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https://www.readbyqxmd.com/read/28227473/use-of-activity-theory-based-need-finding-for-biomedical-device-development
#1
Shalaleh Rismani, Matt Ratto, H F Machiel Van der Loos, Shalaleh Rismani, Matt Ratto, H F Machiel Van der Loos, Shalaleh Rismani, Matt Ratto
Identifying the appropriate needs for biomedical device design is challenging, especially for less structured environments. The paper proposes an alternate need-finding method based on Cultural Historical Activity Theory and expanded to explicitly examine the role of devices within a socioeconomic system. This is compared to a conventional need-finding technique in a preliminary study with engineering student teams. The initial results show that the Activity Theory-based technique allows teams to gain deeper insights into their needs space...
August 2016: Conference Proceedings: Annual International Conference of the IEEE Engineering in Medicine and Biology Society
https://www.readbyqxmd.com/read/28222759/development-and-assessment-of-a-hand-assist-device-gripit
#2
Byungchul Kim, Hyunki In, Dae-Young Lee, Kyu-Jin Cho
BACKGROUND: Although various hand assist devices have been commercialized for people with paralysis, they are somewhat limited in terms of tool fixation and device attachment method. Hand exoskeleton robots allow users to grasp a wider range of tools but are heavy, complicated, and bulky owing to the presence of numerous actuators and controllers. The GRIPIT hand assist device overcomes the limitations of both conventional devices and exoskeleton robots by providing improved tool fixation and device attachment in a lightweight and compact device...
February 21, 2017: Journal of Neuroengineering and Rehabilitation
https://www.readbyqxmd.com/read/28221991/detecting-clinically-meaningful-shape-clusters-in-medical-image-data-metrics-analysis-for-hierarchical-clustering-applied-to-healthy-and-pathological-aortic-arches
#3
Jan L Bruse, Maria A Zuluaga, Abbas Khushnood, Kristin McLeod, Hopewell N Ntsinjana, Tain-Yen Hsia, Maxime Sermesant, Xavier Pennec, Andrew M Taylor, Silvia Schievano
OBJECTIVE: Today's growing medical image databases call for novel processing tools to structure the bulk of data and extract clinically relevant information. Unsupervised hierarchical clustering may reveal clusters within anatomical shape data of patient populations as required for modern Precision Medicine strategies. Few studies have applied hierarchical clustering techniques to three-dimensional patient shape data and results depend heavily on the chosen clustering distance metrics and linkage functions...
February 16, 2017: IEEE Transactions on Bio-medical Engineering
https://www.readbyqxmd.com/read/28217778/a-critical-insight-into-the-development-pipeline-of-microfluidic-immunoassay-devices-for-the-sensitive-quantitation-of-protein-biomarkers-at-the-point-of-care
#4
REVIEW
Ana I Barbosa, Nuno M Reis
The latest clinical procedures for the timely and cost-effective diagnosis of chronic and acute clinical conditions, such as cardiovascular diseases, cancer, chronic respiratory diseases, diabetes or sepsis (i.e. the biggest causes of death worldwide), involve the quantitation of specific protein biomarkers released into the blood stream or other physiological fluids (e.g. urine or saliva). The clinical thresholds are usually in the femtomolar to picolomar range, and consequently the measurement of these protein biomarkers heavily relies on highly sophisticated, bulky and automated equipment in centralised pathology laboratories...
February 20, 2017: Analyst
https://www.readbyqxmd.com/read/28196661/pediatric-medical-device-development-by-surgeons-via-capstone-engineering-design-programs
#5
Bryan S Sack, Rodolfo A Elizondo, Gene O Huang, Nicolette Janzen, Jimmy Espinoza, Magdalena Sanz-Cortes, Jennifer E Dietrich, Julie Hakim, Eric Richardson, Maria Oden, John Hanks, Balakrishna Haridas, James F Hury, Chester J Koh
BACKGROUND: There is a need for pediatric medical devices that accommodate the unique physiology and anatomy of pediatric patients that is increasingly receiving more attention. However, there is limited literature on the programs within children's hospitals and academia that can support pediatric device development. We describe our experience with pediatric device design utilizing collaborations between a children's hospital and two engineering schools. METHODS: Utilizing the academic year as a timeline, unmet pediatric device needs were identified by surgical faculty and matched with an engineering mentor and a team of students within the Capstone Engineering Design programs at two universities...
February 6, 2017: Journal of Pediatric Surgery
https://www.readbyqxmd.com/read/28195202/application-of-pristine-and-doped-sno2-nanoparticles-as-a-matrix-for-agro-hazardous-material-organophosphate-detection
#6
Naushad Khan, Taimur Athar, H Fouad, Ahmad Umar, Z A Ansari, S G Ansari
With an increasing focus on applied research, series of single/composite materials are being investigated for device development to detect several hazardous, dangerous, and toxic molecules. Here, we report a preliminary attempt of an electrochemical sensor fabricated using pristine Ni and Cr-doped nano tin oxide material (SnO2) as a tool to detect agro-hazardous material, i.e. Organophosphate (OP, chlorpyrifos). The nanomaterial was synthesized using the solution method. Nickel and chromium were used as dopant during synthesis...
February 14, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28190507/best-practices-in-early-phase-medical-device-development-engineering-prototyping-and-the-beginnings-of-a-quality-management-system
#7
Kristy Fearis, Aidan Petrie
Kristy Fearis is the founder and president of KPConsulting. She has held various positions in the medical device and research industry. She has led programs for medical industry leaders Medtronic, Edward Lifesciences, and Kimberly-Clark Healthcare to develop and commercialize Class II and III devices. Although a true quality management systems specialist at heart, Kristy has a passion for effectively and efficiently applying quality systems principles to early stage development to maximize benefit while minimizing impact on resources and time to market...
March 2017: Surgery
https://www.readbyqxmd.com/read/28187816/multimodal-neurologic-monitoring
#8
G Korbakis, P M Vespa
Neurocritical care has two main objectives. Initially, the emphasis is on treatment of patients with acute damage to the central nervous system whether through infection, trauma, or hemorrhagic or ischemic stroke. Thereafter, attention shifts to the identification of secondary processes that may lead to further brain injury, including fever, seizures, and ischemia, among others. Multimodal monitoring is the concept of using various tools and data integration to understand brain physiology and guide therapeutic interventions to prevent secondary brain injury...
2017: Handbook of Clinical Neurology
https://www.readbyqxmd.com/read/28168041/developing-and-testing-an-electronic-medication-administration-monitoring-device-for-community-dwelling-seniors-a-feasibility-study
#9
Henry Yu-Hin Siu, Dee Mangin, Michelle Howard, David Price, David Chan
BACKGROUND: Medication non-adherence, polypharmacy, and adverse drug events are major healthcare issues leading to significant morbidity, mortality, and healthcare expenditures. Currently, there are no methods to systematically track medication usage in community-dwelling seniors. The eDosette prototype was created to make medication use patterns visible via the Internet. This study aims to demonstrate feasibility, usability, and acceptability of the eDosette in community-dwelling seniors in primary care...
2017: Pilot and Feasibility Studies
https://www.readbyqxmd.com/read/28165108/predicting-a-graphene-like-wb4-nanosheet-with-a-double-dirac-cone-an-ultra-high-fermi-velocity-and-significant-gap-opening-by-spin-orbit-coupling
#10
Chunmei Zhang, Yalong Jiao, Fengxian Ma, Steven Bottle, Mingwen Zhao, Zhongfang Chen, Aijun Du
The zero-band gap nature of graphene prevents it from performing as a semi-conductor in modern electronics. Although various graphene modification strategies have been developed to address this limitation, the very small band gap of these materials and the suppressed charge carrier mobility of the devices developed still significantly hinder graphene's applications. In this work, a two dimensional (2D) WB4 monolayer, which exhibits a double Dirac cone, was conceived and assessed using density functional theory (DFT) methods, which would provide a sizable band gap while maintaining higher charge mobility with a Fermi velocity of 1...
February 6, 2017: Physical Chemistry Chemical Physics: PCCP
https://www.readbyqxmd.com/read/28155694/%C3%AE-1-integrin-signaling-in-asymmetric-migration-of-keratinocytes-under-mechanical-stretch-in-a-co-cultured-wound-repair-model
#11
Dongyuan Lü, Zhan Li, Yuxin Gao, Chunhua Luo, Fan Zhang, Lu Zheng, Jiawen Wang, Shujin Sun, Mian Long
BACKGROUND: Keratinocyte (KC) migration in re-epithelization is crucial in repairing injured skin. But the mechanisms of how mechanical stimuli regulate the migration of keratinocytes have been poorly understood. METHODS: Human immortalized keratinocyte HaCaT cells were co-cultured with skin fibroblasts on PDMS membranes and transferred to the static stretch device developed in-house for additional 6 day culture under mechanical stretch to mimic surface tension in skin...
December 28, 2016: Biomedical Engineering Online
https://www.readbyqxmd.com/read/28144764/prospective-analysis-of-the-sealing-ability-of-the-enseal-%C3%A2-g2-articulating-tissue-sealer-and-transector-on-human-mesenteric-vessels-in-colorectal-surgery
#12
B Balachandran, G Melich, T Mustafa, S J Marecik, L M Prasad, M Gonzalez, S Sulo, F Dabbous, J J Park
BACKGROUND: The sealing and transection of mesenteric vessels is a crucial step in minimally invasive colorectal surgery. We examined the sealing quality of the ENSEAL(®) G2 Articulating Tissue Sealer in three different articulations in mesenteric vessels. METHODS: This was a prospective experimental study within a tertiary healthcare center, and 30 patients were recruited. Burst pressures for each specimen were measured as the primary outcome. Ten specimens at each of the three articulations were also histologically assessed for the quality of seal...
January 31, 2017: Techniques in Coloproctology
https://www.readbyqxmd.com/read/28135065/direct-electrical-probing-of-periodic-modulation-of-zinc-dopant-distributions-in-planar-gallium-arsenide-nanowires
#13
Wonsik Choi, Eric Seabron, Parsian K Mohseni, Jeong Dong Kim, Tobias Gokus, Adrian Cernescu, Pascal Pochet, Harley T Johnson, William L Wilson, Xiuling Li
Selective lateral epitaxial (SLE) semiconductor nanowires (NWs), with their perfect in-plane epitaxial alignment, ability to form lateral complex p-n junctions in situ, and compatibility with planar processing, are a distinctive platform for next-generation device development. However, the incorporation and distribution of impurity dopants in these planar NWs via the vapor-liquid-solid growth mechanism remain relatively unexplored. Here, we present a detailed study of SLE planar GaAs NWs containing multiple alternating axial segments doped with Si and Zn impurities by metalorganic chemical vapor deposition...
February 9, 2017: ACS Nano
https://www.readbyqxmd.com/read/28106517/traditional-invasive-and-synchrotron-based-non-invasive-assessments-of-3d-printed-hybrid-cartilage-constructs
#14
Adeola Deborah Olubamiji, Ning Zhu, Tuanjie Chang, Chijioke Nwankwo, Zohreh Izadifar, Ali Honaramooz, Daniel Chen, B Frank Eames
Three-dimensional (3D)-printed constructs made of polycaprolactone (PCL) and chondrocyte-impregnated alginate hydrogel (hybrid cartilage constructs) mimic the biphasic nature of articular cartilage, offering promise for cartilage tissue engineering (CTE) applications. However, the regulatory pathway for medical device development requires validation of such constructs through in vitro bench tests and in vivo preclinical examinations premarket approval. Furthermore, non-invasive imaging techniques are required for effective evaluation of the progress of these cartilage constructs, especially when implanted in animal models or human subjects...
January 20, 2017: Tissue Engineering. Part C, Methods
https://www.readbyqxmd.com/read/28092200/the-challenges-surrounding-preclinical-testing-in-transcatheter-device-development-and-the-implications-on-the-clinic
#15
Ralf Holzer, Jake Goble, Ziyad Hijazi
Transcatheter devices have contributed significantly to the advances achieved in treating many cardiovascular conditions over the last few decades. Sophisticated and detailed preclinical testing is not only a regulatory requirement to support an investigational device exemption (IDE) application, but more crucially its success and accuracy is needed to safeguard patients during the subsequent clinical testing stages. Areas covered: This article covers the regulatory background as well as specific considerations related to pre-clinical testing of transcatheter devices...
January 31, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28080154/biocompatibility-assessments-for-medical-devices-evolving-regulatory-considerations
#16
Lesley Reeve, Paul Baldrick
Biocompatibility assessment provides key data supporting medical device development and marketing. Although regional and international guidance is available, differences in proposed biocompatibility assessments or test methods lead to confusion and inefficiencies in generating the package of supporting nonclinical data. Areas covered: Modifications to available guidance for biological safety testing of medical devices, as described by the International Organisation for Standardisation (ISO) and the US Food and Drug Administration (FDA), have, over time, sometimes increased and sometimes decreased the level of harmonisation in testing requirements...
January 21, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28078339/simultaneous-topographical-electrical-and-optical-microscopy-of-optoelectronic-devices-at-the-nanoscale
#17
Naresh Kumar, Alina Zoladek-Lemanczyk, Anne A Y Guilbert, Weitao Su, Sachetan M Tuladhar, Thomas Kirchartz, Bob C Schroeder, Iain McCulloch, Jenny Nelson, Debdulal Roy, Fernando A Castro
Novel optoelectronic devices rely on complex nanomaterial systems where the nanoscale morphology and local chemical composition are critical to performance. However, the lack of analytical techniques that can directly probe these structure-property relationships at the nanoscale presents a major obstacle to device development. In this work, we present a novel method for non-destructive, simultaneous mapping of the morphology, chemical composition and photoelectrical properties with <20 nm spatial resolution by combining plasmonic optical signal enhancement with electrical-mode scanning probe microscopy...
January 12, 2017: Nanoscale
https://www.readbyqxmd.com/read/28025239/off-label-use-of-medical-devices-in-children
#18
(no author information available yet)
Despite widespread therapeutic needs, the majority of medical and surgical devices used in children do not have approval or clearance from the Food and Drug Administration (FDA) for use in pediatric populations. The clinical need for devices to diagnose and treat diseases or conditions occurring in children has led to the widespread and necessary practice in pediatric medicine and surgery of using approved devices for "off-label" or "physician-directed" applications that are not included in FDA-approved labeling...
January 2017: Pediatrics
https://www.readbyqxmd.com/read/28003530/the-stentable-in-vitro-artery-an-instrumented-platform-for-endovascular-device-development-and-optimization
#19
Elizabeth E Antoine, François P Cornat, Abdul I Barakat
Although vascular disease is a leading cause of mortality, in vitro tools for controlled, quantitative studies of vascular biological processes in an environment that reflects physiological complexity remain limited. We developed a novel in vitro artery that exhibits a number of unique features distinguishing it from tissue-engineered or organ-on-a-chip constructs, most notably that it allows deployment of endovascular devices including stents, quantitative real-time tracking of cellular responses and detailed measurement of flow velocity and lumenal shear stress using particle image velocimetry...
December 2016: Journal of the Royal Society, Interface
https://www.readbyqxmd.com/read/27997307/caervest-%C3%A2-a-novel-endothermic-hypothermic-device-for-core-temperature-cooling-safety-and-efficacy-testing
#20
Ashley G B Willmott, Alex Bliss, William H Simpson, Steve M Tocker, Rowland Cottingham, Neil S Maxwell
INTRODUCTION: Cooling of the body is used to treat hyperthermic individuals with heatstroke or to depress core temperature below normal for neuroprotection. A novel chemically activated, unpowered cooling device, CAERvest(®), was investigated for safety and efficacy, with the feedback used to inform device development. METHODS: Eight healthy male participants (body mass 79.9±1.9kg and body fat percentage 16.1±3.8%) visited the laboratory (20°C, 40% RH) on four occasions...
December 20, 2016: International Journal of Occupational Safety and Ergonomics: JOSE
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