The Boon and Bane of Blockchain:Getting the Governance Right

Countless enterprise blockchains fail to live up to high expectations, often because the supporting governance structures are insufficiently established or have become stagnant. Based on interviews with 153 blockchain executives and an analysis of publicly documented use cases, this article offers a guide for blockchain scholars and practitioners. Its framework highlights the coordination and control challenges that exist in blockchain governance contexts and presents four generic governance modes to address them: chief, clan, custodian, and consortium. Managers can use these governance modes as a basis for four strategic moves (connecting, isolating, loosening, and tightening) to navigate blockchain governance challenges

Enhancing the effectiveness of medical device incident reporting: final report of the EU pilot on the manufacturer incident reporting form (MIR form)

Aim of the report This report provides a final assessment by DG JRC of the 'EU MIR form pilot' project, concerning the use of nomenclature for manufacturer incident reporting. The purpose of this analysis is to exploit the submitted data in view of addressing the following key questions: 1. Is reporting of adverse events using nomenclature feasible and helpful? 2. Are existing nomenclatures relating to device problems and evaluations of causes adequate? 3. Is there a need for introducing new terms, e.g. to cover novel technologies? 4. What are the lessons learned from the pilot study in terms of international harmonisation of nomenclatures (IMDRF) and development of future reporting tools (e.g. EUDAMED)? Key findings This report focuses on the use of adverse 'event-type' and 'evaluation' terms which relate to problems with the medical device. The device-related terms were used in a 'Manufacturer Incident Report' form, which was designed for the pilot study, and was called the MIR pilot form. 786 forms, which were submitted by 13 manufacturers reporting from 15 European countries, were analysed. Concerning nomenclature usage, the report analyses whether incidents were reported adequately using (1) existing nomenclature (ISO/TS 19218), (2) newly introduced nomenclature (EDMA's IVD-related terms), and (3) newly proposed terms (by the participating manufacturers of the pilot study). The analysis has shown a number of important issues which concern five main topics: 1. Pilot data relate to approx. 50% of device categories on the market Due to voluntary participation, the submitted MIR pilot forms reflect only a certain proportion of medical devices on the market. This needs to be considered when interpreting and using the pilot data. 2. No participation of SMEs in the pilot project Additional bias may be due to (1) the absence of SME participation; and (2) a single manufacturer submitting >60% of the total number of forms (bias towards a particular device category). 3. Adequacy of term selection by manufacturers We assessed the adequacy of term use by comparing textual incident descriptions with the categorised terms chosen by reporters. It was based on a set of 100 randomly selected pilot forms representative of the pilot's overall device portfolio. Both, the event-type and evaluation terms chosen by manufacturers for reporting incidents were largely adequate. Moreover, the analysis shows that three choices per level to describe the incident (event-type terms) or final investigation (evaluation terms) appear sufficient. 4. Available terminology (ISO/TS 19218) is not fully adequate On the basis of the frequency of some proposed terms it appears that the existing ISO/TS 19218 terms are overall not sufficient. This is not surprising given the fact that the terms were derived from FDA's terminology in 2005 and have, since then, not been updated. To resolve the most frequently encountered issues in the analysis, the JRC has proposed several changes to terms used (cf. Fig. 18-24). 5. Proposals for new terms by manufacturers ISO/TS 19218 uses a 2-level hierarchical coding structure for reporting adverse events. Though the pilot study allowed for new proposals at these levels (level 1, 2), it was particularly designed for new proposals at an additional more granular third level. In line with this is the observation that the majority of new terms proposed concern level three terms. The analysis also showed that, although selection of existing terms was overall adequate, many of the new terms proposed by manufacturers are either redundant or do not reflect device problems but are, in fact, patient outcome terms. This clearly shows a need for reporters to have a better understanding of the terms and the reporting form used. Some of the confusion may stem from the simple fact that ISO's medical device problem terminology is called "Adverse Event Terms", i.e. seemingly suggesting that this nomenclature should be used to report adversity, i.e. clinical phenomena at patient / user level. In cases where level one event-type terms have been proposed, these related mainly (>80%) to the orthopaedic device category (cf. Fig. 13). It therefore appears that there is a need for a more elaborate nomenclature in this device category. Proposed terms that were deemed valid when compared with ISO/TS 19218 were subsequently compared with FDA's terms for device problems. This led to the identification of a number of proposed terms that could be proposed for incorporation into ongoing efforts in the development of a globally used nomenclature in the context of the work of the Adverse Event Terminology Working Group of IMDRF. EDMA has proposed new terms to cover specific needs of reporting incidents with in vitro diagnostic medical devices (IVDs). These were meant to complement the ISO/TS 19218 terms, and several of them have been used in the submissions. A closer look at the definitions of some of EDMA's terms does, however, show that they would need to be revised, for example four terms (corresponding to level 2) have identical definitions adding unnecessary ambiguity to their use. The report also provides in Annex I a summary of agreements reached during the workshop and topics that remain to be addressed when developing future tools for incident reporting including concerns voiced by stakeholders. Annex I also considers additional reflections made after the workshop and provides, as a synthesis, key recommendations for a way forward. In summary, this report shows that the outcome of the 'EU MIR form pilot' project has proven to be extremely useful for three reasons. 1. It confirmed the general feasibility of categorised reporting of incidents by manufacturers. 2. It identified inadequacies of the existing ISO/TS 19218 nomenclature suggesting the need for increased efforts into the development of freely available, scientifically and technically satisfying and, from a regulatory and end-user point of view, adequate nomenclature for adverse event reporting of incidents and events also in the pre-market space. 3. It led to the proposal of several potentially useful terms in view of future developments of nomenclature for incident / adverse event reporting.JRC.F.2-Consumer Products Safet

Impact Of Intranets On Employee Perception And Behavior: A Case Study In A UK Bank

This paper deals with the question of how intranets impact on employee perception and behavior. The study uses a five year longitudinal study following the evolution of an intranet in a UK bank to analyze how it changed the relationships between employees and between managers and employees. The discussion integrates two different research domains, the intranet literature and the organizational trust literature. Qualitative data is presented to show the impact of intranets on communication, sharing of information, collaboration, organizational bonding, feeling of empowerment, power distance and sense of closeness. The discussion uses three metaphors to convey the key findings: The Plumbing System, the Iconic Building and the Soap Opera. The main contribution of this paper is in using constructs from the organizational trust literature to better understand how intranets impact on employee perception and behavior

Trade induced growth impacts of corporate entry in the food sector: A case study of fruits and vegetables sub sector in the Punjab State of India

Study indicated that the entry of corporate sector in the Punjab State is both in retail and wholesale trade of the fruits & vegetables sub sector. At the organized retail stores these companies have provided its consumers a single window service for the various product assortments while within the fruits & vegetables category (have minuscule scales) widened the product selection choices. Corporate entry in wholesale trade has linked several product specific production belts with medium to high income consumers through various market segments such as organized stores, traditional wholesale/retail markets and the food service. These companies have also provided product variety through imports while opportunities for crop diversification towards higher value crops through exports. In the fruits & vegetables sub sector companies engaged in the retail trade have adopted for short to medium while those in wholesale trade for medium to long-term more sustainable approaches for the sourcing of supplies to build up competitive advantages. This has started generating growth in the Punjab state that has manifested in terms of higher incomes for as the partner farmers and creation of employment for the skilled, semi-skilled and unskilled manpower throughout the supply chain. As the market sizes of these companies expand and diversify in the domestic/global markets it shall enhance growth thereby magnify its impacts. --Fruits & vegetables trade,corporate groups,growth

Organisational Policy and Shop-floor Requests in Design: Visualisation of the Argumentation behind an Information System for the Swedish Trade Union Movement

Design Rationale is an approach to the design of information systems which highlights the underlying argumentative reasoning and documentation of design decisions. The Argumentative Design (ArD) method extends Design Rationale to address organisational problem identification and the formulation of needs to be supported by the system. In this study, ArD was further modified and then applied in the early phase of the design of an information system for shop stewards in the Swedish trade union movement. The application of ArD revealed that both similarities and significant discrepancies existed between top-management information technology strategies and shop-floor needs, and that the strategies involve fundamental power-relation issues in terms of centralisation versus decentralisation and individualism versus collectivism. It is suggested that ArD can be of general benefit in early design phases by eliciting fundamental organisational issues and by illustrating what impact chosen information technology solutions may have on organisations. The study is of value for other unions wishing to learn from the Swedish experience and the modified ArD approach can also be used in other contexts where several interest groups are to be satisfied by a system

Network structural properties for cluster long run dynamics. Evidence from collaborative R&D networks in the European mobile phone industry

In a recent literature, the structural properties of knowledge networks have been pointed out as a critical factor for cluster structural changes and long run dynamics. Mixing evolutionary economic geography and network-based approach of clusters, this contribution aims at capturing and discussing the particular influence of hierarchy (degree distribution) and assortativity (degree correlation) in the innovative capabilities of clusters along the industry life cycle. We test our propositions in the field of the mobile phone industry in Europe from 1988 to 2008. We use EPO PATSTAT and OECD REGPAT to capture cluster trends, and R&D relations from European Framework Programs to capture knowledge networks and their evolving structural properties. Our findings provide new insights to understand the organization of clusters over time in order to perform along the industry life cycl

The American Corporation in the Twenty-First Century: Future Forms of Structure and Governance

The last few decades have ushered in many changes and challenges to the American corporation. Foremost among these is the Technetronic or Information Revolution, which paradoxically not only shrank the world (the macrocosm) into a global village, \u27 but at the same time expanded the individual human experience (the microcosm) exponentially. This dual action has created the new Global Economic Order, as well as the sphere of customized industrial production

The American Corporation in the Twenty-First Century: Future Forms of Structure and Governance

This article focuses on corporate governance issues as they relate to the new technological developments and the issue of leapfrogging. I examine various theories about the new technologies and the changes in corporate governance that they may necessitate. I then assess and critique these theories in light of historical and other data. I suggest that our very concept of the corporation will be transformed by the Information Age. I also offer my own view as to the optimal forms of corporate governance that can equip American corporations with sufficient tools to win the accelerating competition anticipated for the next century. In presenting this solution, I also recognize the important role of human capital in the Information Age, and argue that this role will ultimately change the conceptual framework underlying our present system of corporate governance

e-Venture: The Making of 21st Century European Learning Regions

In: A.J. Kallenberg and M.J.J.M. van de Ven (Eds), 2002, The New Educational Benefits of ICT in Higher Education: Proceedings. Rotterdam: Erasmus Plus BV, OECR ISBN 90-9016127-9Within the context of the evolution of 'Europe of the regions' this paper examines the role of higher education in the information age. It contrasts two perspectives on contemporary society in relation to higher education. Ritzer's (1998: 151-163) Post modern perspective which positions McUniversity in the Consumer Society of mega-malls, fast food restaurants, television shopping networks and infomercials. And Postman's (1999) perspective, derived from the eighteenth century, which re-examines our values and calls for a 'future connected to traditions that provide sane authority and meaningful purpose.' Paradoxically, the world-wide information explosion and increasing global competition has resulted in the most enduring competitive advantage being created on the local level within the 'triple helix' (Etzkowitz & Leydesdorff, 2001), that is the emerging clustering of inter-connected firms, institutions of higher education and government (Porter 1998). A new feature of the triple helix is the increased need for higher education to connect and relate with industries and the government and exchange knowledge for funding. It requires the fostering of new partnerships and the adoption of new and better higher education strategies to identify potential 'complementors' with whom to co-evolve towards a value net, that generates a relation rent. The operation of the resulting system is e-Venture designed to support the rapidly emerging field of event management, a medium which responds to the needs of the consumer society and the values that provide meaningful purpose and contribute to the creation of cosmopolitan citizenship. The focus of the e-Venture project is on the critical linkage of both e-content in higher education and relationship management that enables the Triple Helix to support and realise ‘The Making of European Learning Regions'