Standards Development Organizations Research Articles

Involving lead users in firm’s standardization strategy within action groups: evidence from smart robotics

PurposeThis research explores how firms manage the complex technologies standardization in action groups. It considers the strategic issues that technology producers face when involving lead users in architecture design. Drawing on the multi-mode standardization literature, this study addresses two dilemmas regarding value creation and appropriation by technology producers within coalitions. The first dilemma is how to create value by developing solutions in compliance with industry standards. The second one is how to appropriate value while ensuring the technology sharing with action groups. The answers to these two dilemmas contribute to filling the research gap on value creation and appropriation in multi-mode standardization.Design/methodology/approachThe research focuses on technology producers participating in action groups where lead users play a crucial role. We conducted a qualitative analysis based on the standardization experience of a Japanese company specializing in smart robotics. Data are collected through semi-structured interviews with key actors. Action groups are defined operationally as a set of stakeholders including competitors of the technology producers, component suppliers, end users, services providers, research centers and academia. The case study is suitable for highlighting specific aspects of the standardization process during its manifestation. It reveals how firms create and appropriate value, providing details about its standardization strategy.FindingsOur findings show that smart robotics standardization is drivn by collaborative models, where the two dilemmas of value creation and appropriation are evident. Firstly, the case revealed that standardization is lead users oriented. Secondly, lead users’ involvement is crucial to customize technologies. Thirdly, the firm’s position is to share a part of the value with the members. The IPR policy is a matter of interest within action groups, since the collaboration is based on open innovation models to share patents and licenses related knowledge.Research limitations/implicationsThis research has some limitations attributable to the limited generalizability of the results due to the qualitative analysis. In addition, this study considers the perspective of technology producers, but should also take into account the perspective of both collective actions itself and the lead users. Findings have some implications in the strategy negotiation. Participating in action groups is not enough to ensure a competitive advantage. Involving lead users is of strategic importance to acquire a competitive advantage. Lead users contribute to the producers’ technology design, helping firms to differentiate solutions from the industry standard and create value from customized technologies.Practical implicationsThis study helps practitioners understand the competitive side of collective actions, clarifying the value capture and appropriability in standardization. The research provides insights to policymakers and standard development organizations committees when they are called to harmonize standards considering the fallouts on the sector’s competitiveness. Findings suggest appropriate property rights policies to manage the issues related to the value appropriability and technology sharing, recognizing action groups members for their contribution in value creation.Originality/valueThis study shows how firms deal within action groups with the two dilemmas of variety versus technology conformity and property rights versus technology sharing. It fills the research gap in collective actions, emphasizing the perspective of the individual firm in the group rather than the coalition strategy itself. This topic highlights the crucial role of lead users within action groups in managing the two dilemmas, offering a new perspective for understanding critical issues of multi-mode standardization. Reflecting on mechanisms and tools to manage the two dilemmas allows firms to protect their competitive advantage in coalitions.

Towards a fair, reliable, and practical verification framework for Blue Carbon-based CDR

Abstract While the (re-)establishment of Blue Carbon Ecosystems (BCE) is seen as an important tool to mitigate climate change, the credibility of such nature-based solutions has been marred by recent revelations ranging from weak accounting to malpractice. In light of this, there is a clear need to develop monitoring, reporting and verification (MRV) systems towards the reliable, practical, and accurate accounting of additional and durable carbon dioxide removal (CDR). We propose the development of a Blue Carbon Ecosystem Digital Twin (BCE-DT) as a practical solution, integrating real-time data and models into What-If Scenarios of CDR aimed at the quantification of CDR additionality and durability. Critically, such a solution would be amenable to projects across a broad range in spatial scale and ecosytem type. In parallel, we propose the creation of an independent and not-for-profit Standards Development Organization (SDO) for the management of this Digital Twin and oversight of the certification process based on MRV. Considering the interwoven nature of the scientific and policy/legal needs we raise, an improved dialogue and collaboration between the scientific and policy communities is clearly needed. We argue that this BCE-DT, along with its oversight and implementation by a SDO, would fit this niche and support the fair and accurate implementation of MRV critically needed for BCE-based CDR to proceed.

Artificial intelligence co-regulation? The role of standards in the EU AI Act

Abstract This article examines artificial intelligence (AI) co-regulation in the EU AI Act and the critical role of standards under this regulatory strategy. It engages with the foundation of democratic legitimacy in EU standardization, emphasizing the need for reform to keep pace with the rapid evolution of AI capabilities, as recently suggested by the European Parliament. The article highlights the challenges posed by interdisciplinarity and the lack of civil society expertise in standard-setting. It critiques the inadequate representation of societal stakeholders in the development of AI standards, posing pressing questions about the potential risks this entails to the protection of fundamental rights, given the lack of democratic oversight and the global composition of standard-developing organizations. The article scrutinizes how under the AI Act technical standards will define AI risks and mitigation measures and questions whether technical experts are adequately equipped to standardize thresholds of acceptable residual risks in different high-risk contexts. More specifically, the article examines the complexities of regulating AI, drawing attention to the multi-dimensional nature of identifying risks in AI systems and the value-laden nature of the task. It questions the potential creation of a typology of AI risks and highlights the need for a nuanced, inclusive, and context-specific approach to risk identification and mitigation. Consequently, in the article we underscore the imperative for continuous stakeholder involvement in developing, monitoring, and refining the technical rules and standards for high-risk AI applications. We also emphasize the need for rigorous training, certification, and surveillance measures to ensure the enforcement of fundamental rights in the face of AI developments. Finally, we recommend greater transparency and inclusivity in risk identification methodologies, urging for approaches that involve stakeholders and require a diverse skill set for risk assessment. At the same time, we also draw attention to the diversity within the European Union and the consequent need for localized risk assessments that consider national contexts, languages, institutions, and culture. In conclusion, the article argues that co-regulation under the AI Act necessitates a thorough re-examination and reform of standard-setting processes, to ensure a democratically legitimate, interdisciplinary, stakeholder-inclusive, and responsive approach to AI regulation, which can safeguard fundamental rights and anticipate, identify, and mitigate a broad spectrum of AI risks.

The Purpose, Process, and Advancement of Forensic Nursing Standards.

To strengthen the nation's use of forensic science and advance professional practice, forensic practitioners and scientists in the Organization of Scientific Area Committees (OSAC) develop standards in forensic science. The Forensic Nursing Subcommittee was created by OSAC in 2021 to develop standards that improve patient outcomes through delivery of consistent practice guidelines, evidence-based techniques for preservation of evidence, and accurate representation of practice and examination findings. The purpose of this article is to relate the history of forensic science standard development in the United States, discuss the rationale for forensic nursing standards, and describe the standards development process. In this article, we provide an overview of OSAC and the OSAC Forensic Nursing Subcommittee. We discuss how forensic nurses can be involved in the development and advancement of standards that define minimum requirements, best practices, and evidence-based protocols to ensure reliable and reproducible outcomes. The development of forensic nursing standards is an important step in advancing the profession. It is critical that forensic nurses are actively involved in the standards development process, which includes volunteering to serve on the OSAC Forensic Nursing Subcommittee or a forensic nursing standards development organization, providing input into standards drafts during the public comment period, and implementing approved standards into practice.

From animal testing to in vitro systems: advancing standardization in microphysiological systems.

Limitations with cell cultures and experimental animal-based studies have had the scientific and industrial communities searching for new approaches that can provide reliable human models for applications such as drug development, toxicological assessment, and in vitro pre-clinical evaluation. This has resulted in the development of microfluidic-based cultures that may better represent organs and organ systems in vivo than conventional monolayer cell cultures. Although there is considerable interest from industry and regulatory bodies in this technology, several challenges need to be addressed for it to reach its full potential. Among those is a lack of guidelines and standards. Therefore, a multidisciplinary team of stakeholders was formed, with members from the US Food and Drug Administration (FDA), the National Institute of Standards and Technology (NIST), European Union, academia, and industry, to provide a framework for future development of guidelines/standards governing engineering concepts of organ-on-a-chip models. The result of this work is presented here for interested parties, stakeholders, and other standards development organizations (SDOs) to foster further discussion and enhance the impact and benefits of these efforts.

How Do They Do it? An Empirically Based Taxonomy of Standards Development Organizations’ Resilience Strategies

How Do They Do it? An Empirically Based Taxonomy of Standards Development Organizations’ Resilience Strategies

How to Specify a Motor With the Smorgasbord of Standards: A Road Map for Engineers

How does today’s process industry engineer even specify a motor with the plethora of industry standards from various standards development organizations around the globe? This article provides a basic overview of the issues that are essential in the decision process when purchasing a new motor and is directed toward the engineer who must specify motors but is not a motor specialist. Since project engineers are regularly expected to justify the options selected and purchase recommendations, this article provides guidance. Process industry motor standards are used in reviews of motor requirements and options available today.

Updating breakpoints in the United States: a summary from the ASM Clinical Microbiology Open 2022.

Accurate antimicrobial susceptibility testing (AST) and reporting are essential for guiding appropriate therapy for patients and direction for public health prevention and control actions. A critical feature of AST reporting is the interpretation of AST results using clinical breakpoints for reporting as susceptible, susceptible-dose dependent, intermediate, or resistant. Breakpoints are subject to continuous adjustment and updating to best reflect current clinical data. These breakpoint changes can benefit patients and public health only if adopted in a timely manner. A recent survey identified that up to 70% of College of American Pathologists (CAP)-accredited U.S. laboratories and 45% of CAP-accredited laboratories outside the U.S. use various obsolete clinical breakpoints to interpret AST results to guide patient care. The reason for the ongoing use of obsolete breakpoints is multifactorial, including barriers encountered by laboratories, commercial AST device manufacturers, standards development organizations, and regulatory bodies alike. To begin to address this important patient safety issue, CAP implemented checklist requirements for CAP-accredited laboratories to ensure up-to-date clinical breakpoint use. Furthermore, the topic was discussed at the June 2022 American Society for Microbiology Clinical Microbiology Open (CMO) with various stakeholders to identify potential solutions. This minireview summarizes the breakpoint setting process in the U.S. and highlights solutions to close the gap between breakpoint revisions and implementation in clinical and public health laboratories. Solutions discussed include clarification of data requirements and minimum inhibitory concentration only reporting for regulatory clearance of AST devices, clinical data generation to close breakpoints gaps, advocacy, education, and greater dialogue between stakeholders.

Measuring and Indexing the Durability of Electrical and Electronic Equipment

Due to the large and unsustainable use of valuable natural resources and electronic waste generation worldwide, which poses risks to human health and the environment, different organizations have initiated efforts to shift from a linear economy to a circular economy. A crucial aspect of promoting a circular economy is improving product durability, which can reduce resource extraction and waste because products remain in use for a longer period. Methods for measuring and indexing durability should encourage consumers to buy more durable products and incentivize manufacturers to compete in improving durability. This paper reviews past research on measuring product durability. It proposes an overall framework based on the promise of product life as well as its readiness to perform required functions for indexing durability. Finally, it presents an example of durability assessment. The proposed framework enables manufacturers to improve the design and communication of product durability. Furthermore, it supports establishing durability standards by standard development organizations and promotes sustainability through durability initiatives.

The Evolution of the Post-Quantum Cyber Environment

Abstract: Quantum computers are expected to one day be capable of breaking public key cryptography, enabling a step change in cyberwarfare capabilities. Risk can be mitigated using new quantum-resistant cryptography algorithms, but the international migration to a new cryptography standard will be time-consuming, costly, and dependent on the work of international standards-developing organizations. Technical standards are increasingly a focus of geopolitical competition, as China has attempted to manipulate standards organizations to tilt standards in their favor. Contrasting national approaches to this competition could significantly impact the evolution of the post-quantum cyber environment. The United States should continue its domestic efforts to migrate to a new cryptography standard, pursue international standardization, and maintain a measured strategy to counter interference from China in open standardization processes.

Assessing the suitability of cell counting methods during different stages of a cell processing workflow using an ISO 20391-2 guided study design and analysis.

Cell counting is a fundamental measurement for determining viable cell numbers in biomanufacturing processes. The properties of different cell types and the range of intended uses for cell counts within a biomanufacturing process can lead to challenges in identifying suitable counting methods for each potential application. This is further amplified by user subjectivity in identifying the cells of interest and further identifying viable cells. Replacement of traditionally used manual counting methods with automated systems has alleviated some of these issues. However, a single cell type can exhibit different physical properties at various stages of cell processing which is further compounded by process impurities such as cell debris or magnetic beads. These factors make it challenging to develop a robust cell counting method that offers a high level of confidence in the results. Several initiatives from standards development organizations have attempted to address this critical need for standardization in cell counting. This study utilizes flow-based and image-based methods for the quantitative measurement of cell concentration and viability in the absence of a reference material, based on the tools and guidance provided by the International of Standards (ISO) and the US National Institute of Standards and Technology (NIST). Primary cells were examined at different stages of cell processing in a cell therapy workflow. Results from this study define a systematic approach that enables the identification of counting methods and parameters that are best suited for specific cell types and workflows to ensure accuracy and consistency. Cell counting is a foundational method used extensively along various steps of cell and gene therapy. The standard used in this study may be applied to other cell and gene therapy processes to enable accurate measurement of parameters required to guide critical decisions throughout the development and production process. Using a framework that confirms the suitability of the cell counting method used can minimize variability in the process and final product.

Wearing multiple hats—The role of working group chairs’ affiliation in standards development

Standards Development Organizations (SDO) make critical decisions shaping the direction of technological innovation. SDOs are usually considered to offer a neutral venue for the collaborative efforts of different stakeholders, which often pursue competing particular interests. Nevertheless, individuals acting on behalf of the SDO, such as working group chairs, are themselves often employees of individual SDO stakeholders. Recently, there have been concerns that over-representation of the employees of certain powerful stakeholders in SDO leadership positions may undermine the objectivity of SDO decision making. Nevertheless, to date, there exists no empirical evidence to corroborate these concerns. We find that being affiliated with one of the largest SDO stakeholders significantly increases an individual’s likelihood of being appointed to a leadership position at IETF, but not at 3GPP. At the same time, in both SDOs, working groups whose chairs are affiliated with leading stakeholders produce standards that are less cited and less referenced than standards produced by other working groups, in particular those chaired by university affiliates. Our findings suggest that the commercial interests of individuals’ employers may facilitate these individuals’ ascension to SDO leadership positions, but the potential for conflicts between these commercial interests of chairs’ employers and the organizational goals of the SDO may negatively impact the success of the working group’s standards.

Towards Data and Model Interoperability for Industrial Extended Reality in Manufacturing

Abstract Extended reality (XR) technologies have realized significant value for design, manufacturing, and sustainment processes. However, industrial XR, or XR implemented within industrial applications, suffers from scalability and flexibility challenges due to fundamental gaps with interoperability between data, models, and workflows. Though there has been a number of recent efforts to improve the interoperability of industrial XR technologies, progress has been hindered by an innate separation between the domain-specific models (e.g., manufacturing execution data, material specifications, and product manufacturing information) with XR (often-standard) processes (e.g., multiscale spatial representations and data formats optimized for run-time presentation). In this paper, we elaborate on promising research directions and opportunities around which the manufacturing and visualization academic community can rally. To establish such research directions, we (1) conducted a meta-review on well-established state-of-the-art review articles that have already presented in-depth surveys on application areas for industrial XR, such as maintenance, assembly, and inspection and (2) mapped those findings to publicly published priorities from across the US Department of Defense. We hope that our presented research agenda will spur interdisciplinary work across academic silos, i.e., manufacturing and visualization communities, and engages either community within work groups led by the other, e.g., within standards development organizations.

Impact of surface tension on the barrier performance of gowns and coveralls

Health care workers and laboratory workers who are routinely exposed to potentially life-threatening infectious diseases should wear protective clothing when anticipating contact with infectious materials. The most critical property ofprotective clothing is its ability to prevent liquids and viruses from passing through the garment. There are a number of potentially infectious liquids that workers may be exposed to during routine tasks. Each liquid has different physical and chemical properties that affect penetration. However, the current test methods use a limited number of liquids for classifying the barrier performance. The impact of the surface tension of the challenge liquid on the penetration resistance of gowns and coveralls was investigated in this study. Eight isolation gowns and 2 coveralls were tested in accordance with American Association of Textile Chemists and Colorists 42 and American Association of Textile Chemists and Colorists 127 test methods, which were modified to incorporate the substitute challenge liquids. Although current standard test methods only use water to categorize the liquid penetration resistance of minimal to moderate barrier performance gowns, a significant difference in the penetration was found when simulated body fluids were used. The results suggest that safety professionals and wearers should consider the varying barrier performance of personal protective equipment with different liquids and the use limitations when selecting them for the required tasks. Furthermore, standard development organizations should consider multiple challenge liquids when classifying protective clothing for health care settings.

SMART CITIES: AN EMPIRICAL STUDY OF DEFINITIONS

This research has been done alongside the objective of set up a clear definition of smart cities that could possibly utilized globally. Despite a lot of material on smart cities that are accessible, there is no defined, widely used set of terminology that would assist in accurately defining a "Smart City".Around 115 current smart cities definitions were analysed and examined by utilizing as a guideline the themes and attributes of smart cities. These definitions have been acquired from numerous sources such as user-centric definitions, company/corporate profiles, national and international organizations (United Nations, ITU, Indian Smart Cities Mission, etc.), government initiatives, academia & research communities, standards development organizations, and trade associations. A list of thirty important terms that need to be included in a standardized definition was determined, and important indicators and categories were also established. Finally, to conclude on the basis of the given analyses, a suggested definition for the “smart city” was given by the following:An innovative city is known as a "smart city" if it adopts ICTs (“information and communication technologies”) including innovative methods to enhance wellbeing, the effectiveness of urban services and environment, while simultaneously fulfilling the social, environmental, and economic requirements of both the present as well as the future generations.This derived definition is such a definition which can be generalized for any smart city with basic fundamentals terms mentioned in it and can be adopted widely throughout the world.

CnPRTC — Coherent Network Primary Reference Time Clock: A Geographically Distributed Resilient Timescale for Telecommunications

This article describes a new work item under study at the International Telecommunications Union (ITU) standards development organization to provide highly accurate, resilient time throughout a telecommunications network, the coherent network primary reference time clock (cnPRTC). While the traditional approach for delivering time and frequency to a network has involved deploying a number of independent sources of time and frequency, such as the PRTC or enhanced PRTC (ePRTC) along with hierarchical connections to these sources, the cnPRTC adds to this high-accuracy time and frequency connections between sources to combine them for improved accuracy and greatly improved resilience. The result is not simply a clock, but rather what is termed a timescale, much as universal coordinated time (UTC) is the result of combining the best standalone clocks in the world.

What Makes a Quality Health App? Developing a Global Research-based Health App Quality Assessment Framework for CEN-ISO/TS 82304-2: A Delphi Study.

The lack of an international standard for assessing and communicating health app quality and even of consensus about what makes a high-quality health app negatively affects uptake of such apps. At the request of the European Commission, international Standard Development Organizations (SDOs) CEN-CENELEC, ISO, and IEC have joined forces to develop a Technical Specification (TS) for assessing the quality and reliability of health and wellness apps. This study aimed to create a useful, globally applicable, trustworthy, and usable framework to assess health app quality. A two-round Delphi technique with 83 experts from 6 continents (predominantly Europe) participating in one (n=42) or both (n=41) rounds was used to achieve consensus on a framework for assessing health app quality. Aims included identifying the at most 100 requirement questions for uptake of health apps that do or do not qualify as medical devices. The draft assessment framework was built on 26 existing frameworks, the principles of stringent legislation, and input from 20 core experts. A follow-up survey with 28 respondents informed a scoring mechanism for the questions. After subsequent alignment with related standards, the quality assessment framework was tested and fine-tuned with manufacturers of 11 COVID-19 symptom apps. National mirror committees from the 52 countries spanning 6 continents who participated in the SDO technical committees, were invited to comment on 4 working drafts and afterwards vote on the TS. The final quality assessment framework includes 81 questions, 67 of which impact the scores of 4 overarching quality aspects. After testing with people with low health literacy, these aspects were phrased as 'Healthy and safe', 'Easy to use', 'Secure data', and 'Robust build'. The scoring mechanism enables communication of the quality assessment results in a health app quality score and label, alongside a detailed report. Unstructured interviews with stakeholders revealed that evidence and third-party assessment are needed for health app uptake. The manufacturers considered the time needed to complete the assessment and gather evidence (2 to 4 days) acceptable. Publication of CEN-ISO/TS 82304-2:2021 Health software - Part 2: Health and wellness apps - Quality and reliability was approved in May 2021 in a nearly unanimous vote by 34 national SDOs from 6 continents. These included 6 of the 10 most populous countries worldwide (China, India, the US, Pakistan, Brazil, and Russian Federation). A useful and usable international standard for health app quality assessment was developed. Its quality, approval rate, and early use provide proof of its potential to become the trusted, commonly used global framework. The framework will help manufacturers to enhance and efficiently demonstrate the quality of health apps, consumers and healthcare professionals to make informed decisions on health apps, and insurers to make reimbursement decisions on health apps.

Specifying Non-White Light Sources in Outdoor Applications to Reduce Light Pollution

ABSTRACT Anthropogenic (“human-generated”) light at night (ALAN) from outdoor lighting produces light pollution and as a result causes a range of deleterious responses in humans, plants, and animals. An emerging strategy to combat light pollution, especially sky glow, is to use “amber” LEDs in lieu of phosphor-converted white LEDs with high correlated color temperatures. Importantly, however, there is no standardized terminology or chromaticity designation that is applicable to “amber” LED lighting products for outdoor illumination. In this work, we propose a specification structure for light sources with nonstandard chromaticities to increase the precision of language used in the architectural lighting industry and demonstrate that light sources with well-defined chromaticity ranges outside of the ANSI C78.377–2017 quadrangles may be useful for reducing the portion of relative sky glow related to light source spectral power distribution. We encourage lighting standards development organizations to consider standardizing such a system.

Introduction to Time-Sensitive Networking

Since the year 2000, a number of companies and standards development organizations have been producing products and standards for Time-Sensitive Networking to support real-time applications that require zero packet loss due to buffer congestion, extremely low packet loss due to equipment failure, and guaranteed upper bounds on end-to-end latency. Often, a robust capability for time synchronization to less than 1 s is also required. These networks consist of specially-featured bridges that are interconnected using standard Ethernet links with standard MAC/PHY layers. Since the year 2012, this technology has advanced to the use of routers, as well as bridges, and features of interest to Time-Sensitive Net-working have been added to both Ethernet and wireless standards. Since the year 2018, TSN standardization has been expanding to include more queuing and pacing technologies, and to support new markets, such as industrial, automotive, aviation, and service provider applications.

Proceedings for NPL Joint Symposium on Quantum Technologies – 13th and 14th September 2022

The NPL Joint Symposium on Quantum Technologies was hosted as an in-person only meeting at NPL's facilities in Teddington, London on Tuesday 13th and Wednesday 14th September 2022.This symposium brought together an impressive collection of invited and contributing speakers from across the quantum industry and academia. The presentations provided a broad introduction and described the latest advances across all pillars of quantum technologies including:• Quantum Communication and Computation• Quantum Integrated Circuits and Interconnect• Quantum Imaging and Packaging• Quantum Metrology and StandardsThe authors of five contributed papers published in these proceedings were invited to present them alongside invited speakers.This conference was the 6th in a series of symposia organised jointly on behalf of the main international standards development organisations including IEC, ISO, ITU, CEN/CENELEC, IEEE, ETSI and BSI. BSI (the UK national standards body) and the IEEE UK and Ireland Photonics Chapter and Quantum Group provided strong support for these symposia.This was the first of the Joint Symposia to be held as an in-person event.List of titles Sponsorship and Collaborations, Chairs, Conference Organising Committee, Acknowledgements are available in this Pdf.