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Healthcare
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Table of Contents
Software development for medical devices is the core of healthcare. They become more portable, accessible, and smarter, ensuring functionality, accuracy, and patient safety, as technologies evolve. Yet, whatever smart these machines become, they still require deep expertise from developers. Evolving technologies, safety standards, and regulatory compliance are the pieces that cannot be thrown from the puzzle.
In this article, we delve into the intricacies of what medical devices are, how they are built, and what essential things to keep in mind.
The U.S. Food and Drug Administration (FDA) uses the term 'medical device' for any devices 'intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals'. In a nutshell, it is the software applied for diagnosis, treatment, patient monitoring, and healthcare management. It may come as standalone solutions such as apps or be embedded within medical devices.
Medical device software development is not a new field. The earliest medical devices with embedded software date back to the 1960s and 1970s when computer technology was first integrated into healthcare. Early medical devices like pacemakers or infusion pumps used basic software to control functions and process data.
Further advancements in microprocessors and digital imaging led to the appearance of robotic-assisted surgery, MRI, and computerized diagnostic tools. In the 2000–2010s, the rise of the internet, AI tech, and cloud computing made software for medical devices even more sophisticated, which continues up to the present day.
Software for medical devices can be broadly divided into two main groups, according to the platform om which they run: Software in Medical Device (SiMD), or embedded software, and Software as a Medical Device (SaMD).
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SiMD are software solutions integrated or synchronized with medical hardware and cannot function separately (for this reason, they are often called 'embedded software'). Yet, they help control and improve performance and functionality of various physical devices, like:
Software as a medical device is one of the fastest-growing areas within the MedTech sector. There are projections for the market size to reach $8.2 billion and for a CAGR of 11.0% by 2027. Typically, SaMD is not considered part of healthcare equipment and runs on computer platforms that are not necessarily used for medical purposes. It doesn't fulfill the equipment's functions or tasks, but can interact with the interface of certain devices or can be used in combination with their embedded components.
SaMD is used for several aspects:
Advanced solutions transform how healthcare providers operate. Let's explore their key benefits and how different stakeholders stand to gain from such integration.
Fewer mistakes and better patient outcomes are the results any healthcare provider strives for. AI imaging software can detect anomalies with higher precision than the human eye. Automated processes and built-in decision support systems also make diagnostics and treatments more accurate. Thus, healthcare providers are able to make informed choices, and the amount of human errors reduces drastically.
More examples:
Wearables, smart implants, and connected monitoring systems ensure continuous monitoring of patient data. If abnormal patterns appear, these devices can detect them, send alerts to healthcare providers, who, in turn, ensure timely support for the patients.
More examples:
Processes that can be automated should be automated, which is especially true for the healthcare industry. Medical device software makes the workflow smooth and efficient: it improves data exchange among healthcare providers and eliminates redundant paperwork. As professionals are more focused on patient care rather than bureaucracy, costs are reduced. Needless to say that in healthcare, saving time often means saving lives.
More examples:
Software design for medical devices is now able to move to the next step, including solutions for personalized treatment. Patient real-time data and medical history, processed with AI and ML tools, help to get better outcomes and tailored care.
Firstly, creating custom medical device software that can be smoothly integrated with other platforms can extend their product line. Offering devices with built-in software increases product value.
Secondly, it opens up opportunities to explore new markets and proven sources of revenue, like maintenance contracts or licensing.
More examples:
Medical device software improves interoperability between healthcare systems and expands remote healthcare access. Thus, patients in remote or underserved areas who cannot visit in person get virtual consultations and monitoring through telemedicine and mobile solutions.
Almost all medical device software, whether embedded or standalone, is used while being connected to the internet and hospital networks. For this reason, both the devices and sensitive patient data they work with are at risk of cybersecurity attacks and should be protected.
Further, we will talk about the key frameworks you should consider in software design for medical devices.
Each market has unique compliance requirements that impact how patient data is handled, secured, and shared. Navigating cybersecurity and data protection in medical software development requires a deep understanding of these regional standards.
This is the main globally recognized standard setting the framework for developing both SiMD and SaMD, with:
Additionally, it establishes a safety classification system for medical software (the higher the level, the more safety measures are required):
Other International standards crucial for medical device software design are:
One more standard to keep in mind is the International IMDRF Guide on Cybersecurity of Medical Devices. This document aims to promote a globally accepted approach to cybersecurity in healthcare. It focuses on security principles and best practices implemented throughout all stages of the product life cycle, including design, development, testing, post-market monitoring activities, and the End of Support (EoS).
HIPPAA for the US and GPPR for the EU are the most well-known, but not the only standards for protecting personal health data. Also, when you launch a product in international markets, consider that guidelines vary by location.
For the US, cybersecurity regulations for Software as a Medical Device are available in the Guidance issued by the FDA (Food and Drug Administration). This document prioritizes security by design, transparency, and risk management throughout their entire life cycle of a medical device.
HITECH Act (short for Health Information Technology for Economic and Clinical Health Act) is an extension of HIPAA, or Health Insurance Portability and Accountability Act. It encourages healthcare providers to adopt electronic health records (EHRs), improve standards for their interoperability, and implement security measures for electronic patient data, as well as give patients access to this information. Also, it promotes research and development in the field of health information technology (HIT).
In the EU, cybersecurity measures for medical device software should adhere to the European Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostics Regulation (EU) 2017/746 (IVDR). These two legislation documents consider all steps of software development and maintenance involved in risk management and cybersecurity.
Other important regulations include the NIS Directive (or Directive 2016/1148 of the European Parliament and of the Council of 6 July 2016), which focuses on legal measures for the security of network and information systems across the EU, and GDPR, which deals with the protection and transfer of personal information.
In the UK, security for medical software devices is protected by the NIS Regulation 2018 (UK). It provides legal measures for improving security of networks and information systems. The UK version of GDPR (The Data Protection Act 2018) sets the guidelines for the processing and transfer of sensitive personal data in the UK.
Additionally, on January 9, 2024, the UK Medicines and Healthcare Regulatory Agency (MHRA) proposed a roadmap for the regulation of medical software devices, with the focus on patient safety and transformative technologies including AI, implantable devices, and early disease diagnostics.
While in the US, the FDA Guidance includes regulations for food, drugs, cosmetics, and devices, which also apply in Canada, the latter uses a specific regulation for medical devices, known as the Medical Devices Regulations (SOR/98-282), or CMDR, for short.
One more peculiarity: in Canada, healthcare devices are categorized into four classes based on their risk level, from low to highest. Consider this if you want to launch your product in the Canadian market.
PIPEDA, or Personal Information Protection and Electronic Documents Act, regulates how organizations deal with personal information during commercial activities. First, under this law, organizations must only collect, use, and disclose personal information when it is necessary for their stated purposes. Second, an individual's consent to use data is obligatory. And third, when using it, organizations must ensure that the information is complete, accurate, and up-to-date.
Similar to the FDA in the United States, Australia has its own Therapeutic Goods Administration (TGA) which regulates the production and use of therapeutic goods, such as prescription medicines, medical devices, and diagnostic tests. In 1989, it introduced the Therapeutic Goods Act, obliging manufacturers to work safely and maintain the required ethical standards for medical products.
The Australian analog of HIPAA and GDPR, the Privacy Act of 1988, protects personal information and regulates its use by third-party organizations.
Staying up to date with evolving international regulations not only ensures legal compliance and security of medical devices. It also builds trust with your users.
While building devices for healthcare, a standard Software Development Lifecycle (SDLC) gains specifics. The nuances are mostly caused by the increased need for data security, rigorous testing, and adherence to regulatory compliance. Here are the phases developers should follow.
Begin with gathering detailed requirements and inputs from healthcare professionals, patients, and other stakeholders. Understanding the patients’ medical issues and peculiarities of the providers’ workflow, the software aims to solve is crucial.
Cybersecurity, data protection, and compliance considerations should be considered already at this stage. For example, if you develop remote patient monitoring software, think of how it will securely transmit real-time data and how it will be integrated with hospital systems.
Then, ensure to identify potential risks to patients and users, such as software malfunctions, cybersecurity vulnerabilities, and human errors. Refer to the international safety standards we described above and consider the legislation acts specific for the local market you want to work with.
Designing software that is both intuitive, accessible, and safe cannot go without prototypes. At this step, try to test the minimal functionality and receive as much feedback as possible. For instance, if you're working on AI-assisted diagnostic software, early prototypes will help you test the accuracy before full deployment.
After prototyping, it's advisable to run a minimum viable product. Cooperate with stakeholders to gather background data about industry best practices and incorporate it into your pilot product. Test the user experience and analyze what features and interfaces that may be lacking.
This will leave with a data-informed software development plan, which is the next step. Also, you'll gain a better understanding of whether you need more resources and skills to deploy the product.
At this stage, developers code, integrate UI/UX design, and conduct quality assurance testing. This is the perfect time to collaborate with regulatory consultants before submitting the software for commercial use.
A very specific stage in medical device software development is integration with healthcare environments. For instance, if your product is AI imaging software, you should correctly embed it into hospital radiology departments.
Medical software can be developed in-house, if you have the necessary skill set, or in partnership with a seasoned vendor.
The step you should never skip is rigorous testing of the functionality, usability, and safety backed by compliance with medical regulations, especially IEC 62304 and data protection acts.
To validate that your medical device software meets all the requirements, it's advisable to conduct clinical trials and research studies.
After testing and before market release, you are supposed to apply for regulatory approvals of the medical software. Keep in mind that submission and approval are a time-consuming process: it requires preparing extensive documentation, submitting the software, and finally receiving a response from the regulating body (FDA in the USA, MDR in Europe, MHRA in the UK, etc).
Regulations may be more or less strict, depending on the software you deployed. For example, software for wearables must undergo stringent validation, while fitness apps still need validation. However, in most cases, they are mostly about adhering to GDPR requirements.
Once all the medical device software development steps are completed, the work is far from over.
As many devices have been used for decades, they may end up running on outdated operating systems. For instance, software operating on Windows 8 instead of the latest versions, which no longer receive updates, starts accumulating bugs. Over time, vulnerabilities can put patient data at risk.
You can mitigate such problems and complaints from the clients by offering regular security patches and compliance updates. To detect potential issues early, perform continuous monitoring and collect feedback.
It's also important to integrate new technologies that enhance the functionality and efficiency of medical device software. Further, we're going to elaborate on the tech stack you might need.
The range of medical devices is diverse, and the choice of programming languages, tools, and frameworks depends on the functionality of the software. Whether it's embedded, runs on a desktop in a hospital, or supports mobile health applications, your set will differ.
Below is a breakdown of the most commonly used tech stack in medical device software development, along with its real-world applications.
Choosing the right tech stack ensures medical device software is not only functional but also secure and scalable.
When building medical device software, developers often face unique challenges, from regulatory compliance to interoperability and pricing pressure. Here's an overview of key challenges and how software developers can effectively overcome them to create reliable solutions.
We have already mentioned the requirements and standards that manufacturers need to follow. Failing to meet these standards can lead to product recalls or market rejection.
How you can face the challenge:
It is still one of the primary concerns and challenges in medical device software development. According to the report, healthcare accounted for 23% of all data breaches, overtaking finance (22%) in 2024.
How you can face the challenge:
Medical software communicates with EHR systems, imaging systems, and connected devices via Wi-Fi, Bluetooth, and custom protocols. Yet, challenges may arise, especially if the software originates from different vendors or platforms.
How you can face the challenge:
Medical software with a poorly designed interface and unstable performance can result in delays and even harm patients.
How to face the challenge:
As the market of medical device software development is growing, competition rises as well. To stay competitive, they start putting lower price tags on the production, which leave manufacturers in a gridlock. Why so?
Medical devices require many resources on R&D and regulatory compliance, but in the need to make prices lower, such investments do not seem reasonable. The product lifecycle speeds up, with shortcuts on research, testing, and regulatory compliance. In the long run, such a strategy may lead to a lack of innovation and lower quality of services provided to customers.
How to face the challenge:
Successful medical device software development implies input from healthcare professionals, patients, engineers, and regulators. Poor communication can lead to misaligned requirements and delays.
How you can face the challenge:
With all existing tech advancements in healthcare, there's still a lot of potential to revolutionize it. Here we list the most promising technologies that push the industry forward.
When the Internet of Medical Things (IoMT) was applied in healthcare, patient monitoring reached a new level. Healthcare providers and patients themselves can track health conditions remotely and in real time with smart inhalers, wireless ECG monitors, and Bluetooth-enabled glucose meters. If the patient' condition deteriorates, devices help perform early intervention, and reduce hospital visits.
Cloud computing solutions like SaaS allow connecting hospitals with patients via applications without the need to manage on-premise infrastructure.
Cloud-based EHR systems, telemedicine platforms, and AI-assisted diagnostics make updates seamless and healthcare services cost-efficient.
The arsenal of AI and ML algorithms make way for more personalized and accurate medicine. Predictive analytics, personalized treatment plans, automated diagnostics, detection of anomalies in MRIs and CT scans are most vivid examples of how these technologies improve healthcare.
Blockchain technology plays a crucial role in mitigating breaches and cyberattacks, which are so common in the healthcare industry. By encrypting patient information, blockchain improves data integrity in medical records and makes data sharing between providers more streamlined. As a consequence, compliance with privacy regulations also improves.
Testing and validating medical device software has become easier after virtual replicas of medical devices were introduced. With digital twin technology it's possible to simulate real-world usage scenarios, predict failures and optimize performance before real device production. It saves resources and what is most important, enhances accuracy in surgical robotics and biomedical engineering.
As tech innovations continue to evolve and penetrate into healthcare, there is more space for having the lead as a manufacturer and trailblazer. Medical device software engineering is no easy feat, but a reliable development partner can assist you on the way.
Want to make your mark in the healthcare industry? NEKLO will help you create high-class medical software while staying updated on regulations and best practices!
US-based and operating globally, NEKLO spearheads digital transformation initiatives for businesses worldwide. We deliver software solutions complying with your market and legislation.
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