on-demand webinar

Manufacturing product quality excellence: FDA and W.L. Gore collaboration


Manufacturing product quality excellence: FDA and W.L. Gore collaboration

Digitalization in manufacturing brings FDA and medical device and diagnostic firms together. The use of automation, information technology, and data solutions throughout the production process provides manufacturers advantages for minimizing errors, accelerating regulatory processes, increasing business value, optimizing resources, and reducing patient risk.

Register for our webinar and hear straight from the FDA and W.L. Gore what digitalization means for manufacturing product quality excellence. Learn valuable insights from the FDA about how they are shifting the perception of the agency of being a regulated space and its openness to collaboration with the manufacturing industry on the use of automation, information technology, and data solutions throughout the product lifecycle.

FDA strategic programs for medical devices

The FDA’s focus has always been on consumer safety, product efficacy, and regulatory compliance. The challenges that can occur in this space include a focus on meeting regulatory requirements versus adopting best quality practices. The agency sees the need to shift into operational excellence for MedTech through digitalization as a way to bring speed, control, and agility to its approach. Adopting this way of thinking will achieve quicker product innovation while maintaining product quality. The FDA sees the need to drive connections within quality systems to enable simplification, error-proofing, and a culture of rapid learning and continuous improvement. Their readiness to unleash innovation and improvements will be explored more thoroughly during this webinar hosted by Siemens.

Moving towards MedTech automation can help you achieve operational excellence

Medical device companies realize that smart manufacturing is the fastest way to achieve operational excellence in today’s global marketplace. With current world conditions adversely impacting markets and exerting unprecedented pressures on medical device manufacturers, the journey towards smart manufacturing is essential to remain competitive. Accelerating product innovation while at the same time controlling product performance has never been more important. MedTech automation allows you to be connected so you can get real-time data to see how things are shifting and performing – allowing for direct visibility to address problems immediately and continuously improve design. Adopting digitalization improves analytics and fosters error-proofing and paperless manufacturing. The end result is quality and responsiveness to issues, enabling a true total product lifecycle approach that improves the effectiveness and efficiency in the medical device community.

Achieve paperless MedTech by taking an operational excellence approach

The current use of paper-based processes in manufacturing increases the risk of poor quality, delays in time to market and higher costs. It will become increasingly challenging to keep pace with today's efficiency standards – let alone improve them – while maintaining compliance and safety. Industry leaders have evolved and implemented systems to automate manufacturing execution and manage data related to manufacturing processes as an electronic DHR (eDHR). Others have not yet evolved and are still using paper-based processes. As a result, they face challenges in scaling these systems, especially across globally distributed production facilities and when contracting with manufacturing partners. Join this webinar to grow your understanding of how moving away from paper into a virtualized data can open us up to what is most relevant and important in a traceable connected record.

Digitalization in the medical device industry and more is discussed in this webinar

You will learn:

  • FDA strategic programs: unleashing innovation and improvements
  • The value of digitalization: bringing speed, control and agility
  • Manufacturing product quality excellence leveraging on best-in-class MES
  • Safety and Innovation to improve the patient experience