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:

Contact Forma to help you move your medical device idea from concept to commercialization.

Research and
Information Gathering

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

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.

Design Development

Including industrial design, mechanical, electrical and software engineering development.


Prototyping is a critical part of medical product development and is done throughout the process.

Project Documentation

Including design documentation, risk analysis, vendor sourcing, patent research, packaging design, labeling, instructions for use, etc.