Medical Device Software Development Handbook

Key Takeaways

• It is anticipated that more than a quarter of a billion copies of this practical technology will have been marketed by 2025.
• Software medical device is cloud-based or on-premise software designed for a range of healthcare facilities to store, process, and manage medical, financial, and administrative data.
• SaMD can help patients manage their health more successfully, increase diagnostic accuracy, and reduce human error by increasing patient awareness of their health state.
• By utilizing smart devices and apps to automate medical operations, hospitals may free up staff time for other, more critical responsibilities while also saving time and effort. Additionally, healthcare institutions require less physical space since SaMD can lower the number of hospitalizations.

A new health process that offers patients and medical staff significantly more chances has been made possible by new technologies. Thanks to the development of medical device software, smartphones and smartwatches are doubling up as diagnostic equipment.

While the hardware is undergoing transformative progress, the software that powers the medical devices needs to keep up as well.  The relatively new notion of “Software as a Medical Device” (SaMD) is opening up enormous possibilities for the development of enhanced applications for current or prototyped medical equipment.

We’ll talk about how to build custom medical device software and functionality in this post.

To get a custom healthcare software developed for your organization, get in touch with Arkenea, one of the leading software development companies that is exclusively focused on the healthcare sector.

A Brief Overview of Software as a Medical Device

All goods and services that don’t require a particular piece of medical equipment fall under this category of software development for medical devices. For instance, SaMD systems can be used with a variety of non-medical platforms, such as laptops, desktop computers, mobile devices, etc.

This kind of software typically carries out one or more of the following tasks:

• visualization and display of medical data
• processing and interpreting medical data
• particular configuration and technical diagnostics of some medical devices, including health data management and storage

The following characteristics define software as a medical device:

• SaMD is not a component of medical technology, nor is it necessary for a medical device to carry out its features or tasks.
• Infrastructure and general-purpose computers are used to execute SaMD.
• To acquire data obtained by the device or to control its operation, it can interface with specific specialized medical devices, including the devices’ internal/embedded components and embedded software.

The SaMD concept demands specialized knowledge and skills that are not readily accessible in the American market when developing software for medical devices. To discuss the specifics of your project and find out more about our capabilities in medical device coding and other software solutions, please get in touch with our knowledgeable healthcare technology expert.

SaMD is used in various examples, such as:

• Patient imaging or scan analysis: Software that examines patient information to find patterns, indicators, or trends enables medical professionals to more accurately recognize subtle but significant alterations in patient conditions and/or to speed up diagnosis and treatment. For instance, in patients with acute stroke situations, this could involve help for decision-making for accurate classification between ischemic and hemorrhagic stroke. The result may significantly influence the therapy and/or medical intervention that is chosen.
• Prevention of sleep apnea by sound monitoring: An alarm that wakes the sleeper can be automatically set off by a smart device microphone when breathing is stopped while the user is sleeping. The same technology can be used to automatically identify atypical breathing patterns and notify emergency personnel when a situation warrants their attention (this can be done for elderly or single individuals).
• Adhesive or implantable sensors can be used for remote ECG monitoring to track the heartbeat patterns of cardiac patients and identify any unexpected or life-threatening ECG patterns or events (arrhythmia, bradycardia, etc.) that need to be reported right away.
• Applications for displaying medical data: These comprise all software that aids medical professionals in accessing, verifying, visualizing, sharing, documenting, and/or interpreting health information obtained from particular bioelectronic sensors or medical devices, including a variety of metrics like heart rate, blood pressure, skin temperature, and more.

Different Types of Medical Device Softwares

Medical device-specific software falls under a variety of categories. Since the scope and technologies, such as embedded coding and SaMD, can be rather variable, it is essential to formally outline the needs for your medical device software development before beginning a new project.

However, the bulk of initiatives and companies for actual medical equipment aim to use a variety of technologies. Let’s find out more about the key types of medical device software development.

1. SaMD (Software as a Medical Device)

SaMD is an independent medical software that utilizes information from medical devices, and it can treat diseases, plus perform medical procedures. It can be used on smartphones and other hardware devices that aren’t part of medical device software. In addition, it can be stored on a cloud as well. Examples of SaMD are ultrasound examinations and applications to control medication dosages.

2. SiMD (Software in a Medical Device)

SiMD is part of a medical device and accomplishes all medical purposes, however, it doesn’t operate independently from a device like SaMD. Further, SiMD controls and monitors the medical functions of a device and it is also known as embedded medical software.

3. Software as an Accessory to a Medical Device

Software as an accessory to a medical device doesn’t serve a medical purpose, and this is what separates it from the other two types. An example includes maintenance software for MRI machines.

Embedded Medical Systems and Embedded Medical Software Development

This field includes low-level programming for micro components with embedded memory and processors, such as microcontrollers and microchips. Most medical equipment has all of this inside the engine. Examples of medical devices with embedded systems that are controlled or configured by embedded code include:

• Heart rate monitors
• Electronic pacemakers intelligent (bio)sensors
• Programmable infusion pumps
• Glucometers
• Digital thermometers
• Digital blood pressure monitors
• Medical imaging equipment includes X-ray, MRI, ECG, CT, EEG, and a wide range of lab tools.

As it controls the use of various electronic components and aids in the integration of medical devices with non-specific or general-purpose software and hardware, such as PCs, EHRs, Wi-Fi, and many other systems, embedded programming is essential for healthcare equipment and biomedical applications.

While the embedded systems development of some medical devices simply requires basic programming knowledge, some projects call for highly skilled expertise in healthcare device engineering. Just consider how much time and effort it takes to calibrate and configure all the embedded circuits in a big, complex machine like a contemporary MRI tomography.

SaMD Regulatory Compliance Guidelines

To create more general, uniform regulations for software classed as Software as a Medical Device, the FDA has created several guidelines.

One such requirement is that clinical vocabulary be supported by the software as a medical device for use; this has to do with appropriate training and linguistic design in the user interface. Another rule calls for discussing clinical evaluation techniques and data that are pertinent to the usage of medical device software.

According to the FDA, developers of ‘Program as a Medical Device’ products should list any potential negative effects as well as other suggestions that should be attached to the software for analytical purposes.

The regulatory parties have a question about whether there will be an influence on presently regulated devices or any potential negative effects given the peculiarity of medical device software and the proposed framework.

Medical software must comply with HIPPA. Here are the factors that determine if the software for your medical device needs to be compliant with HIPAA.

• Why is the data being collected?
• Does this data contain any personally identifiable information (PHI) or is it identifiable?
• To what extent will PHI be accessible? Only the owner of the data (the patient), a doctor, a professional associate, or a manufacturer?
• Which of these organizations will be able to access PHI stored in the software?

Manufacturers of medical devices conduct verification and validation testing to make sure their products adhere to the specified design inputs and user requirements. Cybersecurity and HIPAA compliance are not entirely different, and both must be taken into account while designing software. Software must be subjected to verification and validation testing by manufacturers to guarantee that it complies with HIPAA regulations.

According to HIPAA standards, patient data is safeguarded and the organizations that store it have procedures in place to safeguard patient data in the event of any data breaches or threats. By validating and verifying their software against realistically predicted data dangers, manufacturers share responsibility for ensuring data protection.

The IEC 62304 Guideline in Medical Device Software Development Process

The International Electrotechnical Commission (IEC) 62304 standard mentions the requirements for the maintenance, development, and lifecycle management of the software used in medical devices. IEC 62304 compliance ensures that the medical device software is developed reliably, is safe to use, and is effective.

Additionally, this regulatory compliance outlines the software process improvement roadmap that must be followed to maintain the safety of medical devices.

Medical Device Software Development Process

Of course, developing custom software for medical equipment takes a lot of engineering work and expertise. Starting with the creation of a thorough medical device/software architecture, project goals and scope are defined.

Let’s talk about the key elements of developing software for medical devices.

Process for Developing Medical Device Apps Seen From a High-Level

Many different medical device software development approaches involve medical device software development and embedded system development. To combine the data, they need a variety of experts, broad engineering knowledge, and skilled health-tech engineers.

Generally speaking, a software development plan needs to take the following steps:

• Define the technology stack for your project to develop software for medical devices: Is the project entirely embedded or blended with Medical device software?
• Determine the FDA regulations for your particular sort of medical device and software and meet them (in compliance with HIPAA) Brand-new medical equipment, needs to be ISO certified and adhere to other requirements.
• Hire or assemble a team of developers who are skilled in embedded and/or traditional software development, which is necessary for medical device software development, depending on the scope of your project.
• Let a health tech engineer create the system requirements for your program or device.
• Make sure a capable project manager is chosen to organize the project’s many tasks and phases.
• Give these duties to the appropriate experts, such as UI/UX designers for health technology, back-end and front-end developers, QA specialists, and others.
• Make sure you have access to medical specialists for testing and consultation. Keep in mind that the end users of your medical product—physicians, nurses, and surgeons—as well as their patients should have their interests reflected.

Medical Device Software Development Tech Stack

There are many technical options and tools available that can be used for the creation of medical equipment software. Your project’s scope and specific settings are dependent on it (which should be discussed and specified with your vendor). Please get in touch with us if you wish to discuss specific technological alternatives and the procedure for developing medical device software with a professional company.

The typical technology stack used in medical device software engineering can mix any of the following:

• Compilers and Integrated Development Environments (IDE)
• Debug devices and software for embedded programming languages such as C, C++, MicroPython, Python, and Java (Debugger) Emulators
• Software and device testing
• Azure, AWS, Digital Ocean, and Google Cloud development
• Wearable, mobile, and Internet of Things devices used in integrated health tech solutions
• Development of the front end using Angular,  Node.js, React, Vue, and Core JavaScript
• C#, JavaScript, Node.js, TypeScript, PHP, Dart, and SQL Middleware are examples of supporting software. Additional modules from different vendors include those for 3D printing, ML, AI, AR/VR, medical SaaS, and more.

Costs of Developing Medical Device Software

Due to the wide range of medical device software, the development costs, which begin at around $150,000, heavily rely on the skills and technology needed.

When budgeting for medical device software operating costs, consider:

• Cloud prices (e.g., for hosting, cloud services usage).
• Support for the medical device software application includes infrastructure upkeep, a help desk for patients and medical professionals, and application maintenance.
• Internal infrastructure compliance and security audits, as well as routine HIPAA compliance testing.

Key Functionality of Medical Device Software

Medical device software features will be heavily influenced by their intended medical usage and target market. We give a brief overview of the typical medical device software functionality in the list that follows.

1. Patient User Functionality

• Monitoring health metrics in real-time with general-purpose equipment (e.g., smartphone).
• Identification of abnormalities (e.g., abrupt breathing).
• comparison and analysis of images (e.g., photos of moles for melanoma risk assessment).
• therapeutic approaches (e.g., video therapy – for anxiety, sound therapy – for tinnitus, ).
• analysis of extraneous data, like air pollution, to prevent symptoms

2. User Features for Medical Staff

• Analysis of patient health information (such as ultrasound images) to locate and diagnose disease
• medical device software algorithms for intricate computations in medicine (e.g., anesthesia or drug dosage).
• proposals produced by medical device software for the diagnosis, management, or treatment of diseases.
• Adjusting medical images for general-purpose devices (e.g., smartphones, tablets).

3. Safe PHI Data Interchange and Storage in the Cloud

• medical device software is a safe collection, examination, and transmission of clinical data from integrated healthcare IT systems (using HL7 standards).
• medical picture transmission and storage (using the DICOM standard).
• using a patient’s account to get PHI (e.g., drug dosage tracking, for heart-rate statistics,).

4. Security and Adherence to Regulations

• access control based on roles.
• Patient and medical staff user authentication with two factors.
• Access PHI logging.
• identification of illegitimate sessions automatically.
• Encryption of data.
• Observance of HIPAA, HITECH, FDA, and ONC rules.

5. Medical Device Software Patient and Medical Staff Guides In-App

• User-friendly instructions (such as FAQs, how-to videos, and self-help manuals) to walk users through medical device software capabilities.
• tips for data entry inline (e.g., suggesting recent entries, showing data format, automated data filling).

6. Marketing

• managing customer loyalty.
• Surveys of user opinions to evaluate and enhance a medical device software.

Detailed Regulatory Landscape Breakdown

In medical device software, understanding the regulatory framework is essential. The framework covers bodies such as the FDA, HIPAA, HITECH, and IEC 62304. For example, the FDA classifies devices into Class I, II, and III, with SaMD risk classifications guiding development based on intended use and potential patient impact. Compliance includes adhering to data encryption standards and cybersecurity protocols.

HIPAA demands strict data handling and privacy measures, while HITECH reinforces the security of electronic health records. IEC 62304 provides a process framework for software lifecycle processes. Comparing these regulations side by side reveals distinct requirements and scopes.

Accessing official documents from regulatory bodies ensures accuracy. Professionals must keep updated with revisions and best practices. As an expert in this field, I recommend frequent reviews of updated guidelines and continuous training.

This approach supports robust software design that meets legal standards and safeguards patient data, offering clarity and practical insights for development teams and compliance officers.

In-Depth Security Considerations

Security in medical device software is critical for protecting patient data and ensuring reliable device performance. Vulnerabilities, such as data breaches or malware infections, can have serious consequences.

Developers must follow secure coding practices and regularly perform penetration testing and vulnerability scanning. Following security standards like the NIST Cybersecurity Framework ensures that measures are robust and comprehensive. Regular threat modeling and risk assessment sessions help identify potential weaknesses before they become critical issues.

Documenting each security measure and update is important for audit trails and compliance. My experience has shown that practical, hands-on training and simulation exercises in a controlled environment help teams better prepare for real-world challenges. Developers should consider using automated security tools to monitor ongoing risks.

Detailed reviews of encryption protocols and authentication methods should be part of the software lifecycle. The goal is to create secure systems that resist attacks and maintain patient safety. Understanding and addressing security concerns is essential for any team developing medical device software in today’s challenging cyber environment.

The Role of AI and Machine Learning in Medical Device Software

Artificial intelligence and machine learning offer innovative approaches to medical device software. AI applications include image analysis, predictive diagnostics, and personalization of treatment. These techniques can improve the accuracy of diagnostic tools and streamline clinical workflows.

Machine learning models assist in analyzing large data sets to identify trends and potential health issues early. However, implementing AI in regulated medical devices requires careful validation. Developers must address challenges like algorithm bias, explainability, and ensuring consistent performance across diverse patient groups.

Successful AI implementations have emerged in areas such as radiology and pathology, where accurate image interpretation is critical. Professionals need to validate algorithms with rigorous testing and provide clear documentation on model performance. It is essential to integrate expert clinical input when designing these systems.

In practice, continuous monitoring and updating of AI models are vital to accommodate new data and maintain compliance with evolving regulations. This balanced approach supports both innovation and reliability, ensuring that AI and machine learning contribute meaningfully to improved patient outcomes and operational efficiency.

Usability and User Experience in Medical Devices

The design of medical device software must prioritize usability and a positive user experience. Clear interfaces and simple navigation reduce the risk of errors during operation. Good design principles focus on straightforward communication, minimizing complexity, and providing immediate feedback to users.

Designers often rely on iterative testing and feedback from actual users to identify pain points. A well-structured interface helps prevent misinterpretation of data and supports clinical decision-making. In practice, simple layouts with clearly labeled controls and real-time error notifications improve performance.

Practical usability testing, including task-based assessments, ensures that the device meets the needs of healthcare professionals. My experience indicates that involving end users early in the design process leads to improvements that might not be evident in theoretical models.

Consistent updates based on user feedback can enhance accessibility and operational efficiency. By focusing on clear, consistent, and easily interpretable designs, development teams can create software that supports safe and effective use in demanding clinical environments.

Integration with Existing Healthcare Systems

Connecting medical device software with existing healthcare systems like EHRs and EMRs is a key factor in operational success. Integration challenges often arise from the need to conform to standards such as HL7 and FHIR. These standards ensure that data flows smoothly between devices and patient record systems.

Different integration approaches, including APIs and middleware solutions, allow for reliable and secure communication. For healthcare providers, seamless integration means better data accuracy and improved workflow efficiency. Practical integration requires close collaboration between software developers, IT departments, and clinical staff to identify specific requirements. Testing interoperability in real-world settings can reveal hidden challenges and allow for timely solutions.

My professional experience shows that establishing clear protocols and communication channels between systems reduces errors and supports continuous improvement. It is important to review each system’s documentation and update integration strategies as standards evolve. Ensuring compatibility with existing systems is not only a technical task but also a crucial step towards enhancing patient care and operational efficiency.

Cloud Computing and Software as a Medical Device (SaMD)

Cloud computing is increasingly relevant for SaMD, offering scalability and remote access capabilities. The use of cloud platforms, such as AWS, Azure, and Google Cloud, provides cost-effective resources and flexible deployment options. With cloud-based solutions, updates can be rolled out efficiently and data can be managed securely with robust encryption protocols.

However, cloud environments raise concerns about data privacy and security, particularly when handling sensitive health information. Developers must balance ease of access with strict security measures, ensuring that data encryption and access controls meet regulatory requirements.

Regular audits and compliance checks help maintain the integrity of the cloud system. In my experience, a detailed risk assessment prior to migration is essential. Teams should also consider hybrid solutions that combine local and cloud storage to optimize performance and security.

Documenting each process and monitoring system performance continually contributes to a stable and secure cloud deployment. Evaluating different cloud platforms against specific needs and compliance requirements is an ongoing task that supports effective management of medical device software in a modern IT landscape.

Future Trends and Emerging Technologies in Medical Device Software

Looking ahead, several emerging technologies promise to reshape the landscape of medical device software. Technologies such as blockchain, digital twins, and augmented reality are beginning to influence product development and patient care. Blockchain can offer secure, traceable records for data sharing.

Digital twins provide a virtual representation of devices or even patients, allowing for predictive maintenance and scenario testing. Augmented reality may enhance training and support clinical procedures by overlaying relevant information in real-time. These innovations are in the early stages but offer potential to improve patient outcomes and streamline operations.

I have observed that keeping abreast of technological advances through continuous learning and professional development is crucial. Engaging with industry experts, attending relevant conferences, and reviewing technical publications can provide practical insights.

A proactive approach to emerging technologies helps organizations plan for future regulatory changes and market demands. Incorporating these trends into long-term strategies can improve efficiency, reduce costs, and support a culture of continuous improvement in medical device software development.