Software has frequently played an important role in medtech as the foundation of software-based devices such as glucose monitors, imaging technologies, or patient monitor systems. The role of software for these medical devices was as part of the system, creating applications to manage device use, analyze data, and manage long-term patient health and outcomes. Software as a medical device (SaMD) is changing the field by becoming the device itself, reaching beyond next-generation device applications and augmenting physician decision-making to allow a greater focus on the patient, especially when this attention is critical to the outcome. 

Why This Is Important

Formerly considered a niche market, SaMD is one of the most rapidly growing medtech segments. Globally, the SaMD market was reported to be $1.8 billion in 2022 and was expected to reach $7.68 billion by 2032 with a CAGR of 17.5% over the forecast period.¹

SaMD is an important market because it represents the development of software applications that can significantly improve patient care by enabling data analysis, personalized treatment plans, remote monitoring, early disease detection, and faster diagnosis—all drivers of better health outcomes. Other potential benefits of SaMD are increasing market access and the reduction of healthcare costs.² SaMD essentially leverages technology to enhance medical practice and decision-making through data-driven insights. 

SaMD is important for several reasons.³

Improved patient engagement and motivation—SaMD can encourage patients to proactively manage their health by tracking vital signs, monitoring symptoms, and adhering to treatment plans through user-friendly mobile apps. 

Real-time data analysis—SaMD can offer healthcare providers real-time insights into patient conditions by gathering and analyzing data continuously, allowing timely interventions and rapid adjustments to treatment strategies. 

Early disease detection—Preventive health measures can be enabled with SaMD’s advanced algorithms and machine learning to identify potential health issues early through data analysis.

Personalized medicine—Treatment plans can be created based on individual patient data, leading to greater targeting and effective therapies.

Remote patient monitoring—SaMD facilitates remote monitoring of patients, particularly those with chronic conditions, allowing for better management without requiring frequent in-person visits. 

Innovation and rapid development—SaMD allows faster development cycles and easier updates compared to traditional medical devices, enabling rapid innovation in healthcare. 

Cost-efficiency—By optimizing healthcare processes and reducing unnecessary visits, SaMD can potentially contribute to lowering healthcare costs. 

SaMD arrived in the nick of time with the ever-growing concern over the U.S. healthcare system’s fiscal costs. In 2009, the Social Security Advisory Board alerted the nation that the healthcare cost trajectory was “unsustainable” and “perhaps the most significant threat to the long-term economic security of workers and retirees.”⁴ In that same year, the United States spent almost $2.5 trillion on healthcare, or $8,160 per U.S. resident.⁵ About a decade and a half later (2023), the U.S. spent $14,570 per person on healthcare, totaling $4.9 trillion—17.6 % of the country’s GDP (Table 1).⁶

In comparison, the U.S. spent 7.2% of its GDP on healthcare in 1970 ($75 billion; $356 per resident).⁵ In addition, relative to the size of its economy, the U.S. spends a greater amount on healthcare than other high-income nations.⁷ Like most wealthy countries, the U.S. tends to spend more per person on healthcare than poorer countries. However, even among its peers, the U.S. spends a far greater amount per person on health. 

Comparing healthcare spending in the U.S. to other countries is complex because each country has distinct social, political, and economic variables that influence its spending. Health spending correlates with country wealth, but on average, other large, wealthy countries spend about half as much per person on health as the U.S.⁷ SaMD may be a factor in reducing the U.S. healthcare spend.

Defining SaMD

The International Medical Device Regulators Forum (IMDRF) defines Software as a Medical Device as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” This means SaMD, as software, is a standalone medical device, intended to treat, diagnose, monitor or drive patient care.⁸ 

Software that performs any of the following tasks are examples of SaMD.

• Collects data from multiple sources and synthesizes that data into a score that can be used by doctors for developing a treatment plan
• Allows a clinician to view imaging from a CT or MRI on a smartphone for diagnostic purposes
• Analyzes image post-processing to detect tumors or vascular issues processing large amounts of data
• Collects and analyzes data, employing an algorithm to develop a treatment plan for a specific disease state
• Collects data from multiple sources (EMR, hardware, etc.) and allows clinicians to view the data in real-time from a remote location
• Analyzes images from an endoscope and displays information such as anatomy to avoid in preparation prior to surgical procedures
• Companion app that provides patient education, personalized goal setting, progress tracking, and real-time support
• Mobile app that monitors a patient’s glucose levels or heart rate and makes treatment recommendations to the doctor and patient

According to the IMDRF, software that does not diagnose, treat, mitigate, or prevent disease is not qualified as SaMD. For example, fitness or wellness apps are not SaMD and are not regulated by the FDA. Also, electronic health records and patient portals that allow patients to access their healthcare plans and appointment information are not examples of SaMD.

Difference Between SiMD and SaMD

Software in a Medical Device (SiMD) refers to software embedded into physical medical devices that controls and manages those devices to guarantee they are performing to their intended use. SiMD either powers the mechanics of a medical device or processes the information produced by the medical device itself (think imaging or patient monitors). If a medical device will not work without specific software, the software is SiMD. Other examples are intra-aortic balloon pumps, pacemakers, infusion pumps, or software that displays the user interface for devices.

The Medi-Vantage Perspective

Healthcare and medtech are complex, and so are the software systems that support them. Knowing what features to include in a new SaMD concept is the critical first step to developing this type of technology and most likely requires the robust voice of the customer. Don’t skip this important first step.

References

¹ tinyurl.com/mpo250101
² tinyurl.com/mpo250102
³ tinyurl.com/mpo250103
⁴ tinyurl.com/mpo250104
⁵ tinyurl.com/mpo250105
⁶ tinyurl.com/mpo250106
⁷ tinyurl.com/mpo250107
⁸ tinyurl.com/mpo250108

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Maria Shepherd has more than 20 years of experience in marketing in small startups and top-tier companies. She founded Medi-Vantage, which provides marketing and business strategy for the medtech industry. She can be reached at mshepherd@medi-vantage.com. Visit her website at www.medi-vantage.com.