Medical Device Product Development
Medical device product development requires a carefully thought-out, comprehensive process that ensures that products are developed in a systematic manner. Nothing can be overlooked and the product must be able to be tested and verified as being safe.
Forma employs a medical product development process that delineates guidelines for each step in bringing a medical product idea from concept to commercialization. We have detailed procedures in place to ensure completeness in:
On products, markets and users — to explore the product space and discover openings for gaining competitive advantage. To identify the real problem the product is intended to solve, which is critical for market success.
User needs form the basis from which all design efforts follow.
From rudimentary sketches for rapid idea generation to more detailed representations that flesh out promising ideas — all shared with project stakeholders to capture valuable input and spark fresh thinking.
Including industrial design, mechanical, electrical and software engineering development.
Prototyping is a critical part of medical product development and is done throughout the process.
Including design documentation, risk analysis, vendor sourcing, patent research, packaging design, labeling, instructions for use, etc.