How to Build Software for Medical Devices? Process, Costs, Types, and More

How to Build Software for Medical Devices

The emergence of technology into the domain of medicine in today’s healthcare world has caused great changes in the software development domain for medical devices. Such solutions of software participate in the process of diagnosis, treatment, and caring for the patients. However, the development of software for these medical devices takes a significantly complicated process that must involve careful planning, regulatory confirmation, and keen consideration of many factors, such as the type of software, among others.

This report takes an in-depth and comprehensive look at how to develop apps in the healthcare industry by exploring the app development process, costs associated with development, various types of medical device software, and trends emerging in the same.

Understanding the Development Process:

In other words, this calls for a properly systemized development of software for medical devices with full attention to safety, efficiency, and regulatory compliances of the developed countries’ standards. Generally, the development process makes its way through the following major key stages. 

1. Requirement Analysis: The first stage is where the requirements of stakeholders, such as health providers, regulatory experts, and end-users, are collected and analyzed. It sets in motion the process of software development for them to at this point be able to understand the intended use of the medical device and user needs.

2. Design: Requirements to be considered are first system requirements gathering. This will be followed by software architectural design and then user interface design. The main points to be considered in this phase are usability and accessibility and integration with the hardware of the medical device. Such designs and collaboration between engineers, designers, and healthcare professionals will assure the software developed is responsive to the user but also compliant with the relevant regulation of use and practice.

3. Development: Functional development software of the coding and JSON programming phase—the translations of design specifications. The developer is expected to follow proper regulatory standards, for example, ISO 13485, IEC 62304, in coding and feature implantation. After-coding processes include quality assurance, which establishes a set of code reviews and testing to set how the software reliability and safety will be ensured. 

4. Testing and Validation: This is the step where rigorous testing in the form of functionality, performance, and security is very important. This may include unit testing, integration testing, and system testing. It has to be ensured during the validation process that software works based on regulatory requirements and, at the same time, it offers the functionality that it was meant to provide in a real-time environment. Documentation of the testing results and regulatory standards must be adequately performed for regulatory approval.

5. Regulatory Approval: The software has to get a go-ahead from the reviewing bodies like FDA (Food and Drug Administration) in the US and its European counterpart called the CE (Conformité Européenne) mark before it is allowed for commercial marketing and deployment as part of medical devices. As a process of filing documentation, test results, and evidence for such tests that clearly states compliance with the applicable standards and regulations.

6. Deployment and Maintenance: In case the receipt of regulatory approval is successful, software deployment is done within the medical device. Continuing support and maintenance should be provided, including on an ongoing update basis, activities on fixing the discovered bugs to enhance the functionality of the product and make it compliant with changed regulation and standards requirements.

Costs Involved in App Development in the Healthcare Industry:

Medical device software development can prove to be an expensive exercise due to specialized domain experience, fulfilling regulatory compliance, and exhaustive testing. The following are some of the key factors to be considered:

1. Development Team: Skilled developers, engineers, regulatory experts, and quality assurance professionals result in the increase in development cost. Few complexities of the project require domain-specific consultants and user experience (UX) designers.

2. Regulatory compliance: Regulatory approval involves documentation costs, testing, and regulatory consulting. Some of the standards generally tend to be resource-consuming, such as IEC 60601 for medical electrical equipment and the FDA’s Quality System Regulation (21 CFR Part 820).

3. Hardware Integration: In case software has to integrate with some of the medical devices or hardware components, then its cost for integration has to be incurred. Sometimes, compatibility testing and validation for different devices may add complexity and expenses attached to the development process.

4. Testing and Validation: The two entail high scrutiny, and allow rigorous testing and validation processes that need to be carried out, ensuring the software is safe and serves its purpose. Testing personnel, testing equipment, and even testing documentation are, therefore, bound to cost even more money, more specifically if the software is for use in vital medical applications. 

5. Maintenance and updates: This includes ongoing maintenance, support, and updating that contributes to the improvement of existing functionality, fixing issues, and ensuring the set regulatory compliance with current regulation requirements. This means that the continuity of the software product is very highly dependent on the budget made towards maintaining and supporting the product in the long term. Although the initial upfront investment in development is relatively high, this should not be an obstacle for high-quality software that ensures patient safety, assures regulatory compliance, and above all, puts your company in a leading position within the market.

Types of Medical Device Software:

Medical device software represents a wide variety of applications catering to different healthcare needs. Here are some common categories:

1. Diagnostic Software: This type involves aiding healthcare professionals in diagnosing medical conditions using patient data, imaging results, or lab tests. It might feature algorithms for interpreting medical images, analyzing physiological signals, or processing diagnostic tests.

2. Software for Monitoring and Tracking: This includes Applications for monitoring patient vital signs, medication adherence, or disease progression. Examples are remote patient monitoring apps, wearables for tracking health metrics, and implants for continuous physiological monitoring.

3. Therapeutic Software: Aimed at delivering therapeutic interventions like biofeedback, rehabilitation exercises, or medication management. This category includes interactive programs to guide patients through exercises, personalized treatment protocols, or medication reminders.

4. Surgical Planning and Navigation Software: Helps with preoperative planning, intraoperative navigation, and guided procedures, using tools for visualizing patient anatomy and simulating surgeries to optimize for individual factors.

5. Healthcare Management Systems: Platforms that manage electronic health records (EHRs), schedule appointments, and handle billing and administrative tasks in healthcare facilities. They may also include modules for patient registration, billing, inventory management, and electronic prescribing.

App Development in the Healthcare Industry: Future Trends and Innovations:

The app development in the healthcare industry is rapidly adopting new technologies, influencing medical device app development. Key trends and innovations include:

1. Artificial Intelligence (AI) and Machine Learning: Utilizing AI for medical image analysis, predictive analytics, and personalized treatment recommendations. Machine learning enables the software to learn and improve from data over time, enhancing diagnostic and treatment accuracy.

2. Internet of Things (IoT) Integration: Connecting medical devices and wearables with software platforms for real-time data exchange and remote monitoring. IoT devices can send patient data to healthcare providers, facilitating early intervention and personalized care.

3. Telemedicine and Remote Patient Care: Transforming healthcare delivery with platforms and apps that allow remote consultations and health monitoring, improving access to care and reducing disparities.

4. Blockchain Technology: Offering secure, transparent data management solutions to enhance interoperability, data integrity, and patient privacy. Blockchain can secure medical records sharing, device authentication, and trace healthcare transactions.

5. Virtual Reality (VR) and Augmented Reality (AR): Applied in medical training, patient education, and therapy, these technologies provide immersive experiences. VR allows for realistic simulation of procedures, while AR aids in surgical navigation and education.


Developing apps for the healthcare industry is complex and dynamic, requiring close collaboration among healthcare professionals, software developers, regulatory agencies, and other stakeholders. Despite the costs and challenges, the benefits for patient outcomes, clinical workflows, and healthcare innovation are significant. By leveraging emerging technologies and adopting best practices in software development, healthcare organizations can enhance patient care, improve efficiency, and foster positive industry changes.