From designing pacemakers safe for MRI machines to 3D printed medical implants, the medical device industry keeps raising the stakes, with companies working hard to develop cutting-edge technology that saves lives and improves quality of life.
But innovation takes relentless effort, as well as constant testing and analysis to ensure the safety and function of medical devices. After all, even the smallest change in components or processes can have a significant effect on the product — and that’s where we come in.
Innovatech Labs has been a trusted partner for medical device manufacturers for years, helping them build top-of-the-line, safe devices. Partnering with manufacturers like you, we use a variety of materials analysis techniques in our lab to identify, troubleshoot, and resolve product issues.
Mitigating Microcontaminants with Cleanliness Testing
From extracting the device out of the mold to cleaning and packaging, device contamination can occur just about anywhere within the production process. However, cleanliness testing and materials analysis can help ensure you’re creating products that are free from microcontaminants that could pose a safety risk to patients.
Not long ago, we received a sample of a titanium electrode with an unknown stain on it. Our client suspected that the stain originated from hard water used in the rinse cycle. Using Auger electron spectroscopy analysis, a surface analysis technique, we found high levels of calcium, chlorine, and potassium in the stain, all of which are found in hard water.
With this information in hand, our client was able to make changes to the rinse cycle’s water source and eliminate the problem.
Troubleshooting Device Failures
Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries, and malfunctions. As such, medical device failure analysis is a key quality control testing technique for determining whether an ingredient, contaminant, or step in the production process caused a device to fail.
One common failure concern is the leaching of residual solvents. In the case of one of our clients, after exposing a polymer coil to hydrochloric acid, the manufacturer was concerned chlorine would leach out when exposed to water. We used ion chromatography (IC) testing to identify whether that was true.
We started the testing process by soaking the polymer coils in deionized water at room temperature overnight. Then the chlorine content of the water was measured using IC. The results? There was indeed residual chlorine in the water, confirming our client’s suspicion and allowing them to make changes to the product process to mitigate the issue in the future.
Examining Passivation Layers to Ensure Safety & Function
When building medical devices meant for implantation into the human body, the passivation layer is critical to ensuring product safety. Passivation layers must have the proper chemical makeup and thickness to prevent malfunction, rusting, or an allergic reaction. But since these layers are usually quite thin, only certain analysis techniques are effective. Electron spectroscopy for chemical analysis (ESCA) is one of them.
In the past, we’ve been asked to measure the surface chemistry and thickness of Nitinol passivation layers to determine whether the layer is thick enough to prevent corrosion. ESCA analysis helps us uncover detailed elemental and binding energy information, allowing us to deliver clients with specific measurements so they can make any necessary changes.
We Want to Help You Build Better Medical Devices
At Innovatech Labs, we’re dedicated to helping you ensure the quality, durability, safety, function, and competitiveness of your products. Learn more about our work with the medical device industry and get in touch with our team.