What is Software as Medical device and why it matters

Emerging technologies and digitalization have a huge impact on the healthcare industry as they can streamline processes, increase transparency, ease communication between all parties, store patient data more securely, improve response times and provide quick diagnoses. 

Software solutions are the core of multiple MedTech apps and HealthTech solutions, and they are integrated across a variety of products and platforms - be it medical or non-medical. 

If you search the internet, you'll find many terms to describe software as a medical device, such as medical device samd, samd software, other samd software, etc. Don't worry; they are all related to the "Software as a Medical Device" term.

Let's see how Software as a Medical Device plays an important role in patient safety, patient data and overall patient health.

What Types of Software Solutions Are Related To Medical Devices? 

There are 3 types of software solutions related to medical devices:

• Software as a medical device (samd software);

• Software in a medical device;

• Software used in the manufacture or maintenance of a medical device.

We'll now go through each type of software product to see exactly what it means, how it's integrated in the health care industry, and how health care providers can get the most out of it while prioritising patient safety.

What Is Software As A Medical Device, And How Can You Use It? 

Software as a Medical Device is described by the International Medical Device Regulators Forum (IMDRF) as "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device."

To put it bluntly, Software as a Medical Device can be anything from a mobile app to any other software product that helps patients by functioning independently from other hardware medical devices; It can use the medical device data from a device, but it is not connected to it. 

Think about all the software functions helping the medical staff to analyze X-rays and MRIs - while there are plenty of devices to take a scan, there are also plenty of software solutions helping you diagnose conditions based on the results. 

Software as a Medical device examples:

• Medical device software that can be used for screening, diagnosis, treating, alleviating, or preventing different conditions.

• Mobile apps to facilitate patient registration, monitor patient symptoms and patient health, alert patients' pain, arrhythmia management, and blood glucose monitoring. 

• Apps used for Chronic condition and disease management.

• Any solution, be it website or mobile, used for digital therapeutics.

What Is Software In A Medical Device, And How Common Is It?

The presence of software in medical devices has become increasingly common due to advances in technology and the desire to enhance device functionality, connectivity, and usability.

Software in a medical device refers to any software function or application that is an integral part of a medical device's functionality, control, or data processing. It can encompass a wide range of software components, from embedded firmware that controls device operations to user interfaces, data processing algorithms, and communication protocols.

For example: a software intended to help radiologists diagnose different conditions when they check a scan. The software that transforms the MRI magnets into an X-ray or something you can look at, or if we are thinking about an interface to control the device, then we are looking at Software in a Medical Device. 

Software used in the manufacture or maintenance of a medical device

Software used in manufacturing or maintaining a medical device refers to medical software applications and tools used in the production, quality control, testing, and ongoing upkeep of medical devices. These software tools play a crucial role in ensuring medical devices' safety, effectiveness, and compliance with medical device regulations.

Here are some examples of software used in this context:

Computer-Aided Design (CAD) Software: CAD software is used in the design and development of medical devices. Engineers and designers use CAD tools to create detailed 2D and 3D models of medical devices, helping to visualize and refine their designs before production.

Computer-Aided Manufacturing (CAM) Software: CAM software is employed to generate instructions for manufacturing processes like CNC machining or 3D printing. It helps translate CAD designs into precise instructions for machinery.

Quality Control and Testing Software: This category includes software for conducting tests, inspections, and quality control checks on medical devices. It ensures that devices meet specified standards and regulatory requirements.

Validation and Verification Software: These tools help in validating and verifying that the medical device functions correctly and meets design specifications. They are essential for ensuring the safety and reliability of the device.

Regulatory Compliance Software: Regulatory agencies like the FDA (U.S. Food and Drug Administration) require extensive documentation and reporting for medical devices. Software is used to manage regulatory compliance, including electronic record-keeping and reporting.

Risk Assessment and Management Software: Software is used to assess and manage the risks associated with medical devices, ensuring that potential hazards are identified and mitigated.

Change Management Software: When modifications or updates are made to a medical device, change management software helps track and document these changes, ensuring that they are properly evaluated and implemented.

Asset Management and Maintenance Software: This type of software is used to track and manage the maintenance and calibration of manufacturing equipment and devices in healthcare facilities.

Electronic Document Management Systems (EDMS): EDMS software is used to store, organize, and manage the extensive documentation required for the manufacture and maintenance of medical devices, including design records, test reports, and regulatory submissions.

Simulation and Modeling Software: Engineers and researchers use simulation and modelling software to simulate the behaviour of medical devices under various conditions, which can aid in optimizing device designs and performance.

Supply Chain and Inventory Management Software: To ensure the availability of necessary components and materials for manufacturing medical devices, supply chain and inventory management software is used to track and manage inventory levels.

Data Analytics and Reporting Tools: These tools help analyze data generated during the manufacturing process or from post-market surveillance of medical devices. They can identify trends, potential issues, and opportunities for improvement.

The prevalence of software in medical devices has led to increased scrutiny by regulatory agencies like the FDA (U.S. Food and Drug Administration) to ensure safe and effective software development. Manufacturers are required to follow stringent regulations and standards, such as the FDA's Quality System Regulation (21 CFR Part 820) and software developers need to follow the International Electrotechnical Commission (IEC) 62304 standard, which specifically addresses software life cycle processes for medical device software.

Build Your Software as a Medical Device with us

We have extensive expertise in the healthcare industry, health care and public health. You can check our projects page to see the digital products we have developed over the years, and we recommend checking BrainCapture, an app certified as software as a medical device.

We have what it takes to build digital health apps for prevention, diagnosis, intervention, treatment, recovery, and patient management & communication, and we look forward to working on the next meaningful medical software, especially in these times.  

We really know how to work with health professionals! 

Do you have a health care startup, or are you looking to digitalize any health care services or any part of the Medical Act? Get in touch with us, and let’s talk!