Resolution Medical, headquartered in Minneapolis, manufactures parts on contract for medical device OEMs. Until recently, the manufacturer mainly used injection molding presses to produce medical devices and components. Although those presses are still a key component of the business, in the last year Resolution Medical has ramped up the use of 3D printers.
Since October 2018, Resolution Medical has invested in six Carbon M2 Digital Light Synthesis (DLS) printers. Although co-founder and president Shawn Patterson had previously used an FDM 3D printer for prototyping since the company’s start in 2012, only in the last year has additive manufacturing been used for production.
“The Carbon printers give us the ability to do different shapes, sizes and textures that our customers and doctors need,” says Patterson. “Carbon’s resins are also biocompatible and sterilizable, which was a value proposition compared to other 3D printing materials and technologies and helps make 3D printing more comparable to injection molding.”
New technology meant bringing inspection in-house. Previously, Resolution Medical would outsource the inspection of many components due to complexity and resources. The addition of AM production is an uncertainty for many in the industry, so there needed to be a quality guarantee. Patterson found that guarantee with Zeiss Industrial Quality Solutions.
“Zeiss has given us a measurement machine technology and functionality that has encouraged our growth,” says Patterson. “The full 3D measurement capability, both tactile and non-contact sensing, has helped with production cycles, iteration loops and designing inspection procedures.”
3D printed parts inspected include threaded black nuts for electrocomponent devices and catheter components, including housings, handles and composite catheter shafts.
“These are complicated handles with complex geometries and tight spaces,” Patterson said. “With high-volume production, with hundreds and even thousands of parts, you start to experience variations. Zeiss O-INSPECT helps us validate that each part is exactly the same each time.”
Resolution Medical also creates components used in Class III medical devices as well as Class III devices. Many parts are assembled, welded, or bonded together to complete the final device. It’s critical that any long-term implantable medical devices are compliant with ISO13485 and FDA regulations.
Zeiss CALYPSO measurement software and Zeiss PiWeb Reporting Plus Software help meet these regulatory requirements. Zeiss CALYPSO develops the measurement program and analyzes the measurement results while Zeiss PiWeb has pre-defined templates and samples that allow reports to be tailored to specific requirements. “The automated inspection reports and storage really helps meet customer requirements as well as when we’re being audited,” Patterson said.
Minneapolis has become the heart of the medical device industry. For Patterson, this has meant an almost unlimited supply of customers and massive growth for his company. “We chose Zeiss because it gets work with big OEMs,” says Patterson. “It gives a lot more confidence to our customers and helps with perception. And we outsource parts to machine shops that also use Zeiss, so it just made sense.”