SOFTWARE AS A MEDICAL DEVICE (SaMD). Part 1: What SaMD is and why it matters when treating diseases

As technology continues to advance all aspects of healthcare, software is widely integrated into digital platforms to support both clinical and administrative tasks. Certain categories of software used in medicine, especially in clinical practice,are basically medical devices.

In this article, we will look at the concept of software as a medical device (SaMD), talk about its importance in the field of MedTech and how the Pre-Cert certification program allows you to quickly bring an SaMD product to market.

According to FDA (US Food and Drug Administration) and International Medical Device Regulators Forum, SOFTWARE AS A MEDICAL DEVICE (SaMD) is a class of software that is designed to perform one or more medical functions without being part of a hardware medical device.

For example, SaMD includes mobile applications for treatment, diagnosis, disease prevention, patient management and routing.

The defining feature of SaMD is that there is no need for medical equipment to perform its functions, but it can be used in conjunction with traditional medical devices or other medical equipment.

It is important to note that SaMD is not software designed to provide a physical medical device (equipment), which is SiMD —  Software in a Medical Device.

SaMD is a stand-alone class of software products designed to perform medical functions, which can interact with other hardware medical equipment or devices, but at the same time exists independently of them. 

To determine if a product under development meets the SaMD definition, the following two questions need to be answered:

Question 1: Is the product a medical device? In other words, is there a medical benefit from using it, is there a risk for the patient if it is defective or used incorrectly, i.e. whether the product has a medical function.

Question 2: Can the product work independently of other medical devices or equipment? If the product supports a medical device and this medical device does not work without it, then such a product is considered SiMD —  Software in a Medical Device, and not SaMD.

• SiMD is the software that helps radiologists and clinicians find and diagnose cardiovascular disease by analyzing MRI scans. And the part of the software that is needed directly for the MRI machine.

•  SaMD is a mobile application that accepts input from a patient's glucometer and nutritional log to provide insulin dosage recommendations for diabetes.  

• SaMD is a mobile application that tracks the growth of a mole over a period of time to assess the risk of melanoma.

• SaMD is software that analyzes the patient's medical history and diagnostic data to determine the correct drug.

It is important to note, however, that the software that collects, extracts, or organizes factual medical data is not SaMD or SiMD. For example, an electronic health record (EHR) system is neither SaMD nor SiMD.

These categories are based on patient or public health exposure levels. The information provided by SaMD is used to treat, diagnose, and adjust the clinical management of patients. The higher the category, the more complex the SaMD device and the more information the software can provide, which has a greater clinical effect. 

Category I — software designed for:

• collecting symptom diary data to calculate the likelihood of asthma attacks;

• analysis of eye movement in the diagnosis of astigmatism;

• storing blood pressure information for later viewing.

Category II:

• software that predicts the risk of heart disease;

• software that combines and analyzes test results to suggest a diagnosis.

Category III:

• software that detects intermittent breathing through a smartphone microphone;

• software for monitoring the progression of dermatological diseases in skin diagnostics.

Category IV:

• software that can perform diagnostic analysis of images;

• software that combines the data provided to search for mutational pathogens.

SaMD does not replace doctors, but is an essential tool for better patient care. By helping with aspects of care that can be automated using the latest technology, SaMD can help expedite the diagnosis, management, and treatment of various diseases. 

Defining characteristics of SaMD include:

1. Improving data-driven health outcomes: SaMD can improve the effectiveness of medical devices and existing treatment plans by collecting high-quality data easily and quickly, leading to better patient outcomes.

2. Faster Manufacturing and Feedback to Accelerate Innovation: SaMD extends existing medical device functionality and extends it with software solutions that are faster, and often cheaper, to update than the entire medical device portfolio.

3. Integration and sharing of health data across multiple platforms including the cloud, connected medical devices, smartphones and more.

4. Since SaMD can quickly collect large amounts of data, it can also easily collect patient feedback thanks to its availability, for example on mobile devices.

5. For SaMD companies, this fast feedback loop can enable faster product iteration, faster time-to-market, and faster innovation.

The market for SaMD is expected to reach $ 86,452 million in 2027; it is estimated to grow by an average of 21.9% from 2020 to 2027.

Over the past 40 years, the amount of software used both in medical devices and on its own has skyrocketed. The past 20 years, in particular, have seen an acceleration in this trend thanks to the emergence of the Internet of Things (IoT), cloud solutions, big data and artificial intelligence (AI), which are transforming work in almost all industries. As these advanced technologies continue to cause a seismic shift in how healthcare is administered and what it provides, software is becoming an increasingly common and essential component of highly complex medical devices.

Market developments are mainly driven by the growing adoption of IoT and connected devices in the healthcare sector, as well as the direct benefits of SaMD.

Because of its use in clinical practice, such as clinical trials, SaMD meets the definition of a medical device. To improve the quality and efficiency of healthcare delivery, develop SaMD capabilities and patient safety, the US Food and Drug Administration (FDA) has established the Digital Health Software Precertification (Pre-Cert) program for medical device software.

This program helps to solve the following problems: 

• how to apply the faster design method used in SaMD development;

• how to collect health data both inside and outside the hospital so that problems can be resolved faster;

• how to improve product performance on a much faster time scale;

• how to create a flexible regulatory model that supports a faster pace of innovation in software products, while ensuring high standards of safety and efficiency.

SaMD should be clinically assessed based on two key criteria:

1. The value of information that is directly provided by SaMD and subsequently used in treatment or diagnosis. There is a need for the SaMD information provided to have higher standards of clinical evidence and both analytical and scientific validity.

2. Disease Condition —  When SaMD is used as an intervention for the treatment and diagnosis of acute illness, it must pass more stringent certification tests.

In 2017, the FDA selected nine companies to participate in its Pre-Cert pilot program. The companies selected included some of the largest technology players (Apple, Google, Samsung, FitBit, Johnson & Johnson); digital therapy companies (Pear Therapeutics); and startups such as Tidepool, which are developing free software for diabetes patients.

The FDA recognizes the need to adapt the regulatory environment to the changing technology landscape. The use of SaMD in clinical practice requires a clear certification model, which is the basis for driving faster innovation without losing focus on patient safety.

As described earlier, the benefits of SaMD include: the ability to improve the clinical performance of patients using data; using fast patient feedback to accelerate time-to-market, etc.

Undoubtedly, all the benefits of SaMD will propel the industry forward. However, there is a fundamental challenge that many SaMD developers face: how to integrate modern product development methodology with patient safety, clinical efficacy, and regulatory compliance. 

Pre-Cert Program FDA is designed to address this fundamental problem, enabling patient safety and clinical efficacy. Software pre-certification working model FDA is a guide for SaMD developers. 

It is also important to remember that there is no one-size-fits-all approach for all SaMD solutions. Some approaches may be better suited for budding startups, while others are more suited to the global giants of MedTech.

Regardless of its type, software is changing the digital medicine industry and is causing change in almost every aspect of the sector, including therapy, genetics, drug development, bioinformatics, robotics, diagnostics, and so on. The SaMD niche has seen particularly rapid growth in recent years.

SaMD opens up new opportunities and challenges for both developers and regulators, while ensuring patient safety and clinical efficacy. The FDA and other regulators recognize the great innovation potential of SaMD.

The future of software-based medical devices is interesting not only for patients and clinicians, but also for society as a whole. Looking ahead, some of the technologies that deliver the most value (in healthcare and other industries) may not necessarily be new devices, but companion software that collects critical data, analyzes it, and then delivers relevant results. 

Sources: researchandmarkets.com, pubmed, globenewswire.com, orthogonal.io, International Medical Device Regulators Forum (imdrf.org), Software as a Medical Device (SaMD) | FDA,  npj Digital Medicine (nature.com), The Medical Futurist, The Lancet Digital Health, Software as a Medical Device Market (theinsightpartners.com), Digital Therapeutics Alliance (dtxalliance.org).

In the second part of the article, we will tell you why SaMD is a driver for the development of not only classical medicine, but also startups in the MedTech field. The third part of SaMD articles focuses on AI-based startups that are certified and approved by the US Food and Drug Administration (FDA).