Rapid Pattern-Oriented Scenario-Based Testing for Embedded Systems

2011 ◽  
pp. 222-262 ◽  
Author(s):  
Wei-Tek Tsai ◽  
Ray Paul ◽  
Lian Yu ◽  
Xiao Wei
Keyword(s):  
Medical Devices ◽  
Rapid Test ◽  
Regression Testing ◽  
Safety Critical ◽  
Industrial Sites ◽  
Test Script ◽  
Software Changes ◽  
Development Processes ◽  
Key Features ◽  
Agile Process

Systems change often, and each change requires reverification and revalidation. Modern software development processes such as agile process even welcome and accommodate frequent software changes. Traditionally, software reverification and revalidation are handled by regression testing. This chapter presents a pattern-oriented scenario-based approach to rapidly reverify and revalidate frequently changed software. Key features of this approach are (1) classifying system scenarios into reusable patterns; (2) application of a formal completeness analysis to identify missing scenarios; (3) identifying scenario patterns (SPs) and corresponding verification patterns (VPs) and robustness patterns (RBPs); (4) rapid test script generation by reusing test script templates. This approach is also compatible with formal approaches such as model checking. This approach has been used at industrial sites to test safety-critical medical devices with significant savings in cost and effort. The chapter presents several examples to illustrate the effectiveness and efficiency of this approach.

The Crowd, the Cloud and Improving the Future of Medical Device Innovation

2014 ◽  
Vol 17 (1) ◽  
pp. 13-20
Author(s):  
Marco Huesch ◽  
Robert Szczerba
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Business Models ◽  
Regulatory Environment ◽  
New Approach ◽  
Current State ◽  
Development Processes ◽  
Reducing Costs ◽  
Innovation Practices ◽  
Start Ups

Abstract Barriers and delays to medical device innovation are often solely attributable to the regulatory environment instead of both the current state of innovation practices and product development processes in the industry. Increasing the pace of innovation while reducing costs requires the creation of a new approach that fits both established medical device corporations as well as entrepreneurial start-ups. In this commentary we advance the concept of innovation platforms to facilitate ideation in the medical device space. Such platforms could also allow the full health benefits from individual medical devices to be reaped, by overcoming interoperability concerns through simulation and credentialing. Given the dramatic benefits of medical device success, such non-traditional business models for development may be potential solutions for industry, users and regulators.

scholarly journals CONTEXT-SPECIFIC AGILE PROCESS DESIGN TO SUPPORT THE PLANNING OF PRODUCT DEVELOPMENT PROJECTS

2020 ◽  
Vol 1 ◽  
pp. 491-500
Author(s):  
J. Baschin ◽  
T. Huth ◽  
T. Vietor
Keyword(s):  
Product Development ◽  
Process Design ◽  
Project Planning ◽  
Distributed Teams ◽  
Development Projects ◽  
Development Processes ◽  
Process Execution ◽  
Agile Process ◽  
Context Specific ◽  
High Degree

AbstractModern products are often developed in local distributed teams involving various engineering domains. As a result, product development processes are characterized by a high degree of complexity and individuality. However, the project context is often not integrated into the project planning, which can lead to uncertainties in the processes. In addition, reflection does not take place adequately in process execution. Therefore, this paper presents a concept for agile process design that enables reducing uncertainties based on context-specific reflections and adapting the processes.

scholarly journals Lessons learnt from IEC61508 software assessments

2018 ◽  
Author(s):  
R H Campbell ◽  
R M Phillips ◽  
C Allsopp
Keyword(s):  
Software Development ◽  
Safety Management ◽  
Critical Systems ◽  
Specific System ◽  
Safety Critical ◽  
Lessons Learnt ◽  
Variable Environments ◽  
Management Processes ◽  
Development Processes ◽  
Safety Critical Systems

With the advances in platform automation and the publication of NAN 06/2018 - Software integrity (previously NAN 02/2016), there has been a drive towards compliance to IEC61508 in the naval domain.  Over the last few years Frazer-Nash have conducted a number of Original Equipment Manufacturer (OEM) audits and assessments to determine whether the requirements for safety critical software development in IEC61508 have been followed for a specific system or if a supplier's development processes are in line with the aspects of the standard which focus on software development, namely Part 3 - Software requirements.  These audits have revealed some common problems across suppliers and highlighted that IEC61508 requires both organisational safety management processes as well as those specific for a system. As the naval industry looks to adopt the processes outlined in IEC61508 or an equivalent standard, this paper will present some of the lessons learnt from our IEC61508 assessments and offer some advice for new and existing suppliers.  The paper will highlight some of the issues going forward as the development of safety critical systems is not a new concept but the specific factors arising in the naval domain from operating in variable environments, changing safe state conditions and ever increasing function complexity, present a key challenge. Included in the paper will be a view on how other industries are tackling IEC61508 compliance and where the strategies that have been adopted may be applicable in the naval domain as well as new tools which could assist with the development of safety critical systems. 

scholarly journals Is User Experience a suitable goal in the development of medical devices?

2021 ◽  
Vol 7 (2) ◽  
pp. 807-810
Author(s):  
Matthias Reisemann ◽  
Angelina Krupp
Keyword(s):  
User Experience ◽  
Medical Devices ◽  
Product Life Cycle ◽  
Medical Technology ◽  
Consumer Products ◽  
International Standards ◽  
Guiding Principle ◽  
Device Development ◽  
Regulatory Affairs ◽  
Development Processes

Abstract Product development in medical technology is largely governed by Regulatory Affairs. In contrast, for consumer products Human-Centred Design (HCD) is the guiding principle. Both approaches are laid down in international standards and overlap many aspects such as procedure, applied methodologies and development activities. For medical devices patient safety and therefore risk management is the guiding development goal. In HCD the focus lies on User Experience (UX), a positive experience throughout the entire product life cycle. The question arises whether UX could play a more important role in medical device development, particularly considering the similarities of the two development processes

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