|
From Concept to the Clinician
Medical device design and development is an extremely challenging
task. Even the best concepts and technologies can be deterred by
regulatory, design, market and/or financial hurdles.
While each project is unique, the following checklist breaks the
process down into typical stages and components and indicates who
will contribute to the completion of each step. Note that certain
components will stretch over two or more stages - notably regulatory
affairs and marketing, which demand attention throughout the entire
process.
| Stage/Component |
Completed by: |
| Embryonic
stage - First idea through proof of concept & business
feasibility |
Proof of concept
|
Fairway |
Market assessment
|
Fairway/Client |
Business model
|
Fairway/Client |
Cost feasibility
|
Fairway |
Patent disclosure
|
Fairway/client |
| Incubation
stage - Design, prototype & initial testing |
Design
|
Fairway |
Prototype
|
Fairway |
Market validation
|
Fairway/Client |
Regulatory affairs
|
Fairway/Client |
Patent application
|
Fairway/Client |
Initial (in-vitro) testing
|
Fairway/Medical Center |
| Refinement stage- development
through in-vivo testing |
Design modification
|
Fairway |
Regulatory affairs
|
Fairway/Client |
Industrial design
|
Fairway |
Development
|
Fairway |
Facility & staffing
|
Fairway/Client |
In-vivo testing
|
Fairway/Medical Center |
Marketing/Distribution Plan
|
Fairway/Client |
| Development stage - production
engineering through clinical testing |
Production design
|
Fairway |
Production engineering
|
Fairway |
Regulatory affairs
|
Fairway/Client |
Marketing/Distribution Plan
|
Fairway/Client |
Clinical testing
|
Fairway |
FDA Submission
|
Fairway/Client |
| Commercial stage - product
launch through post sales service |
Production
|
Fairway |
Marketing/Distribution
|
Fairway/Client |
Sales & service
|
Fairway/Client |
Regulatory affairs
|
Fairway/Client |
R & D
|
Fairway/Client |
|
