The life science industry is rapidly expanding. The global medical device market share is positioned to be valued at $671.49 billion by 2027 and the global pharmaceutical market was valued at $1.27 trillion this past year.
Many of these medical device manufacturers, pharmaceutical and biotech companies are an essential gear in the process of the life sciences industry, providing life-saving technology and medicine to patients who depend on it for quality of life.
However, the majority of these businesses face challenges in achieving the flexibility and scalability required to bring invaluable products and medication to market.
Common Barriers Faced by the Life Science Industry
Legacy Systems Operate in Silos
Companies that manufacture and distribute essential products require powerful systems that handle financials, order processing, management and fulfillment, human capital resource management, product life cycle management, software and process validation, and more. Yet, according to a Deloitte study, only 65 percent of global life sciences manufacturers have implemented data modernization ERP systems.
When systems operate separately, they require new staff to train employees on each program. Additionally, data does not seamlessly update across all systems, meaning operations rely on outdated, conflicting, and inaccurate data for crucial decisions. For those who still operate in data silos, they often experience diminished productivity, innovation, collaboration, communication, and trust.
Manual Data Entry Is Time Consuming and Costly
Companies that manufacture and distribute essential products require powerful systems that handle financials, order processing, management and fulfillment, human capital resource management, product life cycle management, software and process validation, and more. Yet, according to a Deloitte study, only 65 percent of global life sciences manufacturers have implemented data modernization ERP systems.
When systems operate separately, they require new staff to train employees on each program. Additionally, data does not seamlessly update across all systems, meaning operations rely on outdated, conflicting, and inaccurate data for crucial decisions. For those who still operate in data silos, they often experience diminished productivity, innovation, collaboration, communication, and trust.
Systems Do Not Support a Compliant Environment
Without the right systems in place to manage compliance, staff can be easily overwhelmed by ever-changing rules and regulations. New FDA requirements for software and operations as well as the Code of Federal Regulations (CFR) all play a role in compliance.
If businesses fail to comply, the FDA will inspect and issue a public violation documenting the concerns and requiring corrective actions within a specific time frame. If corrective actions are inadequate, the company could face prosecution or civil penalties.
Without systems that update according to regulatory changes, businesses risk noncompliant reporting and confusing audit trails, placing them at risk for FDA inspection and legal repercussions.
Unorganized Inventory Tracking Produces Error and Confusion
There are new unique device identification (UDI) standards for packaging and labeling items and new requirements for enhanced supply chain visibility. Such new standards are difficult to meet without implementing Internet of things technology (IoT), tracking and traceability, and serial identification technology.
Low Operational Efficiency Leads to Sluggish Time To Market
The average time to market is 10 years from invention, with an average of seven years spent in clinical trials and three years in development. When these essential businesses are unable to meet timelines due to inefficient management, time-consuming data entry, poor communication technology, or unorganized processes, the time to market is extended.
When drugs can’t get to market fast enough, manufacturers expend more resources and risk losing their advantage, and patients must once again prolong their wait for life saving drugs.
Having the Right Technology Makes You More Competitive
While current systems could be delaying innovation and time to market, Enterprise Resource Planning (ERP) software offers a solution to fill gaps in processes and scale with growth.
ERP software replaces siloed systems, operating as a financial management system, inventory management system, human capital resource management system, and more all in one solution. With the right ERP in place, your business can meet the rising industry demands by streamlining purchase data and order history to create, release, update and monitor work orders.
To learn more about selecting and implementing an ERP solution optimized and customized especially for your needs, contact our team of implementation specialists.
