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Level Up Your Outsourcing with a Comprehensive Approach to Sourcing and Quality

For many orthopedic and medtech OEMs, outsourcing is not only an accepted practice, but sought after for its competitive advantages. It’s often the most efficient way to ensure capacity, uphold quality, and keep the in-house team focused on core competencies like product design and marketing.

This doesn’t mean that there isn’t room for improvement, especially when there are potential pitfalls to many contract relationships. Add in the fierce competition and high complexity of the orthopedics industry—like a rapidly evolving market, changing regulatory pressure, and sourcing challenges—and you can see why being very selective with a potential outsourcing partner can be the difference between success and setback.

There’s one more layer to consider, as well. With signs of stress persisting in global supply chains, it’s essential to continue to focus on mitigating risk and building resilience. In fact, according to markers across industries, the disruption to supply chains worldwide is worsening 18+ months into the pandemic. This distress is showing up in material and component shortages, higher shipping costs, unexpected delays, and more. With the “next normal” continuing to slip into 2022, businesses across industries, including medtech, must continue to prioritize strategies to strengthen supply chains and reduce shock.

One way for OEMs to accomplish this is by taking a strategic approach to expert sourcing and quality. Doing so can enable an OEM to uphold quality, streamline the supply chain, and unlock the cost savings and efficiencies of outsourcing at far lower risk to the firm. Millstone’s Tier 1 approach elevates the typical outsourcing partnership, addressing the four keys to a comprehensive partnership. Let’s take a closer look.

Identifying the four keys to successful outsourcing partnerships

Ultimately, a successful outsourcing partnership in orthopedics should enable the OEM to deliver on the promise to the patient every time—while realizing the combined advantages of cost savings, increased capacity, and smoother coordination of the supply chain. This hinges on several keys in matching OEM, contract manufacturer, and/or outsourcing provider.

#1: Match capabilities

The type of component, device or service being outsourced must match the contract manufacturer or outsourcer’s capabilities. This is foundational to success. All contract manufacturers are not created equal. There are wide-ranging differences in industry expertise, ability to handle design complexity, and coordination of internal or outside processes and components. In addition, not all contract manufacturers have robust supplier vetting processes in place. Given the fluctuations and pressures in global supply chains, an understanding of any potential partner’s supplier robustness and contingency planning is essential.

#2: Involve expertise early

Not all potential partners are experts. In an industry as complex as orthopedics, expertise should be table stakes. Without it, OEMs expose themselves to greater risk. In addition, you want a supplier to be knowledgeable enough to identify any potential problems early in the process, or as soon as they’re apparent. This is especially important with new product launches. When involved early, expert sourcing SMEs can weigh in on product designs and arrange for sourcing and contingency planning considerations to keep launch timelines moving forward.

#3: Monitor quality

Early involvement can help to head off potential product delays. So can superior quality monitoring, because quality issues can easily lead to delays, which then become supply chain and delivery issues. With little room for error given competitive market pressure, heavy investment, and stressed supply chains, orthopedics OEMs must pull any available levers to lower supply chain stress.

#4: Streamline and simplify

Supply chain coordination is never-ending and highly complex. From addressing sourcing and shipping challenges to coordinating assembly schedules and timelines, successful partnerships are agile with responsive communication. Anything that can relieve pressure on supply chain teams is a plus.

Taking a closer look at Tier 1

Millstone’s Tier 1 service offers OEMs of all sizes a superior and simplified approach to expert sourcing. Tier 1 combines contract manufacturing with quality critical inspection and packaging for a “best of” approach.

Under Tier 1, OEMs can select or continue to work with a preferred contract manufacturer. Millstone manages the inbound supply chain, purchasing components from contract suppliers or receiving finished goods under a contract on an OEM’s behalf.

Once product is received, Millstone oversees the quality inspection process. All components or finished goods are verified to customers’ requirements, which reduces risk and saves time and cost. This includes first-article inspection, CMM programming and inspection, optical and digital comparator measurement and tolerance verification, geometric dimension and tolerance verification, and more. With over 20 years of contract manufacturing experience, Millstone brings vast industry expertise to every Tier 1 engagement.

Once quality inspected, all products are then packaged in our 15,000-square-feet, class 10,000/ISO7-rated clean room operating space. Capabilities include complex device assemblies, packaging and inspection, pre-validated packaging options, and true industry expertise in validations and continuous monitoring and package integrity testing.

Under Tier 1, all services from contract manufacturing to sterilization are streamlined under a single PO, which reduces the coordination of multiple POs while also preserving working capital with delayed payment terms. With Tier 1, OEMs can be confident in fulfilling all four keys of the ideal outsourcer relationship, from matching expertise and ensuring early involvement to upholding quality and streamlining the entire supply chain.

Millstone has recognized a growing need for Tier 1 service over the last few years. This increased need influenced the planning for our 2020 headquarter facility expansion for Fall River, MA. As more OEMs request Tier 1 service, recognizing the value of its comprehensive approach, we’ve added the ability to grow with our clients.

Ready to explore how Tier 1 can be a strategic approach to expert sourcing and superior quality? Reach out to learn how we can help.

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.