Medical 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:
- Collecting up-front information regarding the problem the product is intended to solve, the technology surrounding the product, market intelligence, user intelligence, project timing, product criteria, metrics that will define success, constraints, component architecture, projected annual sales volumes, regulatory strategy and issues.
- Background product and market research.
- User research.
- Ergonomics/anthropometric and human factors data.
- Concept ideation.
- Design development activities, including industrial design refinement, mechanical, electrical and software engineering development.
- User interface design.
- Developing preliminary tooling and manufacturing costs.
- Design documentation.
- User studies, including human factors.
- Risk analysis.
- Vendor sourcing.
- Patent research.
- Patent filing.
- Packaging design.
- Instructions for use.
- Brand identity.
All of these activities follow the requirements of Forma’s Quality System, which is in conformance with the Code of Federal Regulations (21 CFR part 820) Medical Devices – Current Good Manufacturing Processes.