The Importance of Quality Assurance for Medical Devices
Q&A with Martin Schuster, President, Laser Design at the Medical Design and Manufacturing Show, Minneapolis
Q: What’s driving the 3D scanning market, particularly for medical?
A: 3D scanning has become so important. Quality assurance is so important, especially in the medical industry where it can be a matter of life. If a part fails, it could have catastrophic consequences. It’s really important to know everything about the 3 dimensional shape to make sure it will work perfectly.
3D scanning has typically been applied to a lot of high-end devices whether it’s for cell phones, heart pumps, implantable devices, artificial joints or wide variety of complex shapes. You can have mismatch or the inability for the parts to function. This is something you want to avoid because when these parts go together on an assembly line at the last second for example, they better fit perfectly or the assembly line will shut down.
Q: Tell me about Laser Design?
A: Laser Design introduced the first 3D scanning technology in America in 1987. We offer 3D scanning systems and services for high-end, complex, high-value parts and components for a wide variety of industrial, medical and other markets that require precision accuracy.
Q: The 3D CT scanner can measure internal and external geometries?
A: Yes, the DeskTom 3D CT scanner is an x-ray inspection system that provides complete shape capability for non-destructive First Article Inspection level evaluations. It’s suitable for small, intricate or complex medical parts.
Q: Can you tell me about this portable 3D scanner?
A: The Rexcan DS3 is a desktop 3D scanning solution that’s ideal for R&D, product design and for off-line inspection. You can scan small parts and compare it back automatically to the CAD model to show any mismatch between the design intent and the manufactured product. It shows where it’s in tolerance or out of tolerance. This is where we can very easily see the 3D color map to see if it’s a good part, bad part or if a portion of the part is going bad, then it’s time to look at the mold.
Q: Who are your customers?
A: The MD&M show is a good example of people both exhibiting and attending that are our customers. They’re making the parts for the big medical device companies or smaller ones. We sell to product manufacturers as well as the subcontractors. Beyond medical, our customers include a wide variety of world-class companies such as Samsung, Toyota, Hyundai, Schneider Electric, for example.
Q: What do they value about Laser Design systems?
A: Quality assurance is a difficult science. The training requirements for personnel to run some of the older technologies has involved a long learning curve. They need a 3D technology that is fast, accurate and really easy to operate. We offer a +/-5 micron accuracy for plastic injection molding parts, stamped parts, machine parts, die cast parts and critical fit complex shapes that can sometimes be difficult to put together. That’s what our customers say they appreciate about Laser Design systems – The level of accuracy combined with how easy the systems are to set-up and use – this is what’s really appealing. They can reduce their time to market with the right solution for quality assurance.