Verification, Analytical Validation, and Clinical Validation (V3): The Foundation of Determining Fit-for-Purpose for Biometric Monitoring Technologies (BioMeTs)

Digital medicine is an interdisciplinary field, drawing together stakeholders with expertize in engineering, manufacturing, clinical science, data science, biostatistics, regulatory science, ethics, patient advocacy, and healthcare policy, to name a few. Although this diversity is undoubtedly valuable, it can lead to confusion regarding terminology and best practices. There are many instances, as we detail in this paper, where a single term is used by different groups to mean different things, as well as cases where multiple terms are used to describe essentially the same concept. Our intent is to clarify core terminology and best practices for the evaluation of Biometric Monitoring Technologies (BioMeTs), without unnecessarily introducing new terms. We focus on the evaluation of BioMeTs as fit-for-purpose for use in clinical trials. However, our intent is for this framework to be instructional to all users of digital measurement tools, regardless of setting or intended use. We propose and describe a three-component framework intended to provide a foundational evaluation framework for BioMeTs. This framework includes (1) verification, (2) analytical validation, and (3) clinical validation. We aim for this common vocabulary to enable more effective communication and collaboration, generate a common and meaningful evidence base for BioMeTs, and improve the accessibility of the digital medicine field

Gear wear process monitoring using acoustic signals

Airborne acoustic signals contain valuable information from machines and can be detected remotely for condition monitoring. However, the signal is often seriously contaminated by various noises from the environment as well as nearby machines. This paper presents an acoustic based method of monitoring a two stage helical gearbox, a common power transmission system used in various industries. A single microphone is employed to measure the acoustics of the gearbox under-going a run-to-failure test. To suppress the background noise and interferences from nearby ma-chines a modulation signal bispectrum (MSB) analysis is applied to the signal. It is shown that the analysis allows the meshing frequency components and the associated shaft modulating components to be captured more accurately to set up a clear monitoring trend to indicate the tooth wear of the gears under test. The results demonstrate that acoustic signals in conjunction with efficient signal processing methods provide an effective monitoring of the gear transmission process

Incorporating LCA Method into Asset and Facility Life Cycle Management

With the increasing awareness of sustainable development, incorporation of potential environmental impact into the consideration of asset and facility life cycle management is attracting increasing attention. On the one hand, businesses now widely recognize the needs to actively engage in the sustainability arena. On the other hand, companies are now also increasingly accountable for their impacts on the society, environment and economy. This paper presents an initial framework that takes account of sustainability consequences of the products into asset and facility life cycle management. It is shown that major physical assets and facilities in different areas/sectors may have quite different behaviour, thus requiring the uses of different high-level criteria/factors. The evaluation process to incorporate the environmental LCA concept into asset life cycle management is also developed and discussed

Towards design of prognostics and health management solutions for maritime assets

With increase in competition between OEMs of maritime assets and operators alike, the need to maximize the productivity of an equipment and increase operational efficiency and reliability is increasingly stringent and challenging. Also, with the adoption of availability contracts, maritime OEMs are becoming directly interested in understanding the health of their assets in order to maximize profits and to minimize the risk of a system's failure. The key to address these challenges and needs is performance optimization. For this to be possible it is important to understand that system failure can induce downtime which will increase the total cost of ownership, therefore it is important by all means to minimize unscheduled maintenance. If the state of health or condition of a system, subsystem or component is known, condition-based maintenance can be carried out and system design optimization can be achieved thereby reducing total cost of ownership. With the increasing competition with regards to the maritime industry, it is important that the state of health of a component/sub-system/system/asset is known before a vessel embarks on a mission. Any breakdown or malfunction in any part of any system or subsystem on board vessel during the operation offshore will lead to large economic losses and sometimes cause accidents. For example, damages to the fuel oil system of vessel's main engine can result in huge downtime as a result of the vessel not being in operation. This paper presents a prognostic and health management (PHM) development process applied on a fuel oil system powering diesel engines typically used in various cruise and fishing vessels, dredgers, pipe laying vessels and large oil tankers. This process will hopefully enable future PHM solutions for maritime assets to be designed in a more formal and systematic way

A Preliminary Study of Applying Lean Six Sigma Methods to Machine Tool Measurement

Many manufacturers aim to increase their levels of high-quality production in order to improve their market competitiveness. Continuous improvement of maintenance strategies is a key factor to be capable of delivering high quality products and services on-time with minimal operating costs. However, the cost of maintaining quality is often perceived as a non-added-value task. Improving the efficiency and effectiveness of the measurement procedures necessary to guarantee accuracy of production is a more complex task than many other maintenance functions and so deserves particular analysis. This paper investigates the feasibility of producing a concise yet effective framework that will provide a preliminary approach for integrating Lean and Six Sigma philosophies to the specific goal of reducing unnecessary downtime on manufacturing machines while maintaining its ability to machine to the required tolerance. The purpose of this study is to show how a Six Sigma infrastructure is used to investigate the root causes of complication occurring during the machine tool measurement. This work recognises issues of the uncertainty of data, and the measurement procedures in parallel with the main tools of Six Sigma’s Define-Measure-Analyse-Improve-Control (DMAIC). The significance of this work is that machine tool accuracy is critical for high value manufacturing. Over-measuring the machine to ensure accuracy potentially reduces production volume. However, not measuring them or ignoring accuracy aspects possibly lead to production waste. This piece of work aims to present a lean guidance to lessen measurement uncertainties and optimise the machine tool benchmarking procedures, while adopting the DMAIC strategy to reduce unnecessary downtime

An Approach to Assess Solder Interconnect Degradation Using Digital Signal

Department of Human and Systems EngineeringDigital signals used in electronic systems require reliable data communication. It is necessary to monitor the system health continuously to prevent system failure in advance. Solder joints in electronic assemblies are one of the major failure sites under thermal, mechanical and chemical stress conditions during their operation. Solder joint degradation usually starts from the surface where high speed signals are concentrated due to the phenomenon referred to as the skin effect. Due to the skin effect, high speed signals are sensitive when detecting the early stages of solder joint degradation. The objective of the thesis is to assess solder joint degradation in a non-destructive way based on digital signal characterization. For accelerated life testing the stress conditions were designed in order to generate gradual degradation of solder joints. The signal generated by a digital signal transceiver was travelling through the solder joints to continuously monitor the signal integrity under the stress conditions. The signal properities were obtained by eye parameters and jitter, which represented the characteristics of the digital signal in terms of noise and timing error. The eye parameters and jitter exhibited significant increase after the exposure of the solder joints to the stress conditions. The test results indicated the deterioration of the signal integrity resulted from the solder joint degradation, and proved that high speed digital signals could serve as a non-destructive tool for sensing physical degradation. Since this approach is based on the digital signals used in electronic systems, it can be implemented without requiring additional sensing devices. Furthermore, this approach can serve as a proactive prognostic tool, which provides real-time health monitoring of electronic systems and triggers early warning for impending failure.ope

AI and OR in management of operations: history and trends

The last decade has seen a considerable growth in the use of Artificial Intelligence (AI) for operations management with the aim of finding solutions to problems that are increasing in complexity and scale. This paper begins by setting the context for the survey through a historical perspective of OR and AI. An extensive survey of applications of AI techniques for operations management, covering a total of over 1200 papers published from 1995 to 2004 is then presented. The survey utilizes Elsevier's ScienceDirect database as a source. Hence, the survey may not cover all the relevant journals but includes a sufficiently wide range of publications to make it representative of the research in the field. The papers are categorized into four areas of operations management: (a) design, (b) scheduling, (c) process planning and control and (d) quality, maintenance and fault diagnosis. Each of the four areas is categorized in terms of the AI techniques used: genetic algorithms, case-based reasoning, knowledge-based systems, fuzzy logic and hybrid techniques. The trends over the last decade are identified, discussed with respect to expected trends and directions for future work suggested

A Process to Implement an Artificial Neural Network and Association Rules Techniques to Improve Asset Performance and Energy Efficiency

In this paper, we address the problem of asset performance monitoring, with the intention of both detecting any potential reliability problem and predicting any loss of energy consumption e ciency. This is an important concern for many industries and utilities with very intensive capitalization in very long-lasting assets. To overcome this problem, in this paper we propose an approach to combine an Artificial Neural Network (ANN) with Data Mining (DM) tools, specifically with Association Rule (AR) Mining. The combination of these two techniques can now be done using software which can handle large volumes of data (big data), but the process still needs to ensure that the required amount of data will be available during the assets’ life cycle and that its quality is acceptable. The combination of these two techniques in the proposed sequence di ers from previous works found in the literature, giving researchers new options to face the problem. Practical implementation of the proposed approach may lead to novel predictive maintenance models (emerging predictive analytics) that may detect with unprecedented precision any asset’s lack of performance and help manage assets’ O&M accordingly. The approach is illustrated using specific examples where asset performance monitoring is rather complex under normal operational conditions.Ministerio de Economía y Competitividad DPI2015-70842-