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Medical Device Software Development: A Comprehensive Guide

Paul Kovalenko Paul Kovalenko | April 22, 2024 | 12 min

The medical software industry is rapidly growing, expected to jump from $19 billion in 2022 to $167.59 billion by 2032. This growth offers a great opportunity for those interested in developing software for medical devices. However, it’s important to note that creating software for this sector is usually not simple. It requires a unique blend of software engineering skills and a deep understanding of medical standards and regulations. 

This guide will walk you through the process — from the start of your idea to the launch of your software product. We’ll cover navigating regulations, designing user-friendly interfaces, and using the latest technology.

Let’s dive in.

What Is Medical Device Software Development?

This is the process of designing and building apps that integrate with medical devices to deliver health-related functions. Medical devices range from simple tools like wearable medical devices — fitness trackers and smartwatches — to complex systems like robotic surgical systems. These tools are changing how we manage health and treat patients.

To provide a clearer picture of their importance, about 33% of Americans use wearable technology to track their health today. Also, over one million robotic surgeries will be performed in the United States by the year 2028.

Who Needs Medical Device Software Development?

Medical device software is highly sought after in various industries. Here are the leading sectors where it’s in demand.

Medical Device Manufacturers

Medical device manufacturers design and build devices that deliver healthcare functionalities like fitness trackers and defibrillators. However, the functionality of their devices depends on the development of custom medical device software.

Biotech Firms

Biotech companies create biological products like medicines, diagnostic tools, and medical devices. They rely on custom software to manage the immense amounts of biological data they generate. This software helps analyze, interpret, and present data, facilitating new discoveries and enhancing workflows.

Clinical Research Organizations (CROs)

CROs run trials for healthcare companies. They use special software to collect and handle data, monitor patients from afar, and follow regulations. These tailored tools make managing trials easier and speed up data analysis and reporting, helping them develop drugs and medical devices faster.

Diagnostic Equipment Manufacturers

Companies making diagnostic equipment like MRI or CT scanners need advanced software to run the hardware, handle imaging data, and deliver precise results. Custom medical device software will deliver all these and more. This type of software delivers better image quality, customized workflows, and seamless integration with EMRs.

Hospitals and Healthcare Facilities

Hospitals depend on a range of medical devices and systems to provide care. Medical device software is important in handling electronic medical records (EMRs), tracking vital signs, and running equipment. These specialized systems enable smooth data sharing, compatibility, and better decision-making, ultimately enhancing patient outcomes and operational effectiveness.

Healthtech Startups

Startups in the health tech sector invest in custom medical device software engineering to create innovative solutions like health trackers and remote monitoring devices. Agile development methodologies enable them to adapt quickly to market needs and scale effectively.

Pharmaceutical Corporations

Pharmaceutical companies study diseases and carry out important research that helps them discover drugs. They leverage medical device software to operate the specialized systems they need to work. This helps improve administrative functions, enhance monitoring, and lead to faster and better drug discovery.

R&D Laboratories

R&D labs are important in advancing medical research and discovering innovative treatments. They need specialized software to efficiently translate scientific breakthroughs into tangible medical devices. This accelerates the transformation of research discoveries into practical solutions, benefiting patients and healthcare providers.

Telehealth Service Providers

Telehealth services utilize telecommunication technology like video conferencing and remote patient monitoring devices to provide essential healthcare to underserved areas. However, they require specialized software to integrate with medical devices for remote diagnosis, monitoring, and treatment of patients. This integration enhances patient involvement, improves accessibility to healthcare, and revolutionizes the delivery of medical services.

For top-notch medical device software development, partner with Langate today.
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Benefits of Software Development for Medical Devices

Medical device software development brings a lot of benefits to the healthcare niche. Let’s explore a few below.

Market Growth and Expansion

Creating software for medical devices lets companies explore new markets and broaden their product range. By crafting innovative features to meet specific market demands, businesses can attract more customers and stay ahead in the healthcare technology scene.

Competitive Edge

Custom software development gives companies an edge. By intentionally designing features, user-friendly interfaces, and smooth integration with other systems, a company can shine in a crowded market, drawing in customers and expanding its market share.

Revenue Generation

Providing software-enabled medical devices opens up new income avenues through licensing, subscriptions, or added services. Regular software updates, maintenance contracts, and support services can generate a steady income and boost long-term profits.

Better Patient Outcomes

Medical device software improves patient care by making diagnostics and treatments more accurate and efficient. Its built-in advanced algorithm and decision support systems allow healthcare providers to make informed choices. This ultimately leads to better outcomes and fewer mistakes.

Streamlining Workflows

Software development streamlines healthcare processes by automating tasks and improving efficiency. Integrated software solutions make data exchange easier, reducing redundant work and improving communication among healthcare providers. This ultimately benefits patient care and reduces costs.

Enhanced Access and Affordability

Medical device software powers telemedicine, enabling remote healthcare access. These software products facilitate remote consultations and monitoring, extending vital services to underserved communities.

Data Insights and Analytics

Software-enabled medical devices generate valuable data for analyzing patient health trends and treatment outcomes. Healthcare providers can use these insights to make better decisions, optimize resources, and manage care delivery effectively.

Technological Integration

A well-developed Software for Medical devices can seamlessly integrate with other healthcare systems. This interoperability improves data exchange and care coordination across different settings, enhancing patient safety and continuity of care.

Supporting Personalized Medicine

Software-enabled medical devices help tailor treatments to individual patients’ needs and characteristics. By analyzing patient data and biomarkers, advanced algorithms guide personalized treatment decisions, improving overall therapy outcomes and quality of life.

Developing software for medical devices presents unique challenges, just like any other project. Here are the key hurdles.

Compliance and Regulations

Developing medical device software means following strict rules. In the USA, this is the FDA and HIPAA regulations or CE marking in Europe. Understanding these rules, staying updated, and sticking to them during development is hard. Not following them can lead to fines or recalls.

Usability and User Experience

Creating easy-to-use medical software for different users is challenging. You must balance complexity with simplicity, make it accessible to everyone, and test it well to avoid mistakes that could harm patients.

Risk of Medical Data Breaches

Medical software deals with sensitive patient data. Keeping it safe from hackers is important. Software design for medical devices will require strong data encryption, robust security measures, and following laws like HIPAA (for the US market) to avoid breaches that could harm patients and damage reputations.

Specific Customization Needs

Healthcare providers often need software customized to their workflows. It can be challenging to make these customizations while still following rules and ensuring the software works for everyone. Working closely with users and using the agile development methodology will help.

Interoperability Issues

Medical software often needs to work with other healthcare systems. It takes a lot of work and coordination to ensure that it can share data smoothly and work with existing systems while keeping data safe and accurate.

Testing and Validation

Creating a good software product is not enough. It has to be safe, work as well as it should, and meet user expectations. This means thoroughly testing the medical software design, and keeping proper records for regulators and other stakeholders. However, this can be challenging for small development teams.

Performance and Reliability

Medical software must always perform well and be available when needed. However, dealing with different operating conditions, managing resources, and fixing problems quickly, while important, are not as easy for every development team, especially the 14.6% that do not use agile methodology.

Rapid Technological Advancements

Keeping up with new tech like AI, ML, and IoT is tricky while ensuring the software still works with older systems. A recent study found that around 19% of connected medical devices in the US use outdated or unsupported software abandoned by their vendors. This poses significant security risks. It is important to find a balance between new ideas and old systems.

Cost and Time Constraints

Making medical software is expensive and takes time. Balancing cost, expertise, and safety in software development demands careful planning, resource allocation, and risk management for project success. This can be challenging, especially for small teams.

Navigating these challenges requires expertise and diligence. Langate can help.
Contact us today.

Factors to Consider When Developing Software for Medical Devices

Developing software, especially for the medical field, requires careful planning. Key factors include regulatory compliance and data security.

Regulatory Requirements and Quality Standards

Creating software for medical devices demands strict adherence to regulatory standards. These regulations ensure patient safety and effectiveness.

Some common requirements by location are:

  • United States. FDA, HIPAA, HITECH
  • European Union. EMA, MDR, GDPR, CE
  • Canada. PIPEDA, CMDR
  • Australia. TGA, Privacy Act
  • United Kingdom. MHRA, Data Protection Act
  • Internationally Standards. IMDRF and ISO

Data Security and Privacy

Data security is important in the medical device software development industry due to the sensitive nature of stored information. To protect patient data involves:

  • Encryption. Using encryption techniques for data confidentiality.
  • Access Control. Establishing mechanisms to control data access.
  • Auditing and Logs. Maintaining logs to track system activities for security monitoring.
  • Disaster Recovery. Implementing regular backups and recovery plans to minimize data loss.

By integrating these considerations, developers ensure regulatory compliance and robust security measures to safeguard data and privacy in medical device software.

Types of Medical Device Software

Medical device software falls into two categories: Embedded Medical Systems and Software as a Medical Device (SaMD). Let’s discuss each type.

Embedded Medical System Software (EMSSW)

Embedded medical system software (EMSSW) refers to software embedded within medical devices or systems. This type of software is created to control functions in the device or gather data in real-time. Examples of EMSSW include defibrillator software. This software controls the timing and delivery of electrical shocks to restore normal heart rhythm during cardiac arrest. 

Another example is the insulin pump software. This software regulates the delivery of insulin to manage blood sugar levels in diabetic patients. EMSSW programming typically uses C, C++, Java, and Python.

Software as a Medical Device (SaMD)

SaMD is standalone software intended for medical purposes. This medical device software can be used on PCs and mobile devices and is not tied to any particular hardware. Examples include mobile health apps tracking vital signs or diagnostic software interpreting medical images. Programming languages for creating SaMD vary based on platform, with Swift or Java for mobile apps and JavaScript, Python, or Java for web-based solutions.

EMSSW and SaMD are vital in modern healthcare. They power medical devices and offer standalone diagnosis, treatment, and patient care solutions.

Medical Device Software Development Process

Now that we’ve covered the technical points about medical device software, let’s cover what to know about the development process.

Understand Regulatory Requirements

Recognize the laws regulating medical device software in your market before you start developing. Each area has its own set of rules, such as the US FDA and HIPAA or the EU CE certification. Understanding and observing these guidelines up front saves expensive delays later.

Market Research and User Needs

Conduct thorough market research to identify user needs, competitors, and trends. Engage with stakeholders like healthcare pros, patients, and regulators to define the software’s role.

Choose a Seasoned Development Firm

Picking the right IT partner is key. Find a custom software development company with experience in medical device app development, a track record of regulatory compliance, and healthcare industry know-how. Look at their tech skills, regulatory knowledge, and reputation.

Plan with Your Development Partner

Work closely with your IT partner to create a detailed project plan covering project scope, tech stack, timeline, budget, and resources. Decide on the development methodology and set up communication channels. Plan for risk management throughout the project.

Development and Integration

This is where the medical device coding happens. Developers, designers, engineers, and the QA team work together to meet regulatory standards and make the software user-friendly. Integration with hardware or existing systems also happens here.

Implementation and Monitoring

Once development is done, it’s time to deploy the software in healthcare settings. This might involve setup, training, and data migration. Monitor its performance to catch any issues, gather feedback, and stay compliant. Finally, comprehensive testing must be conducted to ensure everything works well before launch.

Support and Maintenance

This phase is ongoing. Support user queries, troubleshoot technical problems, and roll out updates or improvements. Set up systems for tracking bugs, resolving issues, and managing software versions. Keep documentation up to date to reflect changes.

Choosing the Right Development Partner

We’ve already established that choosing a reliable IT partner is important for successful medical device software design and development. Here’s how to choose right.

Industry Experience and Expertise

Look for a company with extensive experience in healthcare software development. Check their track record in handling projects similar to yours, considering complexity, regulatory requirements, and device integration.

Review Portfolio and References

Examine their past projects to gauge quality and diversity. Seek references or case studies to understand their reliability, communication, and ability to meet deadlines.

Check Regulatory Compliance

Ensure they comply with relevant standards, such as FDA, CE marking, ISO 13485, and HIPAA. Confirm their experience navigating regulatory processes.

Evaluate Communication and Collaboration

Assess their communication practices and willingness to collaborate closely. Clear communication fosters transparency and trust.

Consider Long-Term Support

Select a partner with top-notch post-launch support. This typically covers technical help, bug repairs, updates, and user training.

Langate’s Experience in Developing Software for Medical Devices

The secret to medical device software development success is working with a reliable software developer like Langate. With years of experience delivering custom application development services to clients in the healthcare industry, Langate offers innovative, HIPAA-compliant software services tailored to hospitals, health IT providers, research institutions, and more.

Examples of our successful projects in this sector include:

Facial Recognition Solution for Patient and Staff Identification

We developed a web platform and mobile app equipped with facial recognition to help a healthcare client combat duplicate entries and improve data integrity. This helped the client streamline patient verification remotely. Not only did it enhance data management, but it also beefed up patient safety while meeting HIPAA and GDPR standards.

Accessing Patient Data Through Smart Glasses

Working with another healthcare client, we tackled the challenge of cumbersome record-keeping in hospitals. Our CareView software, seamlessly integrated with smart glasses, helps the client and team get real-time access to Electronic Health Records (EHRs), drug dispensing, and teleconferencing functionalities.

See more of our case studies to see why Langate is the right partner for bringing your medical device software vision to life.


As the need for digital health solutions rises, so does the importance of developing medical device software.

Developing medical device software requires careful attention to technology and the relevant health compliance regulations. Using the right medical device software development tool and working with the right partner can streamline this process. Hopefully, this guide has helped you navigate the journey from idea to launch, ensuring your solutions meet industry standards and improve healthcare outcomes.

Frequently Asked Questions

What is software in a medical device?

This is an application built for medical devices that provide health-related functions. These include diagnosing, treating, monitoring, or preventing diseases or other medical conditions.

Does the FDA consider software as a medical device?

Yes, the FDA considers software a medical device as long as it meets the definition found in Section 201(h) of the FD&C Act.

What is the future of software as a medical device?

Outlook software is promising as a medical device. It will involve more advanced technologies like AI, ML, and Internet of Things (IoT) integration, enabling personalized and remote healthcare solutions.

What is the cost of medical device software development?

Software development costs for medical devices can vary depending on different factors. When quoting, developers will consider project complexity, features, regulatory compliance costs, expected timeframe, and ongoing maintenance and support.

How does Langate ensure data security and privacy in medical device software?

At Langate, we make sure to put strong security measures in place. These include robust encryption and tight access controls. We also check to ensure compliance with all relevant regulations. Overall, we make sure to follow best practices for secure software development.

How long does it take to develop medical device software?

The life cycle of medical device software development can vary significantly. It depends on factors like project scope, complexity, and the number of regulatory requirements to tackle. It could range from several weeks to several months.

What sets Langate apart from other medical device software development companies?

Our expertise in both software development and healthcare sets us apart from others. We are also known for prioritizing quality, user-friendly designs, and continuous support for our clients. These are key factors that distinguish us at Langate. 

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