MATLAB and Simulink for Medical Devices

Design, simulate, and build next-generation medical devices while accelerating regulatory compliance

MATLAB® and Simulink® enable engineers to speed up medical device software and hardware development by efficiently integrating and automating the various phases of design, implementation, and verification.

With MATLAB and Simulink, you can:

  • Develop and test advanced algorithms and entire systems before implementation
  • Simulate and test embedded software alongside mechatronic systems early in the design phase
  • Prototype designs and create proof-of-concepts by automatically generating real-time code
  • Use static analysis to find software bugs and prove correctness of your models and code
  • Automate reporting to prove and accelerate compliance with FDA/CE regulations and industry standards such as IEC 62304

“At Ethicon Endo-Surgery, Inc, we have adopted a rapid prototyping workflow based on Model-Based Design that enables us to implement and test new design refinements in minutes and reduce overall development time by months.”

Mark Overmeyer, Ethicon Endo-Surgery, Inc.

Using MATLAB and Simulink for Medical Devices

Biomedical Data Analysis and Algorithm Development

Whether you’re analyzing biomedical datasets or developing advanced algorithms for diagnostic and therapeutic medical devices, MATLAB provides you with the flexibility and power to work with complex data and derive engineering insights.

As an engineer or researcher working with biomedical data, you can: 

  • Import and analyze data from existing programs like Microsoft® Excel®
  • Automate the acquisition and analysis of images, video, and signals from hardware
  • Develop, test, and verify algorithms including artificial intelligence (AI) and machine learning models
  • Deploy MATLAB code on processors, GPUs, and FPGAs for production or prototyping 

Design and Development of Medical Devices

Dynamic system modeling and simulation can speed up product development times as well as the validation and verification phases for complex diagnostic and therapeutic devices such as surgical robots, ventilators, hemodialysers, infusion pumps, and pacemakers. Designs of multidomain closed-loop systems that combine advanced electro-mechanical-fluidic components with complex control software can be error prone and hard to develop and certify.

Using Model-Based Design with MATLAB and Simulink is a modular development approach that enables engineering teams to move from internal research and development to design and implementation in a single environment.


Compliance with FDA/CE Regulations and Standards

Modeling and simulation of medical device systems is increasingly being perceived as an essential component for design, development, and testing. The FDA has been investigating the use of modeling and simulation techniques in the last few years to better understand how it can assess the impact of engineering decisions on device performance and safety without relying purely on animal and human clinical trials.

Using dynamic system modeling and simulation during the medical device development process can help reduce regulatory burden and speed up the submission timelines by automating the creation of many engineering reports. MathWorks tools used can also be validated for use in FDA/CE-regulated workflows and to meet harmonized standards such as IEC 62304.