technologies has the ability to increase clinical trial participant enrollment, retention, and treatment adherence, as well as facilitate data collection and digital analytics. An additional advantage of digitizing clinical trials would be an advance in participant diversity, ensuring that participation in clinical trials is available to under-represented patients.
By bringing comprehensive digital solutions to market, pharmaceutical companies diversify treatment options beyond drug discovery.
Chronic lifestyle diseases make up 80% of healthcare costs and standard treatment often doesn’t improve long-term health. Combining a behavioral approach with traditional pharmacologic solutions could significantly change clinical benefits. At the same time, SaMD usage has the potential to lower the costs of patient care by reducing resource-intensive in-person visits with HCPs. At a larger scale, minimizing the root cause of chronic diseases by changing patient lifestyle factors will also decrease costs by substituting symptom treatment in the current fee-for-service model.
Putting SaMD through the regulatory process sets it apart from other digital health products, and is worth the time required to bring the product to market. Regulatory compliance ensures safety and consistency, which boosts user’s trust in the software, but also conveys the stellar quality of the product.
Software as a Medical Device Classification in the United States
The US was the first country to identify that some software functions qualified as medical devices. By 1980, software that was integrated into medical devices, such as magnetic resonance imaging (MRI) scanners, was subject to review by the Food and Drug Administration (FDA) as part of the premarket approval process.
In 1976, the Medical Device Amendments to the Food, Drug, and Cosmetic Act (FD&C Act) were established, creating a three-class, risk-based classification for medical devices. Class I and II are low and moderate risk devices, respectively, and require a 510(k) premarket notification submission before they’re marketed, unless the device is exempt from the 510(k) requirements.
The 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective (substantially equivalent) to a legally marketed device that is not subject to Premarket Approval (PMA). If there is no existing comparable medical device, but the device is still considered moderate to low risk, it may enter the market through the De Novo pathway (i.e. a regulatory course of action intended for medical devices that are considered generally safe and effective, but with no comparable device on the market); otherwise, it’s classified as a Class III device. Class III medical devices require a Premarket Approval (PMA) from the FDA, which is the most rigorous type of marketing approval.
Challenges in Regulating SaMD
The current regulations for medical devices were designed for hardware, and so the rise of new technology has brought on various regulatory gaps that make it difficult to classify software devices, particularly stand-alone software devices such as SaMD. For example, software can be quickly modified, and these modifications would have to be reviewed each time by the FDA. SaMD may also have more than one type of intended use, which may be hard to define within the existing regulatory framework.
When considering Class I and II devices, the 510(k) process before market launch requires a “substantially equivalent” device, but singular AI/ML algorithms of SaMD may make it impossible to find a device to compare it to. Additionally, cybersecurity and quality control are critical issues when it comes to regulating software.
New FDA Regulations for SaMD on the Way
In February 2020, the FDA made a significant step by granting marketing authorization to AI-based cardiac ultrasound software, via the De Novo premarket review pathway. An Action Plan for AI/ML-based SaMD was published by the FDA in January 2021, which addresses the next steps for regulating medical device software. The Action Plan also mentioned the launch of the FDA’s Digital Health Center of Excellence, whose goal is to “empower stakeholders to advance healthcare by fostering responsible and high-quality digital health innovation.”
In 2017, the FDA established a Software Precertification (Pre-Cert) Pilot Program, which aims to develop a simplified and efficient regulation model for SaMD. Pre-Cert will evaluate both the manufacturer and the product to ensure FDA standards for safety and effectiveness, and they will be continuously verified.
While these new regulations are still in the pipeline, what’s important is that the FDA has recognized that the current regulations fall short when dealing with SaMD and that the process of building new regulatory pathways has been initiated.
Here and Now: Getting a SaMD Up and Running in the US
The first step to registering a new SaMD in the US is to search the FDA product code classification database for the name and product code, which identify the category of a medical device. This database is updated weekly. Alternatively, sponsors can request feedback from the FDA through a pre-submission form. Depending on the class of medical device, the FDA then requires product registration, 510(k), De Novo submission, or a Premarket Assessment.
Effective Partnerships with Existing Digital Platforms
It’s essential for pharma companies to adapt to the new regulations and prioritize SaMD to unlock value in the industry. Recently, Sidekick Health has conducted a pilot study for SaMD that aims to help patients with atopic dermatitis (AD). The AD program will be used in combination with standard treatment, and is designed to monitor patient symptoms, as well as psychological and lifestyle factors.
Digital platforms, like Sidekick Health, partner with pharmaceutical companies to bring together traditional medications with digital treatments. SaMD can be developed to connect with a pharmaceutical company’s drug and then modified specifically towards the clinical program. This also cuts costs for pharma companies, since they don’t have to invest in building digital solutions in-house. High-end digital platforms are trustworthy, as they already have the technology and know-how that engage with users, improving health outcomes. They’re also familiar with navigating the regulatory landscape to launch new products, which also reduces the time needed to get the product to market.