Product family engineering and variability management in a regulated
environment.
Philips Healthcare links clinical expertise with human insights to create solutions that bring added value to the
entire healthcare cycle - from preventing disease to screening, diagnostics, treatment and aftercare - at home as
well as in the hospital. The Business Information Unit interventional X-Ray develops and maintains minimally
invasive X-ray solutions that offer diagnosis and treatment of cardiovascular disease. Philips is market leader in this
domain.
The Healthcare industry is a regulated environment in which rules and laws need to be followed for the end goal:
patient safe diagnostics and treatments. To cope with the complexity of the systems, demand on flexible product
setup (configurations) and the focus on costs in public Healthcare, smart solutions need to be implemented that
support patient safety and the demands on Philips products. One promising solution is product family engineering
and variability management. Product family engineering is based on working with configurations, exchange of
components or parts, parallel development of software, re-use and innovation. However pfe and variability
management are areas with little standardization and best practice implementations. BIU IXR is in need of a clear
definition and approach in working with product families and variability management. This is a challenging
assignment that requires (extensive) research, cross country collaboration and collaboration with companies in the
rail, aerospace and automotive domain (as part of the EU Artemis Crystal Project - http://www.crystalartemis.eu/).
Crystal, an acronym for Critical System Engineering Acceleration, is a European subsidized joint undertaking that
takes up the challenge to establish and push forward an Interoperability Specification (IOS) and a Reference
Technology Platform (RTP) for model-driven development tooling as a European standard for safety-critical
systems. In order to reach this goal, Crystal is driven by real-world industrial use cases from the automotive,
aerospace, rail and health sector, with the support of engineering tool vendors.
Outline
Traditionally, products were developed according a sequential approach. A product is being
developed and as soon as the product development reached the later stages of its
development, a new project was initiated. Growing complexity of the systems lead to the first
needs for a more parallel approach and with it came the need for integration of subsystems into
a system. With the introduction of software the whole approach needed redefinition, agile way of
working, multiple software teams handling the increasing demand of software features. The last
complexity factor is today’s market where shorter time to market is needed to speed up
innovation and handle price reducing demands. This all translates into variants, product families
and configurations and configuration management.
The setup of the system can be devided into 3 major blocks:
Mechanical parts (most important variability aspect for Philips Healthcare is hardware
configuration of the system: 1 C-arm versus 2 C-arms, 1 large monitor versus 4 or 6
smaller monitors. operating or non-operating table etc. )
Electrical parts (smallest need for variability management, component redesigns)
Software parts (features, incremental development, etc.)
Besides identifying the need for variability management on components, development is done
according the V-model. The V-model is a waterfall based approach. In today’s world the focus is
more and more on incremental development to handle complexity and rapidly changing needs
of internal and external customers. This is especialy visible in software development.
As a prestudy to investigate the variability management needs a study has been done in one of
the subsystem teams that creates software to support medical treatment with the use of the
system. The study focuses mainly on handling requirements and test cases on changing
features, developed in incremental and paralell approaches:
With the parallel development comes the need to merge activities from a branch to a baseline.
In most of our process this remains a manual action which is, at best, supported by tooling. The
application used to manage the requirements and test cases for this study is HP Application
Lifecycle Management 11 with the following setup:
Situation:
Working on 2 parallel releases on the same requirements and tests
Requirements and tests reused from release x to release x+1
Work is done in both projects at the same time
When release x is done, changes of x should be merged into x+1
Challenge:
How to manage/control the changes in requirements and testcases happening in parallel
in both releases using tools
Complexity
In an end to end view a requirement is created for the product family. As soon as a specific
release has been defined the requirements process will have to assign the requirements that
are continued, changed, removed and added in relation to the defined predesessor or product
family, basically creating a branch from the product family main line / baseline. For test cases
the same activities need to be executed aswell as the traceability with its changes between the
requirements and testcases (full coverage):
White = unchanged
Green = added
Yellow = changed
Red = removed
Your responsibilities
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Work according a planned approach
Research product family engineering and variability management with a focus on IXR products and the
healthcare industry (determine scope)
Interview relevant stakeholders and identify the main requirements for a conceptual model.
Create a concept and execute a “proof of concept” (t.b.d.)
Present (and preferably demonstrate) your progress to relevant stakeholders at your project milestones.
Create a report with the research results and execution results
Project & Supervision:
research