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PubMed | a Medical Physics and Clinical Engineering ., d Devices for Dignity Ltd and b NIHR Devices for Dignity Healthcare Technology Co operative
Type: Journal Article | Journal: Journal of medical engineering & technology | Year: 2015

This paper describes and discusses the role of unmet needs in the innovation of new medical technologies using the National Institute for Health Research Devices for Dignity (D4D) Healthcare Technology Co-operative as a case study. It defines an unmet need, providing a spectrum of classification and discusses the benefits and the challenges of identifying unmet need and its influence on the innovation process. The process by which D4D has captured and utilized unmet needs to drive technology innovation is discussed and examples given. It concludes by arguing that, despite the challenges, defining and reviewing unmet need is a fundamental factor in the success of medical technology innovation.


PubMed | a Medical Physics and Clinical Engineering . and University of Sheffield
Type: Journal Article | Journal: Journal of medical engineering & technology | Year: 2015

The paper provides an introduction to the regulatory landscape affecting a particular category of medical technology, namely standalone software-sometimes referred to as software as a medical device. To aid the readers comprehension of an often complex area, six case studies are outlined and discussed before the paper continues to provide detail of how software with a medical purpose in its own right can potentially be classified as a medical device. The reader is provided an appreciation of how to go about classifying such software and references to support the developer new to the field in locating detailed regulatory support documents and contact points for advice.

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