دانلود رایگان مقاله مدیریت نیاز به توسعه یک دستگاه توانبخشی جدید آرنج

abstract

The development of new technologies for healthcare must take into consideration customer requirements from different stakeholders. The Voice of the Customer must be identified, analyzed and organized. This study aims to present a new approach of managing requirements from different product value chain stakeholders for a novel elbow rehabilitation device development. The Customer Value Chain Analysis tool was used to identify the product value chain stakeholders and the Quality Function Deployment tool to analyze and prioritize these requirements. The development is described in accordance with the engineering requirement process adapted to this case: 1) elicitation: the requirements come from the literature; benchmarking; questionnaires applied to all parties identified by Customer Value Chain Analysis application; 2) analyses: requirements were understood, and their overlaps, conflicts and prioritization were done by means of Quality Function Deployment (quality, product and part characteristics matrices); and 3) documentation: the identified construct of requirements were: ergonomics, functions, aesthetics, handling, materials, components/elements. The main parts that must be prioritized were: arm support, forearm support, support shaft, joystick, and support base. The association of these two tools is a novel and successful approach of identify different product value chain stakeholders and prioritize technical requirements for health product development.

5. Discussion

A conceptual model that integrates the CVCA tool with QFD tool, which results from the applications, was described following the requirements engineering to collect and prioritize requirements for the development of a novel elbow rehabilitation device. In applying the CVCA, the critical customers identified were clinical engineers, product engineers, process engineers and reliability engineers; project and product managers; financial sector staff; quality system and regulatory affairs staff, internal and external to the organization. According to the organization functional managers interviewed, the end users were: physical therapists, occupational therapists, and physicians, while patients have their interests covered indirectly by other stakeholders such as clinical engineers and regulatory affairs staff. Thus, the researchers also see these users as critical stakeholders and highlighted Capelli et al. (2012) considers essential to understand the information about each individual patient characteristics and the interactions between the device and the patient's anatomy and function. Such information is important to ensure safe device design for the majority of medical applications. The findings of our study showed the model application allowed to identify different stakeholders using the proposed systematic approach. This new approach makes us to believe its inputs probably improve the development process of a novel medical device as soon as the customer different points of view could be taken into account. Consequently, the device can be well aligned to the customer requirements.