How Do You Design And Develop Software For A Medical Device

How Do You Design and Develop Software for a Medical Device?

Medical device & equipment software concept

If you’re new to the world of medical devices, then you may not be aware of how important software development is to your product or service. An integral part of the design, development, and testing process, the software informs each step of the process and enhances many aspects of the finished product. Let’s take an in-depth look at how you can design and develop software that meets the strict requirements of a medical device and its users, so you can make sure your product is safe and effective before putting it on the market!

Types of Software for Medical Devices

Embedded coding and SaMD (Software as a Medical Device) are different approaches to designing and developing software. To understand their differences, let’s look at each one individually. Embedded coding is where programmers write code closely with developers who build hardware. SaMD involves writing software that’s separate from (and acts on) an existing hardware product or system.

When SaMD is used, it’s because there isn’t an existing product to work from—it’s writing code from scratch. This distinction is important because embedded coding requires close coordination between hardware developers and software engineers, while SaMD uses that connection only when necessary (for example, if updates are needed).

Examples of embedded coding in medical devices are pulse oximeters, electronic defibrillators, automated infusion pumps, glucometers, and more. It’s a very common practice in the medical field to have embedded coding in medical devices.

Software as a Medical Device generally performs functions related to medical data being visualized, processed, and stored. SaMD includes medical devices that help surgeons perform surgery remotely, software that helps make sense of electrocardiograms (ECGs), artificial intelligence systems that analyze brain scans, automated diagnostics systems that process genetic information, and more.

Software designed specifically for SaMD can be used across multiple platforms because it’s written separately from existing hardware—it isn’t bound by pre-existing physical components or constraints like embedded coding.

Process of Building Custom Medical Device Software

First, every project needs to begin with clear objectives. Even if these are general or vague goals, they outline what should be accomplished. But taking your first step toward developing custom medical device software is more than simply knowing what kind of program you need; it also requires identifying your user base to meet their needs. The next stage involves laying out what’s required from your hardware/operating system combination and any specialized requirements that will be necessary to fulfill your objectives.

Once those questions have been answered, it’s time to start planning your development cycle. When is your project deadline? How long will it take to build? What kind of testing will be necessary, and how should that be approached to optimize results? All of these factors influence what your team will need from both a technological standpoint and their skillsets.

Choosing a Development Partner

Once your project has been defined, it’s time to start putting together your team. This will depend on what kind of skills are required but is largely governed by one simple rule: The more experienced members you have on your team, the less supervision they require. They will be better able to define how they want their work environment to operate, so you won’t have to step in unless there’s a problem.

When choosing your team, it’s important to find out how they communicate with each other. A good medical software development partner will have made their processes transparent so that everyone knows what needs to be done when it needs to be done, and why it needs to be done.

Your development partner should have experience with medical devices as the field is very specialized. You will want to ensure they are familiar with any standards your product must adhere to. Make sure that they know how to work within those standards, too. In addition to ensuring they understand all of these things, it’s also important to ask about their working style. Do they prefer Agile or Waterfall methodologies? Do they use source control? How frequently do you meet with them? What kind of reporting structure does their company have in place? Can you talk directly to anyone on their team if needed, or will everything go through management first?

DeviceLab’s Experience Creating Healthcare Device Software and Systems

DeviceLab worked with several medical device companies to create life-changing medical device designs. By developing custom applications to control hardware, DeviceLab has demonstrated that it is feasible to produce quality products while saving money on development costs.

Below Are Some Examples of Our Work:

DeviceLab was also responsible for creating user interfaces (UI) and experiences (UX) and implementing firmware in embedded systems. These tasks are extremely important because they can make or break your product. The UI/UX of your product is what people will see first when they use it, so it’s important to get it right!

DeviceLab’s specialties are digital health, wireless & wearable, laser & LED technologies, IVD diagnostic instruments, and patient monitors & advanced medical systems. With experience in developing firmware in embedded systems, designing user interfaces (UI) and experiences (UX), as well as implementing firmware in embedded systems, it’s no wonder we’re a leader in the industry.

DeviceLab is experienced with making life-changing products possible by developing custom applications to control hardware, resulting in cost-effective solutions that improve people’s lives.


As with anything that uses an embedded system, it’s important to consider all necessary safety precautions. Depending on your project, communication lines, wireless capabilities, display size/resolution, and touch input may be crucial parts of your development process. And even if it isn’t, your customer is sure to have their own requirements that can make or break your product—ensure you keep those in mind during each step of development. Hire a reputable company that provides healthcare software development services like DeviceLab to help you through the entire process.