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https://www.readbyqxmd.com/read/28190507/best-practices-in-early-phase-medical-device-development-engineering-prototyping-and-the-beginnings-of-a-quality-management-system
#1
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/28178270/encouraging-entrepreneurship-in-university-labs-research-activities-research-outputs-and-early-doctorate-careers
#2
Michael Roach
This paper investigates how the encouragement of entrepreneurship within university research labs relates with research activities, research outputs, and early doctorate careers. Utilizing a panel survey of 6,840 science & engineering doctoral students at 39 R1 research universities, this study shows that entrepreneurship is widely encouraged across university research labs, ranging from 54% in biomedical engineering to 18% in particle physics, while only a small share of labs openly discourage entrepreneurship, from approximately 3% in engineering to approximately 12% in the life sciences...
2017: PloS One
https://www.readbyqxmd.com/read/28178241/erratum-innovative-academic-startups-2016
#3
Brady Huggett
No abstract text is available yet for this article.
February 8, 2017: Nature Biotechnology
https://www.readbyqxmd.com/read/28167491/simplified-3d-protocol-capable-of-generating-early-cortical-neuroepithelium
#4
Dwayne B Holmes, Vivi M Heine
Here we report a 3D cerebellar differentiation protocol with quick startup method, defined medium, and no special materials or handling requirements. Three fibroblast growth factors (FGF2, 4, and 8) were used for cerebellar patterning and smoothened agonist (SAG) for granule cell development. After 35 days, differentiation products exhibited similar structures and neuronal markers reported in prior "organoid" and "spheroid" protocols. This included cells positive for KIRREL2 (a marker of early cerebellar neuroepithelium) and ZIC1 (a marker for granule cells)...
February 6, 2017: Biology Open
https://www.readbyqxmd.com/read/28153598/a-demonstration-of-mixing-robustness-in-a-direct-compression-continuous-manufacturing-process
#5
Wyatt J Roth, Ahmad Almaya, Timothy T Kramer, Jeffrey D Hofer
The purpose of this work was to assess the impact of continuous mixing on tablet critical quality attributes (CQAs) manufactured using a continuous, direct compression process. A 9-run design of experiments (DoE) that bracketed the range of commercially relevant mixer speeds, mixer orientations, and mass flow rates was executed using a formulation containing a cohesive drug substance at relatively low drug load. Drug substance dispensed concentration using loss-in-weight feeders was within 1% of target for each experiment with 30-s mass flow relative standard deviation values of 3...
January 30, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28129140/committing-to-memory-memory-prosthetics-show-promise-in-helping-those-with-neurodegenerative-disorders
#6
Michele Solis
Cell phone chimes, sticky notes, even the proverbial string around a finger-these timehonored external cues help guard against our inevitable memory lapses. But some internal help to the brain itself may be on the way in the form of what's being called memory prosthetics. Once considered to be on the fringes of neuroscience, the idea of adding hardware to the brain to help with memory has gathered steam. In 2014, the U.S. Defense Advanced Research Projects Agency (DARPA) made a US$30 million investment in memory prosthetic research as part of the Obama administration's Brain Research through Advancing Innovative Neurotechnologies initiative...
January 2017: IEEE Pulse
https://www.readbyqxmd.com/read/28110229/aerobic-granular-sludge-inoculated-microbial-fuel-cells-for-enhanced-epoxy-reactive-diluent-wastewater-treatment
#7
Kai Cheng, Jingping Hu, Huijie Hou, Bingchuan Liu, Qin Chen, Keliang Pan, Wenhong Pu, Jiakuan Yang, Xu Wu, Changzhu Yang
Microbial consortiums aggregated on the anode surface of microbial fuel cells (MFCs) are critical factors for electricity generation as well as biodegradation efficiencies of organic compounds. Here in this study, aerobic granular sludge (AGS) was assembled on the surface of the MFC anode to form an AGS-MFC system with superior performance on epoxy reactive diluent (ERD) wastewater treatment. AGS-MFCs successfully shortened the startup time from 13d to 7d compared to the ones inoculated with domestic wastewater...
April 2017: Bioresource Technology
https://www.readbyqxmd.com/read/28104698/periconceptional-maternal-one-carbon-biomarkers-are-associated-with-embryonic-development-according-to-the-carnegie-stages
#8
F Parisi, M Rousian, A H J Koning, S P Willemsen, I Cetin, R P M Steegers-Theunissen
STUDY QUESTION: Is periconceptional maternal one-carbon (I-C) metabolism associated with embryonic morphological development in non-malformed ongoing pregnancies? SUMMARY ANSWER: Serum vitamin B12, red blood cell (RBC) folate and plasma total homocysteine (tHcy) are associated with embryonic development according to the Carnegie stages. WHAT IS KNOWN ALREADY: Derangements in maternal I-C metabolism affect reproductive and pregnancy outcomes, as well as future health of the offspring...
January 18, 2017: Human Reproduction
https://www.readbyqxmd.com/read/28104552/a-novel-salt-tolerant-bacterial-consortium-for-biodegradation-of-saline-and-recalcitrant-petrochemical-wastewater
#9
Mehdi Ahmadi, Sahand Jorfi, Raheleh Kujlu, Shokouh Ghafari, Reza Darvishi Cheshmeh Soltani, Nematollah Jaafarzadeh Haghighifard
Treatment of a saline petrochemical wastewater with BOD5/COD ratio of less than 0.1 was investigated using a consortium consisted of three isolated salt-tolerant bacteria namely, Kocuria turfanesis, Halomonas alkaliphila and Pseudomonas balearica. Selected bacteria were isolated from petrochemical wastewater containing mineral salt mediums of 3% salinity. A lab-scale activated sludge bioreactor was used for startup in batch mode operation and after obtaining the MLSS concentration of about 3000 mg/L, the operation was changed to continuous flow mode to determine the biokinetic coefficients under different organic loading rates of 0...
January 16, 2017: Journal of Environmental Management
https://www.readbyqxmd.com/read/28072790/innovative-academic-startups-2016
#10
Brady Huggett
No abstract text is available yet for this article.
January 10, 2017: Nature Biotechnology
https://www.readbyqxmd.com/read/28069357/control-strategies-for-drug-product-continuous-direct-compression-state-of-control-product-collection-strategies-and-startup-shutdown-operations-for-the-production-of-clinical-trial-materials-and-commercial-products
#11
Ahmad Almaya, Lawrence De Belder, Robert Meyer, Karthik Nagapudi, Hung-Ren Homer Lin, Ian Leavesley, Jayanthy Jayanth, Gurjit Bajwa, James DiNunzio, Anthony Tantuccio, Dan Blackwood, Admassu Abebe
Continuous manufacturing (CM) has emerged in the pharmaceutical industry as a paradigm shift with significant advantages related to cost, efficiency, flexibility, and higher assurance of quality. The inherent differences from batch processes justify examining the CM control strategy more holistically. This article describes the current thinking for the control and implementation of CM, using the example of a direct compression process and taking into consideration the ICH Q10 definition of "state of control" and process validation requirements...
January 6, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28061940/startup-of-the-anammox-process-in-a-membrane-bioreactor-anmbr-from-conventional-activated-sludge
#12
P Gutwiński, G Cema, A Ziembińska-Buczyńska, J Surmacz-Górska, M Osadnik
  In this study, a laboratory-scale anammox process in a membrane bioreactor (AnMBR) was used to startup the anaerobic ammonium oxidation (anammox) process from conventional activated sludge. Stable operation was achieved after 125 days. From that time, nitrogen load was gradually increased. After six months, the average nitrogen removal efficiency exceeded 80%. The highest obtained special anammox activity (SAA) achieved was 0.17 g (<inline-graphic xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="02268-ilm01...
December 1, 2016: Water Environment Research: a Research Publication of the Water Environment Federation
https://www.readbyqxmd.com/read/28052537/hydrogen-oxidation-selective-electrocatalysis-by-fine-tuning-of-pt-ensemble-sites-to-enhance-the-durability-of-automotive-fuel-cells
#13
Su-Won Yun, Shin-Ae Park, Tae-June Kim, Jun-Hyuk Kim, Gi-Woong Pak, Yong-Tae Kim
A simple, inexpensive approach is proposed for enhancing the durability of automotive proton exchange membrane fuel cells by selective promotion of the hydrogen oxidation reaction (HOR) and suppression of the oxygen reduction reaction (ORR) at the anode in startup/shutdown events. Dodecanethiol forms a self-assembled monolayer (SAM) on the surface of Pt particles, thus decreasing the number of Pt ensemble sites. Interestingly, by controlling the dodecanethiol concentration during SAM formation, the number of ensemble sites can be precisely optimized such that it is sufficient for the HOR but insufficient for the ORR...
January 4, 2017: ChemSusChem
https://www.readbyqxmd.com/read/28046468/su-f-t-583-comparison-of-ebt3-radiochromic-film-densitometry-with-narrow-bandwidth-led-source-in-point-slot-and-full-aperture-geometries
#14
K Jordan
PURPOSE: Film densitometers optimized for radiochromic EBT3 film are not commercially available and flatbed document scanners are limited by broad spectral overlap of the red green and blue channels and polarization effects. Non-polarized, narrow bandwith, intensity stabilized light emitting diode (LED) light sources were constructed and transmission measurements compared for point, slot and full aperture geometries. METHODS: LED's with 10 nm bandwidths were focused to 1 mm spots for point scanning...
June 2016: Medical Physics
https://www.readbyqxmd.com/read/28028322/surviving-and-thriving-your-first-year-in-private-practice
#15
REVIEW
Elizabeth Falk Schwab
Taking the leap toward a career as a private practice owner is daunting. When in the initial stages of starting a private practice, I searched for current advice from an audiologist who had recently confronted the same challenges I was about to face. Because of the limited information available, I documented my process in hopes of providing an overview of my startup experience to help others. Included is a timeline of startup tasks and a sample budget to use as a reference. In this chapter, I share my experiences, both the positives and the negatives, and tips with the goal of helping you survive and thrive in your first year in private practice...
November 2016: Seminars in Hearing
https://www.readbyqxmd.com/read/27995771/one-pot-dopamine-self-polymerization-induced-pd-nanoparticles-anchored-on-n-doped-c-toward-electro-catalyzing-the-methanol-oxidation-reaction-with-higher-activity-and-durability
#16
Xin Li, Xiangheng Niu, Wenchi Zhang, Yanfang He, Jianming Pan, Yongsheng Yan, Fengxian Qiu
Exploration of advanced electrocatalysts to promote the sluggish methanol oxidation reaction (MOR) is of vital importance for developing high-efficiency and low-cost direct methanol fuel cells (DMFCs). Here highly dispersed palladium nanoparticles (Pd NPs) anchored on a nitrogen-doped carbon support are fabricated using a facile one-pot dopamine self-polymerization mediated redox strategy, in which dopamine not only acts as a moderate reductant to induce the formation of Pd NPs during self-polymerization but also becomes the precursor of the nitrogen-doped carbon support for Pd loading...
December 19, 2016: ChemSusChem
https://www.readbyqxmd.com/read/27990654/measurement-of-electroosmotic-and-electrophoretic-velocities-using-pulsed-and-sinusoidal-electric-fields
#17
Samir H Sadek, Francisco Pimenta, Fernando T Pinho, Manuel A Alves
In this work, we explore two methods to simultaneously measure the electroosmotic mobility in microchannels and the electrophoretic mobility of micron-sized tracer particles. The first method is based on imposing a pulsed electric field, which allows to isolate electrophoresis and electroosmosis at the startup and shutdown of the pulse, respectively. In the second method, a sinusoidal electric field is generated and the mobilities are found by minimizing the difference between the measured velocity of tracer particles and the velocity computed from an analytical expression...
December 19, 2016: Electrophoresis
https://www.readbyqxmd.com/read/27987931/rheological-properties-of-nanocrystalline-cellulose-suspensions
#18
Yang Chen, Chunjiang Xu, Jing Huang, Defeng Wu, Qiaolian Lv
Rheological behavior, including linear and nonlinear, as well as transient rheology of nanocrystalline cellulose (NCC) suspensions was studied in this work. Two kinds of polymer solutions, aqueous poly(vinyl alcohol) (PVA) with flexible chain structure and aqueous carboxymethyl cellulose (CMC) with semi-rigid chain structure, were used as the suspension media to further explore the role that the interactions among NCC and polymers played during shear flow. The results reveal that NCC has lower values of percolation threshold in the PVA solution than in the CMC one during small amplitude oscillatory shear (SAOS) flow because the flexible PVA chain has higher adsorbed level onto NCC particles than the negatively charged semi-rigid CMC chain, which is further confirmed by the Fourier transformed infrared (FT-IR) spectroscopy tests...
February 10, 2017: Carbohydrate Polymers
https://www.readbyqxmd.com/read/27925443/graphene-fe3-o4-nanocomposites-as-efficient-anodes-to-boost-the-lifetime-and-current-output-of-microbial-fuel-cells
#19
Rong-Bin Song, Cui-E Zhao, Pan-Pan Gai, Dan Guo, Li-Ping Jiang, Qichun Zhang, Jian-Rong Zhang, Jun-Jie Zhu
The enhancement of microbial activity and electrocatalysis through the design of new anode materials is essential to develop microbial fuel cells (MFCs) with longer lifetimes and higher output. In this research, a novel anode material, graphene/Fe3 O4 (G/Fe3 O4 ) composite, has been designed for Shewanella-inoculated MFCs. Because the Shewanella species could bind to Fe3 O4 with high affinity and their growth could be supported by Fe3 O4 , the bacterial cells attached quickly onto the anode surface and their long-term activity improved...
December 7, 2016: Chemistry, An Asian Journal
https://www.readbyqxmd.com/read/27910613/feasibility-of-line-ratio-spectroscopy-on-helium-and-neon-as-edge-diagnostic-tool-for-wendelstein-7-x
#20
T Barbui, M Krychowiak, R König, O Schmitz, J M Muñoz Burgos, B Schweer, A Terra
A beam emission spectroscopy system on thermal helium (He) and neon (Ne) has been set up at Wendelstein 7-X to measure edge electron temperature and density profiles utilizing the line-ratio technique or its extension by the analysis of absolutely calibrated line emissions. The setup for a first systematic test of these techniques of quantitative atomic spectroscopy in the limiter startup phase (OP1.1) is reported together with first measured profiles. This setup and the first results are an important test for developing the technique for the upcoming high density, low temperature island divertor regime...
November 2016: Review of Scientific Instruments
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