Welcome to the “Medical Device Manufacturing” webinar.
Leading this webinar is Matt Moskal, Atlas Copco’s MicroTorque Product Specialist. In this webinar, we’re exploring the ways medical device manufacturers can boost productivity and quality by addressing low torque assembly challenges in this industry. Matt begins the webinar by describing FDA requirements, specifically section 21 CFR Part 820. In this section, the FDA lists the underlying best practices, which Matt explains as traceability (Part 820.65), product and process controls (Part 820.70), process validation (part 820.75), and general requirements (part 820.180). The FDA leaves it up to manufacturers to interpret this regulation and develop their own methods of adhering to it.
In the next section, Matt provides a side by side look at two stations. One station is a manually operated assembly station and the other is an automated assembly station. In the manually operated station, Matt describes a variety of challenges operators come across. There may be multiple clutch screwdrivers at the station, confusing operators, and leading to reduced productivity and increased errors. These screwdrivers do not have feedback capabilities and are unable to detect errors. Floating screws are another issue that cannot be detected by clutch screwdrivers in a manual assembly station. To combat these challenges, Matt recommends the use of Smart Connected systems to replace manual systems. Smart Connected screwdrivers provide immediate feedback and guidance, and instead of multiple screwdrivers, there’s just one. Matt also recommends using our Scalable Quality Solution for error-proofing and our Tool Positioning Systems for location and sequence guidance.
We then take a look at the automated assembly station. Most manufacturing industries are trending toward automation. Issues on the line with automated stations come in the form of failed screw pick-ups, which lead to missing or misaligned screws and damaged components. Without data collection, there’s no transparency and errors often pass undetected. To combat common issues on the automated assembly station, Matt explains that the use of a Smart Vacuum Pump MT in conjunction with our MicroTorque Power Focus 60000 controller reduces cycle time, eliminates the risk of missing/misaligned screws, and improves yield time. Data is collected and gathered in a database, such as ToolsNet 8, for later use or reference. The webinar then goes into other challenges within the medical device manufacturing industry, such as the use of plastic joints, employee qualifications, and preventative maintenance, and Matt explains smart, intuitive methods to overcome these challenges.
In the final part of the webinar, we explore Atlas Copco’s six pillars of value, which are made possible when the solutions above are implemented. Our six pillars of value are increased uptime, reduction in defects, new product introduction, improved productivity, human interaction, and reduction in energy use. Our goal: Smart manufacturing powered by MicroTorque. Matt ends the webinar on Atlas Copco’s global experience in this industry, explaining that our strong relationships with key manufacturers of pacemakers, ventilators, ultrasound machines, etc., is what makes us ready and eager to help you achieve smart manufacturing powered by MicroTorque.
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