In medical device manufacturing, as well as other regulated industries, we have served two masters. One is the end consumer, without whom we have no business. The other is the FDA (or other regulatory body, depending on the geography of the end consumer), without whom we have no business.
Historically, we focused on product quality to serve the end consumer. We focused on compliance to serve the FDA. Often the compliance efforts distracted resources from the quality efforts. Compliance was reactive, quality was proactive. Now the FDA is trying to align those efforts towards the ultimate goal: serving the healthcare market with the highest quality products possible, and having compliance be the result of the pursuit of product quality.
The FDA is signaling the end of the “Compliance Era,” as recalls are on the rise, and the complexity and the rate of product changes are escalating (introducing even more quality risk). They are shifting from “compliance only” to “quality always.”
Some leading medical device manufacturers are ahead of the curve. They have already anticipated that shift, and implemented an infrastructure that focuses on proactive quality, with compliance being a natural byproduct of those efforts. They have invested in their product design and manufacturing processes, implementing systems that are connected and intelligent. We call such systems “closed loop,” meaning that the desired output of a process depends on the inputs, and feedback loops inform other parts of the process about the characteristics and results of that step. These systems start with R&D/ideation, support manufacturing operations and include post-market surveillance/obsolescence.
It makes good business sense. The systems, along with a culture of product quality improvement, produce better-informed regulatory practices. By facilitating e-inspections, FDA audits and inspections are less disruptive to their business. They have anticipated the changes coming in the FDA’s approach, and already produce and use the key metrics and intelligence the FDA will be requesting. And it’s less expensive for the manufacturer. Moving to electronic systems versus paper, the time required to meet FDA compliance needs is dramatically reduced.
By integrating their key systems, manufacturing operations management (MOM) – particularly the manufacturing execution system (MES) – and product lifecycle management (PLM), manufacturers are creating transparent closed-loop processes that accelerate new product introduction (NPI), as well as streamline an efficient and effective change management process. Approved design and configuration changes to products, processes, and documentation are seamlessly transferred from design to manufacturing, with full traceability and error proofing through MES enforcement. The loop includes consumer use and ultimately patient outcomes, so that quality information throughout the entire product lifecycle is used to understand current quality, and improve quality in the next generation.
So we are seeing a shift in medical device quality and compliance imperatives. That shift is being driven by the recognition that the FDA also serves the end consumer of the medical device manufacturer’s products.
Regulation should not be a master, but rather an influencer and a safety net for encouraging the right practices focused on delivering medical devices that result in the best outcomes for patients. Those medical device companies that live that philosophy are already on board. They are creating a culture of quality, and investing in the infrastructure that supports that culture. Oh, and they are enjoying brand superiority, cost efficiency, and profitability – which makes good business sense.