| Summary: | Design for validation is aimed at designing medical devices to make them easier and more economic to validate. Changes to the medical device regulations within the past few years have forced the industry to focus attention on design and validation in order to ensure that a device and its associated manufacturing and test equipment are reliable and fit for purpose. In order for this to happen, design must affect validation and validation must affect design. However, current guidance on validation as it applies to design is inadequate and, as a result, validation is generally not well understood amongst medical device designers. The goal of design for validation is to provide guidance in order to help designers achieve integrated design, development and validation. It forms part of a wider definition of Good Design Practice which aims to encourage fitness for purpose within commercial reality. Exploratory research was carried out in the form of studying ideal practice and current practice in order to identify the factors which contribute to integrated design, development and validation. Case studies were analysed, a model of ideal practice was developed and interviews were carried out with various medical device designers and project managers. From the information gathered, two basic designer needs were identified which had to be fulfilled in order for designers to integrate design, development and validation. A practical approach to design for validation was formulated in order to address the two designer needs through the use of a model of design for validation and a series of six design tactics. The approach was evaluated by sending questionnaires to industry. The feedback was very positive and, based on the evaluation, revisions were made to the design for validation model and design tactics. The revisions will be carried forward to the next phase of the research which is the development of a Design for Validation Workbook.
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