Manufacturing Product Quality Excellence – FDA and Edwards Lifesciences #1

Siemens recently hosted a webinar featuring Cisco Vicenty, Program Manager for the Case for Quality at the FDA, and Robert Becker, Senior Director of Quality for Edwards Lifesciences. The focus of the webinar was on the collaboration between industry and the FDA, and how they are working together to create a trusted partnership that can advance the entire industry. Mr. Vicenty details the quality programs and latest findings at the FDA, and Mr. Becker reviews the transformational journey of Edwards Lifesciences as they engaged in the FDA’s program, and embarked on a digital transformation.

In this 2-part blog, we review some of the key discussions from the webinar.

The role of Quality in a medical device firm is very similar to the role of the FDA for the US government. They both work to achieve high consumer safety, product efficacy, and regulatory compliance. They face similar complexities of economic success while driving affordable innovation. And they serve stakeholders that include the consumers of medical solutions as well as employees, communities, and manufacturers. It is within this context that the FDA and Quality professionals can join forces to achieve their mutual objectives.

Mr. Vicenty shared some of the FDA’s perspectives on the need for product quality excellence. He stated the purpose of the FDA’s work very succinctly: to ensure that patients have access to high quality, safe, effective medical devices, of public health importance, first in the world. They seek to achieve quality from a patient-centric perspective, with value-driven assurance. They seek to accelerate innovation. And they seek to create an adaptive regulatory framework that can achieve these two objectives simultaneously.

Why the Case for Quality program at the FDA? Because the risk to patients from quality issues was hampering innovation in manufacturing and product development practices. While the industry was focused on meeting regulatory requirements, they weren’t necessarily adopting best quality practices. They weren’t seeing the investment in automation and digital technologies that could actually move the needle on proactive quality. The Case for Quality was developed to engage stakeholders across the industry, including manufacturers, patients, and regulators, to understand what was driving organizational performance, and how behavior could shift from a focus on meeting compliance requirements to a focus on producing higher quality products.

The collaboration has driven some key insights for the FDA. They recognize that their practices must support speed, increasing agility while enabling error-proofing and continuous rapid improvement. They needed to shift from an inspection mindset to a systems-enabled visibility and enforcement mindset that can respond to market drivers. They needed to avoid the creation of silos to make auditing easier – but rather drive more integration in the systems for manufacturers to collaborate, lean out the processes, and make it easy to do the right thing.

Mr. Vicenty described the Voluntary Medical Device Manufacturing and Product Quality Pilot program that was spawned from the Case for Quality work. Based on the maturity of the manufacturer’s quality practices, they can receive FDA adjustments to the compliance requirements that can accelerate their review and approval process, and allow them to shift resources to innovation and improvement.

The returns the FDA is seeing in the program are significant.

• For the FDA, 30-day notices consumed 15-22 FTEs, and site changes consumed 5 FTEs – all of which could be saved through the program and focused on other valuable initiatives.


• For the participating manufacturers, they are seeing some impressive results
  
  
  
  • $30M/month top line
  
  
  • $1.2M/year savings – 1 facility based on optimized processes and resource allocation
  
  
  • $140K in 10 days from reduced FDA audit cost
  
  
  
  


• Patients are benefiting as well:
  
  
  
  • 11 product quality improvements at one facility to patients 60 days sooner
  
  
  • Faster implementation of corrections to safety issues.
  
  
  
  

Mr. Vicenty details exactly what the voluntary program means for the manufacturer, and how it works.

Hear the entire presentation to find out more details about the FDA’s product quality program, and the experience of Edwards Lifesciences in transforming their organization and advancing product quality in the process.