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https://www.readbyqxmd.com/read/27898390/novel-concentrated-insulin-delivery-devices-developments-for-safe-and-simple-dose-conversions
#1
REVIEW
Jeremy L Johnson, Jessica M Downes, Cassandra K Obi, Nana B Asante
To aid the burden of large dosing volumes, concentrated insulin products have been available in some form since the 1950s, albeit requiring significant and cumbersome detail in prescribing, converting doses from other products, and educating patients on how to administer. In 2015 and 2016, new concentrated products have been introduced that are available exclusively in pen devices that perform the conversion automatically, and thus, help to bypass the necessity for confusing calculations or administration. Providers and patients accustomed to traditional methods must recognize the differences and utility of these products to avoid dosing errors, as there are major differences in dosing procedures as well as their role in clinical practice...
November 27, 2016: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/27890135/human-factors-in-the-design-of-medical-devices-approaches-to-meeting-international-standards-in-the-european-union-and-usa
#2
Mary Beth Privitera, Mark Evans, Darren Southee
This paper focuses on the challenges of meeting agency requirements as it pertains to the application of human factors in the medical device development (MDD) process. Individual case studies of the design and development process for 18 medical device manufacturers located in the US and EU were analyzed and compared using a multiple case study design. The results indicate that there are four main challenges in implementing international standards. These include a lack of direct access to users for the purposes of device development; a lack of understanding by users with regards to the impact of their feedback on the development process; contract formalities limiting user exchanges; and the attitude of clinical users directly impacting on the device developer's invitation to participate in the development processes...
March 2017: Applied Ergonomics
https://www.readbyqxmd.com/read/27871889/spontaneous-prosocial-choice-by-captive-bottlenose-dolphins-tursiops-truncatus
#3
Fumio Nakahara, Masayuki Komaba, Ryoichi Sato, Hisako Ikeda, Kumiko Komaba, Akihiro Kawakubo
Dolphins exhibit prosocial behavior across several different contexts. However, only a few experimental studies have investigated the psychological mechanisms underlying this behavior. In this study, we investigated the mechanisms underlying prosociality in bottlenose dolphins (Tursiops truncatus). In the experiments, water shower devices, developed as environmental enrichment items, were used. Two paradigms were used to measure prosociality. The first was the prosocial choice task, involving the subject typically being offered one choice between two options...
November 18, 2016: Behavioural Processes
https://www.readbyqxmd.com/read/27867466/a-training-paradigm-to-enhance-performance-and-safe-use-of-an-innovative-neuroendovascular-device
#4
Donald R Ricci, Thomas R Marotta, Howard A Riina, Martina Wan, Joost De Vries
Training has been important to facilitate the safe use of new devices designed to repair vascular structures. This paper outlines the generic elements of a training program for vascular devices and uses as an example the actual training requirements for a novel device developed for the treatment of bifurcation intracranial aneurysms. Critical elements of the program include awareness of the clinical problem, technical features of device, case selection, and use of a simulator. Formal proctoring, evaluation of the training, and recording the clinical outcomes complement these elements...
2016: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/27855988/development-of-a-platelet-adhesion-transport-equation-for-a-computational-thrombosis-model
#5
Joshua O Taylor, Ling Yang, Steven Deutsch, Keefe B Manning
Thrombosis is a significant issue for cardiovascular device development and use. While thrombosis models are available, very few are device-related and none have been thoroughly validated experimentally. Here, we introduce a surface adherent platelet transport equation into a continuum model to account for the biomaterial interface/blood interaction. Using a rotating disc system and polyurethane-urea material, we characterize steady and pulsatile flow fields using laser Doppler velocimetry. In vitro measurements of platelet adhesion are used in combination with the LDV data to provide further experimental validation...
November 10, 2016: Journal of Biomechanics
https://www.readbyqxmd.com/read/27818053/biosensors-for-plant-pathogen-detection
#6
Mohga Khater, Alfredo de la Escosura-Muñiz, Arben Merkoçi
Infectious plant diseases are caused by pathogenic microorganisms such as fungi, bacteria, viruses, viroids, phytoplasma and nematodes. Worldwide, plant pathogen infections are among main factors limiting crop productivity and increasing economic losses. Plant pathogen detection is important as first step to manage a plant disease in greenhouses, field conditions and at the country boarders. Current immunological techniques used to detect pathogens in plant include enzyme-linked immunosorbent assays (ELISA) and direct tissue blot immunoassays (DTBIA)...
September 28, 2016: Biosensors & Bioelectronics
https://www.readbyqxmd.com/read/27803736/the-location-of-obstruction-predicts-stent-occlusion-in-malignant-gastric-outlet-obstruction
#7
Douglas Grunwald, Jonah Cohen, Anthony Bartley, Jennifer Sheridan, Ram Chuttani, Mandeep S Sawhney, Douglas K Pleskow, Tyler M Berzin, Meir Mizrahi
BACKGROUND: Gastric outlet obstruction (GOO) can occur with locally invasive or metastatic cancer involving the upper gastrointestinal tract at the pylorus or the duodenum. Endoscopic management with self-expanding metal stents (SEMSs) is often the preferred palliative approach. Stent occlusion is a common reason for failure and reintervention. We set out to determine whether the location of the malignant obstruction is associated with the angulation of the stent and can predict stent occlusion...
November 2016: Therapeutic Advances in Gastroenterology
https://www.readbyqxmd.com/read/27782610/development-and-characterization-of-a-high-yield-transportable-pulsed-neutron-source-with-efficient-and-compact-pulsed-power-system
#8
Rishi Verma, Ekansh Mishra, Prosenjit Dhang, Karuna Sagar, Manraj Meena, Anurag Shyam
The results of characterization experiments carried out on a newly developed dense plasma focus device based intense pulsed neutron source with efficient and compact pulsed power system are reported. Its high current sealed pseudospark switch based low inductance capacitor bank with maximum stored energy of ∼10 kJ is segregated into four modules of ∼2.5 kJ each and it cumulatively delivers peak current in the range of 400 kA-600 kA (corresponding to charging voltage range of 14 kV-18 kV) in a quarter time period of ∼2 μs...
September 2016: Review of Scientific Instruments
https://www.readbyqxmd.com/read/27771811/constitutive-description-of-human-femoropopliteal-artery-aging
#9
Alexey Kamenskiy, Andreas Seas, Paul Deegan, William Poulson, Eric Anttila, Sylvie Sim, Anastasia Desyatova, Jason MacTaggart
Femoropopliteal artery (FPA) mechanics play a paramount role in pathophysiology and the artery's response to therapeutic interventions, but data on FPA mechanical properties are scarce. Our goal was to characterize human FPAs over a wide population to derive a constitutive description of FPA aging to be used for computational modeling. Fresh human FPA specimens ([Formula: see text]) were obtained from [Formula: see text] predominantly male (80 %) donors 54±15 years old (range 13-82 years). Morphometric characteristics including radius, wall thickness, opening angle, and longitudinal pre-stretch were recorded...
October 22, 2016: Biomechanics and Modeling in Mechanobiology
https://www.readbyqxmd.com/read/27769741/three-dimensional-printing-with-polylactic-acid-pla-thermoplastic-offers-new-opportunities-for-cryobiology
#10
Terrence R Tiersch, William T Monroe
Development of devices through design, prototyping, testing, and fabrication is especially necessary for enhancement of research and eventual application in cryobiology. The advent of 3-dimensional printing offers unique opportunities for this process, given that the materials involved are suitable for use in cryogenic temperatures. We report herein that 3-D printing with polylactic acid (PLA) thermoplastic is ideally suited for cryobiology device development. Devices that are designed and standardized in open-source fashion can be electronically distributed and created locally on increasingly affordable 3-D printers, and can accelerate cryobiology findings and improve reproducibility of results...
December 2016: Cryobiology
https://www.readbyqxmd.com/read/27718757/growth-hormone-delivery-devices-current-features-and-potential-for-enhanced-treatment-adherence
#11
Tilman R Rohrer, Reiko Horikawa, Anne-Marie Kappelgaard
Adherence to daily growth hormone (GH) injections optimizes treatment benefit; however, adherence rates are sometimes poor. Reasons for poor adherence and persistence are multifaceted. GH injection devices are undergoing continual improvement to enhance adherence. Areas covered: This review evaluates published data on the evolution of GH injection devices to meet patients' needs and preferences, patients' perception of new devices and the projected impact of device developments on adherence. Published studies were identified through literature database searches including EMBASE and PubMed (January 1985-November 2015)...
November 4, 2016: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/27711488/observation-of-nanotwinning-and-room-temperature-ferromagnetism-in-sub-5-nm-bifeo3-nanoparticles-a-combined-experimental-and-theoretical-study
#12
Mandar M Shirolkar, Xiaolei Dong, Jieni Li, Shiliu Yin, Ming Li, Haiqian Wang
Particle size significantly affects the properties and therefore the potential applications of multiferroics. However, is there special particle size effect in BiFeO3, which has a spiral modulated spin structure? This is still under investigation for sub-5 nm BiFeO3. In this report, the structural, electronic and magnetic properties are investigated for chemically synthesized BiFeO3 nanoparticles with an average size of 3 nm. We observed nanotwinning features in the specific size regime of the nanoparticles (2-4 nm)...
September 14, 2016: Physical Chemistry Chemical Physics: PCCP
https://www.readbyqxmd.com/read/27710920/an-interview-with-arthur-j-coury-an-extensively-experienced-perspective-on-medical-device-development
#13
Myron Spector
No abstract text is available yet for this article.
October 6, 2016: Biomedical Materials
https://www.readbyqxmd.com/read/27708372/design-and-fabrication-of-high-performance-diamond-triple-gate-field-effect-transistors
#14
Jiangwei Liu, Hirotaka Ohsato, Xi Wang, Meiyong Liao, Yasuo Koide
The lack of large-area single-crystal diamond wafers has led us to downscale diamond electronic devices. Here, we design and fabricate a hydrogenated diamond (H-diamond) triple-gate metal-oxide-semiconductor field-effect transistor (MOSFET) to extend device downscaling and increase device output current. The device's electrical properties are compared with those of planar-type MOSFETs, which are fabricated simultaneously on the same substrate. The triple-gate MOSFET's output current (174.2 mA mm(-1)) is much higher than that of the planar-type device (45...
October 6, 2016: Scientific Reports
https://www.readbyqxmd.com/read/27707725/advances-in-technology-blood-sampling-at-depth
#15
Paul J Ponganis
A new automated blood sampler for seals is only the third such device developed for research with higher marine vertebrates.
October 5, 2016: American Journal of Physiology. Regulatory, Integrative and Comparative Physiology
https://www.readbyqxmd.com/read/27704776/controllable-laser-reduction-of-graphene-oxide-films-for-photoelectronic-applications
#16
Stanislav A Evlashin, Pavel Dyakonov, Roman Khmelnitsky, Sarkis Dagesyan, Andrey Klokov, Andrey Sharkov, Peter S Timashev, Svetlana Minaeva, Konstantin I Maslakov, Sergey Svyakhovskiy, Nikolay V Suetin
This article presents a new simple method of creating light absorbing carbon material for optical devices such as bolometers. A simple method of laser microstructuring of graphene oxide is used in order to create such material. The absorption values of more than 98% in the visible and more than 90% in the IR range are achieved. Moreover thermal properties of the films, such as temperature dependence and the thermal response of the samples are studied. The change in resistance with temperature is 13 Ohm K(-1), temperature coefficient of resistance (TCR) 0...
October 5, 2016: ACS Applied Materials & Interfaces
https://www.readbyqxmd.com/read/27669080/innovation-in-medicine-and-device-development-regulatory-review-and-use-of-clinical-advances
#17
Michael Rosenblatt, Marc M Boutin, Samuel R Nussbaum
No abstract text is available yet for this article.
October 25, 2016: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/27664403/evaluating-the-functionality-and-usability-of-two-novel-wheelchair-anti-rollback-devices-for-ramp-ascent-in-manual-wheelchair-users-with-spinal-cord-injury
#18
Susan L Deems-Dluhy, Chandrasekaran Jayaraman, Steve Green, Mark V Albert, Arun Jayaraman
BACKGROUND: Difficulty ascending ramps and inclines with a manual wheelchair adversely affects the everyday mobility and overall quality of life of manual wheelchair users. Currently, various anti-rollback devices are available to assist manual wheelchair users to ascend ramps and inclines. However, these devices have 2 main shortcomings: restriction to backward motion limiting recovery from an overturning wheelie, which is a safety concern; and difficulty in engaging/disengaging the device while on the ramp...
September 21, 2016: PM & R: the Journal of Injury, Function, and Rehabilitation
https://www.readbyqxmd.com/read/27658315/clinical-trials-registration-and-results-information-submission-final-rule
#19
(no author information available yet)
This final rule details the requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drug products (including biological products) and device products and for pediatric postmarket surveillances of a device product to ClinicalTrials.gov, the clinical trial registry and results data bank operated by the National Library of Medicine (NLM) of the National Institutes of Health (NIH). This rule provides for the expanded registry and results data bank specified in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) to help patients find trials for which they might be eligible, enhance the design of clinical trials and prevent duplication of unsuccessful or unsafe trials, improve the evidence base that informs clinical care, increase the efficiency of drug and device development processes, improve clinical research practice, and build public trust in clinical research...
September 21, 2016: Federal Register
https://www.readbyqxmd.com/read/27642163/restoration-of-eye-closure-in-facial-paralysis-using-implantable-electromagnetic-actuator
#20
Shaheen Hasmat, Nigel H Lovell, Gregg J Suaning, Tsu-Hui Hubert Low, Jonathan Clark
The most devastating outcome of facial nerve paralysis is the inability to completely close the eye as it can lead to corneal ulceration and loss of vision. Gravity-assisted eye closure with upper lid loading is commonly used; however it is limited in replicating physiological eye closure to adequately lubricate the cornea. Superior results can be obtained using more advanced reconstructive approaches, however they depend on nerve regrowth which may be unpredictable and prolonged. This report describes a novel technique for creating an active eye closure using an implantable actuator...
September 7, 2016: Journal of Plastic, Reconstructive & Aesthetic Surgery: JPRAS
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