Medical Device Development

Simplexity's Priorities in Design

As product realization experts, our priority is to work collaboratively with our clients to meet both the technical and business needs of new products. Our expert team focuses on project priorities such as: 

• Intuitive, safe, and reliable operation  
• Product performance 
• Design for manufacturability (DFM) 
• Device and consumable cost 
• Risk management 
• Development cost 
• Speed to market 

Simplexity’s Capabilities and Medical Device Development Expertise

We are a quality-driven engineering design company, and one way that we ensure high quality results is to bring together an exceptional team of engineers, project managers, and technicians. Our medical device development capabilities and expertise include: 

• Medical device development and design to meet requirements for user needs, reliability, manufacturability, and performance  
• Redesign of cleared or approved medical devices to improve manufacturability, reduce cost, or replace obsolete components  
• Generation of design history file (DHF) documentation to fulfill regulatory submission requirements  
• Identification and management of risk throughout the product development process  
• Controlled builds of pre-production devices for design verification and usability studies  
• Design verification testing  
• Supplier evaluation and selection  
• Design transfer to contract manufacturers 

Our product engineers and project managers have worked with clients to design medical devices in the following product categories:

• Medical wearables and patient monitoring devices 
• Surgical tools 
• Drug delivery systems 
• Endoscopy and catheter-based devices 
• Home health devices 
• Low-power wireless communications  

Simplexity has a deep understanding of the medical device development space and the unique requirements that must be met to achieve success. We look forward to partnering with your company’s core technology experts, working shoulder-to-shoulder to enable the rapid transformation of novel concepts into real, safe products.