Millstone Medical Bets on Testing, Expansion to Meet Outsourcing Surge

NEW YORK, NY – November 19, 2025

The Rising Tide of Medical Device Outsourcing

The medical device industry is undergoing a significant shift, increasingly relying on specialized outsourcing partners to navigate complex regulations, accelerate time-to-market, and control costs. This trend, fueled by an aging global population and advancements in medical technology, is creating both challenges and opportunities for companies like Millstone Medical Outsourcing. While many manufacturers traditionally handled all aspects of device production in-house, a growing number are now turning to third-party providers for non-core functions, like post-manufacturing services, packaging, testing, and logistics.

“The pressure to innovate faster and reduce costs is immense,” says one industry analyst. “OEMs are realizing they can focus on their core competencies – research, design, and marketing – and leave the more specialized, but equally critical, post-manufacturing processes to companies with the expertise and infrastructure to handle them efficiently.” This shift is particularly pronounced in areas requiring stringent quality control and regulatory compliance, such as sterilization validation and biocompatibility testing.

Millstone’s Strategic Investments

Millstone Medical Outsourcing has positioned itself to capitalize on this growing demand through a series of strategic investments in expanded capacity and enhanced service offerings. The company has been actively expanding its facilities, most notably with significant upgrades to its testing capabilities. In early 2024, Millstone broke ground on a 25,000-square-foot expansion of its testing facility in Bloomfield, Connecticut – a move representing a 400% increase in service capacity. The new facility, operational in early Q2 2024, boasts state-of-the-art laboratory upgrades, a world-class BI sterility suite, and a broadened scope of testing services, including reusable instrument cleaning validation and package testing.

“We recognized a critical need in the market for comprehensive, reliable testing services,” explains a company spokesperson. “By expanding our capabilities and investing in cutting-edge technology, we are able to offer OEMs a one-stop solution for all their post-manufacturing testing needs, shortening lead times and reducing the risk of delays.”

Beyond testing, Millstone has also significantly expanded its facilities in Fall River, Massachusetts, adding over 60,000 square feet of production space since 2020. These investments, combined with ongoing upgrades to its quality control processes, demonstrate a commitment to providing a comprehensive suite of services to medical device OEMs.

Beyond Capacity: A Focus on Quality and Compliance

Expanding capacity is only one piece of the puzzle. In the highly regulated medical device industry, quality and compliance are paramount. Millstone understands this and has made significant investments in ensuring its processes meet the most stringent standards. The company is currently transitioning its lab services from ISO 13485:2016 to ISO 17025 accreditation, a move designed to provide customers with even greater assurance of traceability and adherence to international standards.

“The regulatory landscape is constantly evolving,” notes a quality control expert. “Companies like Millstone that are proactive in adapting to these changes and investing in compliance are best positioned to succeed.” This commitment to quality extends beyond the laboratory and throughout all aspects of the company’s operations, from packaging and sterilization to warehousing and logistics.

The company is also responding to shifts in customer needs. One significant trend is a growing interest in supply chain resilience. OEMs are looking for partners who can offer diversified sourcing options and a robust supply chain to mitigate the risk of disruptions. Millstone is actively working to expand its network of suppliers and optimize its logistics processes to meet this demand.

These efforts are not solely focused on current needs. Millstone is also looking ahead to future challenges and opportunities. The company is actively exploring new technologies and services to enhance its capabilities and meet the evolving needs of the medical device industry, like expanding into cardiovascular and pharmaceutical services, and integrating newer testing technologies.