What is SaMD?

Software as a medical device (SaMD) refers to software that is intended to be used for medical purposes. It's like having a medical tool but in the form of software that can perform activities and fulfill purposes autonomously, since it’s not part of a hardware medical device.

SaMD can come in various forms, from systems that track heart rates to complex software used in laboratories. Such solutions are designed to help in many areas of the medical industry, for example with medical diagnosis, treatment, and monitoring patients’ health.

SaMD vs SiMD

What is the difference between SaMD and SiMD? Software as a medical device (SaMD) and software in a medical device (SiMD) are similar terms, but they work in different ways.

Software as a medical device (SaMD)

Stand-alone software: SaMD refers to software applications that operate independently. They don’t require any physical hardware to function and are able to diagnose, treat, monitor, or prevent medical conditions, diseases, or injuries.

Direct patient impact: SaMD directly influences patient care, often serving as a patient-facing solution. It plays a pivotal role in healthcare by providing services like remote monitoring, diagnostics, or personalized treatment plans.

Example: AI-driven software that analyzes medical images, such as X-rays or MRIs.

Software in a medical device (SiMD)

Embedded software: SiMD is software that's intricately woven into the functionality of a medical device. It's like the brain inside a medical machine that ensures that the device operates as intended. Thus, it cannot function on its own without specific software.

Indirect patient impact: Unlike SaMD, SiMD doesn't have a direct interface with patients. Instead, it plays a crucial role in the background and guarantees the proper functioning and accuracy of medical devices.

Example: An app integrated into a pacemaker to control heart rhythms and optimize patient cardiac health.

Who can use SaMD applications?

SaMD is not only for doctors, as it can meet the needs of different groups.

Patients

SaMD can function as medical sensors that measure specific physiological parameters. The software interprets data from these sensors to monitor and manage patients' health.

Laboratories

SaMD can also be used in the laboratory. It can help interpret laboratory results, automate data analysis, and generate reports for healthcare professionals.

Doctors

SaMD can also be a system for doctors – for example, it can help analyze data and make it easier for them to draw accurate conclusions. It can also speed up the process of recognizing disease in order to better diagnose patients.

Surgeons

SaMD can be a surgical tool that can increase precision and control during procedures. It can also offer advanced automation capabilities that contribute to reducing the margin of error and improving overall surgical outcomes, which makes it indispensable in modern healthcare settings.

Clinics

SaMD in this category assists healthcare providers in making informed decisions about patient care. Such systems can help with clinic management, process optimization, and automation, etc.

What are some examples of SaMD?

Now let’s look at some real examples of using SaMD on a daily basis.

1. Radiology software for interpreting x-rays and AI-powered tools for diagnoses

SaMD for medical imaging and visualization aids in the interpretation of images like MRIs, CT scans, and ultrasounds. These SaMD applications analyze different types of data to provide accurate diagnoses.

2. Software that delivers cognitive behavioral therapy for mental health conditions

Therapeutic SaMD is designed to provide treatments or interventions to patients. They can include software-guided therapy sessions, rehabilitation programs, or pain management applications.

3. Remote patient monitoring systems and sleep tracking software

This type of SaMD helps in the continuous monitoring and tracking of a patient's health. It collects data from various sensors or devices and provides real-time insights.

Medication management systems and tools for maintaining personal health records

These examples of SaMD include blood pressure monitors, glucometers, and pulse oximeters. These applications help patients manage their health and wellness. They can help with diet and nutrition, remind people about taking medicines, inform about low metrics, and more.

How is SaMD regulated?

If an entrepreneur wants their system to belong to SaMD then they must adhere to many regulatory standards, conduct clinical evaluations, ensure data security, and meet many other evolving requirements.

SaMD around the world

Regulations for SaMD are not confined to one specific region. In fact, SaMD is subject to global regulatory frameworks due to its potential impact on patient health. Many countries and regions have established their own regulatory bodies to oversee SaMD. These regulations typically revolve around safety, effectiveness, and data security.

However, there are also international organizations like the International Medical Device Regulators Forum (IMDRF). They have a big role in harmonizing regulatory approaches worldwide. Collaboration with the IMDRF aims to streamline SaMD regulatory processes, make it easier for manufacturers to navigate the global market, ensure SaMD compliance with many obligations, and maintain the highest standards of quality and safety.

SaMD in the EU

The European Union has its own regulatory framework. SaMD in the EU falls under Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR), respectively. These regulations classify SaMD based on risk, with Classes I, IIa, IIb, and III. Manufacturers must adhere to specific requirements and conformity assessment procedures based on their SaMD's class.

In addition to classification, EU regulations emphasize post-market surveillance, clinical evaluation, and risk management. Manufacturers must also appoint an authorized representative within the EU if they are based outside the region. This ensures compliance with EU regulations and facilitates market access.

SaMD in the US

In the United States, the Food and Drug Administration (FDA) oversees the regulation of SaMD. The FDA classifies SaMD into three categories based on risk: Class I, Class II, and Class III.

To market SaMD in the US, manufacturers may need to submit 510(k) premarket notifications, premarket approval applications, or follow the De Novo pathway for Class I or II designation. The FDA also emphasizes the importance of post-market surveillance in monitoring SaMD safety and effectiveness.

How is SaMD classified?

And how is software as a medical device classified in the European Union, the United States, and around the world?

Classification of SaMD in the EU

In the European Union, there are four main SaMD risk classes:

• Class I: SaMD with low or minimal risk. This includes software that supports general wellness or is intended for administrative purposes. Class I devices are subject to fewer regulatory requirements.
• Class IIa: SaMD with moderate risk. This category may include software used for monitoring, diagnosis, or treatment that doesn't pose significant risks. Manufacturers must meet stricter requirements than Class I devices.
• Class IIb: SaMD with higher risk. This class includes software used in more invasive procedures or for critical monitoring. Manufacturers must adhere to stringent regulatory requirements, including clinical data.
• Class III: SaMD with the highest risk. This class includes software that supports or sustains life, such as diagnostic software. Class III devices undergo the most rigorous regulatory scrutiny, including clinical trials and conformity assessments.

Classification of SaMD in the US

In the US, the FDA uses a three-tier classification system:

• Class I: SaMD with low to moderate risk. Class I devices pose the least risk and are subject to general regulatory controls. Many Class I devices are exempt from the requirement of premarket notification.
• Class II: SaMD with moderate risk. Class II devices require special controls to ensure safety and effectiveness. Manufacturers may need to submit a 510(k) premarket notification, demonstrating substantial equivalence to an existing device.
• Class III: SaMD with the highest risk. Class III devices undergo the most rigorous regulatory scrutiny including premarket approval (PMA), which requires comprehensive clinical data and evidence of safety and effectiveness.

Worldwide IEC 62304 software classifications

We also have IEC 62304 software classifications, which are another way to categorize medical device software based on its risk level. They are used in various countries around the world. Their three main classes are:

• Class A: Software in this class poses the lowest risk. It includes systems that don't directly impact patient safety, like administrative tools.
• Class B: This class is for software with a moderate level of risk. It includes tools that support healthcare but aren't the primary focus, like monitoring software.
• Class C: Class C is for software with the highest risk. It includes systems that directly affect patient safety, like treatment planning software.

How does SaMD categorization look?

In order for software to be recognized as a medical device, it must go through categorization. This is a meticulous process that requires manufacturers to go through several critical stages and meet rigorous obligations. It takes into account many factors, including risk assessment, intended use, and indications for use.

Once these elements are carefully determined and evaluated, the SaMD is assigned a specific class.

This classification is pivotal for several reasons. For example, it determines the regulatory pathway that the manufacturer must follow, like the requirements for pre-market approval, post-market surveillance, and the extent of clinical evaluation needed. Second, it ensures that the system adheres to the necessary quality standards appropriate for its risk level. Also, thanks to it, regulators and manufacturers work together to guarantee that these innovative products can deliver their intended benefits.

The software development process for SaMD

The development process for software as a medical device is a structured way of creating a medical system. It aims to guarantee that the software is safe, effective, and complies with all the rules.

It includes the following stages:

1. Planning – first, you need to establish what the software will do and how it will help in the healthcare industry. Some questions you might ask are “What should it look like?”, “What features should it have?”, and “What regulations should it comply with?”
2. Design – another crucial aspect is design. Think about how the software should look so it will be easy to use and intuitive. Make sure it's user-friendly and meets the needs of both doctors and patients.
3. Regulatory compliance – make sure the project follows all of the rules and regulations for medical devices. This is very important for safety.
4. Development – this is when the actual coding takes place. Your partner’s programmers write the code that makes the software work according to the design.
5. Testing – next, testing to help find and fix any bugs or problems to ensure correct functionality and safety.
6. Documentation – your software development partner keeps records of everything they did during the development process. This helps in case there are questions or issues later.
7. Maintenance and monitoring – after the software is put into use, it needs to be maintained and monitored. This includes observing and fixing any problems that arise and keeping the system up to date.
8. Feedback – listen to feedback from doctors, patients, and users to improve the software further.

In a nutshell, the software development process for SaMD is like building a reliable and safe tool for healthcare, making sure it follows all the rules and keeping it in good shape for the benefit of patients and healthcare providers.

However, this is not a simple process, that’s why a manufacturer often chooses a software development partner.

Choose a partner for SaMD

Choosing a partner for SaMD projects is not just a matter of convenience but a strategic decision that impacts the product's success and compliance.

Why? Because a specialized partner:

• understands the unique challenges of developing software that interacts with the healthcare ecosystem,
• ensures the software is not only compliant but also user-friendly, accessible, and genuinely useful,
• brings to the table a wealth of experience in navigating the complex regulatory landscape that governs medical devices,
• contributes to strategic planning and helps manufacturers to identify market needs, align product features with those needs, and navigate the product lifecycle efficiently,
• and can offer scalability solutions to guarantee that the software can grow and adapt in response to emerging changes.

The right software development partner, like Polcode, can accelerate the journey from concept to market and ensure the SaMD is built to the highest standards of reliability, safety, and efficacy.

Leverage the power of software as a medical device

SaMD represents a transformative category of healthcare technology that comprises software applications designed to perform medical functions without the need for physical hardware. Such systems continue to evolve, and their impact on healthcare is undeniable. From empowering patients to helping doctors and improving the precision of surgical procedures, they have become an integral part of modern healthcare.

Looking ahead, SaMD promises even greater integration with new technologies. By doing so, it will undoubtedly pave the way for more innovative solutions and further expand its role in healthcare development.

SaMD FAQs

What is SaMD?

SaMD, or software as a medical device, refers to stand-alone software intended for medical purposes that can play a crucial role in healthcare.

What is the difference between SaMD and SiMD?

SaMD refers to standalone software for medical purposes, while SiMD is embedded software within medical devices. SaMD directly impacts patient care, while SiMD ensures the functionality of medical devices.

Who can use SaMD?

SaMD can be used by various groups including patients, laboratories, doctors, surgeons, and clinics for purposes like monitoring, diagnosis, treatment, and health management.

What are some examples of SaMD?

Examples of SaMD include radiology solutions for interpreting X-rays, AI-powered diagnostic tools, mental health therapy software, remote patient monitoring systems, and medication management applications.

How is SaMD regulated?

SaMD is regulated globally, with varying regulatory frameworks in different regions. In the EU, it falls under the MDR and IVDR, while the FDA oversees regulation in the US.

How is SaMD classified?

SaMD is classified based on the level of risk it poses to patients, with categories such as Class I, IIa, IIb, and III in the EU or I, II, and III in the US Classification helps determine regulatory requirements and safety standards.