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European Pharmaceutical Contractor

V Model for Victory

Following a compliant development process reduces the time to benefit, argue Charlie Dean and Hein Smit Sibinga of PA Consulting

Consider the following questions. “How many times have we seen requirements being drawn up during or at the end of the development process?” “How many times has this uncovered ‘new’ requirements?” “How many times have these ‘new’ requirements really been new?” “How many times has this caused significant and unexpected project delay?” The answer to all these questions is usually ‘often’, but why?

From PA’s experience we find that design teams are under immense time pressure to produce a working prototype. These teams generally feel that everyone understood what was trying to be achieved and therefore management of the requirements seemed unnecessary and highly bureaucratic. This is compounded by the fact that during development, the design changes so often, that the documentation becomes a real burden. Discipline in adhering to a well-defined development procedure enables compliance from start to finish. It becomes a key factor in navigating complex development projects.

Effective implementation is crucial and requires buy in from all the stakeholders. From our experience companies rarely have the time or money to do things right the first time, but invariably find the money to do them twice.

One well known structured method is the V model (see Figure 2). This provides a framework to build traceability for the crossfunctional team. The backbone of the V model is a scope and requirements driven development process, steered by solid programme management principles. Although application is challenging, effort upfront reduces overall risk and saves time. The key is to regard it as accelerating development rather than a documentation constraint.


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Charlie Dean is a Consultant for the Global Technology practice of PA Consulting. He is a Chartered Engineer, working primarily in the pharmaceutical and medical device industries, helping clients develop and launch innovative new products. Since moving from the UK to the US, his primary focus has been on improving the efficiency and effectiveness of new product development teams, from concept generation through validation, clinical trials to launch.

Hein Smit Sibinga is one of a team of engineers, consultants and scientists who have pioneered pragmatic approaches to delivering complex programmes for pharmaceutical, biotech and medical device companies. He focuses on reducing programmes down to basic elements and driving these cross-functional decisions which allow organisations to move forward. As a Mechanical Engineer, his 17 years of experience includes development, operations regulatory and quality support, marketing, CMC, program management and technology transfer. Actively using Six Sigma, he directs teams to minimise rework and block risks from turning into problems. He has taken multiple products from inception through to qualification and validation through to commercialisation.

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Charlie Dean
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Hein Smit Sibinga
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