At the recent American Medical Device Summit in Lombard, Illinois, several FDA officials delivered presentations to help the device designers and manufacturers successfully engage with the FDA, physicians and the patient end-consumers. Yet, with the cost of development and launch remaining high along with the brisk pace of product recalls to protect consumers health and safety, many suppliers are seeking ways to modernize their medical device supply chain and streamline their engagement with this very important U.S. federal agency.
When it comes to the health and safety of the public, failure is not an option!
While the FDA is striving to make regulations and communications with suppliers up and down the medical device supply chain as efficient as possible, the overarching theme of their executive’s comments to the makers was this: When it comes to the health and safety of the public, failure is not an option!
Big Shift – The Case for Quality in the Medical Device Supply Chain
There was much discussion about ongoing efforts by the FDA to streamline filings, reporting and informal access to FDA staff for discussions and guidance. Another key element of this evolution of the massive agency is the Case for Quality initiative to encourage manufacturers throughout the medical device supply chain to adopt best practices in product development, launch and on-going production including modern information systems.
According to Dr. Robin Newman, Director of the Office of Compliance, Center for Devices and Radiological Health (CDRH) in the FDA, benchmark device makers need to be able to predictively assess product quality. To do this, manufacturers must develop their own device quality metrics to provide feedback loops that enable continuous improvement.
These exemplary companies also exhibit a proactive approach to leadership, culture built around quality and modern systems that provide daily metrics based on relevant quality metrics.
The FDA is also developing a capability maturity model index for assessing the progress and use of best practices of medical device manufacturers. This model is based on studies from several universities and industry analysts. As the industry expands, FDA leadership is faced with the reality of limited resources.
As this maturity model is vetted and becomes accepted throughout the ranks of agency regulators, specialists, auditors and third parties, leadership is considering how to carefully and successfully manage risk for the end consumers of medical devices. They also want to minimize formal reports, filings, findings and costs for the device manufacturers. The goal is to make the regulatory process effective and efficient.
Benefits vs. Risks
To this end, it appears that for startups and large mature medical device manufacturers who choose to implement modern, effective quality systems and then use the resulting metrics and analytics to continuously improve, the FDA may lengthen audit cycles and / or utilize less intense forms of audit to manage compliance. So, when companies use best practices to consistently deliver quality products as well as predictively manage product issues they will likely enjoy a level of trust from the FDA when it comes to communications, containment / recovery actions, and audits.
At this industry event, several current IQMS customers were also sponsoring exhibitors. AdvanTech Plastics, Phase 2 (P2) Medical Manufacturing and InterTech Plastics use IQMS Enterprise Resource Planning (ERP) and Manufacturing Execution Systems (MES) to run their operations as leaders in quality and delivery to their medical device customers. In fact, InterTech Plastics who presented a breakout seminar at this conference utilizes images of IQMS screens and reports in their sales presentations to their prospective customers to demonstrate their many best practices.
For more information on systems and solutions that help medical device suppliers improve and innovate in support of the Case for Quality, click to IQMS Medical Device Manufacturing Software.