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The Benefits of Outsourcing Medical Device Product Testing

As a medical device manufacturer, you know that every product you bring to market must meet rigorous testing standards to ensure patient safety. Product and packaging testing can be time-consuming, though, and require specialized knowledge, equipment, and resources. With increased regulatory and product complexity, it can be challenging to keep up with all the necessary testing requirements in house.

This is where outsourced product testing can benefit medical device manufacturers, allowing them to streamline development and bring safe, effective products to market faster. In this article, we explore the benefits of outsourcing medical device testing and how it can help OEMs maintain the highest standards of quality and safety.

Overcoming the challenges of medical device product testing

Medical device manufacturers face an array of challenges in safely bringing products to market. One of the biggest is ensuring regulatory compliance. The regulatory landscape is complex and ever evolving, requiring manufacturers to navigate various rules and standards from the FDA as well as international standards bodies. Failure to comply with these regulations comes with significant risk, including the potential for costly recalls, legal challenges, product delays, and even damage to a company’s reputation.

Another challenge is the cost and time required to conduct product testing in house. To do so, OEMs must invest in specialized equipment and expertise to perform testing. Unless specific personnel and capital resources dedicated to in-house testing are available, firms may encounter internal resource competition that could contribute to product launch delays and jeopardize time to market. Unanticipated employee departures can create an internal knowledge gap, increasing the risk of a launch delay or leading to a testing or validation mistake that becomes a major setback. Furthermore, because medical device product testing requires such a significant resource investment, smaller firms may not have the resources to invest in expertise and equipment, which could compromise the quality and accuracy of their testing (and ultimately their products).

Outsourcing medical device product testing can help OEMs overcome the challenges and risks of regulatory compliance, limited resources, time constraints, and even cost. With an expert partner for contract testing, OEMs can:

• Ensure regulatory compliance. Outsourcing offers an alternate route to critical regulatory and industry expertise than adding to overhead and fixed costs through hiring. Regulatory compliance can be complex and costly but outsourcing to an expert can help OEMs reduce the risk of being out of compliance and the associated costs and reputational damage. Outsourcing can also provide the expertise to navigate changes for new product launches, updated regulatory guidance, and other business and industry shifts that could otherwise be knowledge gaps in OEMs’ on-staff expertise.
• Manage costs. Outsourcing product and packaging testing can save OEMs costs in several ways. It allows manufacturers to avoid the high capital expenditures required to purchase and maintain specialized equipment and an on-site laboratory testing facility. Outsourcing also helps OEMs bypass the costs of recruiting, training, and maintaining in-house staff to perform testing. These investments can quickly cut into profitability for OEMs. By outsourcing, manufacturers can leverage both the equipment and expertise of a contract testing service partner, ultimately unlocking significant cost savings.
• Accelerate time to market. Utilizing a contract testing partner’s expertise and equipment can also help OEMs speed time to market. When it comes to specialized product testing or specific functional tests, outsourcing is an express lane compared to acquiring equipment and talent in-house (as noted above). Coordinating in-process and adjacent services can also accelerate time to market. Finally, when every step matters, an expert contract testing partner can help an OEM hit tight product launch timelines.
• Uphold quality and safety. There is nothing more important than ensuring quality and protecting patient safety. An expert contract testing partner will know exactly which test or tests to perform to meet critical patient safety requirements, assess new product materials, assure lot-to-lot acceptability, validate sterilization irradiation dosage, and much more. What’s more, an outsourcing partner can serve as independent verification to further reduce risk and safeguard patient outcomes.

Ultimately, through access to expertise, cost savings, and accelerated time to market, outsourcing product and packaging testing enables OEMs to focus more of their resources on developing and bringing to market life-changing products without sacrificing quality or patient safety.

Choosing the right outsourcing partner for medical device product testing

It’s not just outsourcing that matters, though; realizing the benefits requires selecting an expert partner. In a competitive market with tight margins, OEMs face significant pressure to get everything right—and an expert outsourcing partner can ensure they do.

To evaluate for expertise, medical device manufacturers should consider whether potential outsourcing partners offer the following:

• Industry expertise. The ideal contract testing partner should have proven experience in medical and pharmaceutical device industry, including an expert available to review each test plan. Seek out a potential partner with decades in the industry and a proven track record of success.
• Regulatory expertise. An expert partner will understand exactly what is required to ensure and remain in compliance, including the applicable product and package test and the relevant standard. Consider also how potential partners ensure they are up to date on the latest requirements or anticipated changes. Do they participate in industry work groups, standards bodies, or other review committees?
• On-staff technical expertise. The right partner will know what test is needed, how to perform it, and what validations are required. In addition, ensure that you understand where the contracted tests will actually be performed. Are tests performed in house or contracted out? Be sure you address this.
• Tight process management. Streamlined process management can reduce back and forth and cost while also reducing risk, and a responsive partner can keep you informed of any emergent challenges with enough time to proactively resolve them.
• Robust quality management systems. Quality matters, so be sure to request and review any potential outsourcing partner’s approach, from certifications and registrations to the protocols used in performing all tests.

Millstone Testing Services give medical device manufacturers access to the comprehensive product, packaging, and environmental testing service expertise they need with a single expert point of contact. In addition, Millstone’s end-to-end Tier 1 service, available with adjacent testing, provides a streamlined approach to expert sourcing, with contract manufacturing, quality critical inspection, in-process testing, cleaning, packaging, and sterilization handled under a single PO. Millstone Testing Services are also available as standalone contract 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 clean room packaging, medical device specific warehousing, finished goods distribution, loaner kit management, advanced inspection and testing, and reverse logistics services—all with an unparalleled focus on quality.

What could we help you do better? Learn more at https://millstonemedical.com.