MathWorks MedTech Virtual Forum

Computational modeling and simulation (CM&S) can be used in medical device regulatory submissions to support device safety or effectiveness, and CM&S algorithms can be implemented in medical device software. This session will discuss how FDA’s Center for Device and Radiological Health has developed Guidance and Regulatory Science Tools to assist manufacturers when assessing credibility of their computational models. It will cover traditional applications of CM&S, novel applications such as Digital Twins and in silico clinical trials, and the intersection of CM&S and AI.

Professionals new to modeling often assume that comprehensive, fully validated models are needed to solve most engineering challenges. While such models may be essential for model-based verification and regulatory submissions, they are not always necessary - or even optimal - during early stages of problem-solving. This session will present a pragmatic approach: using simple, intentionally reduced models to gain insight, test assumptions, and identify conceptual errors early in the design process. Through a concrete example, we will demonstrate how a basic model revealed a subtle but critical flaw in reasoning, despite the problem appearing straightforward at first glance.

The presentation aims to encourage a shift in mindset towards viewing models not only as tools to replicate the behavior of physical systems, but as instruments for thinking, exploration, and communication. Attendees will learn how lightweight modeling can accelerate development, reduce risk, and deepen system understanding in medical device applications.

In this session, we will demonstrate how a prototype - developed over years of work - was rapidly converted into a production-ready platform.  Given its strengths within programming for signal processing and information theory, MATLAB was used to evaluate several feature extraction strategies for effective pathogen detection.

After selecting the best strategy, MathWorks tools were also instrumental in translating the pathogen detection model into low-level code for deployment on an embedded processor. With minimal model modifications, the entire model was automatically converted to C code. The generated code was then seamlessly integrated with the existing user interface code and verified for clinical trial use.

In this session, Dr. Antoun Khawaja will share the journey from simulation models to the CE-MDR certified release of KhawajaCode—an AI-powered ECG analysis software at the heart of the ECG.ON cardiac monitoring system. Integrating the ECG.ON patch hardware with KhawajaCode’s advanced, model-based algorithms, the system provides real-time arrhythmia prediction and clinical decision support. Leveraging MathWorks Model-Based Design from day one, Khawaja Medical Technology streamlined development, generated IEC 62304–compliant production code and met ISO 13485 and EU MDR requirements with reduced time-to-market. Attendees will discover practical strategies for turning innovative ideas into certified, safety-critical medical devices.

Key takeaways

• How to accelerate medical device development using Model-Based Design.
• Strategies for building regulatory compliance into your workflow from day one.
• Best practices for seamless hardware–software integration in safety-critical systems.
• A proven blueprint for taking innovative concepts to certified market-ready products.