Medical Device Engineering, Design and Build

Nortech Systems  is a leader in the design, engineering and manufacture of medical device systems. Both our Engineering Design Center in Maple Grove, Minnesota and our Manufacturing Center of Excellence in Milaca, Minnesota are ISO 13485-certified. Our team of program managers and engineers partner with medical device companies to manage the entire lifecycle from initial concept to product launch and commercialization.

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Video Transcript

Mike Lange, Director of Program Management: [00:00:08] We’re a global company with manufacturing capabilities in PCBAs, wire and cable. We serve the medical device industry, and it is a significant client base for us. Also, we do commercial and defense work. Nortech has a history of working with startups and we’re very passionate about it. We’ve got a team of dedicated, experienced engineers. We’ve got supply chain solutions and we’ve got obviously the manufacturing and software capabilities to truly support the startup medical device community. We’ve got our phase design approach. And so each startup is different. They have different needs. You know, a company may come to us with the back of the napkin sketch or they may come with the prototype that’s near finalized and want us to continue the design work and release into manufacturing. That’s really the history that and really what Nortech brings to the medical device community.

John Koski, Director of Operations [00:01:11] Milaca, this is our medical center of excellence. We’re ISO 13485 certified, an FDA registered facility focused primarily on electro-mechanical box builds and medical devices. We also have a 1000 square foot ISO Class 7 clean room that’s available for our customers as well. When working with our engineering team in Maple Grove, our team in Milaca includes onsite engineering and program management to support the transfer of design from prototyping, testing and into production. This helps ensure design for manufacturability for smooth product lifecycle from concept to launch. In the Milaca facility, we work with startups by being able to support production of as few as just a few units up to several thousand units a month so we can scale our production to meet clinical needs, development needs and then all the way up through commercial production and higher volumes. 

Mike Lange: [00:02:09] And our team of experienced program managers, we will work with work with each customer, whether its a start up or large, established company and walk through our design phase checklist to understand the needs. And from that, we will put together a project plan and make recommendations on the key deliverables. In many cases, the customers will want to take some of the responsibility for some of the deliverables, and Nortech would take responsibility for the others. It’s really a partnership. I look at it as a development partnership to help support our startup customers. Ultimately, the goal is to get their product to market and help them be successful.