{"title":"The use, misuse, and abuse of design controls.","authors":"George M Samaras","doi":"10.1109/MEMB.2010.936551","DOIUrl":"https://doi.org/10.1109/MEMB.2010.936551","url":null,"abstract":"<p><p>FDA-mandated design controls for medical devices provide a structured, systematic engineering paradigm that supports human-centered systems engineering. Engineering design controls are nothing more than the fundamental elements of classical systems engineering. The human focus is enabled through the iterative reidentification of stakeholders, reassessment of their NWDs, and reconciliation of their evolving/conflicting NWDs. The implementation of design controls and embedded risk management must begin prior to commercial development to reap the full benefit of the approach; partial approaches dilute or negate the effectiveness and efficiency of this nearly century-old systems engineering paradigm. Properly employing engineering design controls is a strategic business decision. The central value of this proposition is the reduction of economic, technical, and operational risks for both producers and consumers; regulatory compliance is a secondary benefit. Misuse or abuse of design controls only undermines long-term profitability and increases the risks to the consumer.</p>","PeriodicalId":50391,"journal":{"name":"IEEE Engineering in Medicine and Biology Magazine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2010-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1109/MEMB.2010.936551","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29147172","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Wearable technology. Health-care solutions for a growing global population.","authors":"Jesse Jayne Rutherford","doi":"10.1109/MEMB.2010.936550","DOIUrl":"https://doi.org/10.1109/MEMB.2010.936550","url":null,"abstract":"<p><p>Wearable technology may provide an integral part of the solution for providing health care to a growing world population that will be strained by a ballooning aging population. By providing a means to conduct telemedicine-the monitoring, recording, and transmission of physiological signals from outside of the hospital-wearable technology solutions could ease the burden on health-care personnel and use hospital space for more emergent or responsive care. In addition, employing wearable technology in professions where workers are exposed to dangers or hazards could help save their lives and protect health-care personnel.</p>","PeriodicalId":50391,"journal":{"name":"IEEE Engineering in Medicine and Biology Magazine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2010-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1109/MEMB.2010.936550","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29147175","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Silvestro Micera, Thierry Keller, Marc Lawrence, Manfred Morari, Dejan B Popović
{"title":"Wearable neural prostheses. Restoration of sensory-motor function by transcutaneous electrical stimulation.","authors":"Silvestro Micera, Thierry Keller, Marc Lawrence, Manfred Morari, Dejan B Popović","doi":"10.1109/MEMB.2010.936547","DOIUrl":"https://doi.org/10.1109/MEMB.2010.936547","url":null,"abstract":"<p><p>In this article, we focus on the least invasive interface: transcutaneous ES (TES), i.e., the use of surface electrodes as an interface between the stimulator and sensory-motor systems. TES is delivered by a burst of short electrical charge pulses applied between pairs of electrodes positioned on the skin. Monophasic or charge-balanced biphasic (symmetric or asymmetric) stimulation pulses can be delivered. The latter ones have the advantage to provide contraction force while minimizing tissue damage.</p>","PeriodicalId":50391,"journal":{"name":"IEEE Engineering in Medicine and Biology Magazine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2010-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1109/MEMB.2010.936547","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29146023","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Wearable technology for biomechanics: e-textile or micromechanical sensors?","authors":"Danilo De Rossi, Peter Veltink","doi":"10.1109/MEMB.2010.936555","DOIUrl":"https://doi.org/10.1109/MEMB.2010.936555","url":null,"abstract":"<p><p>The possibility of gathering reliable information about movement characteristics during activities of daily living holds particular appeal for researchers. Data such as this could be used to analyze the performance of individuals undergoing rehabilitation and to provide vital information on whether or not there is an improvement during a neurorehabilitation protocol. Wearable devices are particularly promising toward this aim, because they can be used in unstructured environments (e.g., at home). Recently, two different approaches in this area have become very popular and show promising performance: the use of inertial sensors together with advanced algorithms (e.g., Kalman filters) and the development of e-textile, in which the sensing technology is directly embroidered into the garment worn by the user.</p>","PeriodicalId":50391,"journal":{"name":"IEEE Engineering in Medicine and Biology Magazine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2010-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1109/MEMB.2010.936555","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29146015","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Health-care technology. IEEE Engineering in Medicine and Biology, vol. 29, no. 2, p. 17.","authors":"Nicolas Chbat, Emilio Sacristan, Andrew Lane","doi":"10.1109/MEMB.2010.937122","DOIUrl":"https://doi.org/10.1109/MEMB.2010.937122","url":null,"abstract":"","PeriodicalId":50391,"journal":{"name":"IEEE Engineering in Medicine and Biology Magazine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2010-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1109/MEMB.2010.937122","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29146022","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Wearable sensors and systems. From enabling technology to clinical applications.","authors":"Paolo Bonato","doi":"10.1109/MEMB.2010.936554","DOIUrl":"https://doi.org/10.1109/MEMB.2010.936554","url":null,"abstract":"<p><p>It is now more than 50 years since the time when clinical monitoring of individuals in the home and community settings was first envisioned. Until recently, technologies to enable such vision were lacking. However, wearable sensors and systems developed over the past decade have provided the tools to finally implement and deploy technology with the capabilities required by researchers in the field of patients' home monitoring. As discussed, potential applications of these technologies include the early diagnosis of diseases such as congestive heart failure, the prevention of chronic conditions such as diabetes, improved clinical management of neurodegenerative conditions such as Parkinson's disease, and the ability to promptly respond to emergency situations such as seizures in patients with epilepsy and cardiac arrest in subjects undergoing cardiovascular monitoring. Current research efforts are now focused on the development of more complex systems for home monitoring of individuals with a variety of preclinical and clinical conditions. Recent research on the clinical assessment of wearable technology promises to deliver methodologies that are expected to lead to clinical adoption within the next five to ten years. In particular, combining home robots and wearable technology is likely to be a key step toward achieving the goal of effectively monitoring patients in the home. These efforts to merge home robots and wearable technology are expected to enable a new generation of complex systems with the ability to monitor subjects' status, facilitate the administration of interventions, and provide an invaluable tool to respond to emergency situations.</p>","PeriodicalId":50391,"journal":{"name":"IEEE Engineering in Medicine and Biology Magazine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2010-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1109/MEMB.2010.936554","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29147176","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Enhanced Visualization: Making Space for 3-D Images (Blundell, B.G.; 2007) [Book Reviews]","authors":"S. Deutsch","doi":"10.1109/MEMB.2009.935705","DOIUrl":"https://doi.org/10.1109/MEMB.2009.935705","url":null,"abstract":"This 425-page book is about true 3-D volumes that show voxels in contrast with two dimensional (2-D) screens that show pixels. Each of the book's 12 chapters begins with an introduction and all but one ends with homework problems.","PeriodicalId":50391,"journal":{"name":"IEEE Engineering in Medicine and Biology Magazine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2010-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1109/MEMB.2009.935705","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"62475907","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Engineers Find Electric Connection","authors":"J. Rutherford","doi":"10.1109/MEMB.2010.936455","DOIUrl":"https://doi.org/10.1109/MEMB.2010.936455","url":null,"abstract":"When Farah Corona Chavez and Daniel Strauss met at the IEEE EMBS Conference in Cancun, Mexico, in 2003, they did not know it was to be a fateful moment in their lives and in fact did not even speak. Strauss, a native of Germany, and Corona, a native of Mexico, went their separate ways until 2005, when Strauss, who by then had completed his second Ph.D. degree, came to Mexico again as a visiting professor in the Biomedical Engineering Department of Mexico City?s Universidad Autonoma Metropolitana, where Corona was working on her master's degree. She was also working in the research laboratory of Innovamedica, which Strauss toured during his stay, and they talked about the project.","PeriodicalId":50391,"journal":{"name":"IEEE Engineering in Medicine and Biology Magazine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2010-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1109/MEMB.2010.936455","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"62475874","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"threshold for plagiarism [Letters to the Editor]","authors":"A. Johnson","doi":"10.1109/MEMB.2009.935716","DOIUrl":"https://doi.org/10.1109/MEMB.2009.935716","url":null,"abstract":"The editorial on plagiarism (\"Don't Play It Again, Sam\") in the September/October issue of IEEE Engineering in Medicine and Biology Magazine has hit on several subjects for which I have much interest. I have served for many years on the Student Honor Boards at the University of Maryland.","PeriodicalId":50391,"journal":{"name":"IEEE Engineering in Medicine and Biology Magazine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2010-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1109/MEMB.2009.935716","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"62476204","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Information Retrieval in Biomedicine: Natural Language Processing for Knowledge Integration (Prince, V. and Roche, M.; 2009) [Book Reviews]","authors":"Zhengwu Lu","doi":"10.1109/MEMB.2009.935707","DOIUrl":"https://doi.org/10.1109/MEMB.2009.935707","url":null,"abstract":"Natural language processing (NLP) is a subfield of computational sciences addressing the operation and management of texts as inputs or outputs of computational devices. The reviewed book is an excellent resource for researchers or graduate students interested in NLP, artificial intelligence, and linguistics, as well as those interested in the most recent advances in information management and retrieval in a health-care setting.","PeriodicalId":50391,"journal":{"name":"IEEE Engineering in Medicine and Biology Magazine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2010-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1109/MEMB.2009.935707","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"62476156","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}