When the lifesaving and lifechanging products you make are going into patients’ bodies, there is no room for error. Every medical device manufacturer knows this truth. So do regulatory bodies. Taken together, the focus on patient safety and compliance are the driving forces behind comprehensive product, packaging, and environmental testing.
Against this backdrop, medical device and medtech manufacturers are increasingly turning to outsourcing like contract manufacturing and contract testing. This shift has advantages, including reduced facility footprint and access to specialty expertise with lower capital investment. Outsourcing also helps OEMs meet increased demand, which is only expected to grow. Ultimately, for small, medium, and large firms alike, outsourcing is a smart business move: with fixed costs accounting for 60 to 70% of the cost of goods sold (COGS), OEMs must make any moves possible to achieve efficiency in a market with tight margins.
Of course, OEM decision-makers already know this; it’s why the global contract manufacturing market is projected to reach $132 billion by 2026, with an expected CAGR of 10%. But continued and anticipated future disruption are ramping up the stakes even higher. According to a recent McKinsey report, “medtech companies have faced unprecedented disruption and now confront a challenging macroeconomic climate marked by high inflation, constrained capital markets, uncertain supply, and rising geopolitical tensions, among other factors. After a decade of solid performance through 2019, value creation in medtech has decelerated.”
The benefits of expertise
Back to outsourcing: finding the right partner can help an OEM create efficiency and access specialized knowledge. Working with an end-to-end service provider can also enable manufacturers to build resilience and scale up and down as needed, when needed.
In the world of aftermarket and post-manufacturing services, though, not all partners are created equal. With patient safety top of mind, let’s look at what separates an expert testing services partner from the field, with risk management as context.
Comprehensive testing expertise: product, packaging, and environmental testing
Put simply, testing is the linchpin of patient safety. It lowers risk—to patients, and to manufacturers, when you consider the costs and reputational harm of product recalls. Packaging testing safeguards devices from contamination and damage to ensure safe transfer to patients. Environmental testing anticipates real-world challenges, ensuring device resilience and the safety of the production environment.
Complication and delay lurk at every step in the supply chain, however. Coordinating a variety of outsourced vendors can lengthen lead times and put continuity at risk. Long turnaround times can delay product launches and compromise legacy production.
Working with an expert partner that adheres to rigorous testing protocols and offers end-to-end service can help manufacturers navigate these challenges while protecting production and patient safety. Consider, for example, the advantages of working with a single expert point of contact for all testing services:
- Product testing. Ensure safety with product testing and validations that detect contamination levels, assess new product materials, validate sterilization dosage, confirm required sterility levels and more.
- Packaging testing. Confirm the integrity of packaging materials to ensure sterile barrier, assess package durability and validate aging to ensure distribution stresses and shelf life do not compromise product safety.
- Environmental testing. Verify safety and ensure compliance with water analysis for production facilities, and air and surface sampling for production and storage facilities.
Finding a single partner that can perform all required testing unlocks advantages that can help OEMs uphold patient safety and quality, minimize risk, and ensure products stay on the market. It’s about access to valuable expertise with responsiveness—which cannot be achieved with a patchwork of contract partners.
Putting it all together
The McKinsey report noted, among other imperatives, that OEMs need to reimagine their operations for the challenges of the next decade, “to become more reliable, robust, and profitable, ultimately delivering better patient care.” Reimagining comes down to rethinking manufacturing and distribution networks to balance costs and boost flexibility. “Importantly, medtech leaders can invest in quality capabilities that are deeply embedded in business processes.”
A single expert point of contact confers these advantages—flexibility, resilience, and capabilities built to drive business success. The right testing services expertise can help OEMs navigate challenges like sterilization disruption, aggressive product launch timelines, lead time management, and more. Manufacturers should evaluate potential testing services partners’ capabilities and processes with an eye toward:
- Whether testing services are performed in-house
- On-staff technical expertise
- Industry and regulatory expertise
- Process management
- Turnaround time length
In today’s medtech market, continued disruption and continuous pressure are constantly turning the screws for manufacturers. A single expert point of contact for testing services and end-to-end support can help OEMs maximize opportunity and minimize risk. With access to an expert partner, OEMs are better positioned to protect quality and patient safety while remaining competitive.
Millstone offers OEMs industry-leading turnaround times and 90+ combined years of regulatory testing expertise for testing services. In addition, Millstone offers a simplified approach to expert sourcing with our Tier 1 service, with a single PO and point of contact for contract manufacturing, clean room packaging, and sterilization. Tier 1 service can now include testing services.
Today Millstone offers 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 packaging, testing and logistics —all with an unparalleled focus on quality.
What could we help you do better? Learn more at https://millstonemedical.com.