Software Risk Analysis in Medical Device Development

2011 ◽  
Author(s):  
Christin Lindholm ◽  
Jesper Pedersen Notander ◽  
Martin Host
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

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.

Engineering Design Controls for Efficient Medical Device Development

2008 ◽  
Author(s):  
Lisa Henn
Keyword(s):  
Medical Device ◽  
Early Stage ◽  
Design Team ◽  
Medical Device Development ◽  
Device Development ◽  
Development Teams ◽  
Final Design ◽  
Design Proposal ◽  
Effective Design ◽  
University Setting

Early stage medical device development teams investigate many alternatives before selecting a final design proposal. The team must be able to retrace and reproduce successful designs and understand factors that underpin decisions that came before. This is especially important in a university setting due to the natural turnover on the team that is inherent in a successful research group. Effective design control provides this support to the design team.

Using Value Stream Mapping to Improve Medical Device Development

2013 ◽  
Vol 7 (2) ◽  
Author(s):  
Christopher Sweem ◽  
Stan Crossett ◽  
Lori Lucke
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Development Process ◽  
Value Stream Mapping ◽  
Medical Device Development ◽  
Value Stream ◽  
Device Development

In this paper a method is presented for using value stream mapping for improving the development process of medical devices. Two examples are shown to demonstrate the utility of this approach.

scholarly journals Spinal dura mater: biophysical characteristics relevant to medical device development

2018 ◽  
Vol 42 (2) ◽  
pp. 128-139 ◽  
Author(s):  
Sean J. Nagel ◽  
Chandan G. Reddy ◽  
Leonardo A. Frizon ◽  
Matthieu K. Chardon ◽  
Marshall Holland ◽  
...  
Keyword(s):  
Medical Device ◽  
Dura Mater ◽  
Medical Device Development ◽  
Device Development
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