The need: Providing life-saving, high quality products from production to service efficiently
Physicians, hospitals and care providers across the world rely on high quality drugs and medical devices to deliver exceptional care. With growing amount of patient needs and increasing global regulations to fulfill, manufacturers of life sciences products need to improve operational efficiency levels, and they also need to increase agility to stay compliant with ever-changing and upcoming new legal requirements.
In order to achieve operational excellence, flexibility and compliance, collaboration between R&D, supply chain planning, production, quality management, maintenance, distribution, marketing, field services and regulatory affairs has to be tightened. Further, real-time visibility into operational processes, asset status and risk indicators can improve performance significantly.
The strategy: Using technology innovations to change the game
With business networks, in-memory technology and the Internet of Things (IoT), medical device companies can not only streamline processes within R&D, supply chain management, manufacturing and field services. They can also improve global collaboration between these departments internally and with external partners. This leads to improved productivity and product quality while legal and regulatory requirements can be fulfilled more easily, including Good Manufacturing Practices (GMP), the Drug Quality and Safety Act (DQSA), and Unique Device Identification (UDI).
What would be the right technical approach to start with? The first step would be to build a foundation by replacing a large number of legacy applications with one single platform that spans from R&D to services. It should enable real-time analytics, include predictive scenario capabilities, and support collaboration through the integration of different Cloud solutions. Other requirements the platform should fulfill is reliability, flexibility and scalability.
With that, optimized operations can be achieved from R&D to services through real-time analysis and transactions, productivity can be increased through decreased documentation efforts, compliance cost can be reduced through harmonization and collaboration can be simplified.
An Example: First successes in manufacturing by a medical device manufacturer
A large medical device company streamlined their IT landscape and implemented a solution for real-time analytics and reporting. Positive results could be measured pretty quickly: they reduced manufacturing quality reviews from 30 minutes to 10 minutes per batch, and 99.9% of at least 100,000 shipments per month are compliant with DQSA regulations without any manual corrections. They gained the visibility, control, agility and scalability needed to serve growing demand from patients globally. They also could deliver the highest quality products much more efficiently, leaving more time to focus on customers and on innovation.
More process innovations to be expected
The digital transformation will impact all life sciences processes, not only in R&D, supply chain management, manufacturing, but also in the way life sciences manufacturers interact with wholesalers, payers, physicians, and patients. The possibilities are larger than we might imagine today. New ideas on how to run life sciences businesses in a smarter way will also be inspired by other industries, such as consumer products, high tech and chemicals. Therefore, SAP hosts a yearly event where all these industries meet to share best practices and latest innovations. Want to learn more? Attend the SAP Manufacturing Industries Forum 2016 on June 14-15 in Lombard, IL. For details, please visit the forum’s website.