This video provides a comprehensive overview of the crucial role that X-ray inspection plays in ensuring the quality of medical devices. we discuss the three key stages of engagement with medical device companies, emphasizing the importance of pre-market design for inspection, incorporating X-ray systems for production, and addressing recalls with thorough inspection and process improvement.
Much like military and aerospace applications, medical devices must be inspected so we can assure the quality of the product you’re putting out there. Now, over the years, we’ve worked with medical device companies through different stages of their product life. We have two companies that engage us pre-market. So before they put something out, they reach out, figure out how to design for inspection.
People talk about design for Manufacturability or DSM. We develop DF eye design for inspection. So that you know that you can perform the best inspection at the lower cost possible. The second stage we talk to medical device companies is when the product is already in the market and they’re, you know, getting produced. And then those companies realize, hey, we need that extra level of inspection.
That’s where they bring x-ray inspection into their processes and we help them to deploy extra systems like this one or fully automated was with robots conveyor belts so that they can match the throughput, the conflicts that they need to keep the production line working all the way to, you know, our future intelligence so the systems can be fully autonomous.
The third stage, we engage with medical device companies to list on the stage, which is when they have a recall, right? So that’s when those companies are really under a lot of stress. A product has been discovered to be defective in the field. Things are coming back. Maybe the FDA is involved and now they have to actually inspect it, have to up their quality process.
We get involved to help them make sure that whatever happened never happens again. And we give them the traceability, the multiple check assurance. And so we will happen again and that whatever caused the problem is fixed. And they can show those companies, the FDA, for example, that the new process to manufacture the product fixes whatever has caused should do the best.
Now, let’s go back to basics. What is x-ray inspection and how does it work? So I brought up here a pretty common it’s an EpiPen, so it’s an auto injector. It has medication. It has two springs, one for the required one for the thrust of the needle here. And as you can see, the package was opaque. Right?
So if I have a microscope, found a camera, I can’t really see if the product is good or not. Right. So imagine if you automatically a medical device company and you are making devices like these have springs, have electronics, you has needles and has pumps. All these things inside a box that’s opaque. X-ray inspection is the modality that allows you to see through the package so you can properly assess if this product is good or not.
So that’s exactly what I’m going to do now. So I’m going to put this device inside or X-ray chamber, which is right here. I’m going to put layer on the stage, click a button, and you’re going to see the X-ray image right here on my monitor. And we’re going to go over what can you do with that image?
So let’s do it right now. So now the sample is inside the X-ray chamber, a closed door. With that, all the interlocks are engaged, meaning that there’s no radiation, a radiation coming out of this box. It’s fully safe. And by the way, the process of installing the machine, the facility, we do a full x-ray radiation inspection to make sure that there’s no radiation coming out of the system.
So it’s perfectly safe to operate the system even in an office environment like this one. All right. So I’m going to go ahead and push this button here to turn on the X-ray source and in a matter of seconds, as you can see, we have the X-ray image of the whole EpiPen. Right. So what you see here in an X-ray image is the lighter parts of the image are the lighter parts of the sample.
Right. So in this case, this very light gray here is air, right? There’s nothing there. The darker areas here represent denser parts of the sample. In this case, the metal in the springs, the thrust spring and the recoil spring right here. And some of the things that you look for in this specific sample for quality. Right. We have if the springs are correctly positioned or if in any way they are defective and they’ve been compressed incorrectly and they don’t sit in the plastic casing of this medical device, we can check if the needle is straight or if there’s any way damaged.
Right. We have a city example that Anthony is going to put in a link here that shows how you can use computer vision to properly figure out if this needle is straight or if there’s a kink at the end of its belt, the middle. We can also check if the medication here is filled out properly or if you have voids in this area that will cause bubbles to be inserted in some by this body, which is pretty bad.
Lastly, we can check the thread spring to look for any defects or any broken pieces of the plastic casing. I can go ahead and change the density of my imaging so I can highlight the plastic pieces. If I’m looking for that kind of defect. So X-ray inspection is an incredible way to quickly assess if your device is ready for the market or if it’s already market or if it’s it’s complying with your air quality standards.
Thanks for watching. Don’t forget to subscribe. And if you are a manufacturer of medical devices, you’re interested in learning more about X-ray inspection. You know who to call.