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Industry Q&A: Six Questions on Quality Critical Inspection

Quality: it’s essential to ensuring that the products that bear your name live up to it. Even more importantly, when you’re in medical manufacturing, quality is about upholding patient safety—and delivering on your promise to the patient.

This is why everything we do at Millstone is focused on quality, from our commitment to operating under the highest quality standards to our best-in-class systems and processes. As part of our series sharing industry perspectives, Millstone’s Marketing Manager Brittany Arnone recently caught up with Victoria Hughes, Vice President, Quality & Regulatory, to talk about Millstone’s commitment to quality and its approach to quality critical inspection.

BA: Let’s start with quality critical inspection. How does it safeguard quality?  

VH: Quality critical inspection is all about ensuring quality with independent inspection and verification—the emphasis here is on “independent.” We are objectively focused on every quality critical inspection we do, from first article to visual, mechanical, and dimensional verification. Our focus is not the pass rate of something that comes from your supplier; we’re simply evaluating without any bias, as your independent verification. Writers don’t proof their own novels; the work benefits from the objectivity that a proofreader brings. It’s the same here at Millstone.

BA: What should OEMs know that differentiates Millstone from other firms performing quality critical inspection?

VH: This is where I must go from being objective to subjective, but in the best way. In addition to upholding our commitment to the highest quality standards, we are also able to bring standout industry expertise to our quality critical capability. Rather than simply inspecting for quality, we’re continually looking for opportunities to build quality into the process. We can accomplish this by incorporating automation to streamline and error-proof processes. It’s really a strategic shift in the approach to quality.

BA: Can you share a few success stories from customers?

VH: Gladly. I have three, and I’ve chosen them from among many to highlight Millstone’s strategic approach to quality, and the versatility of the solutions we can offer OEMs.

The first is a robotic assisted surgery product and our development of an automated assembly process. The product works to guide the surgeon via a set of retro reflective lenses on an array, and these lenses have a very precise location requirement. It’s absolutely critical to get the placement of these lenses 100% precise, or the surgery will not go well. We were able to contribute our expertise to develop a high-precision automated assembly process allowing the client to meet their very stringent specifications in a cost-effective way.

The second example of a success story entails a vision system that error-proofs the packaging of a family of complex surgical kits. This vision system automatically checks the type, size, orientation, and presence of 25 pieces in multiple different types of kits. It also interfaces with our documentation system and prints out a receipt that goes with the device’s record. This way, we have a record that the kit was correct before it ships. We developed this system specifically for this family of kits—another example of building quality into the process from the beginning.

The last one I’ll share is a process control tool for a particular product. This product, which is packaged in an opaque foil pouch, is very small—in fact, you can’t detect by feel that it is present inside the pouch, and there is no visual verification. We developed an automated pouch gauge that measures the nitrogen head space in the pouch to control oxygen levels and simultaneously verifies that the product is in the pouch.

BA: What should OEMs consider before launching a new program or product?

VH: Every new program and launch provides an opportunity to build quality into the process, through automation whenever possible. Because established processes in our industry can be very difficult to change, it’s important to plan early on. There is a narrow window at the start of the process to engage our approach to quality—so, as with the example of the robotic assisted surgery product, bring us in early.

BA: What’s the piece of equipment that most often knocks customers’ socks off?

VH: When we host customers for walkthroughs, there’s one piece of equipment that proves perpetually attractive to customers: our proprietary laser-cutting system to prepare peel testing samples of thermoformed trays. When they see it, many customers slip their phones out of their pockets, trying to find a bar code or SKU to order one for themselves.

They can’t because it’s not on the market. We developed it, customizing a laser system to repeatably manage sample prep for peel testing, which is required for validating the ongoing integrity of the sterile barrier in tray-packaged orthopedics products. You have to cut a tab off the lid to submit for peel testing. This system is fantastic, because it can manage 10,000 SKUs and 125 different tray configurations, and everything from focus to cutting is automated. And it’s superior—we’ve found that it reduces variation in sample prep by 30%.

BA: From your perspective on quality, what are some of the top emerging trends in orthopedics heading into 2022?

VH: After nearly two years, supply chain management continues to be the lead story. OEMs and their partners must continue to focus on supplier management to ensure material availability and protect timelines—and taking a risk-based approach to supplier management helps during and after this period. This is about establishing redundant suppliers and ensuring, where possible, the availability of additional resources.

We’ve also seen a lot of movement in quality related to converting non-sterile to sterile packaging, in advance of meeting the enforcement date for the EU MDR. Conversion requires incorporating different types of validation, testing, and inspections into the process, which our team at Millstone can help with.

Safeguard quality—and build it into the process early. Learn more about Millstone’s quality critical inspection capabilities.

At Millstone, we understand the challenges OEMs face in the robotic assisted surgery products market. We have successfully launched and supported packaging for four major orthopedic robot platforms and bring a birds-eye view of the growing robotic assisted surgery products 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 https://millstonemedical.com.