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.

Design and selection tools for sports equipment

This report presents work from the first nine month of a project investigating design methodologies and selection tools to promote innovations in sports equipment. Particular consideration is given to product design improvements and new market adoption of advanced materials and processes. Our aim is to couple appropriately similar technologies so as to provide a method of transfer between sports equipment designs. We would like to make barriers between isolated sports equipment markets more transparent without releasing proprietary information. A brief history of sports equipment design is included; issues particularly relevant to material and process technologies are outlined for sports equipment. A start has been made on a software program to express most of this information in a concise and accessible format. The methodology is reviewed with some industrial case studies. There is a need for further research to extend and address the design issues raised in this document; a suggested research programme is attached.

Testing the performance and feasibility of Bluetooth communications in pervasive systems

Smart and mobile environments require seamless connections. However, due to the frequent process of ''discovery'' and disconnection of mobile devices while data interchange is happening, wireless connections are often interrupted. To minimize this drawback, a protocol that enables an easy and fast synchronization is crucial. Bearing this in mind, Bluetooth technology appears to be a suitable solution to carry on such connections due to the discovery and pairing capabilities it provides. Nonetheless, the time and energy spent when several devices are being discovered and used at the same time still needs to be managed properly. It is essential that this process of discovery takes as little time and energy as possible. In addition to this, it is believed that the performance of the communications is not constant when the transmission speeds and throughput increase, but this has not been proved formally. Therefore, the purpose of this project is twofold: Firstly, to design and build a framework-system capable of performing controlled Bluetooth device discovery, pairing and communications. Secondly, to analyze and test the scalability and performance of the \emph{classic} Bluetooth standard under different scenarios and with various sensors and devices using the framework developed. To achieve the first goal, a generic Bluetooth platform will be used to control the test conditions and to form a ubiquitous wireless system connected to an Android Smartphone. For the latter goal, various stress-tests will be carried on to measure the consumption rate of battery life as well as the quality of the communications between the devices involved.

A small arc-heated plasma testing facility for thermal protection materials

Experimental research on a 150 kW arc-heated plasma testing facility was conducted. Stable plasma jets with different gas compositions, temperatures and velocities were obtained at chamber pressure between 400 Pa – 100 kPa. Stagnation ablation experiments were conducted on samples of typical super alloys used for thermal protection systems. The microstructure and hardness of alloys before and after ablation were compared.

The nutritional status of pre-school children, Kainji Lake communities, Nigeria: a follow-up survey

This survey was carried out to provide the Kainji Lake Fisheries Promotion Project (KLFPP), whose overall goal is the improvement of the standard of living of fishing communities around Kainji Lake, Nigeria, managing the fisheries on a sustainable basis, with follow-up data for long-term monitoring and evaluation of the overall project goal. A similar survey, conducted in 1996, provided the baseline against which data from the current survey was evaluated. In a cross-sectional survey, anthropometric data was collected from 576 children aged 3-60 months in 282 fisherfolk households around the southern sector of Kainji Lake, Nigeria. In addition, data was collected on the nutritional status and fertility of the mothers, vaccination coverage of children and child survival indicators. For control purposes, 374 children and 181 mothers from non-fishing households around Kainji Lake were likewise covered by the survey. A standardised questionnaire was used to collect relevant data, while anthropometric measurements were made using appropriate equipment. Data compilation and analysis was carried out with a specially designed Microsoft Access application, using NCHS reference data for the analysis of anthropometric measurements. Statistical significance testing was done using EPI-INFO" software. The results of the follow-up survey indicate a slight increase in the percentage of stunted pre-school children in fishing households around Kainji Lake, from 40% in 1996 to 41% in 1999. This increase is however not statistically significant (p= 0.704). Over the same period, the percentage of stunted children in non-fishing households increased from 37% to 39% (p= 0.540), which is also not statistically significant. Likewise, there were no statistically significant differences between the 1996 and 1999 results for the prevalence of either wasted or underweight children in fishing households. The same applies to children from non-fishing households. In addition, vaccination coverage remains very low while infant and child mortality rates continue to be extremely high with about 1 in 5 children dying before their fifth birthday. There has been no perceptible and lasting improvement in the standard of living of fishing households over the course of the second project phase as indicated by the persistently high prevalence of stunting. The situation is the same for the control group, indicating that for the region as a whole, a number of factors beyond the immediate influence of the project continue to negatively impact on the standard of living. The results also show that the project activities have not had any negative long-term effect on the nutritional status of the beneficiaries. (PDF contains 44 pages)

Testing inflationary cosmology with the BICEP1 and BICEP2 experiments

Recent observations of the temperature anisotropies of the cosmic microwave background (CMB) favor an inflationary paradigm in which the scale factor of the universe inflated by many orders of magnitude at some very early time. Such a scenario would produce the observed large-scale isotropy and homogeneity of the universe, as well as the scale-invariant perturbations responsible for the observed (10 parts per million) anisotropies in the CMB. An inflationary epoch is also theorized to produce a background of gravitational waves (or tensor perturbations), the effects of which can be observed in the polarization of the CMB. The E-mode (or parity even) polarization of the CMB, which is produced by scalar perturbations, has now been measured with high significance. Con- trastingly, today the B-mode (or parity odd) polarization, which is sourced by tensor perturbations, has yet to be observed. A detection of the B-mode polarization of the CMB would provide strong evidence for an inflationary epoch early in the universe’s history.

In this work, we explore experimental techniques and analysis methods used to probe the B- mode polarization of the CMB. These experimental techniques have been used to build the Bicep2 telescope, which was deployed to the South Pole in 2009. After three years of observations, Bicep2 has acquired one of the deepest observations of the degree-scale polarization of the CMB to date. Similarly, this work describes analysis methods developed for the Bicep1 three-year data analysis, which includes the full data set acquired by Bicep1. This analysis has produced the tightest constraint on the B-mode polarization of the CMB to date, corresponding to a tensor-to-scalar ratio estimate of r = 0.04±0.32, or a Bayesian 95% credible interval of r < 0.70. These analysis methods, in addition to producing this new constraint, are directly applicable to future analyses of Bicep2 data. Taken together, the experimental techniques and analysis methods described herein promise to open a new observational window into the inflationary epoch and the initial conditions of our universe.