What is Embedded Medical Device Software and How Does it Work?

Medical Device Software

Now, more than ever, healthcare is leveraging software technology to further patient care. The healthcare industry’s rising dependence on technology is driving rapid growth within the medical device software market, which is expected to have a value of $8.2 billion by 2027.

Embedded software is helping the medical community give patients better access to care, streamline and shorten treatments, and monitor patient health more easily.

This article will explore the growing world of embedded software for medical devices, how it works, and discuss ways it’s impacting the healthcare system.


What is an Embedded System?

In regards to software, embedded systems are software programs built into part of a hardware system, mechanical system, electrical device, or other applications for a specific purpose.

Embedded software is found in almost every electronic device or tool we use today, such as smartphones, vehicle engines, and security systems.

In a medical device, embedded systems can be used to operate a device’s hardware, record and track patient data, send and receive information wirelessly, among other functions. Today’s embedded systems are increasingly incorporating Internet of Things (IoT), artificial intelligence, and machine learning technologies into the development of medical devices.


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What is Embedded Medical Device Software?

Embedded medical device software refers to software programs embedded into medical devices. This could be software for operating the hardware of a medical device, such as a digital thermometer, or software intended to become a device on its own. .

Embedded systems are important for use in medical devices where delay or interruption could have severe consequences. For instance, think of the kinds of interruptions caused in everyday tasks on a standard Windows device. If those seemingly innocent disruptions occurred during a surgical procedure, or in the use of a life-sustaining device, those situations could become outright hazardous.

This is where embedded systems come in. They can operate without user inputs (like a human command); they can accept inputs from other areas, such as sensor measurements without the possibility of system disruption.

These programs are developed specifically for use in the medical industry and must undergo rigorous testing during development to ensure each device meets the safety standards and International Medical Device Regulators Forum’s requirements.

Some embedded software examples found in medical devices include:


Types of Embedded Systems in Medical Devices

Medical devices range in complexity, scope, and function. The types of software used in these devices vary widely as well. While the nature of embedded software is largely the same, there are nuances depending on the type of device it’s being used for.

Examples of these differences include:

  • Diagnostic. Detecting and identifying disease is the focus for software that’s embedded into diagnostic tools. AI algorithms are being leveraged in medical device software to diagnose disease faster and more accurately.
  • Therapy. This includes devices that aid in the delivery of medications and therapies such as insulin pumps, pacemakers or implantable defibrillators.
  • Monitoring. More and more devices are being developed to help monitor patient health inside and out of the doctor’s office. These include glucose monitors, smart hospital beds, or Bluetooth equipped heart monitors.


How Does Embedded Software Work?

When developing embedded software, each piece of software is specifically designed for the hardware it will control. Unlike general-purpose software that we use in our computers, embedded software tends to perform a limited number of functions, and is tailored for efficiency and reliability.


The Basics

At its core, embedded software communicates directly with the device hardware, receiving inputs and controlling outputs. For example, in a pacemaker, the software might receive input from a heart rate sensor, interpret this data, and then output the right signals to control the pacing of the heart.

The software is typically written in a low-level language, such as C or C++, which allows for direct control of the hardware and efficient use of resources.


The Present

Over time, the use of embedded software has become more widespread. Researchers are engaging in new applications of using this technology that provides medical teams with devices that are more impactful, made of higher quality, and deliver better patient care.


The Future

Moreover, with the rise of IoT, these devices are increasingly interconnected, allowing for real-time data sharing and remote control. This helps to significantly enhance medical device capabilities and improve patient care.


Implications of Embedded Software Development for Medical Devices

When embedded software is being developed for use in a medical device, it has vastly different specifications and requirements than non-medical applications.

First and foremost, it must be safe for the patient and operator and cannot have any risk of undergoing system failure.

Embedded software must:

  • Meet the essential requirements of the EU’s Medical Device Directive (MDR).
  • Comply with the FDA’s Center for Devices and Radiological Health (CDRH) requirements.
  • Meet cybersecurity requirements and eliminate medical cybersecurity vulnerabilities.
  • Adhere to other regulatory compliance requirements for the specific type of device being created.


Compliance for medical device design is complicated. Learn the details in our blog:


How Embedded Systems in Medical Devices Are Changing Healthcare

Embedded systems in medical devices are revolutionizing healthcare in numerous ways. Below are a few examples

  • Enhanced Connectivity: Embedded software that incorporates IoT, cloud and AI technology is completely changing the way patients, doctors and medical teams connect. Patients are able to have greater control over their health care plan and doctors can monitor patient conditions with more accuracy.
  • Enhanced Monitoring. Embedded systems have made possible wearable devices that track a variety of biometrics. These devices are increasingly popular and contribute to earlier detection of certain diseases, better patient outcomes and improved patient care solutions.
  • Better Chronic Care Management. Chronic conditions, such as hypertension or diabetes, are notoriously challenging to manage. Embedded systems equipped with cloud-based technology help care teams overcome challenges when managing these conditions.


Develop Embedded Software Solutions for Medical Devices the Easy Way

Embedded software engineering has become an integral part of the modern medical device development process. Not only are the devices being built adding incredible value to the medical community, but the processes used to build new software has also increased in capability and sophistication.

When developing software for a medical device, it’s essential to partner with a team that knows the ropes and has demonstrated excellence in this field. At RBC Medical, we have helped numerous researchers and manufacturers create certification-ready embedded software solutions for new and existing medical devices.

To learn how we do it, contact us.

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