Medical Device Design & Development
Taking your medical device from concept to reality
Engineering is the heart and soul of what we do. We use the latest tools and employ the best talent to ensure our designs meet your needs. As a result, any medical device we develop starts in Engineering, where each component’s use and environmental demands are considered.
The Value We Add
FDI knows your world … because we are in it. We are a medical device engineering and manufacturing company. As a result, we understand the challenges and complexities your company faces in making your ideas a reality.
- We have successfully navigated the FDA 510(k) process for our own Class II medical devices.
- We understand and know how to navigate Product Development Processes whether it be for the U.S. Department of Defense (DoD) or commercial application.
Prototyping
Providing a hands-on experience with your product, early in the development stage, is crucial to avoid costly mistakes and to make the product development process more efficient. Our Engineering design team can quickly take your concept from paper and digital to actual production with our latest tools, including CAD, 3D printing, and CNC.
We are experts in:
- Design for ruggedness and Reliability (e.g., MIL-STD-810H)
- Design for manufacturability
- Design for international standards compliance
- Design for maintenance using Reliability Centered Maintenance Analysis
- Design for Human Factors (e.g., MIL-STD-1472H)
- Supply Chain Analysis, including compliance with the Buy American Act
- Industrial design (i.e., aesthetics)
- Configuration design (i.e., kitting with required accessories such as start-up items)
- Operations and service manual development