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What is SaMD? Software as a Medical Device

Software Development

Healthcare software technology has evolved beyond conventional health information systems and diagnostics IoT devices. Over the last decade, innovations in the medical & healthcare sector have given birth to groundbreaking technologies that are entirely revolutionizing patient services.

Even with global economic sectors slowing down, demand for healthcare software & medical devices has grown considerably over the last three years. Experts predict the total market size of medical devices will increase from 3 billion in 2022 to 6 billion by the end of 2023. The global medical software industry stood at .6 billion in 2022 and is predicted to grow to .1 billion by 2028.

SaMD Market Growth

Source: Med Technews

While several innovative trends are influencing global healthcare, the growing popularity of SaMD or custom Software development as a Medical Device is taking the industry like a storm. Investments in R&D, progress in regulation & compliance, and improved adoption have already identified SaMD as one of the most popular solutions in healthcare.

What is SaMD or Software as a Medical Device?

The International Medical Device Regulators Forum or IMDRF (a non-profit alliance of global medical device regulators) defined SaMD as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” Bernard Kappe discusses in his whitepaper that SaMD includes “software or mobile apps development intended to treat, diagnose, cure, mitigate, or prevent disease or other conditions.”

The IMDRF also adds that these innovative technologies are designed to execute on non-medical computing platforms and don’t necessarily require hardware to achieve their intended medical purposes.

Software is not considered SaMD if its target purpose is to operate medical hardware devices, the IMDRF explain definition are also considered SaMD solutions.

How Do SaMD Solutions Work

Software as a Medical Device solutions use A.I. algorithms (like machine learning, natural language processing, & computer imaging) to input data into the software and produce output. These outputs can be reports, analyses or visual markers utilized to make informed treatment decisions & diagnoses of illnesses.

Samd Algorithm

Source: golden


What Are The Benefits of SaMD Solutions?

Since the IMDRF began regulatory compliance with SaMD solutions, vendors claim that development takes longer. While the ROI and patient value are worthwhile, the real test for professional SaMD vendors is to highlight the unique value of solutions to investors.

Positive Impact on Patient Outcomes

SaMD solutions are essential in patient care and positively influence patient outcomes. SaMDs can be leveraged to personalize treatment plans, allowing medical personnel to reduce treatment timelines through more effective diagnoses, especially for chronic diseases.

Real-Time Patient Monitoring & Alerts for Medical Professionals

SaMD solutions can be combined with IoT devices to monitor patients in real-time through sensor technology. The software can be deployed with smartwatches, phones, health bands, and other hardware for real-time vital signs, heart rates, and many other aspects.

Patients can also easily self-monitor their condition when medicating, performing physical activity, and when exposed to environmental factors. Professionals can monitor patients in real-time, especially when performing physical activities, to determine changes and improve treatment plans based on these changes.

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Better Diagnosis & Effective Treatment Plans

SaMD solutions offer holistic medical care, allowing professionals to identify symptoms and possibly multiple illnesses. Medical personnel can make more informed diagnoses with detailed patient histories enabling more precise treatments.

Increased Trust with Regulatory Compliance

The regulatory control over SaMD solutions by the IMDRF has already increased confidence among medical professionals. In addition to improving adoption, SaMD solutions are more trustworthy than non-regulated health solutions.

Real World Insights & Evidence

SaMD solutions provide more precise and real-time data to extract critical analytical insights for treatment, progress, and development of future solutions. Insights can be leveraged to assist with future treatments and enhance care for patients with similar diagnoses.

Five Real Life SaMD Solutions Assisting Healthcare Professionals in 2023

Software as a Medical Device solutions are employed worldwide, with the USA as the most popular market, followed by China and India. Medical professionals leverage these value-driven solutions to make informed decisions through actionable data streamlining treatment plans & concept plans for future solutions.

North America Software

Source: Theinsightpartners

ECG Analysis Software

SaMD solutions are increasingly facilitating ECG analysis to quickly diagnose abnormal and chronic heart conditions.

One of the most popular examples of ECG analysis tools comes from Kardia. This A.I.-powered software improves diagnostic accuracy & efficiency through qualitative assessments of cardiac tissue, simple video analyses of cardiac structures, and machine learning capabilities to measure the progress of heart disease studies.

Breast Cancer Diagnosis Software

SaMD breast cancer solutions assist medical professionals with imaging analysis enabling them to detect abnormalities & symptoms that indicate the existence of breast cancer. Breast cancer SaMDs leverage imaging technology to analyze breast tissue samples, enabling faster diagnosis and better treatments.

One of the most famous examples Qlarity is an A.I. powered diagnostics software that delivers accurate breast cancer diagnosis earlier than conventional techniques. The software is used to assess and visualize abnormalities based on MRI data.

Behavioural Therapy Software

Behavioural therapy solutions are designed to diagnose and treat cognitive illnesses like insomnia, depression, dementia, and many others. This software helps patients cope with their ailments through physical and mental activities, conditions their mood, improves their sleep habits, and engages them in a routine.

A fantastic example comes from Boston, Massachusetts-based Pear Therapeutics, which offers 3 FDA-compliant behavioural therapy software, including reSET for treating substance use disorder, reSET-O for opioid use disorder, and Somryst, developed to treat chronic insomnia.

Pulmonary Function Testing Software

Pulmonary software is rare, and I mean VERY rare. Utilized to diagnose ailments like asthma, COPD, bronchitis, emphysema, and many other pulmonary illnesses.

ComPAS2 is a popular PFT software with a very successful satisfaction rating from patients diagnosed through it. ComPAS2 was built using patient feedback to improve the user interface and new features based on customer insights.

Sleeping Disorder Diagnosis software

Healthcare professionals are increasingly utilizing SaMD for patient monitoring and diagnostics, especially in sleep disorders. Doctors are actively using SDD software to evaluate sleep habits and quality, which assists in improving sleep disorder diagnosis.

In 2021, Korean startup Honey Naps launched its revered SDD app ‘SOMNUM’, which uses A.I. to diagnose sleep disorders. The application is designed to conduct real-time, multi-channel, large-capacity signal analysis to automatically provide polysomnography diagnosis that Honey Nap’s claims are more accurate than legacy treatments & tools.

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How Progatix Helps You Develop High-Performance SaMD Solutions

Progatix has built a prestigious portfolio of world-class software, website, and app development solutions over the last twenty years. We offer a highly experienced team of developers, a strategic development process, professional project management, and leading-edge tech stacks to facilitate the development of top-tier medical software.

We leverage breakthrough software stacks and combine them with innovative A.I. technologies to craft solutions that simplify healthcare practice, diagnosis, patient care, and treatments. Applying cutting-edge tech, including machine learning, computer vision, natural language processing & predictive modelling, we build purpose-driven SaMD solutions to enrich patients lives.

We can develop premium neurological SaMD applications embedded with image analysis, MRI reporting, 3D visual analysis, DICOM reviews, diagnostics, treatment planning, and neuro-navigation features. Our software can be synched with custom or 3rd party mobile applications to perform analysis and to share diagnostics data.

Our team of Next-Gen Custom Software can also build reliable A.I.-powered computer-assisted diagnosis (CAD) software for accurate respiratory, mental, and breast cancer diagnosis. We fine-tune our solutions to perform comprehensive image analysis leveraging historical medical data (available through cloud servers). Our world-class solutions reduce the number of false positives, accelerate analyses, and deliver data-backed diagnoses for better patient outcomes.

Moreover, our clinical decision-making software allows medical teams to perform analysis before & after diagnosis to make connections between patient medical histories and current health. Our software optimizes treatments, including dosage, preventive measures, and other healthcare remedies.

In addition, we also build premium medical ERP (enterprise resource planning) software to enhance the performance of healthcare institutions & clinics. By synchronizing medical institutions’ operational areas, we introduce automation of processes, streamline staff workflows, generate reports, extract business intelligence, and standardize inventory management for more efficient performance.


SaMD remains one of the fastest-growing global healthcare areas, led by the USA, China, and India. Growing at a rate of almost 40%, the SaMD industry is now regulated by various national medical associations that certify all solutions to ensure reliability and patient trust.

Today, SaMD solutions are utilized for various medical services, including diagnosis, treatment, monitoring, drug trial management, medical database management, and more. Learn more about our exclusive SaMD development services, and get in touch with us for a free consultation.

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