Designing for validation of medical devices and equipment

Validation is important in the design, development and production of medical devices since effective and appropriate validation plays a vital role in defining the success of a product in both technical and economic terms. Regulations and quality standards lay out the requirements for product validation, but it is left to each individual manufacturer to establish and maintain their own validation procedures. More recently, there has also been a change of emphasis in the regulations and standards that encourage the integration of validation into the development process. However, this poses particular challenges to the manufacturer since there is a distinct lack of guidance to assist this integration. This workbook provides the first real guidance on good design practices for medical device development. It has been developed through extensive consultation with device manufacturers and analysis of regulatory requirements. The approach is intended to assist manufacturers in meeting the new regulations.

Direct growth of horizontally aligned carbon nanotubes between electrodes and its application to field-effect transistors

This paper presents direct growth of horizontally aligned carbon nanotubes (CNTs) between two predefined various inter-spacing up to tens of microns of electrodes (pads) and its use as CNT field-effect transistors (CNT-FETs). The catalytic metals were prepared, consisting of iron (Fe), aluminum (Al) and platinum (Pt) triple layers, on the thermal silicon oxide substrate (Pt/Al/Fe/SiO2). Scanning electron microscopy measurements of CNT-FETs from the as-grown samples showed that over 80% of the nanotubes are grown across the catalytic electrodes. Moreover, the number of CNTs across the catalytic electrodes is roughly controllable by adjusting the growth condition. The Al, as the upper layer on Fe electrode, not only plays a role as a barrier to prevent vertical growth but also serves as a porous medium that helps in forming smaller nano-sized Fe particles which would be necessary for lateral growth of CNTs. Back-gate field effect transistors were demonstrated with the laterally aligned CNTs. The on/off ratios in all the measured devices are lower than 100 due to the drain leakage current. ©2010 IEEE.

Spray visualisation and acoustic analysis in a gas-turbine type burner

This paper presents the characterisation of self-excited oscillations in a kerosene burner. The combustion instability exhibits two different modes and frequencies depending on the air flow rate. Experimental results reveal the influence of the spray to shift between these two modes. Pressure and heat release fluctuations have been measured simultaneously and the flame transfer function has been calculated from these measurements. The Mie scattering technique has been used to record spray fluctuations in reacting conditions with a high speed camera. Innovative image processing has enabled us to obtain fluctuations of the Mie scattered light from the spray as a temporal signal acquired simultaneously with pressure fluctuations. This has been used to determine a transfer function relating the image intensity and hence the spray fluctuations to changes in air velocity. This function has identified the different role the spray plays in the two modes of instability. At low air flow rates, the spray responds to an unsteady air flow rate and the time varying spray characteristics lead to unsteady combustion. At higher air flow rates, effective evaporation means that the spray dynamics are less important, leading to a different flame transfer function and frequency of self-excited oscillation. In conclusion, the combustion instabilities observed are closely related with the fluctuations of the spray motion and evaporation.

Influence of a bow of finite width on bowed string motion: numerical modelling and experimental evidence

An enhanced physical model of the bowed string presented previously [1] is explored. It takes into account: the width of the bow, the angular motion of the string, bow-hair elasticity and string bending stiffness. The results of an analytical investigation of a model system - an infinite string sticking to a bow of finite width and driven on one side of the bow - are compared with experimental results published by Cremer [2] and reinterpreted here. Comparison shows that both the width of the bow and the bow-hair elasticity have a large impact on the reflection and transmission behaviour. In general, bending stiffness plays a minor role. Furthermore, a method of numerical simulation of the stiff string bowed with a bow of finite width is presented along with some preliminary results.

Feedback control and the arrow of time

The purpose of this paper is to highlight the central role that the time asymmetry of stability plays in feedback control. We show that this provides a new perspective on the use of doubly-infinite or semi-infinite time axes for signal spaces in control theory. We then focus on the implication of this time asymmetry in modeling uncertainty, regulation and robust control. We point out that modeling uncertainty and the ease of control depend critically on the direction of time. We finally discuss the relationship of this control-based time arrow with the well-known arrows of time in physics. © 2008 IEEE.

Ultrastructural mechanical and material characterization of fossilized bone

Bone plays a key role in the paleontological and archeological records and can provide insight into the biology, ecology and the environment of ancient vertebrates. Examination of bone at the tissue level reveals a definitive relationship between nanomechanical properties and the local organic content, mineral content, and microstructural organization. However, it is unclear as to how these properties change following fossilization, or diagenesis, where the organic phase is rapidly removed and the remaining mineral phase is reinforced by the deposition of apatites, calcites, and other minerals. While the process of diagenesis is poorly understood, its outcome clearly results in the potential for dramatic alteration of the mechanical response of biological tissues. In this study, fossilized specimens of mammalian long bones, collected from Colorado and Wyoming, were studied for mechanical variations. Nanoindentation performed in both longitudinal and transverse directions revealed preservation of bone's natural anisotropy as transverse modulus values were consistently smaller than longitudinal values. Additionally, modulus values of fossilized bone from 35.0 to 89.1 GPa increased linearly with logarithm of the sample's age. Future studies will aim to clarify what mechanical and material elements of bone are retained during diagenesis as bone becomes part of the geologic milieu. © 2007 Materials Research Society.

Measurement of liquid film thickness by optical fluorescence and its application to an oscillating piston positive displacement flowmeter

The movement of the circular piston in an oscillating piston positive displacement flowmeter is important in understanding the operation of the flowmeter, and the leakage of liquid past the piston plays a key role in the performance of the meter. The clearances between the piston and the chamber are small, typically less than 60 νm. In order to measure this film thickness a fluorescent dye was added to the water passing through the meter, which was illuminated with UV light. Visible light images were captured with a digital camera and analysed to give a measure of the film thickness with an uncertainty of less than 7%. It is known that this method lacks precision unless careful calibration is undertaken. Methods to achieve this are discussed in the paper. The grey level values for a range of film thicknesses were calibrated in situ with six dye concentrations to select the most appropriate one for the range of liquid film thickness. Data obtained for the oscillating piston flowmeter demonstrate the value of the fluorescence technique. The method is useful, inexpensive and straightforward and can be extended to other applications where measurement of liquid film thickness is required. © 2011 IOP Publishing Ltd.

External corporate venture capital investment: Towards a framework for capturing and measuring strategic value

This paper presents the initial results of on-going research in the field of external Corporate Venture Capital (CVC) investments, i.e. equity investments of large corporations in entrepreneurial ventures which originated outside the corporation. The research is motivated by the fact that external CVC plays an increasingly important role within the strategy of corporations. Driven by a general trend towards a more open approach to innovation, companies see particular value in external corporate venturing as a tool to gain, for example, access to complementary technologies and a general window on technology developments. The review of literature in the field of external corporate venturing clearly reveals that theoretical gaps exist in understanding mechanisms for capturing value and measurements of this value. To help close these gaps, the research addresses the underlying question "How do corporations and start-ups capture and measure strategic value through external CVC investments" by using embedded, multiple case studies. Following an initial set of case studies, steps towards the development of a framework for capturing and measuring strategic value from CVC investments are outlined within this paper and the resulting preliminary framework is presented. The paper closes with an outlook on ongoing and future research steps. © 2009 PICMET.

A Physical Interpretation of Stagnation Pressure and Enthalpy Changes in Unsteady Flow

This paper provides a physical interpretation of the mechanism of stagnation enthalpy and stagnation pressure changes in turbomachines due to unsteady flow, the agency for all work transfer between a turbomachine and an inviscid fluid. Examples are first given to illustrate the direct link between the time variation of static pressure seen by a given fluid particle and the rate of change of stagnation enthalpy for that particle. These include absolute stagnation temperature rises in turbine rotor tip leakage flow, wake transport through downstream blade rows, and effects of wake phasing on compressor work input. Fluid dynamic situations are then constructed to explain the effect of unsteadiness, including a physical interpretation of how stagnation pressure variations are created by temporal variations in static pressure; in this it is shown that the unsteady static pressure plays the role of a time-dependent body force potential. It is further shown that when the unsteadiness is due to a spatial nonuniformity translating at constant speed, as in a turbomachine, the unsteady pressure variation can be viewed as a local power input per unit mass from this body force to the fluid particle instantaneously at that point. © 2012 American Society of Mechanical Engineers.

Alternating current loss of second-generation high-temperature superconducting coils with magnetic and non-magnetic substrate

It is widely believed that the second-generation high-temperature superconducting (2G HTS) tapes with magnetic substrates suffer higher transport loss compared to those with non-magnetic substrates. To test this, we prepared two identical coils with magnetic and non-magnetic substrates, respectively. The experimental result was rather surprising that they generated roughly the same amount of transport loss. We used finite element method to understand this result. It is found that, unlike in the single tape where the magnetic field-dependent critical current characteristic can be neglected and the effect of magnetic substrate dominates, the magnetic field-dependent critical current characteristic of 2G tape plays as an equally important role as magnetic substrate in terms of HTS coils. © 2012 American Institute of Physics.

A comprehensive study of lysozyme adsorption using dual polarization interferometry and quartz crystal microbalance with dissipation.

Protein adsorption plays a crucial role in biomaterial surface science as it is directly linked to the biocompatibility of artificial biomaterial devices. Here, elucidation of protein adsorption mechanism is effected using dual polarization interferometry and a quartz crystal microbalance to characterize lysozyme layer properties on a silica surface at different coverage values. Lysozyme is observed to adsorb from sparse monolayer to multilayer coverage. At low coverage an irreversibly adsorbed layer is formed with slight deformation consistent with side-on orientation. At higher coverage values dynamic re-orientation effects are observed which lead to monolayer surface coverages of 2-3 ng/mm² corresponding to edge-on or/and end-on orientations. These monolayer thickness values ranged between 3 and 4.5 nm with a protein density value of 0.60 g/mL and with 50 wt% solvent mass. Further increase of coverage results formation of a multilayer structure. Using the hydration content and other physical layer properties a tentative model lysozyme adsorption is proposed.

A comprehensive study of lysozyme adsorption using dual polarization interferometry and quartz crystal microbalance with dissipation

Protein adsorption plays a crucial role in biomaterial surface science as it is directly linked to the biocompatibility of artificial biomaterial devices. Here, elucidation of protein adsorption mechanism is effected using dual polarization interferometry and a quartz crystal microbalance to characterize lysozyme layer properties on a silica surface at different coverage values. Lysozyme is observed to adsorb from sparse monolayer to multilayer coverage. At low coverage an irreversibly adsorbed layer is formed with slight deformation consistent with side-on orientation. At higher coverage values dynamic re-orientation effects are observed which lead to monolayer surface coverages of 2-3 ng/mm2 corresponding to edge-on or/and end-on orientations. These monolayer thickness values ranged between 3 and 4.5 nm with a protein density value of 0.60 g/mL and with 50 wt% solvent mass. Further increase of coverage results formation of a multilayer structure. Using the hydration content and other physical layer properties a tentative model lysozyme adsorption is proposed. © 2012 Elsevier Ltd.

New application of temperature-dependent modelling of high temperature superconductors: Quench propagation and pulse magnetization

We present temperature-dependent modeling of high-temperature superconductors (HTS) to understand HTS electromagnetic phenomena where temperature fluctuation plays a nontrivial role. Thermal physics is introduced into the well-developed H-formulation model, and the effect of temperature-dependent parameters is considered. Based on the model, we perform extensive studies on two important HTS applications: quench propagation and pulse magnetization. A micrometer-scale quench model of HTS coil is developed, which can be used to estimate minimum quench energy and normal zone propagation velocity inside the coil. In addition, we study the influence of inhomogeneity of HTS bulk during pulse magnetization. We demonstrate how the inhomogeneous distribution of critical current inside the bulk results in varying degrees of heat dissipation and uniformity of final trapped field. The temperature- dependent model is proven to be a powerful tool to study the thermally coupled electromagnetic phenomena of HTS. © 2012 American Institute of Physics.

Stiffness and strength of tridimensional periodic lattices

This paper presents a method for the linear analysis of the stiffness and strength of open and closed cell lattices with arbitrary topology. The method hinges on a multiscale approach that separates the analysis of the lattice in two scales. At the macroscopic level, the lattice is considered as a uniform material; at the microscopic scale, on the other hand, the cell microstructure is modelled in detail by means of an in-house finite element solver. The method allows determine the macroscopic stiffness, the internal forces in the edges and walls of the lattice, as well as the global periodic buckling loads, along with their buckling modes. Four cube-based lattices and nine cell topologies derived by Archimedean polyhedra are studied. Several of them are characterized here for the first time with a particular attention on the role that the cell wall plays on the stiffness and strength properties. The method, automated in a computational routine, has been used to develop material property charts that help to gain insight into the performance of the lattices under investigation. © 2012 Elsevier B.V.

Magnetic properties and anisotropy of orthorhombic DyMnO3 single crystal

An orthorhombic DyMnO3 single crystal has been studied in magnetic fields up to 14 T and between 3 K and room temperature. The field dependent ordering temperature of Dy moments is deduced. The paramagnetic Curie Weiss behavior is related mainly to the Dy3+sublattice whereas the Mn sublattice contribution plays a secondary role. DC magnetization measurements show marked anisotropic features, related to the anisotropic structure of a cubic system stretched along a body diagonal, with a magnetic easy axis parallel to the crystallographic b axis. A temperature and field dependent spin flop transition is observed below 9 K, when relatively weak magnetocrystalline anisotropy is overcome by magnetic fields up to 1.6 T. © 2013 Elsevier B.V.