Successfully Navigating the Challenges of Compliance

As a medical device manufacturer, you have one priority that takes precedence over all others: getting to market as quickly as possible to help patients—without, of course, sacrificing quality, safety, or outcomes. Actually getting to market quickly, though, is far from simple. What usually gets in the way?

Regulatory compliance issues.

We don’t have to tell you that medical device manufacturing is a heavily regulated market—you already know that, because you live that reality every day. Let’s tease apart what contributes to the challenges of being in compliance, why the stakes are so high, and how you can reduce the risk of being out of compliance.

The challenges of compliance

As scrutiny of the impact devices have on patients and patient safety has increased, regulatory compliance standards have tightened. Today, the FDA focuses on objective evidence supplied by OEMs in package design and validation and quality management systems to determine if firms are in compliance. Achieving and remaining in compliance, therefore, requires a high level of specialized expertise, both about the regulatory standards themselves as well as quality management systems and their inputs.

Recently—for the first time in more than a decade—significant revisions were made to ISO 11607, the global standards that govern packaging. Packaging design and validation, of course, is one of the most highly scrutinized areas of this industry. With the revisions to ISO 11607 Parts 1 and 2, OEMs now must bring an increased focus to issues of materials selection, design, process, and quality controls. Individual interpretations of these standards can make being in compliance even more challenging.

The stakes

The costs of establishing and operating in a federally compliant manner are significant—yet failure to do so is even more costly. For instance, consider that you can reasonably expect the FDA to audit you at any time. If you are a manufacturer of Class II or Class III products, you should expect the FDA to come calling every two years or more (and, if you’ve had any compliance issues, you can certainly expect that interval to be shorter). If, during an audit, the FDA flags any issue as non-compliant, you’re hit with a Form 483 letter, which outlines any objectionable issue and puts you on notice. You then have 15 days to respond, and if you’re issued a warning letter, things can get expensive quickly. Consider the cost, for instance, of high-priced hourly consultants—and associated travel and on-site costs, on top of necessary equipment expenditures—to address warning letter issues, rectify them, and usher you back into compliance. And, of course, add to the above the costs of any delays in getting to market or producing product, of lost sales, accounts, and other opportunities, and of the diversion of cash crucial to reinvestment in your business.

The benefits of expertise

Navigating the challenges of being in compliance, of course, can be far easier with an expert partner. The following aspects of regulatory compliance are easier with true expertise:

  • Interpretation. This is where the entire process begins. Interpreting regulatory compliance and ISO standards—which as we’ve noted can be somewhat open to interpretation—is complex in itself. An expert partner can bring a birds-eye view of the regulatory landscape as well as a broader perspective on how others in the market are interpreting the standards.
  • New regulatory deadlines. UDI compliance regulation deadlines for part-marking are coming into effect over the next two years, with the ultimate goal of transforming chain of custody visibility in the interest of patient safety. It’s best to be prepared with a partner who is already scanning the horizon.
  • Chain of custody. To comply with the increasingly challenging requirements of UDI compliance, OEMs must ensure appropriate documentation for components and finished goods, particularly in documenting inspection returns. Without a highly systemized process in place, chain of custody visibility is nearly impossible.
  • Recall processing. Processing a federally mandated recall can be difficult, particularly with comingling of inventory amid a lack of ideal visibility and traceability. Consider the crucial nature of enhanced visibility and traceability at the part number and lot number, and the potential power of always knowing where something came from, where it went, and where it is now. Having that kind of real-time visibility would certainly affect how quickly and effectively you could act on a recall.
  • Compliant packaging. The package design and validation process can be enormously complex, time-consuming, and costly—but it’s absolutely essential to do it in a fully compliant manner to reach the market quickly and safely. Advancements in pre-validated packaging solutions offer OEMs robust options that can cut time to market by as much as 50%. Read more on pre-validated packaging and time to market here.

With the stakes so high and the challenges of compliance so enormous, success often hinges on having the right partner. Outsourcing quality-critical processes to such a partner can provide welcome insight, best practices, perspective, and expertise to ensure that you are operating in compliance—and that you’re prepared to meet new challenges as the regulatory landscape evolves.

At Millstone, we get it. We believe quality drives patient success. That’s why we’ve perfected all the capabilities medical device manufacturers need to get to market. Today we offer post-manufacturing and aftermarket services to more than 50 customers, including some of the top 10 orthopedic companies in the world. We are constantly evolving our processes and services to help OEMs achieve sustainable success. We offer clean room packaging, medical device specific warehousing, finished goods distribution, loaner kit management, advanced inspection and reverse logistics services—all with an unparalleled focus on quality.

What could we help you do better? Learn more at


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