The requirements for FDA 21 CFR Part 11 are in place for a good reason: When companies are making a part that goes inside your body, the engineering and manufacturing process must be meticulously documented, tested and controlled. People’s lives are at stake.
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The human factor is sometimes just too cumbersome in manufacturing. Take the German chipmaker Infineon: By using an autonomous robot called Scout from MetraLabs for the last several years, the automotive supplier shrank to 10 from 300 the number of minutes it takes to collect the clean-room data needed to measure the presence of rare gases in the air.
Some in the medical industry are using silicone rubber molds made with a 3D-printed master pattern for low-to-mid production runs of cast polyurethane device housings.
Intelligent factories have existed since manufacturing’s historical inception, but intelligence—defined as the acquisition and application of manufacturing knowledge—resided only with the factory’s staff.
I’ve had quite a month, again, covering clever software and gadgets that continue to inch their way into performing tasks once reserved for humans. These tasks range from mundane material handling to highly skilled engineering design. It has made me think quite a bit about how our world of manufacturing and engineering will be affected by all this artificial cleverness.
Analytics solutions. The industrial Internet of Things. Robotics. Automation. Manufacturers looking for tech solutions that will help them control costs and gain a competitive edge have many great options. In fact, deciding what type of technology to invest in and why can seem overwhelming.
Contract manufacturers, aka job shops, are the heart and soul of US manufacturing. Their survival and success are imperative.
Digitization of industry has become an established global trend. Despite all the enthusiasm of visionaries, the machine tool is, was and will remain the core element in production.
It’s not often you get the opportunity to witness rapid, life-impacting change, but for those of us who have been in the 3D printing industry over the last few decades, we have witnessed just that. In the last 20-plus years, 3D printing has changed the definition of manufacturing from merely “one-size-fits-all” to “customized” production and from “high-volume” to “high-complexity/low-volume”—a startling paradigm shift that has enabled many new applications for the manufacturing industry.
More durable and versatile therapeutic wearable material, more accurate part measurement and improved automation and 3D printing were among the many technologies on display at this year’s Medical Design & Manufacturing (MD&M) East conference, June 12-14, in New York City.