Lean thinking for regulatory processes /
Abstract
Medical Device Manufacturers are faced with the challenge of changing regulations. Although
there are global harmonization efforts, regulations are become more complex and challenging
to manage. In the next few years’ manufacturers must manage significant transformations to
their organization due to the changes in regulations e.g. EU MDR and MDSAP. Not all
manufacturers are able to allocate sufficient resources to handle the changes. Instead of adding
more resources, manufacturers should look at smarter ways manage their regulatory processes.
While some companies are taking innovative steps to changing the way they manage regulatory
compliance, it is not something that is widely adopted in industry. There is hesitation to change
the way we work for fear of cost implications, project delay and even product withdrawals. In
Regulatory Affairs, the instinct may be to provide too much information, to cover all potential
scenarios. However, provided the risk to the patient is always at the forefront, over-information
may be to our detriment. Over-information is a form of waste, as it hides problems and
inefficiencies. There are many forms of waste in Regulatory processes e.g. over-information,
rework, waiting. If manufacturers look at smarter ways to manage the processes, they can
reduce the waste, reduce the process time, improve compliance and improve quality of data.
Lean tools are an excellent way to manage these process transformations. Using lean tools like
Kaizen, Just-in-Time, Kanban, Standardisation and 5S manufacturer can transform these
processes. Although there are challenges with using lean tools, the challenges can be overcome
through education and training of employees; commitment from management to drive the lean
culture; and through the correct use of lean tools. The medical devices industry is an innovative
and competitive industry. For manufacturers to stay competitive they must be able to bring their
products to market in quick and cost effective way. The manufacturer that uses lean tools on
their regulatory processes, will be able to get their products to market quicker than those who
don’t use lean. Not only does the use of lean tools benefit the manufacturer, it ultimately
benefits the patient, as new products will be brought to the market quicker than before.
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- Theses - Science ITS [171]