As medical technology and software become more advanced, the potential for life-threatening failures becomes more likely. To combat these increased risks, medical device companies must do more to test their product during development to assure a safe and reliable device. Software emulators are key to accomplishing this goal.
In this article, we’ll look at what software emulators are and how they differ from simulators. We’ll also look at the advantages of using emulators during medical software development and other considerations specific to developing diabetes software devices.
What Are Software Emulators?
A software emulator is software that allows an existing system to behave like a different system. Specific to software testing, an emulator allows developers and device manufacturers to test software meant to work within a hardware system before the hardware is built.
Traditionally, in order to test how software interacts with firmware, hardware, and other aspects of a physical system, the device would need to be created first. This has many obvious drawbacks. Most notably, if there are major bugs in how the software and hardware interact, you won’t know until both systems have already been completed.
Software emulators allow you to build computer systems capable of testing software and hardware interactions in a virtual environment. If there are any bugs, they can be purged before the device is built. This kind of testing helps reduce expenses and increases the odds that the final hardware device will work seamlessly with the software.
Emulators vs. Simulators
When building software, there are many ways to test the system before it is complete. Simulators have long been used for this purpose. Emulators are very similar to simulators, but with a few key differences that all medical device and SaMD developers need to understand.
Simulators are software-focused testing systems. They simulate an environment that contains all the configurations and variables written into the new software system. These work well for testing individual components as well as larger interacting systems and complete software sets.
The fact that simulators create an environment strictly for software means they can be implemented using complex, high-level programming languages. But what these kinds of tests fail to do is predict how the software will interact with the physical device it is meant to be used with.
Emulators are virtual environments meant to test the interaction between software and hardware. Like simulators, they work entirely in a virtual system. But these don’t just test software interactions, they also mimic the features of the production environment within the hardware. This allows developers to see how their software interacts with different aspects of the intended physical device.
Emulators are often used to test how firmware updates and changes to hardware might affect the response from the software. They can also be helpful in determining how a software application or mobile medical device will behave on a different operating system.
Because emulators simulate interactions between software and hardware, they are typically built using assembly language. This can restrict how authentic the interactions are, which means emulators should not be used as a substitute for actual device testing. However, they offer many benefits to medical device creation that make them worth including in device development workflows.
Which to Use When Testing Medical Device Software
When it comes to creating SaMD or medical device software, it is imperative to test the software at all stages of development to remove bugs before they compound and to reduce risk to the end user. ISO 14971 outlines a framework of risk analysis to help medical device companies create safe and effective software-based devices. Among the recommended steps are tests specific to software risk analysis. Simulations are one of many tests that should be performed early and often in the development of medical software.
As software nears its final stages of development, it is important to begin testing to understand how that software will interact with the intended hardware. This is where software emulators come into play.
By testing software in an emulated environment, you can identify bugs long before the device itself is put into production. Or, for software meant to work with existing tech, such as MMA, you can test a range of potential and theoretical interactions beyond what exists in the steady state of the operating system. Doing these tests in an emulator rather than using physical testers reduces the odds that something will be missed and allows you to test all possible variations of every system interaction.
When creating medical technology, it is important to use both simulations and emulations to assure your software is ready for the final stages of development.
The Advantages of Using Emulators in Med Tech Development
Creating emulators specific to your software and device interactions can take time, but rarely involves much monetary investment. More importantly, this type of testing has a range of benefits that can help save money overall and ensure your products are safer for the end user.
Some of the major benefits of using emulators in software and medical device development include:
- Low cost. Emulators for existing hardware systems are freely available at little to no cost. These existing systems are capable of replicating a range of conditions from low battery to poor Bluetooth connection to version upgrades and downgrades.
- Allow you to test sooner. Building new hardware systems takes time. Waiting for your device to be ready to upload software means delays in testing that will push your launch date. Emulators can be built quickly and used earlier in the software development process to expedite production.
- Allow you to make quick changes. In order to switch parameters on a physical hardware device, you must build a new model. This isn’t just time-consuming, but costly. Parameters on emulators can be changed and modified easily and quickly and as often as needed.
- No ongoing maintenance. When working with existing physical hardware, you must maintain and manage it to keep it in optimal condition for testing. Emulators are ready to work whenever you need them and will not degrade over time.
- Test multiple devices at once. For MMA meant to be used on multiple platforms and OS, emulators can save an incredible amount of time and money. With multiple emulations set up, you can test your software on various mobile systems simultaneously and make adjustments as needed for each system set.
- Identify bugs missed by human testers. Planning for every possible scenario when looking at device and software interaction is impossible. But computer emulations come far closer to attaining this goal than human testers prone to distraction and boredom. Furthermore, emulators are capable of running unlimited iterations to find inconsistencies often missed by human testers.
- Create safer products. All of these benefits combine to create a safer product that carries a lower risk for the manufacturer and the user. Because medical devices, especially those in the diabetic niche, often come with the potential for deadly failures, risk mitigation should always be of the highest priority.
Considerations for Testing Diabetes Medical Device Software
For as many advantages as there are to using emulators to test medical device software, it is important to remember that emulators cannot replace real-world testing. That is, even after using emulators to scrub your software of bugs and assuring it works seamlessly with the theorized hardware, you must still complete real-world hardware testing as you would in a traditional workflow.
Emulators are very good at recreating hardware and software interactions in a virtual environment, but they cannot take the place of final-stage device testing. What they can do is greatly lower the risk of incompatibilities and remove the majority of bugs and functionality issues to reduce failures. For medical device companies battling quickly changing markets and constant technological advancements, this kind of advantage is necessary in order to expedite delivery.
Have more questions about how software emulators can help your diabetes device or software company prepare for development? Or in the market for an emulator that can help you reach your delivery goals? Contact us today to find out how Sequenex can help.