1. A process for creating a specification for a customized device for a subject, the device having clinical shape characteristics and functional characteristics, the process comprising the steps of: (a) providing a digital model that is fully parameterized at least for characterizing the clinical shape characteristics and functional characteristics of the device, the model configured to accept a plurality of customization inputs, the customization inputs comprising a plurality of design parameter values and 3-dimensional coordinates corresponding to a plurality of landmarks; (b) providing 3-dimensional coordinates corresponding to a plurality of captured landmarks relative to a subject, the captured landmarks comprising points characteristic of elements selected from the group consisting of: anatomical characteristics of the subject, means for attachment of the device to the subject, and a reference plane; (c) calculating 3-dimensional coordinates for one or more virtual landmarks based upon the captured landmarks; (d) constructing a customized model of the customized device by populating the digital parameterized model with the design parameter values and the virtual and captured landmarks; and (e) generating an output from the customized model corresponding to the specification for the customized device.