What is Software Engineering? – An Overview

Software engineering is a branch of engineering that deals with the development of software products. Specifically, software engineering is a systematic approach to software development that involves analyzing user requirements and then designing, building, and testing software applications intended to satisfy those requirements. Software itself can be defined as the programs and other operating information used by a computer that tell it how to work. This is in contrast to hardware, which includes the physical components of the computer from which the system is built.

What Does a Software Engineer Do?

The terms ‘software engineer’ and ‘software developer’ are often used interchangeably. Although these titles are very similar, the main distinction between the two is that software engineers apply computer science principles to architect software solutions while software developers build those solutions with code.  In a broad sense, individuals skilled in software engineering design, build, test, and maintain software.  They are responsible for ensuring that a software product offers all of the features intended, and that it can be easily used and understood by the end user.

Software Engineering for Medical Devices

The use of software is prevalent throughout the medical industry today. This includes traditional healthcare software, such as Electronic Health Records (EHRs) and imaging systems, as well as medical software used to monitor, analyze and interpret a patient’s medical state. 

When it comes to software engineering for medical devices, two important terms to understand are Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD). Software as a Medical Device (SaMD) is defined 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.”  This type of software is a standalone product that functions independently of any existing device. Some examples of Software as a Medical Device include:

  • Software that displays MRI, CT scan, and other types of medical imaging on mobile devices
  • An app which calculates insulin dosages based on a patient’s blood glucose levels
  • Treatment planning software that interprets patient-inputted information to develop a treatment plan

Software in a Medical Device (SiMD) is defined as software that is integrated into a medical device or medical equipment. If the software in question helps to run a medical device in any way, such as by powering the device mechanics or processing information produced by the device, then it is classified as SiMD and not SaMD.  A few examples of Software in a Medical Device are:

  • Software used to control the pumping of medication in an infusion pump
  • Embedded software that operates a pacemaker
  • Mobile applications that control a medical device through Bluetooth, WiFi, or other functionality
  • Medical equipment monitoring software that monitors the performance of a device for the purpose of servicing that device or identifying errors

Medical Device Software Engineering at Gilero

As electromechanical medical device and drug delivery system requirements become more intricate, the ability to produce intuitive, reliable, and robust software for these devices is critical. With the growing complexity of medical devices, it has become increasingly common for other engineering specialities, such as software engineering, to intersect with the mechanical development of a device. Gilero’s skilled engineering teams coupled with our expansive service offerings enable us to provide holistic medical and drug delivery device solutions. Our software engineers have developed standalone applications, software for control systems, embedded software, and embedded firmware in the medtech space.

Gilero’s Firmware & Software Engineering Capabilities

  • Embedded software and firmware development
  • Software verification and validation
  • Embedded systems design
  • GUI development with consideration to human factors and usability
  • Internet of Things (IoT)
  • Algorithm development
  • Application development
  • Programming languages (C/C++, Java, Swift, Python, Verilog/VHDL, LabVIEW, MATLAB, Simulink)
  • Operating systems (Android, iOS, Linux, Windows, embedded RTOS)

Gilero offers contract design and development and manufacturing services for electromechanical and consumable medical devices, drug delivery systems, and combination products. Skilled engineering teams, including dedicated software engineers focused on design and product development, allow us to service medtech customers around the world. If you need help with software engineering for your medical device, contact Gilero today.

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