Designing for validation of medical devices and equipment

Validation is important in the design, development and production of medical devices since effective and appropriate validation plays a vital role in defining the success of a product in both technical and economic terms. Regulations and quality standards lay out the requirements for product validation, but it is left to each individual manufacturer to establish and maintain their own validation procedures. More recently, there has also been a change of emphasis in the regulations and standards that encourage the integration of validation into the development process. However, this poses particular challenges to the manufacturer since there is a distinct lack of guidance to assist this integration. This workbook provides the first real guidance on good design practices for medical device development. It has been developed through extensive consultation with device manufacturers and analysis of regulatory requirements. The approach is intended to assist manufacturers in meeting the new regulations.

A global model for effective use and evaluation of e-learning in health.

Healthcare systems worldwide face a wide range of challenges, including demographic change, rising drug and medical technology costs, and persistent and widening health inequalities both within and between countries. Simultaneously, issues such as professional silos, static medical curricula, and perceptions of "information overload" have made it difficult for medical training and continued professional development (CPD) to adapt to the changing needs of healthcare professionals in increasingly patient-centered, collaborative, and/or remote delivery contexts. In response to these challenges, increasing numbers of medical education and CPD programs have adopted e-learning approaches, which have been shown to provide flexible, low-cost, user-centered, and easily updated learning. The effectiveness of e-learning varies from context to context, however, and has also been shown to make considerable demands on users' motivation and "digital literacy" and on providing institutions. Consequently, there is a need to evaluate the effectiveness of e-learning in healthcare as part of ongoing quality improvement efforts. This article outlines the key issues for developing successful models for analyzing e-health learning.

Pneumatic and hydraulic microactuators: A review

The development of MEMS actuators is rapidly evolving and continuously new progress in terms of efficiency, power and force output is reported. Pneumatic and hydraulic are an interesting class of microactuators that are easily overlooked. Despite the 20 years of research, and hundreds of publications on this topic, these actuators are only popular in microfluidic systems. In other MEMS applications, pneumatic and hydraulic actuators are rare in comparison with electrostatic, thermal or piezo-electric actuators. However, several studies have shown that hydraulic and pneumatic actuators deliver among the highest force and power densities at microscale. It is believed that this asset is particularly important in modern industrial and medical microsystems, and therefore, pneumatic and hydraulic actuators could start playing an increasingly important role. This paper shows an in-depth overview of the developments in this field ranging from the classic inflatable membrane actuators to more complex piston-cylinder and drag-based microdevices. © 2010 IOP Publishing Ltd.

A global model for effective use and evaluation of e-learning in health.

Healthcare systems worldwide face a wide range of challenges, including demographic change, rising drug and medical technology costs, and persistent and widening health inequalities both within and between countries. Simultaneously, issues such as professional silos, static medical curricula, and perceptions of "information overload" have made it difficult for medical training and continued professional development (CPD) to adapt to the changing needs of healthcare professionals in increasingly patient-centered, collaborative, and/or remote delivery contexts. In response to these challenges, increasing numbers of medical education and CPD programs have adopted e-learning approaches, which have been shown to provide flexible, low-cost, user-centered, and easily updated learning. The effectiveness of e-learning varies from context to context, however, and has also been shown to make considerable demands on users' motivation and "digital literacy" and on providing institutions. Consequently, there is a need to evaluate the effectiveness of e-learning in healthcare as part of ongoing quality improvement efforts. This article outlines the key issues for developing successful models for analyzing e-health learning.