In the face of increasing global competition, there are four overriding challenges facing the Life Science industry today.
Organizations are under increasing pressure to simultaneously increase productivity and reduce waste.
Life Science companies operate in a competitive global marketplace being intensified by expiring patents, new product introductions, price pressure from generics and concern over rising healthcare expenditure.
Modernization combined with digital transformation is one of the biggest challenges today. Better use of data and analytics is needed to drive a continual cycle of improvement that improves production capacity, increases availability, reduces downtime, improves processes and decision making, and eliminates waste.
Stability and meeting production targets are no longer enough. Time to market is critical and companies have to be able to react and adapt quickly.
The ability to respond quickly to opportunities and challenges is now a key success factor within all areas of Life Science activities.
Whether driven by market dynamics, company strategy or short-term targets, management are demanding greater flexibility from operations. An agile approach is needed to meet production changes (e.g. product value, potency and volumes), implement new technologies, increase delivery precision, and shorten time to market.
Quality systems need to be established and managed in a way that meets requirements and strengthens operations.
Life Science companies operate within a stringent regulatory framework, which is subject to constant change and is strictly controlled by different national and regional authorities.
It is a complex environment where patient safety is paramount. Quality systems need to support GxP guidelines, ensure compliance with regulations and facilitate regulatory inspections. Being successful requires an integrated and pragmatic risk-management approach that strengthens operations and optimizes the use of resources.
Around 80% of change programs fail to meet expectations. Ensuring change delivers sustainable value is today’s key business challenge.
Meeting the combined challenge of efficiency, flexibility and quality requires change in some form. Implementing change, however, is only half the battle. Ensuring it results in greater sustainable value is the real challenge.
Change is almost never a straight journey from A to B. Succeeding with value-driven change requires taking a persistent, stepwise journey along a winding path. It requires insight and an integrated, flexible approach that combines people, processes and technology.