title: Taking a Concept to Commercialization: Designing Relevant Tests to Address Safety.
abstract: Taking a product from concept to commercialization requires careful navigation of the regulatory pathway through a series of steps: (A) moving the idea through proof of concept and beyond; (B) evaluating new technologies that may provide added value to the idea; (C) designing appropriate test strategies and protocols; and (D) evaluating and mitigating risks. Moving an idea from the napkin stage of development to the final product requires a team effort. When finished, the product rarely resembles the original design, but careful steps throughout the product life cycle ensure that the product meets the vision.
authors.affiliation: Orthokinetic Testing Technologies, Southport, NC.
authors.forename: Lisa A
authors.initials: LA
authors.lastname: Ferrara
mesh_terms: D003257:Consumer Product Safety; D006801:Humans; D009983:Orthopedic Equipment / Q000191:economics / Q000592:standards; D011474:Prosthesis Design; D013131:Spine / Q000601:surgery*; D014481:United States