In spite of the best intentions, it turns out that mandating compliance with U.S. Food and Drug Administration (FDA) regulations is no guarantee of quality medical devices. In fact, based on its analysis of data over a nine-year span, the FDA detected an increase in adverse events even as compliance levels rose. According to the FDA, medical device recalls grew by 97% between 2003 and 2012.
With this in mind, the FDA launched a Case for Quality that is intended to shift the primary focus from regulatory compliance to a state of sustained product quality. Though the FDA is still working on its multi-year initiative to transform its approach to compliance and quality, we believe the end result could actually help medical device manufacturers get to marketer faster with innovative products.
Here’s why: If manufacturers share quality-related data and demonstrate a solid track record of quality, they may be able to jump to the head of the line, so to speak, when it comes to getting their product submissions reviewed. Think of it as a Trusted Traveler status for medical device manufacturers. The U.S. Customs and Border Protection agency makes it possible for pre-approved, low-risk travelers to move more quickly through dedicated lanes and kiosks. In the same way, medical device manufacturers with a quality record could bypass the long FDA waiting line that most companies find themselves in. Instead, they could get directed to the short line for faster review and – hopefully – approval.
Satisfying the FDA’s emerging Case for Quality criteria can ease the path to market. Plus, it makes good business sense: According to McKinsey, poor quality costs the medical device industry between 12-18% of revenue.
Understand Where to Focus
So how can medical device manufacturers boost their product quality and likelihood of compliance? The first step is understanding what the main causes of poor quality. It turns out that failures in product design and manufacturing process control were to blame for more than half of all product recalls, according to the FDA’s study.
The next step is understanding what the FDA looks for.
The FDA’s Case for Quality calls for manufacturers to ensure the highest levels of device quality and safety throughout product design, manufacture and service. That said, it includes several critical KPIs that are post-launch focused:
Medical device manufacturers have long recorded KPIs to set quality goals, compensate employees and departments, and identify improvement opportunities. However, they often use a mishmash of spreadsheets, business intelligence (BI) software, and master data management (MDM) solutions to handle this. Aggregating the necessary data in such a manner puts companies at risk of data issues that could jeopardize their ability to satisfy regulatory requirements.
At the core, quality is a result of product standards and process standards. With process standards in place, medical device manufacturers have the needed fundamentals to drive a culture of quality. A mature digital engineering environment can unify product intelligence, quality processes and compliance processes, which is essential to achieve the highest levels of quality.
Establish a Solid Foundation
A proven option is to use a combination of Product Lifecycle Management (PLM) and Quality Management (QLM) systems as the backbone for controlled processes. According to Aberdeen, this approach can help lower internal and external failures by 50%. That’s because the right PLM solution supports a digital product definition, which consolidates disconnected, siloed information to ensure consistent, clean data. In tandem with QLM, this enables closed-loop quality management.
Unifying quality and product development processes also provides the necessary framework for manufacturers whose devices are being deployed to the Internet of Medical Things (IoMT). Enabling smart, connected medical devices requires a careful orchestration of numerous core back-end systems, including PLM, MES, and CRM, to name a few. With a standards-based, open and extensible platform for medical device engineering, device makers can minimize complexity and establish the foundation for a closed-loop quality approach.