Redesign, Implementation and Evaluation of the Effectiveness of the Aktio Myoelectric Prosthesis

Methodology and work plan of the pre-commercial validation process The methodology for the redesign of the transradial myoelectric prosthesis will seek to add value to the current design, by increasing the value perceived by the buyer by providing additional attributes to the current ones. The methodology will be divided into five main phases that go from the clarification of the objectives that are expected to be satisfied with the design, to the creation and evaluation of a functional prototype that has been improved after carrying out performance tests, and carrying out an evaluation. of effectiveness, in addition to a parallel phase to all that includes the financial analysis. The details of each of the phases are found below.

Conceptual design During this phase, we will seek to define the concept on which the redesign of the transradial prosthesis will be developed based on the Cross Design Method. Initially, a complete and clear approach must be made of the objectives that the prosthesis must satisfy through the clarification of objectives. Then, we will continue with the establishment of functions. Starting from the identification of the level of generality or detail at which to work, the functions and limits of the problem to be solved will be defined, establishing the specific functions that the prosthesis must satisfy, regardless of the physical components that could be used.

Subsequently, the requirements will be set, where the performance specification of the prosthesis will be defined, which will allow evaluating that the proposed solutions are within acceptable limits. In addition, the determination of characteristics will be elaborated, where the desirable attributes of the new product will be compared - from the customer's point of view - with the previously defined engineering requirements. This comparison will be made through the deployment of the quality function, which implies interviews or surveys with possible users and experts on the subject, group sessions, search for the state of the art, among others.

Finally, the generation of alternatives and their evaluation will be carried out. The generation of alternatives is based on the morphological diagram method, which presents the full range of elements, components or secondary solutions that can be combined to form different solutions, from which the alternative designs will be defined. During the evaluation of alternatives, the different alternative designs will be evaluated according to the previously defined requirements and objectives.

For these activities, there will be a group of participants with transradial amputation who agree to enter the study. In the session, the priorities and preferences of patients regarding the use of prostheses and the needs that these should cover will be qualitatively evaluated. It will investigate aspects such as usability, comfort, adaptation, strength, mobility, performance in activities of daily living and quality of life.