<p dir="ltr">It is difficult to think of an area of our day-to-day life that has not been affected by rapid technological development. From our phones and smart home appliances to enormous databases that entire industries rely on, modern humans are intertwined with solutions that help us live more fulfilling lives. It was only a matter of time until the medical sphere was completely revolutionized by portable devices powered by innovative software that allowed medical personnel to perform their services more efficiently. </p> <p dir="ltr"><a href="https://media.market.us/medical-image-analysis-software-statistics/">According to the latest market forecasts</a>, the medical device software market will see a revenue rise to around USD 4.26 billion by 2025, making SaMD development one of the most profitable areas for both aspiring and established entrepreneurs. Luckily, there are plenty of tools and approaches available for those who want to strike the iron while it is still hot. To help you get the best results, we have created a comprehensive guide to the best medical device software engineering practices in 2025. </p> <h2 dir="ltr">Medical device software (SaMD)</h2> <p dir="ltr">Software as a medical device (SaMD) is a program designed for medical purposes. It can interact with various hardware but exists independently from it. SaMD can provide a variety of services, such as diagnostics and patient monitoring. One of the most popular examples of such software is insulin management software, which helps patients monitor their blood sugar levels and promptly reports information to healthcare professionals. In general, SaMD makes healthcare more accessible and efficient. </p> <pre class="language-contactus"><code>{{ "title": "Write ChilliCode", "description": "To help you acknowledge your business needs and decide whether IT services will work for you, I’ve sorted out a list of cases.", "buttonText": "Contact us" }}</code></pre> <p dir="ltr">SaMD applications deal with sensitive data, which makes the process of designing and programming medical devices challenging. When someone’s health is on the line, errors are unacceptable, so all medical device software is held to very high standards. </p> <h2 dir="ltr">Who uses SaMD technology?</h2> <p dir="ltr">Medical device software development is in extremely high demand nowadays. The number of institutions, organizations, and businesses that see the benefits of using SaMD continues to grow, so more enterprises are going to implement it. </p> <p dir="ltr"><img src="https://chillicode.dev/uploads/1_8bc8f1acf8.png" alt="1.png"></p> <h3 dir="ltr">Medical device manufacturers</h3> <p dir="ltr">The first on the list of SaMD users are medical device manufacturers. The hardware part of MedTech solutions developed by those companies requires software for them to function. Without seamlessly integrated software, those devices would not be able to perform the majority of important functions, including data processing and analysis.</p> <h3 dir="ltr">Healthcare organizations</h3> <p dir="ltr">Healthcare organizations and hospitals are among the major clients of SaMD development companies. They often need custom custom medical device software to fit their specific devices to perform patient monitoring and diagnostics and otherwise provide timely care to their patients. </p> <h3 dir="ltr">Research organizations</h3> <p dir="ltr">Similarly to healthcare institutions and hospitals, companies conducting clinical research use software to standardize and store the data they collect with the help of medical devices. </p> <p dir="ltr">Medical device software serves various purposes in the healthcare ecosystem. The intended audience and application area of the solution will dictate the development process. </p> <h2 dir="ltr">Types of medical device software: SaMD vs SiMD</h2> <p dir="ltr">While researching the topic of medical device software, you might have seen another abbreviation mentioned apart from SaMD. SiMD, which stands for software in a medical device, is a concept that seems similar to SaMD at first but is actually completely different. A medical device software developer needs to understand the difference between these two terms. </p> <p dir="ltr">We have already discussed that, in the case of SaMD, the software part of the solution works independently of the device. While SiMD is software that is integrated into the hardware and supports it, SaMD is a separate device that carries out separate functions. For example, software that manipulates the MRI hardware in hospitals and research labs (e.g., taking MRI scans) and enables it to collect data is a SiMD, and the software that interprets the results is a SaMD. Medical applications are almost always SaMD because they mainly display the information they receive from the device in a concise and user-friendly way. </p> <h2 dir="ltr">Classification of SaMD</h2> <p dir="ltr">Each country has its own regulations concerning the quality and safety control of medical devices. For example, in the US, the FDA (U.S. Food and Drug Administration) defines three classes of medical devices. This system is utilized to assign classes from I to III depending on the level of risk a device can potentially pose to users, as well as the level of control and evaluation its needs to be subjected to to be considered safe for use. </p> <div dir="ltr" align="left"> <table><colgroup><col width="200"><col width="200"><col width="233"></colgroup> <tbody> <tr> <td> <p dir="ltr"> </p> </td> <td> <p dir="ltr">Description</p> </td> <td> <p dir="ltr">Example</p> </td> </tr> <tr> <td> <p dir="ltr">Class I</p> </td> <td> <p dir="ltr">The impact on the health of a patient/op operator is minimal</p> </td> <td> <p dir="ltr">Continuous glucose monitoring software</p> </td> </tr> <tr> <td> <p dir="ltr">Class II</p> </td> <td> <p dir="ltr">A higher chance of causing harm to a patient’s/operator’s health; might come into contact with internal organs or be used for diagnostic purposes </p> </td> <td> <p dir="ltr">Medical image processing software</p> </td> </tr> <tr> <td> <p dir="ltr">Class III</p> </td> <td> <p dir="ltr">Devices that support life, can be implanted, or have a high risk of harming a patient’s/operator’s health</p> </td> <td> <p dir="ltr">Ophthalmic surgery software</p> </td> </tr> </tbody> </table> </div> <h2 dir="ltr">The process of medical device software development</h2> <p dir="ltr">While the process of developing medical device software is similar to that of any other software, it has its unique challenges. Let’s review the main steps in developing a SaMD. </p> <h3 dir="ltr">Setting the regulatory requirements </h3> <p dir="ltr">The first step of the SaMD development process always consists of setting the requirements for the future application. When developing SaMD, it is vital to remember that each country has its own regulations concerning medical device software. Thus, developers must be familiar with the regulatory requirements of the countries the product is intended for. For example, in the United States, regulatory bodies like the FDA and HIPAA set the standards that all medical device software developers must follow. </p> <p dir="ltr">Not only is this step crucial to receiving market approval, but it is also an irreplaceable part of ensuring the safety of future users. After all the necessary requirements are gathered, they will be used as a guide for all future decisions. </p> <h3 dir="ltr">Researching the market </h3> <p dir="ltr">Market research is an essential part of any application development process. Identifying the main trends in the industry and pinpointing market gaps will help create a well-received and high-performing product. No less importantly, this stage includes gaining insight from individuals whose interests must be considered. Since the target audience of SaMD technology includes medical device manufacturers, healthcare organizations, hospitals, and research organizations, medical device software developers must familiarize themselves with the specific requirements of each field. </p> <h3 dir="ltr">Building and testing the solution </h3> <p dir="ltr">Finally, it is time to start building custom medical device software. Developers write software based on the previously conducted research, incorporating all the required features in a way that looks authentic and seamless while still adhering to strict standards. They then test the software to ensure it functions as it is meant to. Creating a user-friendly medical device software design and executing quality assurance are the final steps of building medical service software. </p> <h3 dir="ltr">Gaining market approval</h3> <p dir="ltr">Before the medical device software is ready to be released, it has to be approved by local regulators. Once the approval is received, the deployment stage begins. </p> <h3 dir="ltr">Releasing the solution into the world</h3> <p dir="ltr">The last step of the medical device software development process is the release of the solution. However, the work of developers is not done there. Like all software, SaMD has to be monitored after its release to see how it operates in real-life settings. During the monitoring stage, issues that were not caught during the development process are identified. In addition, the software solution has to undergo regular maintenance checks to ensure it works properly at all times. </p> <h2 dir="ltr">Which Tech Stack Should Be Used for Medical Device Software Development?</h2> <p dir="ltr">One of the main challenges of medical device software development is the abundance of tools and solutions available. When assembling the toolkit for your future project, you have to take into consideration its specific features, such as its goals, scope, and the resources you are willing to allocate to it. </p> <p dir="ltr">While the tech stack configuration will look different depending on the situation, some popular tools are used almost universally. Here are a couple of things no software can be created without:</p> <ul> <li dir="ltr" aria-level="1"> <h3 dir="ltr" role="presentation">Integrated development environments (IDE)</h3> </li> </ul> <p dir="ltr">An integrated development environment, or IDE, is a program that provides a platform for software development to occur. It is a combination of various tools that usually include a compiler, debugger, and profiler. Each IDE has its own features and requirements, so developers need to make informed decisions depending on their needs. </p> <ul> <li dir="ltr" aria-level="1"> <h3 dir="ltr" role="presentation">Programming languages</h3> </li> </ul> <p dir="ltr">In 2024-2025, some of the most widely used programming languages are Java, Java Script, C/C++, and Python. In the medical field, the MatLab programming platform is also popular because it offers the necessary analysis tools for processing large loads of biometric data, as well as other functionalities that make the process of programming medical devices more efficient.</p> <ul> <li dir="ltr" aria-level="1"> <h3 dir="ltr" role="presentation">Tests </h3> </li> </ul> <p dir="ltr">To ensure the software works seamlessly, developers use special tools designed to check for bugs. While some tests cannot be automated, the majority of them can be. There is a great number of libraries that can be utilized to rule out most scenarios in which errors might occur. </p> <ul> <li dir="ltr" aria-level="1"> <h3 dir="ltr" role="presentation">Cloud platforms</h3> </li> </ul> <p dir="ltr">All software needs to be hosted somewhere. Today, more and more developers switch to cloud platforms, which have quickly replaced physical servers as the ultimate solution for application hosting. Services like Azure, AWS, Digital Ocean, and Google are used by developers all over the world to store data effectively and securely. </p> <ul> <li dir="ltr" aria-level="1"> <h3 dir="ltr" role="presentation">Front-end development tools</h3> </li> </ul> <p dir="ltr">User interfaces play a major role in SaMD development. Medical device software has to be accessible to anyone, so developers need to ensure that their product offers a user-friendly and intuitive interface. Tools like Node.js, Angular, Vue, and React are often preferred by developers because they provide quick and efficient solutions for building user interfaces. </p> <ul> <li dir="ltr" aria-level="1"> <h3 dir="ltr" role="presentation">Integrated tech and wearables</h3> </li> </ul> <p dir="ltr">Integrated solutions like health wearables are often part of developing high-performing SaMD. With their help, patients can monitor their condition and receive up-to-date information about their health. Such technology also allows medical professionals to make more accurate diagnoses and even predict and prevent health issues. </p> <p dir="ltr"><img src="https://chillicode.dev/uploads/2_068f8e1966.png" alt="2.png"></p> <h2 dir="ltr">Benefits of developing medical device software </h2> <p dir="ltr">Considering the possibilities of medical device software, what benefits does its implementation have for healthcare businesses?</p> <h3 dir="ltr">Efficiency and accuracy</h3> <p dir="ltr">SaMD helps healthcare specialists make the process of medical intervention more efficient and accurate, which is especially vital when it comes to people’s health. SaMD solutions are capable of processing and collecting massive loads of data and assisting healthcare professionals with analytical and diagnostic procedures. With the help of partial automation of routine healthcare processes, the healthcare system can offer personalized care to as many patients as possible, all while reducing the workload put on healthcare workers. </p> <h3 dir="ltr">Patient safety</h3> <p dir="ltr">Modern-day databases can store amounts of information that have never been seen before. When working with sensitive data, like personal health information, it is important to take advanced measures to protect patient confidentiality. This is why medical device software has to adhere to strict regulations regarding data and personal information security. </p> <h3 dir="ltr">Improved accessibility and affordability</h3> <p dir="ltr">Previously, if you needed medical attention, you would have to seek it out in person. Medical device software development makes healthcare services more accessible to people who would otherwise have difficulties receiving proper help (for example, people with reduced mobility). Since practically everyone has smartphones or computers in some shape or form, people can get a health examination, diagnosis, and monitor their condition without being in a clinical setting in person. </p> <h3 dir="ltr">Integrated technology</h3> <p dir="ltr">SaMD solutions are flexible and can be integrated with other technologies to enhance efficiency. For example, Artificial Intelligence and IoT technology are often used in the medical field to provide more accurate diagnoses, track symptoms, and elevate the performance of healthcare services overall. </p> <h2 dir="ltr">What to Consider When Developing Medical Device Software </h2> <p dir="ltr">Do you feel prepared to venture into the world of medical device software development? There is one more thing left to discuss. When building a solution that has the power to impact someone’s health and safety, it is important to be as careful and precise as possible. Therefore, if you want your software to be high-performing, efficient, and secure, it is in your best interest to keep in mind the following factors:</p> <h3 dir="ltr">Regulatory compliance</h3> <p dir="ltr">We have already mentioned how important it is for your medical device software design to adhere to the standards established by regulatory bodies. Not only is it crucial to ensure the software provides the highest quality service to its users, but it is also a necessary part of the market approval process. Businesses that do not meet the requirements risk facing various forms of penalties.</p> <h3 dir="ltr">Security and data privacy</h3> <p dir="ltr">The vitality of security cannot be stressed enough when it comes to SaMD development. Before releasing your solution, make sure it has measures like encryption and access authorization in place to protect the private data of your users. The violation of laws regulating medical data safety can result in serious consequences for a business and cause a loss of trust from clients.</p> <h3 dir="ltr">User experience</h3> <p dir="ltr">Is your software easy to use? If your application seems straightforward to medical professionals, that is not a guarantee that it is user-friendly. Users might be put off by your product if it is slow-performing or overcomplicated. When developing medical device software design, it is important to center the user experience of patients. The more seamless and smooth the experience is, the more likely they will continue using the software. If you are creating software for patients, avoid using terminology that the majority of users will not be familiar with.</p> <h3 dir="ltr">Interoperability </h3> <p dir="ltr">SaMD solutions cannot exist in a vacuum because they are part of the healthcare ecosystem. To function properly, medical device software has to be interoperable with other devices. Seamless interoperability ensures that no data is lost or damaged while being transported from point A to point B.</p> <h3 dir="ltr">Risk assessment and management </h3> <p dir="ltr">Continuous risk management, monitoring, and evaluation are crucial to creating a worthwhile product. Ideally, the risk management procedures should be integrated during the entire medical device software engineering cycle. It consists of identifying potential issues, evaluating their acceptability, and developing measures to prevent them. </p> <h3 dir="ltr">Collaboration with stakeholders</h3> <p dir="ltr">The input of interested parties, such as healthcare professionals, patients, and regulatory bodies, is absolutely necessary in medical device software development. Not only will this ensure that the product adheres to regulatory compliance, but it will also help you create a product that effectively solves real-world issues and benefits its users as much as possible.</p> <h3 dir="ltr">Testing </h3> <p dir="ltr">Software testing is an integral part of any software development process. During this phase, developers make sure that all features of the software function as intended in real-life situations. All software systems must be meticulously tested in order to detect any errors and create the highest-performing solution possible. </p> <h3 dir="ltr">Maintenance</h3> <p dir="ltr">Last but not least, medical device software should be vigilantly monitored even after its deployment. Creating strategies that will help you continue sustainably improving your medical device software design is crucial to retaining high performance levels.</p> <h2 dir="ltr">Creating the best medical device software in 2025: Final remarks </h2> <p dir="ltr">Today, we have discussed the ins and outs of building custom medical device software in 2025. Let’s quickly review everything we have learned so far. </p> <p dir="ltr">As you approach the beginning of the actual medical device software development, keep in mind what this process entails. From market research to choosing the right technology stack to finally building, testing, and deploying the solution, there is a lot to consider before beginning your medical device development journey. However, all that is crucial to creating secure, safe, and high-performing medical device software system. </p> <p dir="ltr">Remember that medical device software development involves dealing with sensitive data, which presents many challenges requiring a highly informed approach. In addition, making your software user-friendly and intuitive plays a crucial role in making it accessible to as many people as possible. </p> <p dir="ltr">Custom medical device software is an incredible tool that, if done right, can increase the efficiency and accuracy of medical intervention, enhance patient safety, and improve accessibility. Moreover, SaMD solutions encourage innovation by being flexible and interoperable with the latest technological advancements, for example, AI and IoT. The SaMD market is growing exponentially each year, which makes it a promising endeavor for companies looking for long-term investment opportunities. </p> <pre class="language-subscription"><code>sub</code></pre> <p dir="ltr">The landscape of medical device development in 2024-2025 is filled with opportunities and challenges. The introduction of medical device software has transformed the way healthcare services are provided. As you navigate this dynamic industry, it crucial to recognize that medical device software, particularly SaMD, plays a critical role in patient care and safety. Therefore, developers must prioritize robustness, security, and reliability in their solutions.</p> <p dir="ltr">Looking ahead, the future of medical device software development promises continued growth and innovation. As technology advances and healthcare practices evolve, developers will be at the forefront of creating solutions that enhance patient care, streamline processes, and contribute to the overall improvement of healthcare delivery.</p>
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