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Despite being considered niche, the SaMD market is one of the fast-developing medtech subindustries. The global SaMD market accounted for $1.02 billion in 2022 and is anticipated to reach $3.39 billion by 2029 (source ). It is expected to register a CAGR of 18.7% over the forecast period from 2023 to 2029.
One of SaMD's essential advantages is that building applications for SaMD requires fewer resources than hardware development, resulting in rapid growth and maturity.
Therefore, the largest medical centers, pharmaceutical, and insurance companies, for example, Mayo Clinic, Aetna, or Cleveland Clinic, are actively using SaMD in their practice and for research purposes. Besides, they develop their own and invest in third-party next-generation medical products (source ).
At Binariks, we provide SaMD development services to businesses interested in driving the future of healthcare.
Use cases of SaMD include a wide range of medical manipulations, like diagnosing, monitoring, clinical management, suggesting treatments, and more. So, in this article, let's consider various examples of software as a medical device and its benefits in addressing the different needs of patients.
SaMD for diagnosis and treatment
By analyzing complex medical data and providing insights into a patient's health, SaMD companies assist healthcare providers in making informed decisions that lead to better treatment planning.
From ECG analysis to breast cancer diagnosis and CBT, SaMD can improve patient outcomes and streamline healthcare delivery.
ECG Analysis Software
SaMD for electrocardiogram (ECG) analysis is used to diagnose heart conditions such as arrhythmia, myocardial infarction, heart failure, etc. The software analyzes the electrical activity of the heart captured in the ECG signal and provides insights into the patient's heart health.
For example:
- KardiaAI
Computer-aided diagnosis software for breast cancer
SaMD for breast cancer diagnosis uses image analysis techniques to assist radiologists in detecting lesions, masses, and other abnormalities that may indicate the presence of cancer. The software analyzes mammograms or other medical images of breast tissue.
For example:
- Koios DS
Cognitive behavioral therapy software
SaMD for cognitive behavioral therapy (CBT) helps to treat depression, chronic insomnia, and other mental health conditions. Such software can provide interactive exercises and interventions that help patients learn new coping skills, improve their mood and sleep, etc.
For example:
- Somryst
- Feel Therapeutics
Pulmonary function testing software
This example of SaMD is used to diagnose respiratory conditions like asthma, bronchiolitis obliterans syndrome (BOS), chronic obstructive pulmonary disease (COPD), and combination diseases.
For example:
- ComPAS2
- AI-Rad Companion (Pulmonary)
Sleep diagnostics software
Some SaMD for sleep analysis serves as a diagnostic tool. Physicians can use it to evaluate a patient's sleep quality and improve the efficiency of diagnosing various sleep and respiratory-related sleep disorders.
For example:
- Sandman Elite
Learn whether your product has to comply with the latest regulations Read more What regulations apply to your SaMD?
SaMD for monitoring and management
SaMD for monitoring and management offers real-time tracking and sharing of data with a healthcare provider, allowing for more informed decision-making.
Thus, physicians can track and react in time to initial symptoms or any changes in the condition to avoid complications.
Continuous glucose monitoring software for diabetes
This type of software analyzes data from glucose meters and provides real-time information on blood glucose levels, including trends and patterns. It allows individuals with diabetes to make informed decisions about their diet and medication management.
For example:
- One Drop Blood Glucose Monitoring System
- Dario Blood Glucose Monitoring System
Sleep apnea monitoring software
This software analyzes data from a microphone-enabled device to detect breathing patterns and apnea events, and it can rouse the patient in case of interrupted breathing. Using such SaMD, healthcare providers obtain reports regarding the effectiveness of treatment, such as continuous positive airway pressure (CPAP) therapy
For example:
- EnsoSleep
- SleepImage System
Medication management software
This is one of the most common SaMD examples. Such apps are designed to help patients manage their medication schedules. Besides, this software allows healthcare providers to monitor patient medication usage and adjust prescriptions as needed.
For example:
- Medisafe
- AiCure
Remote Patient Monitoring Software
RPM software is designed to help healthcare providers track patients' vital signs, symptoms, and medication usage from a distance. This enables them to intervene quickly if necessary and prevent complications.
For example:
- Capsule Surveillance
- Healthentia
We've revamped an FDA-authorized self-testing outbreak monitoring app, read how Read more COVID-19 Testing Mobile App
SaMD for prevention and wellness
Examples of software as a medical device for prevention and wellness include various apps that promote healthy behaviors and increase a patient's engagement. They typically monitor health metrics and offer personalized insights and guidance for lifestyle changes.
Fitness and nutrition tracking software
Most consumer apps promoting a healthy lifestyle are not software as medical device examples. Yet, a lot of diseases can be prevented and managed by the means of diet and physical activity. Fitness and nutrition SaMD solutions often target obesity, eating behavior problems, diabetes, migraine, etc.
For example:
- sinCephalea
- Fitterfly
Mobile apps for smoking cessation
Such apps track users' progress, provide personalized guidance, and even measure carbon monoxide levels in their breath. Smoking cessation SaMD can also automatically share the relevant data with a physician, providing them insights into the patient's response to treatment.
For example:
- CureApp SC
Women's health software
Women's health software can provide personalized insights into fertility, track symptoms, and recommendations for birth control and reproductive health management. Certain SaMD solutions are positioned as a method of digital contraception.
For example:
- Natural Cycles
- Clue Birth Control
We engineered a platform for patient monitoring and data management Read more Primary Care Platform
What medical devices are not SaMD
Not all medical software or software for medical devices are examples of SaMD solutions. All these tools have significant differences, even if targeting the same clinical conditions.
Complete guidance on SaMD is provided in IMDRF documents. Yet, for easier understanding, we'll go from the opposite.
Let's clarify what products are NOT SaMD examples, though often confused with them:
- Software that is embedded in a medical hardware device, since it does not have an independent medical function
- Software that encrypts data from a medical device before it is transmitted elsewhere, because it does not have a true medical purpose
- For the same reason, any medical device software examples that are intended to analyze and monitor the performance or functioning of medical hardware
- Software that enables clinical communication, workflow, etc., including EHR systems, E-prescribing software, hospital management software, and others created for non-medical purposes
Finally, for software to be positioned as a SaMD, it must conform to the relevant regulatory requirements.
According to the FDA:
"The assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety, performance, and effectiveness of the device when used as intended by the manufacturer."
In other words, SaMD must be based on clinical evidence generated with a level of rigor corresponding to their impact and risks.
Thus, far from all health and wellness apps can be considered examples of SaMD. For instance, the research on smoking cessation apps showed that out of more than 700 apps, only 30 had at least some kind of publicly available studies associated with them (source ).
Our experience and solutions
Binariks specializes in providing businesses with custom software development services. In particular, our developers are skilled in building healthcare solutions and can assist in creating SaMD of any type.
The Binariks expertise in SaMD development is demonstrated by our portfolio, which includes developing a remote patient monitoring platform .
We provide a broad range of services, from product ideation, UI/UX design, and software development to testing and deployment, ensuring compliance with HIPAA Rule, reliability, scalability, and security of the software.
To get more insights into the SaMD development process , we have made a comprehensive guide that may be of interest to healthcare organizations and other companies interested in developing such software.
Conclusion
Technology is rapidly transforming the healthcare industry by offering innovative, cost-effective, patient-centered tools like SaMD.
For now, software as a medical device is one of the fastest-growing sectors in digital healthcare. It has already proven its benefits in many areas, including monitoring, diagnosis, disease management, therapeutics, and more.
Do you want to contribute to the growth of this field and create your own product? Binariks provides customized software development services, compliance expertise, and quality assurance for building SaMD solutions of any type.
