Most medical device manufacturers utilize a classic water fall development process. This is a risk –averse, top down approach that does not keep pace with demands of today’s market place. We at AMDD are the first to develop a set of design and development processes that leverage modern rapid prototype techniques in circuit design and 3D printing and modern Requirement management tools to iterate elements of a medical device piece wise; creating all supporting documentation, requirements, risk elements, traces, test cases etc. that creates a single medical device work product. This creates iterations of products and product features that are tested, verified and validated allowing for tweaks, requirement changes, risk updates and compliance updates as needed.