When people think about medical devices, most might picture big, complicated equipment that seems too cumbersome for use outside hospital settings. Progress, however, does not stand still. Advances in technology and electronics have made health monitoring devices accessible and usable anywhere, thanks to medical device software (MDS). This type of software can replace some traditional healthcare equipment with smartwatches and smartphones we all use daily and has as much potential to improve our health outcomes.
As a healthcare software development service provider, we’ve created and tested software for diverse healthcare-related projects. From our experience, there are many intricacies of medical device software development, and we’re here to guide you through them. We’ll touch upon regulations, review different types of medical software, and share the steps our team uses to develop digital health solutions.
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The story of medical device software started with simple goals: make hospitals work smoother and patient care better. Early on, this meant software that helped keep track of all the patient info or made that big, complex equipment a bit smarter. From the early days when software was simply firmware or embedded systems within medical devices (SiMD), its capabilities have been growing alongside processors and electronics that became smaller yet more powerful and affordable.
Back in the ’90s, when the Internet and laptops started getting big, this set the stage for significant technological advancements. Followed by smartphones in the 2000s and then cloud computing, AI, and the Internet of Things in the 2010s, these developments profoundly changed the game for the software we use today. Modern healthcare digital solutions are now highly advanced and connected to databases and remote systems. This newer generation of software has evolved from being a component of medical processes to being at the heart of healthcare progress.
The figures say the same. Statista predicts that the value of the medical device software market will jump from its present $511 billion to an impressive $719 billion by the year 2028.
Although the potential revenue and increasing market value are a big attraction, they’re not the sole reasons organizations are investing in custom medical device software engineering.
In essence, the development of MedTech software brings a host of advantages for healthcare entities:
As you can see, developing healthcare apps and software for medical needs is a sound investment. But, creating medical software demands specialized expertise and a solid grasp of healthcare regulations. That’s why a lot of health organizations team up with experienced custom software development companies who know the ins and outs and can guarantee the success of the project.
But before we examine the compliance rules more closely, let’s understand the different kinds of medical software solutions.
Complete clarity around how the medical device software you’re developing or planning to develop qualifies is critical, as it will tell you what industry regulations your software must meet. Therefore, let’s understand the two main types of it:
SiMD | SaMD | |
Purpose | Directly manages device functions, processes data, and delivers therapy as part of the device’s intended use. | Doesn’t directly control device functions, but analyzes data, provides insights, or facilitates communication between devices. |
Device Integration | Embedded within a device | Standalone software, but can interact with and utilize data from medical devices. |
Device Association | Designed and validated for a specific device or a compatible set. | Can work with a specific device or group of compatible devices depending on functionalities. |
Device Dependence | Heavily dependent on the specific hardware and functionalities of the associated device. | Operates independently of specific hardware but may require data from or interact with medical devices. |
Regulation | Typically falls under higher risk classifications due to its direct impact on patient safety and device operations. | Can fall under lower-risk classifications depending on functionalities and potential impact, but still subject to regulations. |
Examples | Infusion pump software for calculating and administering insulin doses, image processing software that processes medical images displayed by the device. | Mobile app providing personalized exercise recommendations based on wearables data, software analyzing medical images from a diagnostic device. |
Key Differences | Embedded, directly controls device functions, higher risk classification. | Standalone, supports and enhances device function, potentially lower risk classification. |
SiMD or Software in a Medical Device is essentially software embedded within a physical medical device, responsible for its operation and functionalities. Putting simply, any software that operates a physical medical device, whether it’s driving the device’s mechanics or creating its user interface, falls under the category of SiMD. This kind of software is often referred to as “firmware,” “embedded software,” or “micro-code.” Some examples of SiMD include:
SaMD, or Software as a Medical Device, is software that operates independently of any hardware medical device. This type of software is capable of running on general-purpose computing platforms (such as smartphones, tablets, or laptops) and does not control or interact directly with the mechanics of a hardware device. While it can carry one or more medical functions (diagnosing, health monitoring, or treatment recommendations), it shouldn’t be a part of hardware to be categorized as software as medical device. As strange as it may sound, it’s considered a medical device, and here are a few of such medical device examples:
So, regardless of specific role, whether it’s
they can fall under SiMD or software as a medical device, depending on their implementation and functionality. Some software for clinical decision support could combine the elements of both. For example, an app displaying data from a wearable device while providing analysis could be considered a combination of SiMD (interacting with the device) and SaMD (offering independent analysis).
Ultimately, the classification hinges on a specific regulatory assessment considering:
With various international and regional medical device software standards in place, understanding these regulations is essential to ensure medical tools’ quality, safety, and effectiveness. The EU and US markets for medical devices are the largest by far, so we’ll focus on them.
Since SiMD and software as medical device are primarily viewed as medical devices, they are regulated as such. The FDA sorts medical devices into three risk-based classes, with Class I being the lowest risk and Class III the highest, determining the regulatory controls and approval path needed.
State of healthcare situation or condition | Treat or diagnose | Drive clinical management | Inform clinical management |
Critical | IV | III | II |
Serious | III | II | I |
Non-serious | II | I | I |
For most Class II and some Class I devices, a 510(k) submission is necessary, proving your device matches another on the market. Class III devices require Pre-market Approval (PMA), showing through scientific evidence that the device is safe and effective. All devices must comply with the Quality System Regulation (QSR), which sets standards for manufacturing, quality control, and documentation, regardless of the device’s class.
Here are compliance steps for you to follow:
Unlike the FDA’s approach in the United States, which classifies devices based on risk and has distinct pathways like 510(k) and PMA for device approval, the European Union’s Medical Device Regulation (EU MDR) emphasizes clinical evidence, post-market surveillance, and a unique device identification system to enhance traceability. Other international standards, such as the International Organization for Standardization (ISO) series for medical devices (like ISO 13485 for quality management systems), play a crucial role in harmonizing global regulatory requirements.
In the US, the Health Insurance Portability and Accountability Act (HIPAA) is a critical aspect of medical device software because it sets the standard for protecting sensitive patient data. It requires healthcare providers and their business associates to safeguard electronic protected health information (ePHI) with both physical and technical measures.
Europe has a similar standard, the General Data Protection Regulation (GDPR), which imposes strict rules on data privacy and security and demands the implementation of appropriate security measures. Compliance with these rules and regional laws has one goal – to encourage medical software developers to embed robust security features (encryption, access controls, and regular security audits) from the ground up.
The medical device software development requires strong engineering expertise and goes through the same stages as any other type of software, with the addition of a more complicated validation stage and regulatory approval. Here are the main steps and important aspects you should consider when building your medical software product.
Today, users’ expectations are so high that user-friendly interfaces and visual appeal are a must. Otherwise, they will just leave. That’s why the design has to be clear and straightforward, whether it’s for patients’ use or doctors’ who are working under a lot of pressure.
The interface should be comfortable for a tech-savvy young adult yet simple enough for older individuals who might not be as familiar with technology. Accessibility is another critical aspect of medical device software design, so don’t neglect it. Also, remember, the main goal of a good design is to help users quickly get to the most important functions and info they need.
Medical coding software deals with lives, not just likes. A malfunction or bug can have catastrophic consequences. QA and testing services ensure that your software meets stringent regulatory requirements and functions as intended, mitigating risks and building trust with patients and healthcare professionals.
Here are key QA and medical device software testing protocols you should pay attention to:
How to embrace the agility and speed of modern development methodologies while ensuring the rigorous quality and compliance required for medical software? Even though regulations are laid out in a sequential manner that aligns well with a traditional waterfall development method, it’s very much possible to employ an agile approach while still adhering to all necessary standards.
By making some adaptations to the agile software development life cycle, you can make it work for your medical software:
At this stage, you should integrate your software with hardware devices (smartphones, smartwatches, or specific medical equipment) and ensure smooth interaction with them. There are several ways to facilitate the medical device integration software process.
First, you can connect your software using the APIs provided by smart devices and medical equipment makers. Another way is cloud-based platforms, which can simplify the storage, analysis, and sharing of data across various devices. For scenarios where off-the-shelf solutions don’t quite fit, custom development is a sure way to go.
Medical devices generate a wealth of valuable patient data, but managing it effectively poses several challenges:
Interoperability, the ability of devices and systems to exchange data seamlessly, holds the key to overcoming these challenges. Here are the best ways to achieve that interoperability:
While developing software is the main part of the product life cycle, its journey doesn’t end there. Ongoing support, regular updates, and functionality improvements are continuous processes you should invest in if you want to keep your medical device software secure and compliant.
With clinical advances and tech innovations happening on all fronts of the healthcare industry, here are some of the key medical software trends you should keep an eye on in 2024:
More and more medical software products leverage artificial intelligence due to the many benefits of AI in healthcare. This technology contributes to the software’s capabilities to diagnose more accurately, personalize treatment plans, and monitor conditions on a whole new level.
In fact, this trend gave rise to the software as a medical device adoption by empowering software to collect patient vital statistics remotely. No doubt, telemedicine solutions will continue to dominate the market and keep the demand for medical software in the foreseeable future.
Considering the huge popularity of wearables and mobile health apps amongst fitness chronic patients, enthusiasts, and the elderly, these are trending tech medical solutions used in software right now. They offer an endless array of functions aimed at patient care, which are expanding at a constant rate.
Dealing with strict regulations and constantly shifting trends when developing medical device software may seem insurmountable, yet with the right approach and people, entirely manageable.
If you have Relevant Software on your side, your organization can surely build high-quality healthcare software with ease. Our team, experienced in the nuances of medical software, will share its expertise to help you overcome all the complexities of healthcare software design. Don’t let the challenges hold you back. Contact us, and let’s create healthcare solutions that make a difference.
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