Historically, product designers and engineers typically viewed product regulations and standards compliance as imposed on them by quality assurance departments, to limit their freedom as designers and spoil the product development party. Product developers typically held-off regulatory considerations until later in the development process and then undertook costly scrambles to recover designs and documentation from regulatory pit-falls and hurdles – but how times have changed!
Many product regulatory compliance frameworks have now matured to the point that they are not only directly driving innovation in products and product development processes but are actually providing astute system designers and product development professionals with exciting new opportunities to reduce product costs, development costs, and improve time-to-market.
Some product regulatory frameworks are more mature than others and there is clear tested leadership coming from a few product sectors that will ultimately influence others. As detailed regulatory frameworks unfold regulators and standards bodies are not only looking to harmonised approaches across different sectors but are actually embracing the potential of wider innovative product development techniques such as Lean and Agile.
Effective product regulatory compliance driven innovation provides greater focus at early stage product development concepts and architectures enabling product cost reductions and in many cases considerable reduction in product development costs and delivery timescales. Good regulatory compliance and risk management strategies are key to successful product innovation. It’s no longer just about end product compliance, good compliance management shapes the product concept and architecture and directly adds value from early in the product development lifecycle.
The application of Lean principles to product regulatory and risk management is an example of innovative product development methods, where focus on identification and elimination of project waste provides direct cost benefits within the product and across the product development lifecycle. Product regulatory compliance and risk management requirements have become key front-end drivers for product innovation and development. Companies are not just accountable for the end product regulatory compliance, compliance requirements are actually directly driving the way product innovation happens.
Sustainability (environmentally-conscious product design) driven innovation provides an alternative and exciting new focus for product designers and engineers and is generating proven product cost reductions and business revenue benefits. Global regulatory changes are driving product development companies to improve the environmental performance of their businesses and products. The medical electronics sector is a test case for environmentally-conscious product design from which other industry sectors can learn. Companies need to develop effective Eco-Innovation product development strategies and processes that respond to global Eco-Design legislation and remain compatible with the combined complexities of product regulatory and risk management strategies – but where there is change there is clear opportunity!
To find out more about how Good Product Regulatory Compliance Management can help your company, please contact us now.