Medical device software development: Key insights and tips

Medical device software helps healthcare providers use advanced technologies to improve patient care and operational efficiency. Whether it's embedded software in medical devices like pacemakers or standalone solutions for remote patient monitoring, the software development process must address stringent compliance and security requirements.

For healthcare businesses, this involves abiding by regulatory standards, integrating with existing healthcare software and systems, and ensuring data protection. This article reviews the software needs of healthcare organizations, from hospitals to biotech and medtech firms, and offers practical tips to streamline medical device software development.

What is medical software?

According to the Food and Drug Administration (FDA), medical-purpose software can be of two types:

• Software in a medical device (embedded software): software that requires specific medical equipment to work on (e.g., medical imaging systems, continuous glucose monitoring (CGMs), pulse oximeters, etc.)
• Software as a medical device (SaMD): software that can be used on desktops, tablets, and smartphones (e.g., data analytics platforms, telemedicine platforms, electronic health records systems (EHR), etc.)

Let's review the healthcare businesses that may need both types of software.

Healthcare businesses needing medical device software development

Various healthcare companies may need medical device software development. They include medical device manufacturers, hospitals, medtech startups, and more. Let's review what they can typically request from software development companies.

The mentioned software and firmware solutions operate with clinical data, patient information, personal identifiable information (PII), and protected health information (PHI) in different formats and need to provide accurate output for the medical devices to work as designed. To get their digital products certified and cleared by the authorities, the companies should consider various factors during custom medical device software development. Here are a few tips from N-iX that will help you build a successful development strategy.

Top 8 tips to streamline medical device software development

The process of medical software development will vary from product to product due to several factors. They include specific product requirements, integration strategy, software safety level, availability of legacy software, industry requirements, market specifics, country-specific regulations, and others.

Having experience in providing quality software development services for healthcare businesses and proven expertise in building embedded software and firmware solutions for this industry, N-iX has a few suggestions for healthcare businesses on where to start their medical device software development process.

1. Learn regulatory compliance requirements for medical device software development

The development of medical device software is strictly regulated worldwide. Each country has specific criteria for the software to be cleared by the authorities. When planning your project, you should clearly understand the class of software it will fall into based on the risk level. It will help you set up development processes that can undergo external audits, create robust risk mitigation strategies, and get software cleared by the authorities more easily.

Typically, the software of the medical device can fall into one of three classes:

• Class A: The software's malfunctioning can't cause risk of injury or harm to the user's/patient's health;
• Class B: The software's malfunctioning can potentially cause a risk of injury to the user's patient health, but it's not severe;
• Class C: The software's malfunctioning can cause severe harm and irreversible changes to user/patient health, including serious injury or death.

Each country has its requirements for the medical device software development process. Below is a list of the most common regulations and standards.

• IEC 62304 (or EN 62304 as European adaptation): an internationally recognized quality standard defining life cycle requirements for medical device software. It provides a framework for developing and maintaining software for medical devices. The standard defines the procedures the developers should adhere to during software development planning, requirements analysis, architectural and detailed design, implementation, verification, integration, testing, software release, and maintenance (especially for medical devices).
• IEC 60601-1: a standard including requirements for the safety and performance of medical electrical equipment, including software. It focuses on electrical safety and basic safety functions, which are critical for software that controls or is part of an electronic medical device.
• ISO 62366-1: a standard focusing on usability engineering to ensure that medical devices, including software, are designed with the user's safety in mind. It helps identify user interface design flaws that could lead to use errors and potential risks to patients.
• IEC 81001-5-1: an international standard for cybersecurity in health software and health IT systems, including software used within medical devices. It outlines requirements for risk management, data protection, and security controls to ensure healthcare data's confidentiality, integrity, and availability throughout the software's lifecycle.
• IEC 82304-1: an international standard specifying the requirements for the safety and quality of health software, including standalone software and software as part of a medical device (SaMD). It focuses on ensuring that software used for healthcare purposes, like health apps or clinical decision support systems, meets high standards of reliability, usability, and security throughout its entire lifecycle.
• ISO 14971: a standard framework for risk management of medical devices, including software. It guides developers through hazard identification, risk analysis, risk evaluation, and the implementation of risk control measures.
• ISO 13485: an international standard for a quality management system (QMS), ensuring that medical devices are consistently designed, developed, and manufactured with a focus on safety and quality. It covers all stages of the device lifecycle and is crucial for regulatory approvals in markets like the U.S. and EU.
• ISO/IEC 27001: a standard for information security management systems (ISMS), it provides guidelines for protecting the confidentiality, integrity, and availability of sensitive patient data managed by medical device software. It is crucial for ensuring data security and meeting compliance requirements.
• EU Medical Device Regulation (MDR 2017/745): a regulation defining requirements for the approval and marketing of medical devices, including software, in the European Union. It includes stricter guidelines for clinical evaluation, post-market surveillance, and device classification.
• General Data Protection Regulation (GDPR): a European Union regulation that governs the collection, processing, and storage of personal data, including health data from medical devices. It requires developers to implement data protection measures to ensure patient privacy and secure data handling.
• Health Insurance Portability and Accountability Act (HIPAA): a US regulation protecting the privacy and security of patient health information. Medical device software that handles patient data must comply with HIPAA's requirements for data encryption, access control, and patient consent.
• FDA 21 CFR Part 820 (Quality System Regulation-QSR): a US FDA regulation requiring medical device manufacturers to establish and maintain quality systems for designing, producing, and servicing medical devices. It includes guidelines for software validation and design controls.
• FDA 21 CFR Part 11: a regulation outlining the criteria for electronic records and electronic signatures to be considered trustworthy and equivalent to paper records. It is crucial for software that manages clinical data to ensure data integrity and security in software development.

You should always consider the development requirements for medical software, including the data collection and processing of the target country. While legal requirements are obligatory to follow, international standards like ISO and IEC serve more like recommendations on how to organize and run the process. However, these guides will help you prepare for the certification projects and pass the necessary audits required by the local authorities.

2. Analyze the current IT landscape

Before creating any medical device software, you need to understand how it will interact with already established systems or communicate with the users. Analyzing the current IT landscape as a part of the discovery phase helps companies identify existing infrastructure, capabilities, and gaps. This analysis also provides a clear understanding of legacy systems, software tools, and hardware that the new solution needs to integrate with, ensuring seamless implementation.

For example, if a hospital uses a specific Electronic Health Record (EHR) system, understanding its integration requirements ensures that the new medical device software can share data smoothly. This step defines technical specifications, selects compatible technologies, and addresses integration challenges, reducing development time and costs. It also helps prioritize necessary IT infrastructure upgrades to support the new software's performance and compliance.

3. Prepare user requirements

This step is essential for aligning the software's features with the needs of healthcare professionals and patients, ensuring it meets real-world use cases. It helps identify core functionalities early, preventing scope changes and costly redesigns later in the development process.

Clearly defined requirements guide the user interface (UI) and user experience (UX) design, making the software intuitive and easy to use. This stage also ensures that the software meets regulatory needs regarding usability engineering, helping streamline FDA or ISO compliance.

4. Decide on how to manage data security and privacy

Data security is a top priority in medical device software development due to the sensitive nature of patient data. Planning for data security and privacy measures early ensures compliance with regulations like GDPR, HIPAA, and ISO standards, which is critical for approval in healthcare markets. It also helps establish encryption, access controls, and data anonymization protocols to protect sensitive patient information.

Addressing security from the start prevents vulnerabilities that could lead to costly data breaches. It also saves time and resources by integrating security features during early stages rather than retrofitting them later. Moreover, a clear plan for data management will help you build trust with users.

5. Choose the necessary tech stack

Choosing the right tech stack that supports interoperability and compliance ensures smoother integration and scalability as the software evolves. The selected programming languages, frameworks, and cloud services should align with the software's requirements, such as real-time data processing, compatibility with embedded systems, or cloud integration.

For example, C++ and Python are popular for developing software and firmware for embedded medical devices, while JavaScript frameworks like React or Angular can be used to create user-friendly interfaces. For one of our projects, we used Python to build embedded firmware for an air filtration system and developed a cross-platform application on Flutter.

Explore more: Computer vision in healthcare: trends, use cases, and reasons to adopt

6. Ensure interoperability with other systems

Interoperability is crucial for integrating medical device software with existing Electronic Health Records (EHR) systems, Hospital Information Systems (HIS), and other healthcare platforms. Using interoperability standards like HL7 and FHIR ensures seamless data exchange between different systems. Addressing interoperability early reduces the risk of compatibility issues and expensive integration fixes later. It also enhances the device's value, making it more attractive to healthcare providers looking for systems that integrate well into their workflows.

For instance, if a medical device is designed to monitor heart rate, sharing data with a hospital's EMR system means clinicians can easily access and analyze patient-generated health data (PGHD). As a result, it enhances workflow efficiency and improves patient care.

7. Plan post-development support and maintenance

Proper post-development support and maintenance are critical to medical device software development standards and requirements. To ensure that the software remains secure, compliant, and functional throughout its lifecycle, healthcare businesses should keep it updated with the latest regulatory changes and technological advancements. Continuous support and maintenance include bug fixes, software updates, and ongoing monitoring to ensure the device operates effectively in different conditions.

For example, a medical imaging device may need software updates to add new functionalities or address security vulnerabilities identified after launch. Moreover, a proactive support plan helps manufacturers keep up with evolving regulatory requirements and user needs, reducing downtime and maintaining quality service provisioning.

8. Partner with an experienced medical device software development company

Collaborating with a company that has a strong track record in developing medical device software can significantly streamline the process. Experienced partners understand regulatory frameworks and the technical nuances of medical devices. In addition, they are familiar with the challenges regarding international and local regulations, such as ISO 13485, IEC 62304, GDPR, and others.

Software development companies like N-iX bring valuable technical skills in the Internet of Things (IoT) and embedded development, healthcare cloud computing and integration, AI, ML, cybersecurity, healthcare Big Data, and data analytics and management, ensuring a high-quality product. Their knowledge of the healthcare landscape helps in designing user-friendly and compliant solutions tailored to end-user needs. Additionally, their experience with past projects allows them to set up audit-friendly processes and identify potential challenges early, saving time and reducing development costs.

Explore more: 15 top healthcare software development companies

How N-iX can help you with medical device software development

With over 21 years of experience in the market and over 160 active clients featuring Fortune 500 companies, N-iX has solid tech expertise in software development for various industries, including healthcare. We provide quality medical device software development services to medical manufacturing clients like WEINMANN Emergency, health service providers like Cure Forward, and more.

Here are a few examples of what we can deliver.

1. Embedded software and firmware development. N-iX develops reliable and compliant embedded software and firmware for medical devices, ensuring seamless control over hardware components and real-time data processing.
2. Cloud integration. We integrate medical devices with cloud platforms such as AWS, Azure, and GCP, enabling scalable data storage and real-time data access for remote monitoring and analysis.
3. IoT solutions. Our expertise in IoT helps businesses adopt Internet of Medical Things (IoMT) solutions for improved patient care and operational efficiency.
4. UI/UX design. We design user-centric interfaces for medical device software, such as diagnostic tools, patient monitoring systems, and medical mobile apps.
5. Interoperability solutions. N-iX enables seamless integration of medical devices with EHR, HIS, and other healthcare platforms using standards like HL7 and FHIR. This allows for smooth data exchange between systems, helping healthcare providers access comprehensive patient information for better decision-making.
6. Cybersecurity services and data integrity. We implement encryption, access control, and data anonymization protocols to ensure patient data is secure during transmission and storage. Our solutions comply with GDPR and other privacy regulations.
7. Data management. We design systems for efficient data storage, processing, and integration with healthcare platforms, enabling seamless and compliant data handling throughout the software lifecycle.
8. Data analytics and AI integration. We integrate data analytics and AI capabilities into medical device software to derive actionable insights from various data. Our solutions enable predictive analytics, anomaly detection, and automated data analysis, helping healthcare providers make informed decisions and improve patient outcomes.
9. Post-development support and maintenance. N-iX provides ongoing support and maintenance to ensure your software stays updated, secure, and functional after deployment. We offer bug fixes, updates, and performance monitoring to maintain regulatory compliance and ensure the long-term success of your medical device.
10. Custom medical software development. N-iX offers end-to-end custom software development for unique medical device needs. We tailor solutions to your specific requirements, whether it's remote patient monitoring, diagnostic software, or telehealth platforms, ensuring they meet both technical and regulatory standards.

Our team has over 2,200 software engineers with expertise in cloud, data analytics, IoT, computer vision (CV), cybersecurity, AI, ML, Data Science, and robotics. If you're looking for a reliable tech partner for developing medical device software, contact N-iX. Let's discuss how our experience in embedded, IoT, and other technologies can help you build reliable and scalable medical device software.