There are different software classifications specific to medical equipment. Before starting a new project, it’s necessary to clearly define the requirements for your medical device software development, as the scope and technologies can be pretty diverse, including embedded coding and SaMD.

However, the majority of real-life medical equipment startups and projects are looking to employ a mixed set of technologies. Let’s learn more about the major domains of software development for medical devices…

Embedded Medical Systems and Embedded Medical Software Development

This domain encompasses low-level programming of micro-components—like microcontrollers and micro-chips—with microprocessors and embedded memory. This can all be found under the hood of most healthcare equipment. Some examples of medical devices featuring embedded systems driven/configured by embedded code are:

• pulse oximeters
• electronic defibrillators
• smart (bio)sensors
• automated infusion pumps
• glucometers
• electronic thermometers
• electronic blood pressure sensors
• medical imaging equipment: X-ray, ECG, EEG, MRI, CT, etc.
• a great variety of lab equipment

Embedded programming is crucial for healthcare equipment and biomedical applications, as it regulates the usage of various electronic components and helps integrate medical devices with non-specific or general-purpose software and hardware, including PCs, EHRs, Wi-Fi, and many other systems.

While embedded system development for some medical devices does require only primitive programming skills, other projects require advanced competence in healthcare device engineering. Just imagine what it takes to program and calibrate all the embedded electronics in a large, sophisticated machine like a modern MRI tomograph.

Software as a Medical Device (SaMD)

This realm of medical device software development covers all products and solutions that don’t need a specific medical device. For example, SaMD systems run on non-specific medical platforms, including laptops, desktops, mobile devices, etc.

This type of software usually performs one or several functions related to:

• medical data visualization and representation
• medical data processing and interpretation
• medical data management and storage
• specific configuration and technical diagnostics of certain medical devices

Basically, software as a medical device is characterized by the following features:

• SaMD is not a part of medical equipment, and it is not required for a medical device to execute its functions or tasks.
• SaMD runs on general-purpose computers and infrastructure.
• It can interface with certain dedicated medical devices including devices’ inner/embedded components and embedded coding to receive data obtained by the device or to manage its functionality.

Some examples of Software as a Medical Device (SaMD) include:

• Patient imaging or scan analysis: Software that analyzes patient data to discover patterns, signs, or trends helps physicians to better identify barely noticeable yet important changes in health conditions and/or facilitate diagnosis and treatment. For example, this could include support in decision-making for correct differentiation between ischemic and hemorrhagic stroke in patients with acute stroke conditions. The outcome has the potential to greatly affect choice of therapy and/or medical intervention.

• Sound monitoring for sleep apnea prevention: A smart device microphone can be used to automatically detect interrupted breathing during sleep and trigger an alarm to wake the sleeper. The same technology can be used to automatically detect unusual breathing patterns and send an alarm to emergency responders if dangerous conditions are detected (this can work for single and/or elderly patients.)

• Remote ECG-monitoring: Adhesive or implantable sensors can be used to remotely observe cardiac patients and record their heartbeat patterns while detecting unusual or life-threatening ECG patterns and/or events (arrhythmia, bradycardia, etc.) that should be immediately reported.

• Medical data-viewing applications: These include any type of software that helps healthcare professionals access, check, visualize, share, record, and/or interpret health data received from specific bioelectronic sensors or medical devices, including multiple metrics like heart rate, blood pressure, skin temperature, and more.

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