Benefits of Outsourcing Testing for Medical Device Development

When it comes to selecting the best materials for medical devices, the stakes are high for manufacturers. As new devices continue to go to market, safety, regulatory compliance, and scientific expertise are paramount to the success of medical devices.

However, the in-house testing capabilities of many medical device manufacturers may not meet the rigorous demands of medical device product development. Manufacturers face limited technological resources and expertise. This can cost them the ability to conduct comprehensive and unbiased testing, slowing progress.

Specialized outsourced laboratory services offer solutions to these challenges, providing access to advanced equipment, expert insights, and third-party verification and materials testing. 

Medical device product development requires the highest standards of accuracy, making outsourcing a strategic move that enhances your product development outcomes. Let’s take a deeper look at the benefits of outsourced testing for medical device development.

The Advantages of Outsourced Testing

Outsourced labs don't just add to your medical device product development efforts; they expand your capabilities, offering access to high-end gear and the expertise of specialized professionals in materials science. Partnering with an outsourced testing firm allows for innovative testing and insights into material characterization and performance beyond in-house capabilities. This collaboration helps manufacturers navigate materials engineering challenges, ensuring their products meet the highest standards of quality and reliability.

Access to Next-Level Equipment and Experts

An outsourced testing partner can offer a comprehensive laboratory setup with the capacity to perform more in-depth tests. For example, in-house laboratories are great for quality control and checking known materials, but a testing partner can help you test new materials with a variety of product parameters in mind. These may include increased flexibility, durability, and a higher tolerance for exposure to certain chemicals.

Consider some of the technologies that certain outsourced laboratories offer:

• SEM: Scanning electron microscopes can provide access to high-quality imaging.

• XRD: X-ray Diffraction tools with the capacity for high sample throughput allow for the quick, accurate characterization of almost any material.

• XRF: X-ray Fluorescence gives you a precise understanding of the elemental composition of any material.

• CCSEM: Computer-Controlled Scanning Electron Microscopy, combined with laser diffraction, provides foreign particulate matter characterization.

An outsourced testing partner not only has the capacity to provide manufacturers with comprehensive material testing, but can provide data management, visualization, and reporting. 

You may also lack expertise in certain fields when it comes to medical device product development. For example, metallurgy expertise is invaluable when deciding how to develop implants. A testing partner can provide a metallurgy expert to consult on these issues during medical device development, as well as experts in fields like materials analysis, nanomaterials, and chemistry.

Receive Objective Testing and Verification

When you work with an outsourced partner, you get the benefit of having a third party perform different types of testing throughout the medical device development process. This may include new materials testing, developing new testing protocols, and performing failure analysis. Your testing partner can weigh in on the benefits and downsides of new materials as you navigate alternative sourcing, too.

Failure analysis is a particularly good place to have an objective party for testing. Third parties may pick up on small changes or discrepancies in material formulations or specifications that in-house teams may dismiss as insignificant.

Sometimes, they are insignificant – but sometimes, small changes can be quite considerable and even lead to product failure. Your testing partner can help you understand what led to product failure and what actionable steps can prevent the problem from occurring.

Third-party testing ultimately allows for independent verification of your material choices, giving you confidence in your materials selection and regulatory compliance.

How Outsourced Testing Can Benefit Each Stage of Medical Device Development

Integrating an outsourced laboratory into each stage of the medical device product lifecycle can significantly enhance innovation, safety, and compliance. From initial concept and ideation through to manufacturing, specialized labs offer critical insights and testing capabilities that can shape the development of medical devices.

Concept & Ideation

At this early stage, an outsourced lab can help evaluate the feasibility of materials for a proposed medical device. For instance, assessing the biocompatibility or durability of new composite materials can guide the ideation process toward designs that are both innovative and practical.

R&D

During research and development, labs contribute detailed material analysis and prototyping tests. They can, for example, conduct stress tests on materials to predict how they will behave under various conditions, providing invaluable data for refining product designs.

Testing & Validation

In this phase, outsourced labs play a crucial role in ensuring that the product meets regulatory standards. By performing comprehensive tests, such as accelerated aging or wear simulation, they can validate the device's safety and efficacy before it goes to market.

Manufacturing

Finally, during manufacturing, labs can assist in quality control, monitoring the consistency of materials and manufacturing processes. They might use spectroscopy to detect any deviations in material composition that could affect the final product's performance, ensuring every unit meets the required specifications.

Market Surveillance & Post-Market Analysis

After launching a medical device, continuous monitoring and analysis are vital to ensure its ongoing safety and efficacy. Outsourced labs can assist in this phase by conducting post-market surveillance studies, analyzing device performance in real-world settings, and investigating any failure incidents. Through techniques like failure analysis and root cause analysis, labs provide critical insights into any issues that arise, helping manufacturers address them promptly and maintain compliance with regulatory standards.

Real-World Example: Overcoming Product Launch Delays

A company faced manufacturing issues and product launch delays due to issues with cured silicone components for medical devices. The scientific experts at RJ Lee Group stepped in to investigate. Leveraging insights from a comprehensive assessment of the product’s life cycle, we designed experiments to pinpoint the root cause.

We found an unreported formulation change to be the problem. Our scientists developed more robust raw material specifications for the client and implemented rigorous testing protocols to prevent the issue in the future.

Selecting the Right Partner for Medical Device Development Testing

Choosing the right outsourced testing partner is crucial for enhancing product quality throughout the medical device development lifecycle. A reliable partner offers expertise in selecting appropriate materials and conducts testing at every stage, contributing to the durability of your product.

A good testing partner also plays a key role in quality management, bringing innovative ideas for product enhancements and a competitive edge. They collaborate closely with your team to implement new testing protocols and ensure seamless integration with your processes.

Look for laboratories with relevant certifications and accreditations, such as FDA cGMP, FDA QMSR, ISO 17025 and 13485, and Six Sigma, to guarantee the quality and reliability of their services.

You can gain even deeper value by seeking a partner that not only offers testing but also offers consulting expertise, providing precise, field-specific insights that enhance innovation and strategic decision-making.

Speed Up Your Development Process with an Outsourced Testing Partner

When you work with an outsourced testing partner like RJ Lee Group for medical device development, you aren’t just investing in the immediate success of your product. You’re investing in product quality, longevity, and an increase in total manufacturing quality. 

You’ll receive timely, expert support throughout the medical device product development process. RJ Lee Group can rigorously test your materials within the parameters of your design to ensure that your product is compliant and high-performing.

Enjoy the expertise of 175+ scientists, equipment designed to streamline your workflow, and third-party validation and testing with our partnership. Schedule a meeting with an RJ Lee Group expert today to discuss our testing capabilities.