Managing requirements for medical IT products

Higgins, S.A.; Laat, M. de; Gieles, P.M.C.; Geurts, E.M.

doi:10.1109/ms.2003.1159026

Cited by 11 publications

(6 citation statements)

References 5 publications

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“…Therefore, effective prioritisation and cost/impact assessment is needed to support the release planning task [2,23,33]. Moreover, the RE process needs to include procedures to capture and preserve this steady stream of requirements [16].…”

Section: Market-driven Requirements Engineeringmentioning

confidence: 99%

Requirements engineering challenges in market-driven software development – An interview study with practitioners

Karlsson

Dahlstedt

Regnell

et al. 2007

Information and Software Technology

131

127

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Section: Market-driven Requirements Engineeringmentioning

confidence: 99%

Requirements engineering challenges in market-driven software development – An interview study with practitioners

Karlsson

Dahlstedt

Regnell

et al. 2007

Information and Software Technology

131

127

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“…The realization that requirements are often speciWed on diVerent levels of abstraction and in varying stages of reWnement has been recognized by others in both industry and academia [9,23]. We have conWrmed this during process assessment and improvement eVorts conducted at both Danaher Motion Särö AB and ABB Automation Technology Products [5].…”

Section: Related Workmentioning

confidence: 83%

A controlled empirical evaluation of a requirements abstraction model

Gorschek

Svahnberg

Borg

et al. 2007

Information and Software Technology

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“…Enhancing the management of requirement engineering processes of diagnostic imaging equipment is the research goal of the studies in [10]. The authors describe empirically validated improvements in processes that rely on continuous information flows and study the influence of the identified improvements in time-to-specification metrics.…”

Section: A Compliance With Regulatory Requirementsmentioning

confidence: 99%

On What Goes on With Goal-Oriented Healthcare Equipment Regulations: An Exploratory Case Study on the Diagnostic Imaging Equipment Industry in Brazil

Duarte

2020

IEEE Access

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Few economic sectors are more regulated than healthcare. Although excessive healthcare regulation is a bad thing, regulatory compliance may bring with it many benefits, such as market entry, product quality and availability, as well as access to tax rebates and financial incentives. Goal-oriented regulations, in particular, embody in their formulation specific propositions to maximize compliance benefits provided the achievement of public policy goals. In this paper, we develop an in-depth study of goal-oriented healthcare equipment regulations. We use expert knowledge and process-mining techniques to investigate what goes on with regulatory compliance and with the benefits obtained by equipment manufacturers when the healthcare equipment regulation is goal-oriented. We present here a multi-company exploratory case study on the variability of mean times-to-benefit after compliance and on regulatory process improvement, focused on the diagnostic imaging equipment segment and the regulatory context in Brazil. We show that, in some cases, mean times-to-benefit depend on the compliance of different categories of diagnostic imaging equipment with technical requirements found in the applicable norms. Moreover, we present process improvement cases elicited during goal-oriented regulatory process analysis and modeling activities. Our study illustrates the usefulness of applying expert knowledge and process mining techniques together in the healthcare equipment domain. It also suggests that healthcare equipment product-management practices should be concerned not only with analyzing and ensuring regulatory compliance but also with regulation dynamics. INDEX TERMS Diagnostic imaging equipment, regulatory requirements, goal-oriented regulation, healthcare processes, public policy.

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Managing requirements for medical IT products

Cited by 11 publications

References 5 publications

Requirements engineering challenges in market-driven software development – An interview study with practitioners

Requirements engineering challenges in market-driven software development – An interview study with practitioners

A controlled empirical evaluation of a requirements abstraction model

On What Goes on With Goal-Oriented Healthcare Equipment Regulations: An Exploratory Case Study on the Diagnostic Imaging Equipment Industry in Brazil

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