Software as a Medical Device (SaMD): Embracing the Digital Healthcare Revolution

Quick Summary: Software as a Medical Device (SaMD) is a next-era healthcare software used for medical purposes without being an integral element of a hardware medical device. In this blog, we will understand all the ins and outs of the same, alongside its regulatory frameworks, critical implications, major trends, and challenges in the way of implementation. We will also understand how SaMD is distinct from Software in a Medical Device (SiMD), and how Radixweb can help you with your next healthcare venture. So, get reading and exploring.

As per one of the reports by Fact MR on Software as a Medical Device (SaMD), it could be known that the global SaMD market is charged up with a CAGR of 16.7%. With this, it will hit its highest-ever valuation of USD 5.4 billion by 2032. One of the happening statistics on the board, right?

Well, the growth of SaMD is justified, given its major role in evolving the healthcare industry from version 1.0 to 3.0. Presently, in the Healthcare 5.0 era, we can understand the importance of SaMD as a standalone device. It could effectively help in diagnosing, treating, and preventing a wide range of diseases by streamlining certain care aspects to save time.

In this guide, we will explore the different benefits, challenges, and solutions to this medical software in healthcare. Moreover, we will discuss how partnering with a custom healthcare software development company could help you get the best of SaMD. We will guide you in every possible aspect of SaMD and enlighten you with ideas for your next step in the journey.

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What is SaMD? Let’s Start with the Basics

Software as a Medical Device (SaMD) is an individual class of healthcare software capable of performing different medical functions like diagnosis, treatment, monitoring, and prevention, even without the need for other hardware.

IMDRF answers what is SaMD in its Key Definitions Document, “A software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”

For example:

• Medical software development in mobile to view MRI reports
• Medical-purpose software for non-medical platforms
• Fertility applications

The Valuable Role of SaMD in Medical Settings

SaMD founds its place under the umbrella of Digital Health, which further includes applications like EHRs, wearables, mobile health apps, and telemedicine app development. Given this, the benefits of SaMD to the medical setting are of substantial value. Let’s check how worthwhile is SaMD in the healthcare sector -

• Recognizing Medical Condition: SaMD can help patients with customized plans for treatment and minimize the gap between diagnosis and treatment.
• Practicing Observation: SaMD healthcare solutions can be integrated with wearable sensors to collect patient vitals for constant monitoring and alerting.
• Disease Management: It helps patients and doctors to keep a tab on health data and modify treatments accordingly in a personalized manner.
• Digital Therapeutics: It helps in the treatment of acute or life-threatening illnesses as well as chronic diseases by getting embedded on any smart medical device.

Challenges in SaMD Development and Its Solutions

SaMD has become a popular name in virtual health, providing its ability to better the patient's health remotely with quick feedback mechanisms and swifter product iterations. But this popularity doesn’t come easy; it is loaded with a lot of challenges, as mentioned below -

• Integration of modern SaMD development process with patient safety and standards compliance.
• FDA faces concerns about instilling healthcare effectiveness and patient safety alongside boosting medical innovation.
• Best-practices implementation and quick-feedback loops within pilot programs are the challenges faced by large-scale organizations.

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The core challenge of SaMD implementation resides in the misalignment between the different regulatory platforms, such as the MHRA, FDA, and EU MDR. This issue can be best addressed by formulating a common framework for SaMD principles that allows all stakeholders and regulators to instill progressive innovation and prioritizes patient safety.

Another solution could be manufacturers adhering to international compliances, including IEC 62304 and quality management systems. This would help them implement varied standards acceptable by governing bodies, thereby mitigating the complexity of regulatory compliances. This would even provide a solution to locating a global device identification system capable of tracing the SaMD across its medical device software development lifecycle.

Additionally, the FDA has brought in a novel solution in the form of the “Software Precertification Pilot Program” - a SaMD certification. This is a great one, as it will give a single certification to companies that undertake SaMD development rather than focusing on individual SaMD products.

2 Major SaMD Regulations Across the Globe

It is evident from simple research on digital transformation in healthcare that among many markets for medical devices, the US and the EU are the most prominent ones. You must know that any SaMD product is primarily viewed as a medical device, and thus such regulations apply to it.

The US market makes it mandatory for you to adhere to the QSR - Quality System Regulations by the FDA. While on the other hand, the EU market wants you to follow the EU MDR standard (or EU IVDR if it is an in vitro diagnostic device).

Simply put, your SaMD device would be regulated and classified per the province you are in. With that on the board, let’s learn about both the regulations -

1. SaMD Regulation in the United States

FDA’s medical device regulations are formulated with conventional medical devices in focus. This requires them to release guidance documents at specific intervals of time. These are usually targeted at particular software solutions for areas such as premarket submissions, and likewise.

The very initial guidance document for premarket SaMD submission was in the year 2005. Since then, the FDA has been releasing guidance documents, with the latest one put out in the year 2021.

2. SaMD Regulation in the European Union

The EU SaMD regulation is similar to the US SaMD regulation, as it has a lens on the specific standards for conventional medical devices. The SaMD regulations in the EU make it mandatory to adhere to the specific requirements of the EU IVDR and EU MDR.

One differentiation factor is that EU regulations popularize the term “Medical Device Software” or “MDSW,” unlike US regulations that use “Software as a Medical Device.”

Ultimately, we can extract that many regulations were written with conventional hardware medical devices as the base subject. This led them to follow a linear software product development approach, also famous as the waterfall methodology.

But it is worth noting that still, these regulations can use agile in medical device development without hampering any compliance with the relevant standards and compliances.

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How to Ensure Safety and Security of SaMD Medical Devices?

It is no surprise that cyberattacks are increasing with every passing minute, and of course, they are affecting medical device software development companies too. Device makers today prioritize cybersecurity as no other aspect to ensure the safety and privacy of the device users. Here is a list of what different regulatory bodies would demand from the healthcare industry for ensuring the safety and security of SaMD medical devices -

1. Playbook for Threat Modeling Medical Devices: FDA-developed Threat Modelling Playbook offers you a dash of resources for bettering your company’s SaMD security and safety practices.

2. Cybersecurity for Networked Medical Devices: This guidance is specifically for the risks of Off-the-Shelf (OTS) or mass-marketed software in medical devices that could hamper device operations substantially.

3. Post-Market Management of Cybersecurity in Medical Devices: An FDA guidance offering useful recommendations for handling post-market cybersecurity issues and facilitating a 360-degree cybersecurity lifecycle approach.

4. MDCG 2019-16: This guidance document is specially curated for manufacturers who must adhere to Annex I of both EU MDR and EU IVDR for the cybersecurity of medical devices.

5. IMDRF Principles and Practices for Medical Device Cybersecurity: This IMDRF guidance states suggestions, best practices, and general principles for SaMD cybersecurity for device manufacturers and external stakeholders.

The above-mentioned guidelines by different regulatory bodies must be integrated into the SaMD during the software design for medical devices phase to get the best of cybersecurity. You can hire industry's best healthcare software developers who work with you across the development cycle to understand your privacy and security concerns and provide solutions accordingly.

Fine Line of Distinction: SaMD vs Software in a Medical Device (SiMD)

Software as a Medical Device (SaMD) is often confused with Software in Medical Device (SiMD). But there’s a fine line of distinction between the two, that we must consider while segregating our medical devices as one.

SiMD

Software in Medical Device (SiMD) is software that supports the operation of any hardware medical device, whether it be providing mechanics to it or offering a graphical interface. A few instances of SiMD are -

• An embedded software that manages its expansion and shrinkage in a BP (Blood Pressure) cuff.
• A firmware software that manages the conveyance of the correct insulin amount in an insulin pump.
• A micro-code software for a pacemaker employed in a closed-loop system.

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SaMD

Software as a Medical Device (SaMD) is independent software that can operate without being an integral part of any hardware. It can carry out the functions that classify it as a medical device. The IMDRF guidance documents add different clarifying points to make the SaMD definition clear to understand -

• SaMD is classified as a medical device and comprises IVD – In-Vitro Diagnostic device.
• It can perform seamlessly on non-medical purposes or general-purpose computing platforms.
• Any healthcare software solution that intends to operate a hardware medical device is not considered a SaMD.
• SaMD software habitually realizes its deliberate medical purpose, even if it is not an integral element of a hardware medical device.
• SaMD can be used alongside other solutions, like medical devices, in the form of a module.

Major Trends That Shape the Future of SaMD

SaMD is one of the significant moves in the spectrum of digital transformation in healthcare. And this step is supported by an array of trends that one must follow -

Internet of Medical Things (IoMT): IoMT is a top enabler to navigate the data collected by the SaMD devices in an efficient and effective way. It facilitates healthcare data sharing in a way that is beneficial to make timely decisions for both the patients and doctors. Given this, in today’s era, we can see SaMD developers getting into partnerships with IoMT systems for meaningful data sharing.

Smart Wearables: Wearables are advancing minute-by-minute, given their popularity amongst fitness enthusiasts, chronic patients, and even laymen. They have an endless array of smart applications aimed at patient care which is expanding at a constant rate. One example could be medical practitioners using SaMD devices to remotely monitor the crucial vitals of patients, like their BP or heart rate.

Telehealth or Telemedicine: Telemedicine has taken an innovative form since the strike of the pandemic, to make it more user-friendly and efficacious. This trend has boosted the Software as a Medical Device implementation as well, given its ability to gather patient vital rates even from a remote location. This would further boost the demand for medical devices that foster remote monitoring, like EHR and EMR software development.

Other trends that you must follow for SaMD are AI and Robotics, Personalized Medicine, Home Diagnostics/ Diagnostics Consumerization, AR/VR, and likewise.

Medical Device Software by Radixweb: A Sure-Shot Healthcare SolutionSaMD is a prominent player when it comes to medical software development services. It is equally beneficial for developers, patients, doctors, and even investors. Digital health technology has long passed the horizon and healthcare providers are now more habituated with it. You can count on SaMD to be a massive crux of the future of the healthcare industry, capable of lending a bunch of benefits and possibilities towards medical purposes.Though there are certain challenges and grey areas to meet up with, even now, if you have the best healthcare software development company on your side, your organization can surely get your hands on the top-notch SaMD that enhances the lives of millions of patients. It would be a successful equilibrium that leverages both software and technology to improve patient care, optimize processes, and streamlines the quality and efficiency of healthcare delivery.Contact us today and let our seasoned healthcare tech developers guide you every step of your journey, connecting you through every dot of your project, and automatically illustrating closed-loop traceability from within the software.