Advancing Medical Device Development with MBSE
Challenge
Strict FDA regulations and complex integration bring innovative medical devices to a competitive market.
Solution
Guided by TECHNIA, the MBSE approach was adopted with Magic Cyber, Model Analyst, and Collaboration Studio.
Results
- Reduced time to market by 20%
- Improved quality
- 4x variants
- Saved 600+ hrs/month
- Empowered 40+ users
A leading medical device company sought to enhance its product realization process by leveraging an MBSE (model-based systems engineering) approach. The focus was on integrating sensors, pumps, and software while navigating stringent FDA regulations for in-body devices. By adopting MBSE with CATIA Magic solutions, the company streamlined its development workflow, ensuring compliance, efficiency, and faster time to market.
Deployment timeline
• Phase one: Completed in under four months.
• Ongoing expansion: Continuous improvement and scaling of MBSE practices.
Working together, the company’s MBSE champions initiated a successful trial, demonstrating the value of a model-based approach. Within six months, they transitioned to a full coaching engagement, refining their medical device development process for sustained success.
Challenge
Operating in a highly competitive industry, the company faced challenges in bringing innovative medical devices to market. Key obstacles included:
• Complex FDA regulations requiring rigorous validation and documentation
• The need for seamless integration of hardware and software components
• Pressure to accelerate product development while maintaining high reliability and safety standards
Solution
To address these challenges, the company implemented a structured MBSE approach using CATIA Magic roles:
• Magic Cyber Systems Engineer for systems architecture and model validation
• Magic Model Analyst to enhance analysis and decision-making
• Magic Collaboration Studio to facilitate seamless team collaboration
TECHNIA provided expert coaching to balance traditional aerospace & defense methodologies with FDA requirements, ensuring a smooth transition to an MBSE-driven workflow.
Results
The adoption of MBSE and a systems architecture approach delivered significant benefits:
• Accelerated development cycles, achieving a 20% reduction in time to market
• Enhanced product quality and reliability, minimizing risks of device failure
• Scalable documentation and testing, enabling rapid product variant introduction
• 4x more product variants introduced efficiently
• 600+ hours saved per month through improved workflows
• 40+ active users leveraging MBSE tools to drive innovation
