Recent studies in the MedTech sector show a dramatically widening gap in stock market performance that can be associated with good and poor quality and regulatory compliance. For decades, ‘poor design controls’ have been leading the list of the most frequent FDA-initiated recall reasons - accounting for more than a third. The ability to consistently meet regulatory requirements throughout the product lifecycle without compromising agility and speed of innovation has become a strategic differentiator.
However, achieving quality throughout the product lifecycle, from design to manufacturing to service, involves significant complexity. In our session, we will discuss how the ‘digital thread’, which is a continuous flow of data and information that connects all the stakeholders and activities, can help MedTech organizations automate regulatory compliance, and improve quality, and patient outcomes. We will answer questions and share insights on how the digital thread can enable:
- Better design and validation of products that meet the regulatory and customer needs
- More efficient and reliable manufacturing and testing of products that ensure compliance and traceability
- More proactive and effective service and maintenance of products that reduce downtime and enhance performance
- More collaborative and innovative product development and improvement that leverage data and feedback from all sources.
Takeaways:
- how the digital thread connects processes and functions
- how digital technologies increase patient safety
- why quality should be weaved into product data early