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Human factors engineering and design validation for the redesigned follitropin alfa pen injection device

EXPERT OPINION ON DRUG DELIVERY 2015年第5期12卷 715-725页

作者： Mahony, Mary C. Patterson, Patricia Hayward, Brooke North, Robert Green, Dawne EMD Serono Inc Rockland MA 02370 USA Agilis Consulting Grp LLC Cave Creek AZ 85331 USA Human Centered Strategies LLC Colorado Springs CO 80908 USA

Objectives: To demonstrate, using human factors engineering (HFE), that a redesigned, pre-filled, ready-to-use, pre-asembled follitropin alfa pen can be used to administer prescribed follitropin alfa doses safely and accurately. Methods: A failure modes and effects analysis identified hazards and harms potentially caused by use errors;risk-control measures were implemented to ensure acceptable device use risk management. Participants were women with infertility, their significant others, and fertility nurse (FN) professionals. Preliminary testing included 'Instructions for Use' (IFU) and pre-validation studies. validation studies used simulated injections in a representative use environment;participants received prior training on pen use. Results: User performance in preliminary testing led to IFU revisions and a change to outer needle cap design to mitigate needle stick potential. In the first validation study (49 users, 343 simulated injections), in the FN group, one observed critical use error resulted in a device design modification and another in an IFU change. A second validation study tested the mitigation strategies;previously reported use errors were not repeated. Conclusions: Through an iterative process involving a series of studies, modifications were made to the pen design and IFU. Simulated-use testing demonstrated that the redesigned pen can be used to administer follitropin alfa effectively and safely.

关键词： failure modes and effects analysis follitropin alfa pen human factors engineering usability validation testing

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Usability engineering study in the European Union of a redesigned follitropin alfa pen injector for infertility treatment

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EXPERT OPINION ON DRUG DELIVERY 2016年第9期13卷 1221-1229页

作者： Jeannerot, Fabien Stuedeli, Thomas Gunther-LaVergne, Lisa Hirning, David Schertz, Joan Merck Serono SA Med Devices & Serv Coinisins Switzerland Merck KGaA Darmstadt Germany Merck Serono SA Human Factors Engn Coinisins Switzerland HirLan Inc Carlsbad CA USA EMD Serono Inc EMD Serono Res & Dev Inst Global Clin Dev Billerica MA USA

Objectives: The prefilled, multidose, GONAL-f (R) (follitropin alfa) pen injector was redesigned to improve ease of use and pen functionality. This usability engineering evaluation aimed to demonstrate that the redesigned pen injector could be used by the intended users to safely and effectively deliver follitropin alfa. Methods: Formative and summative usability engineering evaluations of the pen injector, training and instructions for use (IFU) were conducted. This included an expert review, and formative and summative evaluations involving patients with infertility and fertility nurses. For the summative evaluation, participants received training and subsequently performed tasks based on three selected hazard-related use scenarios to evaluate real-world use, including simulated injections. Results: The formative evaluations confirmed that the pen injector was ready for summative evaluation. Task performance was high in the summative evaluation for both patients and nurses;the tasks that were observed to be most difficult to complete were priming the pen, completing an incomplete injection and completing the treatment diary. Participants rated the device as having above average usability. Most patients ranked the overall system (pen injector, device training and IFU) and its individual components to be either 'extremely easy' or 'somewhat easy' to use. Conclusions: These usability engineering evaluations demonstrated that patients and nurses could safely and effectively use the redesigned GONAL-f pen injector, and that they also found the IFU and device training to be easy to use.

关键词： Follitropin alfa human factors engineering pen injector usability engineering validation validation testing

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Simulation Speak

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JOURNAL OF SURGICAL EDUCATION 2011年第5期68卷 382-386页

作者： Fairhurst, Katherine Strickland, Andrew Maddern, Guy J. Queen Elizabeth Hosp Dept Surg Woodville SA Australia

The concept of using simulation to gain and improve practical skills in a safe and low-risk environment has been employed extensively in the airline industry to train pilots for many years now. The use of simulation techniques to train surgeons, however, is a new but rapidly expanding and developing area of surgical education. The introduction of simulation to surgical training curricula has inevitably led to a plethora of simulation technology entering the commercial market, as well as the introduction of new terminology used to describe both the equipment itself, and the methods used to test and validate it for use in the training of surgeons. The terminology has its basis mostly in statistical methodology, and the terms are used throughout the surgical literature, often interchangeably and with multiple meanings. In our experience, this terminology is where most confusion arises. Interpreting the literature is difficult for those not directly involved in the field. This article aims to define the statistical terms used to describe the many forms of validity testing and types of surgical simulator, and consequently to act as a reference guide for those unfamiliar with this rapidly evolving field of technology and surgical training. (J Surg 68: 382-386. (C) 2011 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.)

关键词： surgical simulation training validation testing

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Validating Combination Throat-Nasal Swab Specimens for Coronavirus Disease 2019 Tests Would Improve Early Detection, Especially for the Most Vulnerable

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CLINICAL INFECTIOUS DISEASES 2024年第4期79卷 815-818页

作者： Winnett, Alexander Viloria Stenzel, Timothy Ismagilov, Rustem F. CALTECH Div Chem & Chem Engn Pasadena CA USA CALTECH Div Biol & Biol Engn Pasadena CA USA Univ Calif Los Angeles CALTECH Med Sci Training Program Los Angeles CA USA US FDA Off Vitro Diagnost Silver Spring MD USA

Early detection of severe acute respiratory syndrome coronavirus 2 infection by diagnostic tests can prompt actions to reduce transmission and improve treatment efficacy, especially for vulnerable groups such as immunocompromised individuals. Recent evidence suggests that sampling the throat in addition to the nose improves clinical sensitivity during early infection for both antigen and molecular coronavirus disease 2019 tests. We urge test manufacturers to validate tests for use with throat swab, in combination with nasal swabs.

关键词： COVID-19 validation testing early detection rapid diagnostics specimen types

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SPE staying strong

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JPT, Journal of Petroleum Technology 2020年第5期72卷 6-7页

作者： Noonan, Shauna 2020 SPE President

President's column“Success is neither magical nor mysterious. Success is the natural consequence of consistently applying the basic fundamentals.” —Jim Rohn, American businessman and author This month’s column is dedicated to technology evaluation, an area where I have spent the majority of my career. For at least 2 decades, I have been approached almost weekly by either one of my engineers or an inventor who has found the “next best thing that will revolutionize our industry.” While I have been a champion for innovation and technology development, I have also applied critical thinking in forming my opinion of such claims. The first questions I always ask myself are: “Do I need this new technology?” and “Do I understand the root cause of the problem well enough to determine if applying existing technology and accepted practices cannot solve it?” To adequately answer these questions, a good understanding of the fundamentals, such as fluid or mechanical dynamics, is often needed. Is this new tool or method genuinely innovative, or has it been born out of engineering ignorance?“Being ignorant is not so much a shame, as being unwilling to learn.” —Benjamin Franklin For context, let me provide an example. The downhole rod-driven reciprocating pump has existed since the late 1800s (Beckwith 2014). For a century, the design practices for deter-mining the optimal tolerance between the downhole plunger and barrel were theoretical equations and often used rules of thumb. Too large of a tolerance would lead to excess fluid slip-page and decreasing efficiency of the pump. Too tight of a tolerance could lead to rod buckling and the inability to handle particulates such as sand. As an industry, we typically erred on the side of caution toward tighter tolerances, and many “gadgets” were invented to prolong the life of the downhole rods and pumps and to counter issues caused by this design practice. It wasn’t until the late 1990s when a group of operators in the Permian Basin began

关键词： gas injection investment efficiency gas lift april 2020 president artificial lift system upstream oil & gas validation testing design practice Artificial Lift Systems Gas lift Research and Development and Emerging Technology Programs

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validation of Context Preserving Thread-Level Speculative Execution Using N-Queens Comparison of Non-CPSE and CPSE-enabled Applications 18

Validation of Context Preserving Thread-Level Speculative Ex...

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18th International Workshop on Microprocessor and SOC Test, Security and Verification (MTV)

作者： Mason, Jack L. Pema Technol Inc Elk Ridge UT 84651 USA

ISBN: (纸本)9781538633519

Due to simulation overhead, validation of proposed microarchitecture enhancements may be limited to simple test scenarios, which focus on the known architectural deficiencies. These test scenarios often avoid a complete simulation of the eventual target environment in which the enhancements will be employed. A case study is presented, comparing and contrasting the performance of an 8x8 N-Queens algorithm, in both a non-Thread-Level Speculation (TLS) configuration, and utilizing the Context Preserving Speculative Execution (CPSE) configuration. validation is performed within the constraints of a simulated target environment. A brief introduction of TLS proposals is also included.

关键词： speculative execution validation testing system simulation target environment

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NAMT framework for discrete parts manufacturing: Experience report

NAMT framework for discrete parts manufacturing: Experience ...

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Conference on Plug and Play Software for Agile Manufacturing

作者： Christopher, N National Institute of Standards and Technology (United States)

ISBN: (纸本)0819423157

Industry need for standards to support integration of distributed manufacturing information technology systems is driving a process for creating validated pre-standard specifications. These specifications are likely to be the basis for manufacturing information technology standards in the future. The Framework for Discrete Parts Manufacturing project has implemented a distributed manufacturing software system as a basis for validation testing and analysis of emerging manufacturing information technologies. This paper describes a testbed project for validation of pre-standard specifications for integration of distributed manufacturing information technology systems. This project begins with a scenario for manufacturing operations and deploys several related specifications against this scenario. This deployment provides the opportunity for analysis and local validation of the specifications. It also provides the opportunity to explore the relationship among several specifications that could be the basis for standards in the future. This paper discusses the preliminary implementation of the specifications under analysis and projects future work involved in validation testing of industry consortia developed manufacturing information technology specifications.

关键词： manufacturing standards information technology validation testing information models interface definitions SDAI CORBA STEP NAMT machine control factory control systems integration

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Home pregnancy tests in the hands of the intended user

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Journal of Immunoassay and Immunochemistry 2019年第6期40卷 642-652页

作者： Boxer, Jackie Weddell, Sarah Broomhead, David Hogg, Cameron Johnson, Sarah Clinical Affairs SPD Development Company Limited Bedford United Kingdom Statistics and Data Management SPD Development Company Limited Bedford United Kingdom

The objectives of this study were to investigate the usability and performance of seven visual home pregnancy tests, available in Europe. Part one of the study was home-based and involved volunteers testing a selection of four home pregnancy tests. The tests used and order of use were randomized. Part two, performed at a study site, involved volunteers reading and interpreting the results of the same selection of home pregnancy tests used in part one, but using urine standards representing early pregnancy (25 mIU/mL human chorionic gonadotropin) or a ‘not pregnant’ (0 mIU/mL human chorionic gonadotropin) sample. The volunteers completed a questionnaire after each test in both parts. Three of the seven tests met their accuracy/reliability claims: tests A (99.8%), B (100%), and F (97.6%) (not statistically different from the claimed 99% accuracy). The remaining four tests had accuracies/reliabilities of <99% at 81.6% (C), 89.0% (E), 92.5% (D), and 95.9% (G), respectively. Test A was the highest-rated test for each attribute tested in both settings. Test D was ranked the lowest in part one and test C was ranked lowest overall for part two. Home pregnancy tests vary in performance and usability, therefore requiring better standardization and performance evaluation in Europe. Clinical Trials Reference Number: NCT03589534. © 2019, © 2019 SPD Development Company Ltd. Published with license by Taylor & Francis Group, LLC.

关键词： accuracy Home pregnancy tests human chorionic gonadotropin in vitro diagnostic device regulation sensitivity validation testing

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Target Environment Simulation and its Impact on Architecture validation Case study of Thread-Level Speculative Execution 14

Target Environment Simulation and its Impact on Architecture...

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14th International Workshop on Microprocessor Test and Verification (MTV) - Common Challenges and Solutions

作者： Mason, Jack L. Simco, Gregory E. Nova SE Univ Grad Sch Comp & Informat Sci Ft Lauderdale FL 33314 USA

ISBN: (纸本)9781479932467

Due to simulation overhead, validation of proposed microarchitecture enhancements may be limited to simple test scenarios, which focus on the known architectural deficiencies. These test scenarios often avoid a complete simulation of the eventual target environment in which the enhancements will be employed. A case study is presented, comparing and contrasting the performance of previous Thread-Level Speculation (TLS) proposals with that of a new, context-preserving proposal. validation is performed within the constraints of a simulated target environment.

关键词： speculative execution validation testing system simulation target environment

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Multi-modal functional test execution

Multi-modal functional test execution

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9th International Conference on Agile Processes in Software Engineering and Extreme Porgramming

作者： Park, Shelly Maurer, Frank Univ Calgary Dept Comp Sci Calgary AB T2N 1N4 Canada

ISBN: (纸本)9783540682547

Multi-modal test execution allows execution of the same test against various layers of a software system, e.g. the GUI layer, the web service layer and the business logic layer. Multi-modal test execution helps with identifying the location of software bugs during debugging and maintenance as well as in tracking the progress of the development effort. This paper presents a method that effectively encodes multi-modal functional tests without creating large test maintenance overhead. Our approach extends the Fit table specification structure by multi-modal fixtures and presents the results of test execution in a way to help with debugging and progress reporting.

关键词： executable acceptance testing test driven development functional specifications functional testing validation testing architectural design decisions multi-modal test execution

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