Design Excellence in Medical Device and Why?

By Ryan Bauer

Design Excellence for Medical Devices – that’s a big topic!  In order understand what this entails, let’s consider some of the pressures on the industry to execute better. For starters, the complexity of medical device design and compliance continues to increase. Consumer demands both at the patient and provider levels require increased product capabilities & intelligence to provide better safety and efficacy. Also, business expectations and competition are driving faster product improvements to market.  Lastly, regulatory scrutiny continues to push for evidence-based reporting, end-to-end risk management and decision support, with improved design controls, all with a focus on product and patient quality. This dichotomy of increased product complexity and an ever-higher bar for compliance necessitates design process mastery. This is essential to maintain a competitive advantage and meet patient needs.  

So how do we approach this challenge? Modern Design Excellence for medical devices achieves complexity mastery through a digital twin on top of traditional design controls to enable agility and compliance.  

We will explore 5 key areas of design excellence enabled by this digital transformation through a series of blogs: 

  1. Advanced Design & Evidence Re-use across products and programs. Data based – not document based – for intelligent platforming 
  2. Robust, Concurrent Design to enable quick domain specific progress with highly capable design tools for efficient cross-domain workflow merges 
  3. Design File Integrity – accessible, integrated, high quality data throughout the product lifecycle for trusted compliance and product maintenance.  
  4. Comprehensive Risk Management – traceability, application, & decision support through Requirements, Design, and Verification & Validation 
  5. Digital Evidence to reduce costly physical tests and iterate quickly through Verification & Validation 

Design Excellence combines multi-disciplinary design collaboration with advanced design tools and multi-physics simulations to achieve competitively differentiated, premium-value devices. Unlock your design potential to a distinct competitive advantage! Join us as we delve into these topics and see how you can move the needle in your design excellence journey.  

To Learn more about Design Excellence at Siemens please visit here.  

Leave a Reply

This article first appeared on the Siemens Digital Industries Software blog at