In the MedTech sector, the biocompatibility of materials is critical for patient safety and product efficacy. Every material needs to be tested, with suppliers often providing quality and biocompatibility assurances.
As convenient as it is to take them at their word, the stakes are too high to trust your suppliers. MedTech companies are ultimately responsible for their products and any failings will likely result in severe legal and regulatory problems for the company — not the supplier.
In this article, we explore what MedTech businesses can do to gain greater control and understanding over supplier-provided materials. Let’s start by first unpacking the risks of relying on supplier data.
Can You Trust Supplier-Provided Data?
Ensuring the biocompatibility of materials requires clear sightlines over testing. This is the only way to guarantee all materials comply with key regulatory and quality checkpoints. When it comes to supplier-provided biocompatibility data, however, tests are often performed in a black box.
In other words: you know what materials are being tested and you are handed the test results. But, as you have no view of the procedure, you have no idea how rigorous and accurate the testing is. This black box scenario leaves significant room for error and misinterpretation.
The supplier, for instance, might declare a material as medical grade, yet the definition of 'medical grade' is far from consistent across the industry. The supplier's testing methods may lack the thoroughness and expertise required to uncover potential contaminants, degradation products, or individual chemical components that jeopardize patient safety.
Supplier testing processes may not align with evolving regulatory requirements and industry standards, leading to inadequate or incomplete biocompatibility tests. This can delay the time-to-market for products. Fortunately, a proactive approach can minimize these risks and guarantee the biocompatibility of materials.
Mastering Knowledge Over Product Materials
Biocompatibility testing should take place both before and after MedTech materials are provided by new suppliers. The more meticulous and proactive your approach, the smoother your path to regulatory compliance. To gain full knowledge of supplier materials, follow these three steps:
- Perform Preliminary Tests Before Engaging Suppliers
Early-stage chemical profiling reveals the inherent properties of materials, potentially uncovering attributes that could either be beneficial or detrimental in the medical device's real-world application. This should be conducted long before a supplier is engaged.
- Conduct Verification Testing After Supplier Engagement
Once materials are provided, you must validate the supplier’s biocompatibility claims. This involves unboxing the 'black box' of supplier-provided data and engaging in rigorous testing to ascertain the true biocompatibility of the materials. This verification phase also accounts for any new variables that the manufacturing process might introduce, which could affect biocompatibility.
- Implement Continuous Quality Control Testing
Quality control testing is a continuous commitment to ensuring that materials uphold the required standards and specifications over time. By maintaining a vigilant eye, you also ensure materials remain compliant with evolving regulatory standards.
The meticulous approach of early and thorough verification of materials' biocompatibility pays dividends in the long run. It paves the way for a smoother regulatory approval process and significantly mitigates the risks associated with supplier-provided data.
A key risk is that suppliers may change their materials without informing you. These changes might be identified too late in the quality control process. This brings us to our next point.
The Necessity of Robust Quality Agreements
Establishing robust quality agreements with suppliers is critical for successful and transparent collaboration. These agreements define the standards, specifications, and responsibilities that govern the supplier–manufacturer relationship.
A robust quality agreement sets clear specifications for the materials, stipulating the testing and quality control measures that must be adhered to. It lays down the terms for quality assurance, inspections, and audits, ensuring a coherent understanding between all parties.
A well-structured quality agreement ensures that you are notified about any changes to the materials, processes, or sub-suppliers. This is crucial, as any alterations can have significant implications on the biocompatibility and overall safety of medical devices.
Building a Resilient Supply Chain for MedTech Materials
To secure continual access to quality materials, you need a network of reliable alternative suppliers. After all, recent global supply chain vulnerabilities such as those caused by the COVID-19 pandemic have been extremely disruptive for the MedTech industry. Those relying on a handful of suppliers found their product line impacted by stock-outs and delays. To avoid these situations, MedTech companies must find alternative material sources.
This is difficult news for many, as focusing on a single material source for regulatory approval saves time and money. Not to mention the work that goes into establishing new supplier relationships and performing additional material testing.
So, what can your business do to balance supply chain concerns with the need to quickly get your product to market? One strategy is to rely on a single source of materials for regulatory approval. Once approval is secured, you can focus on finding alternate suppliers and protecting your supply chain. Here, comparative studies, side-by-side material testing, and statistical analysis can help simplify the qualification process — potentially reducing the need for extensive biological testing.
Either way, partnering with alternate suppliers is a crucial long-term strategy for building resilience and guaranteeing a continuous supply of quality materials.
How RQM+ Can Help Verify Your Suppliers and Materials
In MedTech, the only materials you can trust are the ones that you’ve verified yourself. Adopting a verification-centric approach requires performing precise chemical characterization and biocompatibility testing. You also need to keep pace with shifting standards and regulatory requirements.
This is where RQM+ can help. As a full-service CRO, RQM+ provides comprehensive testing, analysis, and validation services to support regulatory compliance. Our expert Lab Services team can help you vet your suppliers and develop long-term strategies to safeguard the quality of your materials.
Speak with our experts and ensure that you’re using the safest and most efficient materials for the job. Contact our team now to find out how we can support your material verification process.