Let’s take a look at the chain of events that have and will alter the Medical Device Industry indefinitely. Medical Device recalls and incidents have escalated over the past decade. This escalation provides indicative evidence that the current system is in need of an evaluation. As a result, the FDA constructs a consortium of professionals and makes plans to change the current system to ensure public safety and reduce the industry recalls.
Jeff Shuren MD, director of FDA’s Center for Devices and Radiological Health stated in the FDA’s Case for Quality video “Device manufacturers can meet FDA requirements and still make a poor quality device.”(1)
The FDA’s Center for Devices and Radiological Health (CDRH) issues their 2016 – 2017 Strategic Priorities which include an “Establishment for a National Evaluation System for Medical Devices.”
The FDA states, “To successfully harness from the diverse set of real-world evidence in an efficient manner, the U.S. must develop the necessary infrastructure – a National Evaluation System for medical devices.”
Goals of this initiative include:
– Strengthen product and manufacturing quality within the medical device ecosystem
– Increase “access and use” to real-world evidence to support regulatory decision making
How medical device companies plan and respond to the changing climate will determine their long term sustainability and company success. There will be both a proactive and a reactive response by companies as they conform to the new requirements while balancing cost vs. patient outcomes.
The reactive approach will arise when companies do not prepare for the new climate. This will likely result in quality issues that can have a negative impact on reputation, costs, and consumer satisfaction. When there is a negative impact on consumer satisfaction, there is often a reduction in revenues. In extreme cases, a medical product or an entire company may be removed completely from the market.
This change of events and economic pressures are now requiring “A New Perspective, A New Approach.” This new approach includes an increased focus and evaluation on compliance, optimization and sustainability.
EngiLifeSciences has aligned their business model with these upcoming FDA strategic initiatives in order to help their clients navigate the new landscape of requirements. This system optimizes product realization with a unique approach that recognizes the co-dependency between quality and business performance. As part of the EngiLifeSciences approach, we provide strategic and tactical evaluations of the value chain and focus on the development and implementation of roadmaps to achieve ideal quality and business performance.
This focus on product quality and implementing best practices allows companies to meet regulatory requirements while managing cost vs. patient outcomes. This is the equation that companies will want to incorporate to thrive in the new regulatory environment.
|(1) CDRH 2016-2017 Strategic Priorities. FDA.gov. CDRH 2016-2017 Strategic Priorities. Retrieved 2016-04-03|