What is medical device software development?

While Software as a medical device isn't identical as conventional medical devices, it has the same chance for enhancing the standard of life for patients worldwide.

Software as a Medical Device is one of three forms of software related to medical devices. The other two forms of software connected to medical devices are software that is incorporated into a medical device (software in a medical device) and software used in the production or upkeep of a medical device.

What is medical device software?

"A medical device is any tool, apparatus, appliance, software, substance, or other product designed to aid in the diagnosis, prevention, monitoring, treatment, or relief of sickness or injury.

The use of software as a medical device is steadily increasing. It is compatible with a wide variety of technological platforms, including medical device platforms, commercial "off-the-shelf" platforms, and virtual networks, to mention a few.

Types of Medical Device Software Development

Medical device software development is divided into two groups based on where it runs: Software as a Medical Device (SaMD) and Software in Medical Device (SiMD).

Software as Medical Device (SaMD)

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

Software in a Medical Device (SIMD)

Software in a Medical equipment (SiMD) refers to software solutions that are integrated or external to a physical medical equipment, enhancing its functionality and performance. SiMD cannot function alone and must be used in conjunction with connected medical devices.

Who Might Need Software Development for Medical Devices?

Medtech software development can be required by a wide range of businesses, from established medical device manufacturers to new healthtech startups.

To improve their products and services, these firms might look for specialised medical device coding, offshore medical device app development, or entire medical device development services.

Medical device manufacturers 

Companies that specialise in the manufacturing of medical devices and require software solutions to improve their products, with a focus on medical device coding and application development.

Biotechnology businesses

Firms active in biotech research and development that require software solutions for their medical devices, with a focus on computing medical devices to improve functioning.

Telehealth service providers

Companies that provide telehealth solutions require medical device technology to allow for remote patient monitoring and meetings, with a focus on medical devices app development.

HealthTech startups

Emerging enterprises focused on novel healthcare solutions, including medical devices, requiring software development and pharmaceutical app development.

Research and development labs

Developing firms focused on new health care products, including medical devices, need the development of medical software for devices and medical device applications.

Clinical research organisations (CROs)

Organisations running investigations that require software for medical devices used in research, with a focus on programming medical devices for data gathering and research.

Software Development Process for Medical Devices

Medical device software goes through the same development phases as other types of software; however, it requires a special emphasis on compliance with certain standards and norms, which differ depending on the product's categorisation.

The following are the five steps in designing software for medical devices:

Planning and defining requirements

The first step is to establish the software's needs in detail with stakeholders such as healthcare professionals and potential patients. This phase entails identifying required functionalities, determining regulatory restrictions, and planning the product's entire life cycle.

Architecture and detail design

During this phase, a technical group develops the app's overall architecture, selecting relevant technologies and specifying interfaces within parts. The design must be solid and scalable to allow later updates and integration of additional skills.

Development and coding

Medical device programs put their code into action depending on the parameters established earlier through the process. This stage necessitates careful attention to code quality and the use of program best practices, with a priority on limiting errors and boosting productivity.

Testing & verification

Medical software must go through a series of rigorous tests to guarantee it satisfies all safety, functionality, and effectiveness standards. This covers unit testing, assessment of integration, performance assessment, and system testing.

Release

After testing, the software is ready for release. This stage includes ensuring that all verification operations have been performed and examined, documenting the published version, and then making it available for use (also known as installation or deployment).

In conclusion, hire software developers for medical devices

If you require a competent IT team to collaborate with you on custom medical device software development and/or project augmentation, Deliverable is here to help! There are still some grey areas in SaMD laws and recommendations that have to be dealt with in the years ahead. There is still more work to be done on concerns such as cybersecurity. And there is a severe learning curve for software professionals transitioning into medical devices, and vice versa.

Deliverable understands the specific dynamics of software development in the medical device business.