Technology confidence in early stage development of medical devices

Innovation is a critical factor in ensuring commercial success within the area of medical technology. Biotechnology and Healthcare developments require huge financial and resource investment, in-depth research and clinical trials. Consequently, these developments involve a complex multidisciplinary structure, which is inherently full of risks and uncertainty. In this context, early technology assessment and 'proof of concept' is often sporadic and unstructured. Existing methodologies for managing the feasibility stage of medical device development are predominantly suited to the later phases of development and favour detail in optimisation, validation and regulatory approval. During these early phases, feasibility studies are normally conducted to establish whether technology is potentially viable. However, it is not clear how this technology viability is currently measured. This paper aims to redress this gap through the development of a technology confidence scale, as appropriate explicitly to the feasibility phase of medical device design. These guidelines were developed from analysis of three recent innovation studies within the medical device industry.

维生素B_(12)对萼花臂尾轮虫种群的影响

温度为15℃时,添加20,40,80和100μg/mL维生素B12后,萼花臂尾轮虫(Brachionuscalyciflorus)种群密度随时间增加而增长,其回归方程依次为:y=e(0.1757+0.2974x),y=4.6765x1.2079,y=7.7798x1.0175和y=e(0.6117+0.3469x),密度显著高于对照组(t=4.56,8.15,8.53和9.86;P<0.01)。对照组和添加组最大混交雌体百分率依次为57.69,76.09,73.81,60.00和45.15%,最大卵雌比依

固定化芽孢杆菌对鱼虾池亚硝酸盐的控制

广东省科技计划重点扶持项目 ( 2 0 0 3C5 0 10 5)

A comparison of 0°-0° and 45°-45° bridge-seeded, YBCO single grains

A variety of multiseeding techniques have been investigated over the past 20 yr in an attempt to enlarge bulk (RE)BCO superconducting samples fabricated by the top-seeded melt growth (TSMG) process for practical applications. Unfortunately, these studies have failed to establish whether technically useful values of trapped field can be achieved in multiseeded bulk samples. In this work specially designed, 0°-0° and 45°-45° bridge seeds of different lengths have been employed to produce improved alignment of the seeds during the TSMG process. The ability of these bridge-seeded samples to trap magnetic field, which is the key superconducting property for practical applications of bulk (RE)BCO, is compared for the samples seeded using 0°-0° and 45°-45° bridge seeds of different lengths. The grain boundaries produced by these bridge seeds are analyzed in detail, and the similarities and differences between the two bridge-seeding processes are discussed. © 2013 The American Ceramic Society.

Evaluation of the p-y method in the design of monopiles for offshore wind turbines

Monopile foundations, currently designed using the p-y method, are technically viable in supporting larger offshore wind turbines in waters to a depth of 30 m. The p-y method was developed to better understand the behavior of laterally loaded long slender piles required for the offshore oil and gas installations. The lateral load-deformation behavior of two monopiles, 5 and 7.5 m dia, installed in soft clays of varying undrained shear strength and stiffness, was studied. A combination of axial and lateral loads expected at an offshore wind farm location with a water depth of 30 m was used in the analysis. It was established that the Matlock (1970) p-y curves are too soft and under-estimate the ultimate soil reaction at all depths except at the monopile tip. At the pile tip, the base shear was not accounted for in the p-y curves, hence resulting in the over-estimation of the soil reaction. Consequently, the Matlock (1970) p-y formulation significantly underestimates the monopile ultimate lateral capacity. The use of the Matlock (1970) p-y method would result in over-conservative designs of monopiles for offshore wind turbines. This is an abstract of a paper presented at the Offshore Technology Conference (Houston, TX 5/6-9/2013).

Long-term changes of Copepoda community (1957-1996) in a subtropical Chinese lake stocked densely with planktivorous filter-feeding silver and bighead carp

In contrast to the relatively well documented impact of particulate-feeding fish on zooplankton communities, little attention has been devoted to the impact of filter-feeding fish. Filter-feeding silver and bighead carp are the most intensively cultured fish species in Asia and comprise much of the production of Chinese aquaculture. However, little information is known about the impact of either fish on the zooplankton community. Long-term changes in the Copepoda community (1957-1996) were studied at two sampling stations of a subtropical Chinese lake (Lake Donghu) dominated by silver and bighead carp. For both calanoids and cyclopoids, the littoral station (I) was much more resource profitable than the pelagic station (II). There has been a tremendous increase in the annual fish catch over the past 30 years due to the increased stocking with fingerlings of the two carp species. There was a notably higher fish density at Station I than at Station II. Cyclopoid abundance was notably higher at Station I than at Station II during the 1950s to the 1980s, while the reverse became true in the 1990s. This is probably because when fish abundance increased to an extremely high level, the impact of fish predation on the cyclopoids became more important than that of food resources at the littoral station. At both stations, cyclopoid abundance was relatively low in spite of the presence of abundant prey. Similarly, calanoid density did not differ significantly between the two stations in the 1950s and 1960s, but was significantly lower at Station I than at Station II during the 1980s and 1990s. Such changes are attributed to the gradient of fish predation between the stations and an increasing predation pressure by the fish. The increased fish predation also correlated with a shift in summer-dominant calanoids from larger species to smaller ones. In conclusion, the predaceous cyclopoids are affected by fish predation to a much lesser extent than the herbivorous calanoids, and therefore increased predation by filter-feeding fish results in a definite increase in the cyclopoid/calanoid ratio. Predation by filter-feeding fish has been a driving force in shaping the copepod community structure of Lake Donghu during the past decades.

Raman scattering of non-planar graphite: arched edges, polyhedral crystals, whiskers and cones

Planar graphite has been extensively studied by Raman scattering for years. A comparative Raman study of several different and less common non-planar graphitic materials is given here. New kinds of graphite whiskers and tubular graphite cones (synthetic and natural) have been introduced. Raman spectroscopy has been applied to the characterization of natural graphite crystal edge planes, an individual graphite whisker graphite polyhedral crystals and tubular graphite cones. Almost all of the observed Raman modes were assigned according to the selection rules and the double-resonance Raman mechanism. The polarization properties related to the structural features, the line shape of the first-order dispersive mode and its combination modes, the frequency variation of some modes in different carbon materials and other unique Raman spectral features are discussed here in detail.

室内海底沉积物热导率测量的原理与方法——以TK04热导率测量系统为例

沉积物热导率是计算海底热流的一个重要参数。文中以TK04热导率测量系统为