The Life Science sector is driven for the most part by innovation and growth. Behind these two driving forces is the complex world of the medication or medical device life cycle. Of course, companies that can ensure quality continually and collaboratively, satisfy regulatory compliance and mitigate risk at every stage of the life cycle have a competitive advantage. But what is needed to obtain this?
Understanding and facing challenges is the first step in obtaining this competitive advantage. Below are the four most important challenges the industry faces.
Challenges for Life Science companies
Organizations are under increasing pressure to simultaneously increase productivity and reduce waste.
Life Science companies operate in a competitive global marketplace, intensified by patent expiration, new product launches, price competition from generics and concerns over rising health care costs.
Modernization, together with the digital transformation, is one of the most significant challenges today. What is required is a better use of data, analysis and processes for a continuous cycle of improvements that enhance production capacity, increase availability, reduce downtime, improve processes and decision making, and eliminate waste.
Stability and meeting production targets are no longer enough. Time to market is critical and companies need to react and adapt quickly.
Today, the ability to respond quickly to opportunities and challenges is a key factor for success in all areas of Life Science company activities.
Whether driven by market dynamics, company strategy or by short-term targets, management requires greater flexibility in operations. An agile approach is necessary to meet changes in production (such as product value, power and volumes), implement new technologies, increase delivery precision and reduce time to market.
Quality systems need to be established and managed in a way that meets requirements and strengthens operations.
Life Science companies operate under a rigorous regulatory framework that is subject to constant change, and which is strictly controlled by different national and regional authorities.
It is a complex environment where patient safety is paramount. Quality systems need to support good practice guidelines, ensure compliance with regulations and facilitate regulatory inspections. Success requires an integrated and pragmatic approach to risk management that strengthens operations and optimizes resource use.
About 80% of change programs do not meet expectations. Ensuring that change delivers sustainable value is the main business challenge today.
Facing the combined challenges of efficiency, flexibility and quality requires change in some form. Implementing change, however, is only half the battle. Ensuring sustainable results is the real challenge.
Change is almost never a direct path from A to B. Value-oriented change requires a persistent and gradual journey along a winding path. An integrated and flexible approach that brings people, processes and technology together is indispensable for success.
Integrating quality and manufacturing
When it comes to technology in the Life Science sector today, many companies are investing in Enterprise Quality Management (EQM) software to enhance visibility and collaboration between functional areas that affect the product. In addition to quality issues, there are also supply chain optimization issues, which are obviously very relevant to the manufacturing environment, as well as the use of Manufacturing Operations Management (MOM) technology. MOM software solutions help ensure operational consistency while tracking production details and providing insights on performance.
We are starting to realize that many of the most successful Life Science companies devote a great deal of attention and invest heavily in integrating quality and manufacturing – between EQM and MOM.
By linking EQM and MOM, additional manufacturing data in processes is added to quality processes across the company, managed by EQM. This allows for a richer, more proactive quality management.
Cohesive integration and clear communication across different company sectors make a big difference in the final result. With this in mind, SoftExpert created an eBook especially for Life Science companies, whether pharmaceutical, medical device or biotechnology organizations. Read the eBook and learn how to transform the life science industry landscape and achieve business excellence.