Medical Device Software Development: Process, Cost & Standards

What is software as a medical device (SaMD)?

Medical devices software development is the process of designing and coding apps for healthcare-based firms seeking opportunities to improve treatment plans, enhance personalization and decision-making procedures with advanced analytics, and more.

If you are using an Apple Watch or other smart device, you are already familiar with the resolutions we consider today, as they are able to monitor your life measures, from breathing/minute to heart rate through sleep, to indicate deviations.

It’s one of the dozens of possible software that can be implemented, with functionality that expands real-time remote observation: data collection and analysis, encrypted storage for enhanced security, integrations with clinic systems, custom software for treatments, and other that is typically built by healthcare software development companies.

That sounds promising, doesn’t it? — therefore, let’s move past the introductions and jump right into the stages that take place in medical device software engineering.

What are the steps in medical device software development?

If, for now, this area seems to you like a turbulent ocean, keep reading, and you will reveal that there’s calm water beyond, as we will dive deeper into the stages you can follow to receive a comprehensive solution for your obligations.

Outlining the steps based on our experience, we will also invite you to the journey of defining and overcoming challenges, for example, with the condition for extensive documentation, integrations with EHRs, critical functions for life-supporting apparatus, which have to be contemplated by a medical device software engineer.

Step 1. Analyze beforehand

Without addressing your calls, the building process will look like, “I don’t know what I want but make it well and don’t mess it up.” We are sure you wouldn’t like to receive such a task outline, so the very first concept to make is to define your Whys.

For instance, your employees are overwhelmed with manual work and you want them to dedicate more time to urgent assignments, which means automation and workflow optimization come into the game.

A reliable provider, for example, one of the UK software development companies, will automate scheduling and inventory tracking (or other activities that are supposed to be enhanced).

After determining the demands, move on.

Step 2. Study up the market

In furtherance of success and cost-saving software development for medical devices, our advice is to not skip the analysis phase during which you are able to outline current statements, the pain points of your end-users, what is trending, what your competitors use and what they miss, and more.

To put an example here, sometimes, ignoring the remark of patients’ demands — literally someone you are making this app for — leads to additional cost spending and the guideline to rethink the fixes from scratch.

Step 3. Design and prototype

User experience is your strategic value as you build the workaround for them and you have to consider what is vital and what can be added further or even removed as unnecessary.

For example, not every end-user will be a tech-savvy person with years of experience using wearable devices, therefore, your goal is to provide a user-friendly and intuitive interface.

Many providers have a separate yet correlated service, which stands for UI and UX, as no one wants to lose leads and buyers.

Step 4. Build as stated by defined points

Here, you have to become a software expert or hire remote developers who will implement cutting-edge practices for security, the regulations we have outlined below, and future scalability.

As the components we will determine further, here we would like to note that construction is one of the time-consuming parts to cogitate about:

• the tech stack,
• plan information architecture,
• code the skeleton,
• conduct front-end, etc.

Engineered right, such an app will make you a digital pioneer with enhanced income and better productivity, which is essential for your patients and healthcare workers.

Step 5. Test, test, and test

This stage is the keystone in the arch that has to be applied if you want to save time and money as well as your reputation, since you are providing a crucial resolution in terms of such a creation that literally defines treatment plans, medication dosage, prescriptions, real-time monitoring, and more.

The error-free solution is a must; it helps you avoid additional spending on refining the bugs that may come after going live.

Another influential argument is about cybersecurity, since the HIPAA Journal indicates that for 2025, 84% of healthcare providers experienced a cyberattack across the last 1 year. Also, we can’t ignore the necessity to adhere to the essentials of patients’ safety.

Step 6. Introduce it to the market

Here, you are rolling out the red carpet for what you have created and posting it, opening opportunities for your workforce or patients, end-users worldwide. Here, you may think that “We did it,” and mostly yes, but we have a little spoiler for you — there’s an objective to maintain your software, which can be conducted by a medical device software developer.

Well, we have come a long way and now you are armed with essential information to continue going to your dream engagement but keep reading as we have more to say so that you receive a comprehensive synopsis of the medical-related project building.

Risks and challenges

Medtech software is a complex concept that can feel like finding a well-marked trail in the wilderness when you are aware of tricky moments that can be involved in the creation. As you are about to cover medical device software design and engineering, there are some points to be aware of for a smoother tech process:

• The landscape of regulators. The healthcare industry is not the one you can burst into as there are many legal rules to be followed and met. Each of them we will consider further, so now, let’s consider them as a challenge, from the European Commission to the U.S. Food and Drug Administration.

  Without them, you will not have the right to launch and sell your product, so you have to dive deeper into these regulations and be forewarned with experts so that you can avoid any penalties and rejections.

• Safety. A simple word but there is more than meets the eye depending on the literal responsibility for other lives. That’s why top-tier healthcare app development companies set protection as a priority, including not only sensitive information storage but also advanced analytics and various validations.

  When it comes to the software, you need to ensure there are no defects and outdated functions or security gaps. Whether you are building an app for long-term glucose monitoring, an ECG one, or else, you have to provide patients with appropriate levels of protection.

• Higher costs. Receiving a market-ready platform is not a walk in the park because you need to pay a significant amount of money and be ready for long-term investment. Software design for medical devices requires experts who have experience and tech knowledge, special tools, regulations, and more.

  Moreover, a risk of re-developing brings more than just the need to rewrite code but re-certification after finishing the development stage. It is advantageous to mitigate and calculate these risks, and pay attention to the requirements for ongoing support you will pay for additionally.

These high-stakes efforts are worth the result, and all hurdles can be overcome with a reliable team of engineers and designers who are pros in cutting-edge technologies and security. Keep reading to learn more about the crucial functions, standards, and more, which will make your overall understanding expanded.

What are the key features of medical device software?

Considering the life-sustaining functionality, we will make this question easy with the core features outlined in this part of the material. The number of them depends on the type of product you would like to receive.

For example, at Limeup, we program custom medical platforms, EMR/EHR, fitness and wellness apps, systems for hospital management, and more, and the attributes vary from e-prescriptions to nutrition monitoring and web/mobile applications. Therefore, let’s dive into the basic ones provided across medical device software development services:

• Risk-managing functions can’t be doubted in the healthcare niche, as you are responsible for patients’ conditions and take on monitoring functions. That’s why the building part is vital, as coders have to be aware of challenges related to the device.

  You may think that again, we are referring to the regulations, and we say a big yes, as the healthcare sector can’t be imagined without following methods like ISO (a variety of them).

• Data manipulation is another factor that was presented after the pandemic, well, it meant that interoperability is more than a nice-to-have feature that enables teamwork between different systems, devices and platforms. In other words, it’s coordination that improves productivity and reduces the time needed for transferring information.

  For instance, a glucometer is a gadget that is feasible to connect to an application and store, process, and share data about blood glucose levels to other systems that, in this order, can be installed in a clinic.

• Real-time processing is a little attached to the previous one as it represents an indispensable tool, especially for medical employees and sick persons who are dependent on urgent alerts that indicate odd signals from the monitoring system. Experienced medical device software developers will receive an in-depth understanding of your processes and provide a suitable function.

  Let’s say that you expect software for a heart rate monitor, which is pivotal for patients whose lives depend on that device, and you want to receive alerts about sudden drops and abnormalities for doctors to react immediately, that’s where this feature is integral.

• Additional controls are worth noting here as professionals operate with gigabytes of data and documents/audits that have to be stored and tracked. The implementation will vary depending on your demands. It also includes the access nuances when you have a repository and can control who has access to data and prevent security risks.

Here’s also the point we need to mention: employee training can take place if you are creating a complex structure that requires additional knowledge and time to adapt to it. In this case, all the procedures can be managed effectively, for example, if you cooperate with software companies in the UK or globally.

By leveraging these named perspectives, you are able to choose the ones that suit you and add more as your project requires, the key is in cooperation with programmers who deliver full-fledged propositions.

Regulatory standards in medical device software engineering

When conditions are met, you are ready to enter the market and present your solution. Without adjusting to the authorities, you will be banned in the healthcare niche, so today, we will navigate you through the core ones so that you receive a clear vision of the requirements of this set.

Medtech software development is not a separate process that has to meet not only medical-related rules but also common standards, for example, GDPR. Further, we will consider only the healthcare-focused ones that will help you with your product creation:

1. MDR for the EU stands for the Medical Device Regulation, and it has also been implemented for the UK from 2002 (UK MDR), and a global one called MDSAP (Medical Device Single Audit Program).

   They work for different software types, as well as applications, so even if you are about to launch your product on the App Store or Google Play, you have to follow the rules.

2. FDA, a regulation for the US and other locations, as it is said on the official website, “applies the same risk-based approach to device software functions as the agency uses to assure safety and effectiveness for other medical devices.”

   It is related to the rules above, as here, you also have to ensure your software is protected and well-tested, fine-tuned and safe for usage by patients. You can learn more about it while consulting with a reliable provider who has experience meeting this guidance.

3. IEC 62304 refers to the safety and covers SDLC (Software Development Lifecycle) in terms of its effectiveness, protection, how documents are made, and more. It also combines with other regulations for risk management, like ISO 14971.

4. HIPAA is the US standard that works towards full security of patients’ data, from diseases to personal information and treatment plans. Data encryption, third-party authentication control and more — it will be tested by experts and can not be ignored.

This part of our article may seem the most challenging one, and it is, but not for those businesses that dived deeper into this topic and cooperated with suitable and experienced engineers who can build medical device software according to market requirements, without delays and attempts to re-launch it when going live.

What is the cost of software development for medical devices?

What if we start with average numbers? — $10,000–$500,000+ sounds like too wide a range but it’s the reality we will consider in the table below, so stay tuned. From the approach you choose for building complex functionality and the number of coders, it all influences the final price.

We will outline the most popular ones (that we also have experience working with and survey our employees), so let’s dive into the comparison for services you can receive if you decide to hire dedicated developers:

To keep it short, the difference in the price for medical device software engineering services is in the hours needed for creation plus compliance (yes, we are talking a lot about this point), as well as the provider’s location and integration demands.

If you are wondering how to save costs, it’s advisable to start with an MVP and build the necessary modules to test them within your target audience, and you can also outsource these tasks to a vendor with a suitable rate, and how to select such a one, as described below.

Future trends in medtech software development

The healthcare market is growing rapidly, as according to the latest statistics from the Grand View Research, it is predicted to reach $1,834.3 billion by 2030, which means a 15.8% CAGR. How is that? Current tendencies reshape this nicely, engage investors and use the pain points of end-users to bring them reliable solutions.

Here, you will review the modern trends that improve the medtech area and make it more appealing for more investments, just like cracking open a geode of something that seems ordinary at first glance.

1. Artificial intelligence. Yes, this word has been spread widely, and it feels like each business has already implemented it in their operations or features, but stay with us, as it can make or break a healthcare-related platform.

   First of all, it is used for analytics: heart rate, breathing, and more, alerting users of a device or an app that something is wrong with their condition. Secondly, it can help in treatment plans as it can analyze large amounts of data quickly, supported by doctors and other medical experts.

2. Internet of Medical Things (IoMT) can sound familiar if you know about IoT (Internet of Things) and is a perfect trend for wearable devices and related software that is used by patients for constant monitoring (especially if they have a chronic illness).

   It is also about the patient’s (end-users’) experience, as they want software that will be usable and precise, so that they can trust it with their health. Combined with the trend above, it becomes a robust solution for better treatment, remote access to medical help, and more.

3. Telemedicine. This tendency makes healthcare accessible for those who need it remotely and immediately: video calls with doctors, chats, synchronization with devices like Apple Watch, checker for symptoms, etc.

   This innovation can be used in various areas, from mental care, which can be available for users through special platforms for those who are struggling with depression or need to detect it, to chronic illness long-term monitoring that allows doctors to ensure their patients’ condition is OK.

4. Wearables. For the past few years, it has been called the next frontier of the healthcare industry, from cardiovascular to fitness and biosensors across companies that build medical device software. It seems like a large usage, and that’s the fact as the statistics say it is able to reach $324.73 billion by 2032.

   Why so? Some experts state that it is because of an increase in illnesses that need to be monitored, from hearing to blood pressure, and such devices will be in demand for decades.

Following the trends that suit your target audience’s needs, you will work toward three goals: fulfilling end-users’ pain points, staying competitive in the filled niche, and enhancing the quality of life for your patients.

If you have the question, “How do I choose the trend that suits my organization?” Our specialists have the answer based on the projects they completed. Here are some easy steps that will help you with this challenge:

1. Tell yourself, is it just trending or will it be useful for your users? Not every tendency is the cream-of-the-crop option for you, so define what it can fix for your businesses and patients.
2. Ensure you have the capabilities to handle this trend, as some of them require more than just standard regulations, and you will have to spend more money and time to adopt them effectively.

It is also advisable to manage risks: if you are a startup, it may not be profitable to select the robotic tendency for your application, so it is better to wait until you gain more opportunities.

Remain user-centric, be mindful in selecting trends for your company, and you will see which of them will bring success, not only the fact that you get the trending technology when you have no idea how to implement it into your processes and software as well.

Why is Limeup the right partner for you?

For the past 10 years, we at Limeup have been delivering reliable software for our customers in the medical area. Our team covers every aspect, from helping clinics enhance their operations to ensuring safe data storage and management to adjusting to cutting-edge regulations.

WIth our services, clients pass local and global audits and certifications as we are proficient in compliance as EU MDR, FDA, ISO, HIPAA, and others. We focus on the needs for your end-users’ and your organization, aligning with your requirements and capabilities as we have done for 200+ projects.

Collaborating with Limeup, you will receive:

• Future-proof software with user-centricity
• Patient-first approach for data, usability and accessibility
• 75+ middle and senior professionals in the MedTech niche
• End-to-end development with traceable and clear deliverables

One of our cooperations in the portfolio of works that is related to this niche, Raccoon.Recovery, won a €700,000 grant for growth with the software we delivered for them. As for the other products related to SaMD, we helped our clients expand patient engagement by 26% with the implementation of AI-based personalization for USA-based Apex Assure.

If you need to receive custom software from scratch or improve an existing product, Limeup can help you. Together, we will discuss your demands and determine the way to accomplish your objectives.

Conclusion

Currently, patients and users expect medtech-related firms to deliver high-quality, rich-in-feature, fast software that will simultaneously match their vibe, needs, and be visually appealing. For healthcare organizations, it means creating a secure and interoperable solution that will also be user-friendly and mitigate well-calculated risks.

After reading this guide, you have learned all the nuances and strategies to create medical device software that will be profitable and in demand among your target audiences. The success of your product will depend on the team of engineers who work on it, how proficient they are in the tech stack, if they are able to write code that is aligned with compliance.

Such a challenging project can hardly be handled by a company without an in-house IT department and the required knowledge. If you would like to receive help from a reliable IT provider with a well-established development process and proven track record, get in touch with Limeup. Let’s team up for your product creation and bring successful outcomes.

FAQ about how to build medical device software