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

发状念珠藻对盐胁迫的响应

探讨了发状念珠藻 (NostocflagelliformeBorn etFlah )对盐胁迫的耐受适应机制 ,采用含不同浓度NaCl(0、0 1、0 2、0 4、0 6、0 8、1 0mol/L)的BG110 培养液处理具有正常生理活性的丝状体 ,2 5± 0 5℃ ,4 0 μmol/m2 /s下照光培养12h ,测定藻体光合作用、呼吸作用等生理活性以及体内一些物质的含量 ,结果表明 :随培养液中NaCl浓度的升高藻体光合作用、呼吸作用以及PSⅡ活性 (Fv/Fm)降低 ;质膜透性不断增大 ,丙二醛含量

评价湖泊富营养化的一个综合模型(英文)

湖泊富营养化的评价 ,即确定水体的状态属性 ,实际上是一个将定性问题定量化的多变量的综合决策过程 ,因此 ,对湖泊的富营养化程度进行评价应以综合评价为主 .在综述国内外若干综合评价方法的基础上 ,指出营养状态指数 (TSI)法应可作为湖泊富营养化评价的主要方法 ,因其可对湖泊的营养状态进行连续的数值化分级 ,从而为富营养化机理的定量研究提供坚实基础 .采用层次分析 (AHP)法确定综合评价指标中的权重分配 ,构建一综合评价模型 :TSI =W (Chla)×TSI(Chla) +W (Sd)×TSI(Sd

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.

Ni silicide nanowires analysis by atom probe tomography

The Ni silicide formed at low temperature on Si nanowire has been analyzed by atom probe tomography (APT) thanks to a special technique for sample preparation. A method of preparation has been developed using the focused ion beam (FIB) for the APT analysis of nanowires (NWs). This method allow for the measurement of the radial distribution when a NW is cut, buried in a protective metal matrix, and finally mounted on the APT support post. This method was used for phosphorous doped Si NWs with or without a silicide shell, and allows obtaining the concentration and distribution of chemical elements in three-dimensions (3D) in the radial direction of the NWs. The distribution of atoms in the NWs has been measured including dopants and Au contamination. These measurements show that δ-Ni2Si phase is formed on Si NW, Au is found as cluster at the Ni/δ-Ni2Si interface and P is segregated at the δ-Ni2Si/ Si NW interface. The results obtained on NWs after silicidation were compared with the silicide on the Si substrate, showing that the same silicide phase δ-Ni2Si formed in both cases (NWs and substrate). © 2013 Elsevier B.V. All rights reserved.

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.

Changes in the structure of a zooplankton community during a Ceratium (dinoflagellate) bloom in a eutrophic fishless pond

The community structure of zooplankton was studied in a eutrophic, fishless Japanese pond. The ecosystem was dominated by a dinoflagellate, Ceratium hirundinella, two filter-feeding cladocerans, Daphnia rosea and Ceriodaphnia reticulata, and an invertebrate predator, the dipteran Chaoborus flavicans. The midsummer zooplankton community showed a large change in species composition (the Daphnia population crashed) when a heavy Ceratium bloom occurred. It is shown that (i) the rapid density decline of D.rosea in mid-May was mainly caused by a shortage of edible phytoplankton, which was facilitated by the rapid increase in C.hirundinella abundance; (ii) the low density of D.rosea in June-July was considered to be mainly caused by the blooming of Ceratium hirundinella (which may inhibit the feeding process of D.rosea), while predation by C.flavicans larvae, the changing temperature, the interspecific competition and the scarcity of edible algae were not judged to be important; (iii) the high summer biomass of the planktonic C.flavicans larvae was maintained by the bloom of C.hirundinella, because >90% of the crop contents of C.flavicans larvae were C.hirundinella during this period. The present study indicates that the large-sized cells or colonies of phytoplankton are not only inedible by most cladocerans, but the selective effect of the blooming of these algae can also influence the composition and dominance of the zooplankton community, especially for the filter-feeding Cladocera, in a similar way as the selective predation by planktivorous fish. The large-sized phytoplankton can also be an important alternative food for ominivorous invertebrate predators such as Chaoborus larvae, and thus may affect the interactions between these predators and their zooplanktonic prey. In this way, such phytoplankton may play a very important role in regulating the dynamics of the aquatic food web, and become a driving force in shaping the community structure of zooplankton.

水肥处理对黄瓜土壤养分、酶及微生物多样性的影响

以津优1号黄瓜为试材,设3个土壤相对含水量水平(50%～60%、70%～80%、90%～100%)和2个肥料追施量(600kgN·hm-2和420kgP2O5·hm-2,420kgN.hm-2和294kgP2O5·hm-2)处理,研究了不同水肥供应对日光温室黄瓜土壤养分、酶活性及微生物多样性的影响.结果表明:土壤中NH4+-N含量随施肥量的增加而提高,随土壤相对含水量的增加而降低;水肥供给的增加有利于提高土壤中速效磷含量和蔗糖酶活性;肥料增加使土壤中蛋白酶活性降低,而水分降低使土壤中脲酶活性提高.土壤中微生物多样性与土壤中养分含量无显著相关性,与土壤脲酶活性呈显著正相关,与蔗糖酶活性呈显著负相关.土壤相对含水量70%～80%、氮肥追施量600kgN·hm-2和420kgP2O5.hm-2处理的土壤养分含量、蔗糖酶、磷酸酶和脲酶活性较高,且土壤中微生物多样性和均匀度显著高于其他处理,土壤生产潜力最优.