The development, evaluation, and eventual deployment of novel medical devices is a complex process involving various areas of expertise. Although the need for a User Centred Design approach to the development of both hardware and software has long been established, both current regulatory guidelines and widespread evaluation approaches fail to reflect the challenges encountered during day-to-day clinical practice. As such, the results from these evaluations may not provide a realistic account of the problems encountered by users when introduced to clinical practice. In this paper, we present a case study on designing the evaluation of a novel device to support laparoscopic liver surgery. Through a reflective account of the design of our usability evaluation, we identify and describe seven primary dimensions of ecological validity encountered in clinical usability evaluations. These dimensions are: 'user roles', 'environment', 'training', 'scenario', 'patient involvement', 'software', and 'hardware'. We analyse three recently published clinical usability evaluation articles to assess (and illustrate) the applicability and completeness of these dimensions. Finally, we discuss the compromises encountered during clinical usability evaluations and how to best report on these considerations. The framework presented here aims to further the agenda of ecologically valid evaluation practice, reflecting the constraints of medical practice.
Background Accurate camera and hand‐eye calibration are essential to ensure high‐quality results in image‐guided surgery applications. The process must also be able to be undertaken by a nonexpert user in a surgical setting. Purpose This work seeks to identify a suitable method for tracked stereo laparoscope calibration within theater. Methods A custom calibration rig, to enable rapid calibration in a surgical setting, was designed. The rig was compared against freehand calibration. Stereo reprojection, stereo reconstruction, tracked stereo reprojection, and tracked stereo reconstruction error metrics were used to evaluate calibration quality. Results Use of the calibration rig reduced mean errors: reprojection (1.47 mm [SD 0.13] vs. 3.14 mm [SD 2.11], p‐value 1e−8), reconstruction (1.37 px [SD 0.10] vs. 10.10 px [SD 4.54], p‐value 6e−7), and tracked reconstruction (1.38 mm [SD 0.10] vs. 12.64 mm [SD 4.34], p‐value 1e−6) compared with freehand calibration. The use of a ChArUco pattern yielded slightly lower reprojection errors, while a dot grid produced lower reconstruction errors and was more robust under strong global illumination. Conclusion The use of the calibration rig results in a statistically significant decrease in calibration error metrics, versus freehand calibration, and represents the preferred approach for use in the operating theater.
Ortopedi ve Travmatoloji alanındaki ürünlerin pazarlanmasında ise hasta seçimde ve ödemede rol almaz. Hedef kitle hekim ve cerrahlardır. Aynı şekilde, geleneksel pazarlamada genellikle kullanıcı ürünün bedelini öder. Fiyat satıcı tarafından pazar koşullarına göre belirlenir. Ortopedi ve Travmatoloji alanında ürün P azarlama faaliyetleri pazarlamanın "4P"si denen bileşenlere ayrılır. Bu bileşenlerden Fiyat (Price), Promosyon ve Pazarlanan Yer (Place) ortopedik pazarlamada farklılık göstermektedir.Geleneksel pazarlamada, müşteri hedeflenirken genelde malı satın alan da seçimi yapan da aynı kişidir.
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