A Case Study on Software Risk Analysis in Medical Device Development

2012 ◽  
pp. 143-158 ◽  
Author(s):  
Christin Lindholm ◽  
Jesper Pedersen Notander ◽  
Martin Höst
Keyword(s):  
Risk Analysis ◽  
Medical Device ◽  
Medical Device Development ◽  
Device Development ◽  
Software Risk

A case study on software risk analysis and planning in medical device development

2013 ◽  
Vol 22 (3) ◽  
pp. 469-497 ◽  
Author(s):  
Christin Lindholm ◽  
Jesper Pedersen Notander ◽  
Martin Höst
Keyword(s):  
Risk Analysis ◽  
Medical Device ◽  
Medical Device Development ◽  
Device Development ◽  
Software Risk

scholarly journals A Case Study of Physician Interaction in the Medical Device Development Process

2010 ◽  
Vol 4 (2) ◽  
Author(s):  
Lauren Aquino Shluzas ◽  
John H. Linehan ◽  
Larry J. Leifer
Keyword(s):  
Medical Device ◽  
Risk Perceptions ◽  
User Interaction ◽  
Team Members ◽  
Medical Device Development ◽  
Device Development ◽  
Wide Range ◽  
Contextual Framework ◽  
Case Based

A multiphase empirical field study is being conducted at Stanford University to examine the process of physician interaction during medical device development. The initial component of this study involved creating an analytic framework for case-based research that provided a conceptual guide for the pilot case study documented in this paper. The pilot case study examined the process of engaging physicians in medical device development within the context of an entrepreneurial device company. The methods used in this study included a combination of interviews with cross-functional team members, a quantitative survey, and the collection of archival data. Data analysis first involved documenting physician-developer interaction practices that had been used within the company, from needs finding to post-market surveillance, across multiple product generations. Leading development factors involving physicians that had influenced the company’s clinical and financial outcomes were next identified. The case study illustrated the importance of working with and understanding the user experiences of a wide range of physicians when developing new products. The case also captured how physician interaction influences risk perceptions toward medical device performance for both surgeons and developers. The case likewise highlighted the benefits of a systems-based design approach, as opposed to designing products for a single technical end point. From a methodological perspective, the case study revealed the importance of examining user interaction within a contextual framework, as opposed to an isolated examination of input and output variables. The study presented in this paper has provided a foundation for future case-based analyses regarding the process of physician interaction in medical device development.

scholarly journals A user-centred approach to requirements elicitation in medical device development: A case study from an industry perspective

2012 ◽  
Vol 43 (1) ◽  
pp. 184-190 ◽  
Author(s):  
Jennifer L. Martin ◽  
Daniel J. Clark ◽  
Stephen P. Morgan ◽  
John A. Crowe ◽  
Elizabeth Murphy
Keyword(s):  
Medical Device ◽  
Requirements Elicitation ◽  
Medical Device Development ◽  
Device Development

Evaluation of success factors for medical device development using grey DEMATEL approach

2017 ◽  
Vol 12 (2) ◽  
pp. 204-223 ◽  
Author(s):  
Milind Shrikant Kirkire ◽  
Santosh B. Rane
Keyword(s):  
Sensitivity Analysis ◽  
Medical Device ◽  
Success Factors ◽  
Future Research ◽  
Content Type ◽  
Medical Device Development ◽  
Active Involvement ◽  
Device Development ◽  
Medical Device Manufacturers

Purpose Successful device development brings substantial revenues to medical device manufacturing industries. This paper aims to evaluate factors contributing to the success of medical device development (MDD) using grey DEMATEL (decision-making trial and evaluation laboratory) methodology through an empirical case study. Design/methodology/approach The factors are identified through literature review and industry experts’ opinions. Grey-based DEMATEL methodology is used to establish the cause-effect relationship among the factors and develop a structured model. Most significant factors contributing to the success of MDD are identified. An empirical case study of an MDD and manufacturing organisation is presented to demonstrate the use of the grey DEMATEL method. Sensitivity analysis is carried out to check robustness of results. Findings The results of applying the grey DEMATEL methodology to evaluate success factors of MDD show that availability of experts and their experience (SF4) is the most prominent cause factor, and active involvement of stakeholders during all stages of MDD (SF3) and complete elicitation of end-user requirements (SF1) are the most prominent effect factors for successful MDD. A sensitivity analysis confirms the reliability of the initial solution. Practical implications The findings will greatly help medical device manufacturers to understand the success factors and develop strategies to conduct successful MDD processes. Originality/value In the past, few success factors to MDD have been identified by some researchers, but complex inter-relationships among factors are not analysed. Finding direct and indirect effects of these factors on the success of MDD can be a good future research proposition.

Recent Statistical Contributions to Medical Device Development

2014 ◽  
Vol 48 (1) ◽  
pp. 90-97 ◽  
Author(s):  
Brian L. Wiens ◽  
Theodore C. Lystig ◽  
Scott M. Berry
Keyword(s):  
Medical Device ◽  
Medical Device Development ◽  
Device Development

scholarly journals The medical device development landscape in South Africa: Institutions, sectors and collaboration

2017 ◽  
Vol 113 (5/6) ◽  
Author(s):  
Kylie de Jager ◽  
Chipo Chimhundu ◽  
Trust Saidi ◽  
Tania S. Douglas ◽  
◽  
...  
Keyword(s):  
South Africa ◽  
Medical Device ◽  
Centrality Measures ◽  
Collaboration Network ◽  
Medical Device Development ◽  
Device Development ◽  
Healthcare Needs ◽  
Scientific Papers ◽  
Future Policy ◽  
Local Healthcare

A characterisation of the medical device development landscape in South Africa would be beneficial for future policy developments that encourage locally developed devices to address local healthcare needs. The landscape was explored through a bibliometric analysis (2000–2013) of relevant scientific papers using co-authorship as an indicator of collaboration. Collaborating institutions thus found were divided into four sectors: academia (A); healthcare (H); industry (I); and science and support (S). A collaboration network was drawn to show the links between the institutions and analysed using network analysis metrics. Centrality measures identified seven dominant local institutions from three sectors. Group densities were used to quantify the extent of collaboration: the A sector collaborated the most extensively both within and between sectors; local collaborations were more prevalent than international collaborations. Translational collaborations (AHI, HIS or AHIS) are considered to be pivotal in fostering medical device innovation that is both relevant and likely to be commercialised. Few such collaborations were found, suggesting room for increased collaboration of these types in South Africa.

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