Process of designing robust, dependable, safe and secure software for medical devices: Point of care testing device as a case study

This article has been made available through the Brunel Open Access Publishing Fund.Copyright © 2013 Sivanesan Tulasidas et al. This paper presents a holistic methodology for the design of medical device software, which encompasses of a new way of eliciting requirements, system design process, security design guideline, cloud architecture design, combinatorial testing process and agile project management. The paper uses point of care diagnostics as a case study where the software and hardware must be robust, reliable to provide accurate diagnosis of diseases. As software and software intensive systems are becoming increasingly complex, the impact of failures can lead to significant property damage, or damage to the environment. Within the medical diagnostic device software domain such failures can result in misdiagnosis leading to clinical complications and in some cases death. Software faults can arise due to the interaction among the software, the hardware, third party software and the operating environment. Unanticipated environmental changes and latent coding errors lead to operation faults despite of the fact that usually a significant effort has been expended in the design, verification and validation of the software system. It is becoming increasingly more apparent that one needs to adopt different approaches, which will guarantee that a complex software system meets all safety, security, and reliability requirements, in addition to complying with standards such as IEC 62304. There are many initiatives taken to develop safety and security critical systems, at different development phases and in different contexts, ranging from infrastructure design to device design. Different approaches are implemented to design error free software for safety critical systems. By adopting the strategies and processes presented in this paper one can overcome the challenges in developing error free software for medical devices (or safety critical systems).Brunel Open Access Publishing Fund

Diagnosing Errors in DbC Programs Using Constraint Programming

Model-Based Diagnosis allows to determine why a correctly designed system does not work as it was expected. In this paper, we propose a methodology for software diagnosis which is based on the combination of Design by Contract, Model-Based Diagnosis and Constraint Programming. The contracts are specified by assertions embedded in the source code. These assertions and an abstraction of the source code are transformed into constraints, in order to obtain the model of the system. Afterwards, a goal function is created for detecting which assertions or source code statements are incorrect. The application of this methodology is automatic and is based on Constraint Programming techniques. The originality of this work stems from the transformation of contracts and source code into constraints, in order to determine which assertions and source code statements are not consistent with the specification.Ministerio de Ciencia y Tecnología DPI2003-07146-C02-0

Highly accurate model for prediction of lung nodule malignancy with CT scans

Computed tomography (CT) examinations are commonly used to predict lung nodule malignancy in patients, which are shown to improve noninvasive early diagnosis of lung cancer. It remains challenging for computational approaches to achieve performance comparable to experienced radiologists. Here we present NoduleX, a systematic approach to predict lung nodule malignancy from CT data, based on deep learning convolutional neural networks (CNN). For training and validation, we analyze >1000 lung nodules in images from the LIDC/IDRI cohort. All nodules were identified and classified by four experienced thoracic radiologists who participated in the LIDC project. NoduleX achieves high accuracy for nodule malignancy classification, with an AUC of ~0.99. This is commensurate with the analysis of the dataset by experienced radiologists. Our approach, NoduleX, provides an effective framework for highly accurate nodule malignancy prediction with the model trained on a large patient population. Our results are replicable with software available at http://bioinformatics.astate.edu/NoduleX

Evidence-based decision support for pediatric rheumatology reduces diagnostic errors.

BACKGROUND: The number of trained specialists world-wide is insufficient to serve all children with pediatric rheumatologic disorders, even in the countries with robust medical resources. We evaluated the potential of diagnostic decision support software (DDSS) to alleviate this shortage by assessing the ability of such software to improve the diagnostic accuracy of non-specialists. METHODS: Using vignettes of actual clinical cases, clinician testers generated a differential diagnosis before and after using diagnostic decision support software. The evaluation used the SimulConsult® DDSS tool, based on Bayesian pattern matching with temporal onset of each finding in each disease. The tool covered 5405 diseases (averaging 22 findings per disease). Rheumatology content in the database was developed using both primary references and textbooks. The frequency, timing, age of onset and age of disappearance of findings, as well as their incidence, treatability, and heritability were taken into account in order to guide diagnostic decision making. These capabilities allowed key information such as pertinent negatives and evolution over time to be used in the computations. Efficacy was measured by comparing whether the correct condition was included in the differential diagnosis generated by clinicians before using the software ( unaided ), versus after use of the DDSS ( aided ). RESULTS: The 26 clinicians demonstrated a significant reduction in diagnostic errors following introduction of the software, from 28% errors while unaided to 15% using decision support (p \u3c 0.0001). Improvement was greatest for emergency medicine physicians (p = 0.013) and clinicians in practice for less than 10 years (p = 0.012). This error reduction occurred despite the fact that testers employed an open book approach to generate their initial lists of potential diagnoses, spending an average of 8.6 min using printed and electronic sources of medical information before using the diagnostic software. CONCLUSIONS: These findings suggest that decision support can reduce diagnostic errors and improve use of relevant information by generalists. Such assistance could potentially help relieve the shortage of experts in pediatric rheumatology and similarly underserved specialties by improving generalists\u27 ability to evaluate and diagnose patients presenting with musculoskeletal complaints. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT02205086

Using hardware performance counters for fault localization

In this work, we leverage hardware performance counters-collected data as abstraction mechanisms for program executions and use these abstractions to identify likely causes of failures. Our approach can be summarized as follows: Hardware counters-based data is collected from both successful and failed executions, the data collected from the successful executions is used to create normal behavior models of programs, and deviations from these models observed in failed executions are scored and reported as likely causes of failures. The results of our experiments conducted on three open source projects suggest that the proposed approach can effectively prioritize the space of likely causes of failures, which can in turn improve the turn around time for defect fixes

The relevance of lean thinking to sustainable improvement of public office buildings in Nigeria

This study looked into the relevance of lean thinking, particularly the application of muda as a supplement to the sustainable improvement diagnosis technique of existing office buildings, for a fuller assessment of user's requirement in Nigeria. The impact of muda as related to the triple bottom line of sustainable development on perceived job productivity and design features was estimated from end-user's perspective, using diagnostic POE as data acquiring tool while the confirmatory analysis was done through AMOS, SPSS and MS Excel to explain the relationship between the different variables. The findings showed that muda is inherent in public office buildings and it has highly significant causal effects of 0.66 and 0.76, respectively on perceived job productivity and design features; it also has strong effect sizes of 44 and 58% in explaining both their variances, respectively. The result revealed that users require more improvement in facilities as against spatial plan and structures while there is a medium and positive correlation of 0.48 between perceived job productivity and design features implying that the improvement of one will consequently lead to the improvement of the other. The study concludes that lean thinking is relevant to building improvement and could serve as good supplement to the current improvement diagnosis of existing public office buildings but not as a substitute since data were only collected from users who are not able to provide the required technical data that would otherwise warrant use of equipment

Computer-Aided System for Wind Turbine Data Analysis

Context: The current work on wind turbine failure detection focuses on researching suitable signal processing algorithms and developing efficient diagnosis algorithms. The laboratory research would involve large and complex data, and it can be a daunting task. Aims: To develop a Computer-Aided system for assisting experts to conduct an efficient laboratory research on wind turbine data analysis. System is expected to provide data visualization, data manipulation, massive data processing and wind turbine failure detection. Method: 50G off-line SCADA data and 4 confident diagnosis algorithms were used in this project. Apart from the instructions from supervisor, this project also gained help from two experts from Engineering Department. Java and Microsoft SQL database were used to develop the system. Results: Data visualization provided 6 different charting solutions and together with robust user interactions. 4 failure diagnosis solutions and data manipulations were provided in the system. In addition, dedicated database server and Matlab API with Java RMI were used to resolve the massive data processing problem. Conclusions: Almost all of the deliverables were completed. Friendly GUI and useful functionalities make user feel more comfortable. The final product does enable experts to conduct an efficient laboratory research. The end of this project also gave some potential extensions of the system