As medical devices become increasingly high-tech and connected, more and more are being designed with software architecture. Software-as-a-Medical-Device (SaMD) has emerged in the medical device industry from this trend. As you might imagine, medical device software design must follow stricter standards compared to the typical software development process.
The other challenge with medical device software development is that it’s simply a young field of discipline. As new research emerges, standards quickly change. This makes quality assurance much more difficult compared to other forms of device development.
These challenges don’t mean that adding valuable software solutions to your medical devices is impossible. Rather, it warrants a specific design process that keeps these challenges in mind. This guide is here to help you navigate software design for medical devices. We’ll explore the steps of the development process, how to navigate challenges, and discuss best practices.
Why is Medical Device Software Valuable?
Medical device software is valuable to the healthcare industry due to its ability to enhance the functionality, reliability, and usability of medical devices. For example, a smart insulin pump can automatically adjust insulin levels based on a patient’s real-time data.
On that note, medical device software can also let medical practitioners manage and transmit vital patient data. This helps them make informed clinical decisions, effectively help patients manage conditions, or even predict potential health issues based on data trends.
Here are 4 examples of useful medical software tools.
4 Examples of SaMD
1. Medical Device Applications
Medical device applications refer to software programs designed to assist medical professionals and patients as they manage various aspects of healthcare digitally. These applications are usually accessible via smartphones or computers.
These applications may be used to schedule appointments, view medical records on the field, facilitate communication between patients and providers, or measure healthcare metrics such as glucose levels.
2. Screening Technologies
Screening technologies encompass software tools designed that help professionals conduct preliminary checks for specific health conditions. Electronic devices have been used for this purpose for decades, but an increasing number are now leveraging software.
The biggest advantage to this shift is that algorithms can provide quick analyses, which expedites screenings and promotes early detection. They can also swiftly detect very subtle health changes which provides more precise results.
3. Digital Therapeutics
Digital therapeutics involve software platforms that deliver therapeutic interventions and support directly to patients, typically via a mobile app. These platforms guide patients through specific therapeutic activities, exercises, or interventions designed to manage or treat particular health conditions.
4. Embedded Software
Embedded software in medical devices refers to integrated software that enables the device to perform specific functions automatically. For instance, a medical device implanted in a patient’s body might continuously monitor a specific health parameter and automatically adjust its functioning to provide optimal support, such as a pacemaker monitoring a natural heartbeat.
Usually, embedded software is defined as a separate medical tool rather than as SaMD. However, it is still important to develop it following similar software requirements.
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3 Requirements for Medical Device Software
1. IEC 62304 Compliance
IEC 62304 highlights specific regulatory requirements that must be met during the medical device software development life cycle. IEC 62304 must be followed during the development of SaMD and embedded software.
Specifically, it warrants that all risk management procedures have clear documentation to prove that risk mitigation efforts have been made. Risks are defined as anything that may cause harm to the patient if any software failure or anomaly occurred.
2. Clear Definition of Usage
To ensure your tool qualifies as an SaMD, it must meet the definition and usage guidelines provided by the International Medical Device Regulators Forum (IMDRF). SaMD is defined by the IMDRF as a tool that serves one or more medical purposes without being part of a medical device’s hardware (if it’s part of the hardware, it’s embedded software).
You must present your tool’s clear use or uses for approval. There can be no ambiguity in how the tool is intended to be used. In the case of embedded software, ensure that you are adding software to your device for a clear medical or usability benefit. Never add software simply for the sake of adding software.
3. Risk Management
IEC 62304 requires documentation that highlights your risk management process. To perform this task, first categorize your tool into one of the four risk categories (I, II, III, and IV) based on its impact on patient or public health with I being the lowest impact and IV being highest.
Here are the definitions of those categories.
| State of Situation | Tool will treat or diagnose | Tool will perform clinical management tasks | Tool will inform clinical management practices |
| Critical | IV | III | II |
| Serious | III | II | I |
| Non-Serious | II | I | I |
Then, you must follow compliant risk mitigation practices based on your tool’s risk category. These standards can vary greatly based on your category in the above matrix. Please consult official documentation for specific guidelines.
6 Best Practices in Medical Device Software Engineering
1. Identify User Needs
Understand and document the needs of the end-users and stakeholders. Consider why you are developing this software and what issue it will solve. Your tool must have a clearly defined purpose; instead of innovation for innovation’s sake, as that is not specific enough.
2. Set Clear Objectives
Establish clear and possibly quantifiable goals for what the software should achieve based on user needs. Use these goals to inform later development and testing procedures.
3. Compliance Planning
Ensure understanding and planning for compliance with relevant regulations and standards. Take time to consider standards in every country where you intend to release your product.
4. Risk Management
Identify, analyze, and manage potential risks based on the aforementioned risk management standards. Define these now, and continuously test for them throughout the design and development processes.
5. Design & Development
Implement a structured design and development process. This process must ensure the software is developed according to specified requirements and design controls. Every line of code must go through rigorous debugging based on your risk management protocols.
6. Verification & Validation
Conduct thorough testing to verify that the software meets all specified requirements and validate that it performs correctly. You may have to cycle back to previous steps if any errors are found.
Quickly & Compliantly Bring Your Device to Market: Software Included
Medical software development is pivotal in advancing healthcare technologies and enhancing patient care through innovative solutions. The creation of robust, secure, and compliant medical software requires a blend of technological expertise and a deep understanding of healthcare regulations and standards.
RBC Medical Innovations has over two decades worth of this kind of expertise. We’ve helped countless others bring their medical software innovations to market while staying within strict safety and compliance regulations.
Reach out to us today to get the same treatment for your next development project.
