Medical Device Software Development: From Software Design to Launch

Picture this: the global population is aging, quicker than you can say ‘baby boomers’, and their demand for medical products is shooting up like fireworks on New Year’s Eve.

According to the United Nations, by the time 2050 rolls around, we’ll have 1.5 billion people aged 65 and older, a giant leap from 793 million in 2019. Now, translate that into potential users, potential customers, who will be clamoring for the latest in medical instrument technology. We’re talking about a market on the cusp of exploding, like a star going supernova!

You want figures? We’ve got them. Statista foresees that the medical device software market will surge from its current worth of $570 billion to a whopping $719 billion by 2028. It’s like witnessing a small town growing into a megacity overnight.

From diagnostic tools to therapeutic devices, the future of healthtech is practically being written in code.

We’re helped to build and test software for dozens of digital health projects. Now, we offer you to delve into the intricacies of medtech software development, navigating the maze of regulatory landscape and many other challenges that developers face in this brave new world.

So, ready to decode the future of safe and effective medical devices? Let’s dive in!

Custom Medical Device Software: Types and Application

What’s the secret ingredient that brings a medical gadget to life? It’s the medical device software (MDS) – an essential component that orchestrates the functionality of these gadgets whether they’re seamlessly integrated or operating independently.

Take, for instance, a wearable fitness tracker on your wrist, quietly monitoring your health metrics (like heart rate) and counting steps as you go about your day. This everyday device is empowered by complex software designed to deliver critical data right at your fingertips.

On a larger scale, there’s radiology imaging software, enhancing X-Ray machines’ ability to produce detailed images, or ventilator software, adjusting the air flow delivered to patient rooms in hospitals. The breadth and depth of applications are truly extraordinary.

Let’s turn our attention to exploring the diverse types of clinical device software. 

Key MDS Types In the Current Market

In a nutshell, there are two primary categories:

1. Embedded Medical Systems and Software

This software is integrated directly into the med. device and controls its core functionalities. Examples of devices that use embedded software include pulse oximeters, electronic defibrillators, and various types of medical imaging equipment.

2. Software as a Medical Device (SaMD)

Unlike embedded software, SaMD operates independently of any physical device. It is used for medical data visualization, processing, management, and specific technical diagnostics. One advantage of SaMD is that it can be more easily updated compared to traditional medical devices.

All SAMD and embedded software must adhere to regulatory compliance measures regardless of the category. This includes guidelines set by the FDA and specific safety and security standards. Now, let’s take a closer look at some additional variables fueling the healthtech device software development market growth.

Grown Factors Every Medical Device Software Development Company Should Consider 

The expansion in this sector hinges primarily on two driving forces: our escalating reliance on software within healthcare devices and the burgeoning rise of telemedicine and remote patient monitoring. These dynamics pave the way for a broad spectrum of stakeholders, ranging from manufacturers of medical tools to hospitals, NGOs, and healthtech companies, enabling them to enhance care delivery and pioneer innovative solutions.

On top of that, new technologies like AI, ML, and IoT are creating fresh opportunities. AI and ML are paving the way for smarter patient monitoring, while IoT is connecting medical instruments like never before. To stay ahead, companies need to keep up with trends, regulatory changes, and tech advances.

Healthtech device software is changing the game for doctors and patients alike. While the growing market value and potential revenue are a big draw, they’re not the only reasons companies are investing in custom medical instrument software development.

Top-5 Reasons Why Companies Need Software for Medical Devices 

Putting it simply, medtech software development is vital for healthcare organizations, offering numerous benefits:

  1. Enhanced Patient Care. Custom healthtech device software enables real-time patient monitoring, accurate diagnosis, and effective treatment plans, improving patient outcomes.
  2. Operational Efficiency. Medical soft automates administrative tasks, reduces paperwork, and streamlines workflows, freeing up staff time for patient care.
  3. Regulatory compliance induced safety. Software for a medical product must comply with stringent regulations. Failing to do so comes with massive fines. Custom software can be designed to meet these specific requirements, ensuring devices are safe for patient use and don’t cause financial trouble.
  4. Remote Patient Care. Medical soft facilitates remote patient care, enabling data-driven decision-making and providing a platform for telemedicine services.
  5. Advanced Functionalities. With technologies like AI and ML, healthtech software can support functionalities like predictive analysis and personalized patient care. This is particularly important considering the existing drag of the legacy business.

Medical app and desktop software development is a necessity for healthcare organizations, not a luxury. It significantly enhances patient care and operational efficiency, making it a worthwhile investment.

However, developing medtech software requires specialized skills and knowledge of healthcare regulations. Many companies partner with experienced software development services to leverage their expertise and ensure project success. However, before going into detail about compliance, let’s look at the type of medical gadgets one can upgrade with medical gadget software development services.

How Software Solutions Make Medical Devices Better

In the rapidly evolving healthcare landscape, software solutions play a crucial role in augmenting the capabilities of medical devices. This might be as simple as improving the readability of data from a heart monitor or as complex as enabling remote diagnostics. Here’s how these advancements contribute to enhancing medical devices:

  1. Diagnostic Equipment. MRI, CT scanners, and X-ray machines rely on software for data processing, image creation, abnormality identification, and diagnostic reporting.
  2. Therapeutic Devices. Software in devices like insulin pumps and pacemakers ensures accurate medication or electrical stimulation delivery.
  3. Patient Monitoring Devices. Heart rate, blood pressure, and glucose monitor software collects and analyzes patient data, providing real-time feedback and alerting healthcare providers to significant changes.
  4. Devices with Embedded Sensor Systems. Wearable fitness trackers and smartwatches use software to analyze real-time health data, provide insights, and offer personalized health and fitness recommendations.

Hospitals and clinics use these medical tools for diagnosis, treatment, patient monitoring, baby care devices management and personal health tracking. In such a context, developing software for these devices is a chance to kill two birds with one store — make healthcare services more effective, and build new revenue streams. Nevertheless, only a few companies dare to enter the realm of healthcare software development in general. The reason for that is two-fold—compliance and regulation. 

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Regulatory Requirements for SAMD Development and Beyond

Navigating the regulatory landscape is a critical aspect of healthtech device software development. With various international and regional standards in place, understanding these regulations is essential to ensure medical tools’’ safety, effectiveness, and quality. The regulatory environment for the phenomenon is intricate and governed by various international and regional standards. 

  • In the United States, the Food and Drug Administration (FDA) oversees the development and distribution of medical instruments, including software. The FDA’s regulations aim to ensure the safety and effectiveness of these devices, focusing on risk management and quality assurance. In addition, there is the Health Insurance Portability and Accountability Act (HIPAA). HIPAA is a crucial aspect of medtech software development in the United States, as it sets the standard for protecting sensitive patient data. Any healthcare-related software must ensure that all necessary physical, network, and process security measures are followed.
  • The Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) regulate medical gadget software in the European Union. These regulations, effective in May 2021, emphasize clinical evaluation and post-market surveillance, requiring manufacturers to monitor and report their devices’ performance continuously. Regarding data protection, adhering to General Data Protection Regulation (GDPR) is vital.
  • In the global landscape, ISO 13485:2016 is a globally recognized standard for quality management systems in the medical instrument industry. It supports healthtech device software creators in designing quality management systems that establish and maintain their processes’ effectiveness. This standard ensures the consistent design, development, production, installation, and delivery of healthtech devices that are safe for their intended purpose.

Regulations and standards environment for new software in the healthcare industry is complex but necessary to ensure patient safety and device effectiveness. Adherence to these regulations, from the FDA guidelines to the ISO standards, is a legal obligation and a commitment to quality and safety in healthcare. As we move forward to the dev process, keeping compliance in mind is a must. 

Understanding the Impact of IEC 62304 on Healthtech Software Development

In the realm of digital health software development, one international standard has taken precedence as a guiding force: the International Electrotechnical Commission’s IEC 62304. This standard lays out the lifecycle requirements for medtech device software, providing a comprehensive framework that ensures safety and performance. 

Key facets of IEC 62304 include:

  1. Risk Management. The standard insists on the adoption of risk management process compliant with ISO 14971, which ensures all possible risks are identified, evaluated, and mitigated effectively.
  2. Software Development Lifecycle (SDLC). IEC 62304 mandates a well-structured SDLC, which includes planning, development, testing, maintenance, and eventual retirement of the software.
  3. Software Classification. It introduces a classification scheme (Classes A, B, C) based on the potential risk to patients — the higher the risk, the stricter the development requirements.
  4. Configuration Management. A robust configuration management system is necessary, allowing for the traceability of all software versions and modifications.
  5. Problem Resolution. The standard requires a systematic process for identifying, documenting, and resolving all software-related problems.
  6. Software Maintenance: It prescribes the need for ongoing maintenance to address software issues, continuously improve functionality, and manage updates.

IEC 62304, by covering every aspect of medtech software development, from inception to sunset, offers a clear and solid foundation for developers. It ensures patient safety and product efficacy while providing a roadmap for consistent, high-quality software development.

In conclusion, compliance with IEC 62304 is not just a regulatory requirement, but a blueprint for success. It streamlines processes, mitigates risks, and instills confidence among users, ultimately elevating the software reliability and credibility in a dynamic and demanding healthcare landscape.

The Ins and Out of the Medical Device Software Development Process

Developing software for medical instruments is a meticulous process involving several critical steps. From identifying a market need to ensuring the software’s safety and effectiveness, each stage of the software development life cycle (SDLC) plays a crucial role in successfully deploying healthtech device software. At this point, let’s take a closer look at these steps.  

Step #1. Requirements gathering and specification approval

The initial phase of the process involves:

  • Identifying the software concept.
  • Prioritizing software requirements.
  • Creating a detailed specification of the medical instrument software.

This phase also includes risk analysis and creating a risk management plan, following the ISO 14971 standard in medical tool manufacturing. 

Any oversights or missteps at this juncture can lead to significant issues further down the road. Moreover, this stage serves as the platform to identify potential software-related hazards, assess the associated risks, and evaluate their potential impact.

Step #2. Medical device software architecture design

Next, software developers design a reliable and scalable healthcare device software architecture. This architecture allows for adding new modules or device types with minimal rework. It ensures system configurability, clear module interfaces, and good encapsulation of every module. 

The architecture design phase is pivotal in shaping the software’s performance, scalability, and ease of maintenance and updating. This stage also serves as a platform where engineers of clinical device software examine its interoperability with other systems and devices, aiming for a seamless and secure exchange of data.

Step #3. UX/UI design 

Designing software for medical devices is an intricate task that hinges greatly on user experience. Our aim is to create a user interface that is not only sleek but also accessible for everyone, no matter their age or level of tech expertise.

Consider, for example, a heart rate monitor app on a smartwatch. The interface needs to be easy for a tech-savvy young adult to navigate, but also simple enough for an elderly person who may not be as comfortable with technology. This delicate balance is one of the world’s most vital challenges in medical device software design.

The interaction between the user and the software significantly impacts user satisfaction. So, we don’t just build software; we design software that helps people. It has to be intuitive and user-friendly, serving healthcare professionals and patients alike.

In short, the focus is on creating a software design for medical devices that enhances healthcare delivery and user satisfaction, while being easily navigable by all users. It’s all about making sure technology is an aid, not a hindrance, to care. 

Egor Sokhan

In one of my healthcare projects, we worked on a medical device that pricked your arm and drew blood. We didn’t want our users feeling uneasy or scared about it. So, we prioritized their experience and expectations from designing the app’s interface stage to drafting the packaging. We wanted them to trust us and our device. And that kind of trust only comes when you genuinely empathize with your end users. By empathizing, you create devices and interfaces that cover practical functionality and a human touch.

Yehor Sokhan, Head of Design at QArea

Step #4. Medical device software development

The software is developed with cross-platform compatibility during this phase to cater to multiple operating systems. It is integrated seamlessly with healthcare software (EHR, ADT) via HL7 v.3 or FHIR. The development methodology can be either Waterfall (full-fledged version delivered in one iteration) or Iterative (Agile, Scrum) with MVP delivery and updates every 2-4 weeks. 

This step is all about coding the software according to the specifications and design documents created in the previous steps. It’s also the moment where the software’s ability to interact with wearable and non-wearable smart devices is considered, ensuring regular communication with the IoMT system for patient monitoring.

Step #5. Quality Assurance

During software testing and quality assurance, OWASP’s Secure Software Development Life Cycle (S-SDLC) practices are applied. These involve comprehensive multi-level QA. In addition, the step includes continuous testing, software validation/verification, and regular code reviews.  

Testing strategies validate that the software meets its intended use purpose and can operate safely under normal and abnormal conditions. This step is crucial to ensure the software is defect-free and performs as expected. It’s also the stage where the software’s cybersecurity measures are considered, including data encryption, secure user authentication, and regular security audits.

Step #6. Premarket submission

To meet the requirements of the FDA and the Council of the European Union and ensure software safety, development services are provided according to ISO 13485, IEC 62304, and IEC 82304-1. During this stage, experts prepare detailed documentation for FDA 510 (k) premarket notification, CE marking, HIPAA compliance audits, etc. This step is critical to ensure the software meets all regulatory requirements and is safe for use.

Step #7. Integration with smart devices

At this stage, the software for the medical instrument is enabled to ensure smooth interaction with the devices. Stable communication with the IoMT system is ensured for remote patient monitoring, and comprehensive analytics of patient-generated health data collected by devices is provided. This step ensures the software can effectively communicate with other devices and systems.

Step #8. Medical instrument software support and evolution

Finally, if required, support is provided for the healthtech device software. It manages the software’s performance and security. Routine software administration tasks are mainly performed, and the software is helped to evolve further. This step is crucial to ensure the software is always up-to-date.

The stages above give you an idea of custom medical tool software development. The rule of thumb dictates—the better you handle each step, the more cost-efficient the process will be. Yet, even for clinical device software developers with years of experience, some crucial challenges remain to consider during the entire dev and design process.

Medical device software engineering challenges: From regulation to device application

The development of healthtech device software involves navigating a complex landscape of challenges. Developers must address many factors, from regulatory compliance to cybersecurity, to ensure successful software deployment and operation.

Challenge 1: Regulatory compliance

Again and again, regulatory compliance is crucial to remember within the dev and design process. The price of non-compliance can go as high as $1.5 million. Medical device software must adhere to FDA guidelines, HIPAA, and EU MDR regulations. 

Developers must stay updated with these regulations and design the software to meet these standards. Outsourcing to experienced partners can be a viable strategy to navigate these complex regulatory waters. 

Challenge 2: Interoperability

Medtech devices frequently have to communicate and exchange data with a variety of other systems and devices. This interaction is vital for the consolidation and comprehension of the data received from multiple sources, aiding in accurate diagnosis and effective treatment plans.

Let’s take the example of a heart rate monitor and a glucose level tracker in a hospital setting. These devices need to share information with the hospital’s main system so doctors can get a complete view of a patient’s health status. To enable this seamless exchange of information, developers adopt standard communication protocols and data formats, such as HL7 or FHIR.

In addition, the integration of these protocols is not a one-time event but must be maintained throughout the software lifecycle. As technology evolves and upgrades, these standards may also be updated. Your development team needs to ensure that the software remains compatible with these changes, maintaining the smooth flow of data exchange.

Challenge 3: Cybersecurity

Healthtech devices handle sensitive data, making them attractive targets for cybercriminals. A recent report by IBM indicates the average cost of a healthcare data breach surpasses $10 million. To avoid data breaches, MDS developers must implement robust security measures, including Advanced Encryption Standard (AES), SSH File Transfer Protocols (SFTP), encryption tools like BitLocker/FileVault, two-factor (2FA) or multi-factor (MFA) user authentication, single sign-on (SSO), and regular security audits including vulnerability assessment, penetration testing, and code reviews.

Challenge 4: Usability

The usability of SAMD and software for medical procedures and monitoring plays a crucial role in their effectiveness. It’s essential that these tools are user-friendly for everyone involved — from healthcare professionals to patients.

Let’s think about a future medical app designed to help patients track their symptoms. If the app is too complex, it may discourage users or lead to inaccurate data input. That’s why developers need to adopt user-centered design principles.

When we design and build healthtech soft, it’s not just about technical functionality. The software must be intuitive, ensuring users can operate it efficiently and effectively without added stress.

Challenge 5: Software validation

Rigorous testing and validation processes should be in place to verify the software’s functionality and performance. This includes coordinating, designing, and conducting trials and research studies for product validation.

To develop and deploy medical device software successfully, several hurdles must be overcome. For those developing this type of software, smooth sailing is possible through continuous learning about new regulatory changes, making certain that the software can interact seamlessly with other systems, implementing strong cybersecurity defenses, prioritizing user-friendly design, and thoroughly validating the software. It’s essentially about remaining adaptable, secure, user-oriented, and thorough in all stages of the software creation process.

The future of medical device app development

The medical device software development services now have a potential to thrive is an ever-evolving landscape. Technological advancements and the need for improved healthcare solutions also drive it. The following points highlight some of the key trends shaping this field:

  • Artificial Intelligence (AI) and Machine Learning (ML). These technologies are revolutionizing healthtech device software capabilities by enhancing diagnostics, predictive analytics, and personalized medicine. They analyze vast data sets to identify patterns and make predictions, improving patient outcomes. For example, AI can analyze imaging data for early disease detection.
  • Internet of Medical Things (IoMT). The IoMT, a connected infrastructure of medical tools, software applications, and health systems, allows devices to communicate and exchange data, improving efficiency and patient care. The trend of increasing device connectivity is expected to continue.
  • Telemedicine and Remote Patient Monitoring. The COVID-19 pandemic has accelerated the need for distance patient monitoring and telemedicine. Medical device software is being developed to facilitate remote consultations, monitor patient health data, and provide real-time feedback to healthcare providers.
  • Personalized Medicine. Leveraging AI and data analytics, healthtech device software is being developed to provide personalized treatment plans based on a patient’s unique characteristics. This approach can improve treatment outcomes and patient satisfaction.
  • Blockchain Technology. Blockchain can provide a secure and transparent platform for patient data exchange. It can maintain patient privacy, ensure data integrity, and facilitate interoperability between healthcare systems.

These trends highlight the dynamic nature of medical device software development. Outsourcing to experienced medical software development services can be a strategic move to leverage the opportunities presented by these trends.

Wrapping up

Faced with rigid regulations and constantly shifting trends, the challenges of development of medical device software are hefty but, with the right approach, entirely surmountable.

Agile development plays a significant role in tackling these challenges, allowing for flexibility and quick adaptation to changing circumstances or requirements. Mobile development, too, is an exciting frontier that brings healthcare tools right into the hands of those who need them, making care more accessible and efficient.

It’s in this environment that the innovative medical software truly shines — helping healthcare providers deliver superior patient care, improving clinical outcomes, and streamlining workflows.

The importance of high-quality medical tool software continues to grow exponentially. This makes it an ideal time to explore and leverage the immense potential that software design for healthtech devices holds.

However, navigating these waters and turning challenges into opportunities requires not just the right tools and strategies, but also the right team. A professional development partner, experienced in the nuances of healthcare software, can guide you through the intricate labyrinth of regulations, lifecycle management, and more, ensuring your product is not just compliant, but a step ahead.


The journey may be intricate, but the results — improved healthcare outcomes through powerful, intuitive software — are undoubtedly worth it.



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