Medical Device Development Using Model-Based Design

Model-Based Design enables medical device engineers to cleanly separate the design phase from the implementation steps. It also helps engineers integrate agile approaches into their existing software development workflows.

Using Model-Based Design, you can:

  • Model and simulate diagnostic and therapeutic algorithms and devices before implementation
  • Verify and validate complex multidomain systems at a higher level of abstraction
  • Prototype design and create proofs-of-concept by automatically generating C, C++, GPU, or HDL code from the models
  • Produce customizable reports that can be used as evidence of FDA/CE regulatory compliance
  • Prove your code is safe under all possible run-time conditions using static analysis

“Model-Based Design with Simulink enabled us to reduce costs and project risk through early verification, shorten time to market on an IEC 62304–certified system, and deliver high-quality production code that was first-time right.”

Michael Schwarz, ITK Engineering

Using Model-Based Design for Medical Device Development

Dynamic System Modeling and Simulation

The development of medical devices can span multiple engineering domains such as software, mechanical, electrical, and fluidic systems. By using Simulink® in dynamic system modeling, you can  integrate these different domains in a unified simulation environment to efficiently design and implement complex medical devices. With this approach, you can:

  • Develop models of software systems agnostic of environment and target hardware
  • Perform simulation-based testing to understand and iterate on requirements and specifications
  • Perform design tradeoffs and evaluate behavior of a complex multidomain device
  • Test units and entire subsystems at the model and code level

Deployment and Real-Time Prototyping

Once the models have been developed and tested in simulation, you can automatically generate code for prototypes or final production units. This eliminates the need to manually write thousands of lines of and leads to increase in productivity and improved quality.

Real-time simulation and testing provides a way to verify designs early, evaluate design tradeoffs, and create working clinical prototypes at a fraction of the time and cost.


Verification and Validation of Models and Code

The extensive verification and validation capabilities within Simulink allow you to perform rigorous testing and verification of models and code for target hardware. With Simulink Test™ and Simulink Requirements™, you can:

  • Author, analyze, and manage requirements and create traceability reports
  • Perform model and code coverage analysis that measures completeness of testing
  • Manage simulation-based tests of models, generated code, and simulated or physical hardware
  • Identify hidden design errors such as integer overflow, dead logic, and division by zeros
  • Produce customizable reports that can be used as evidence of FDA/CE regulatory compliance