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.