Your fundamental requirement.
"This team has been nothing less than amazing about working with us as clinicians about furthering our device. They have worked tirelessly to understand the device, the market, and what is required to make it a clinical reality."
-Physician Innovator at a leading healthcare organization
At Midwest Interventional Systems we partner with inventors and medical device companies to bring your therapies to life. We expedite your design process with rapid, cost-effective prototyping and testing. We use our variety of experience and quality-focused approach to engineer solutions that meet your requirements and ensure that manufacturability won't be a barrier to long-term success.
We specialize in catheters, delivery systems, and minimally invasive devices for markets including:
Whether you need finished devices or critical components, at Midwest Interventional Systems we understand what you're looking for in your development and manufacturing partner. Our core capabilities cover the full spectrum of engineering services required to bring your product from the drawing board to market.
We also provide the following additional services:
Clean room assembly
Packaging and labeling
Extrusion design and sourcing services
Catheter tipping and secondary operations
Nitinol components and assembly
Confidence and control through all 5 phases. Medical Device Product Development at MIS can take any form that you require. Our role can be as simple as supporting you with braid and coil, or as involved as holding and managing your Design History File.
We confidently help develop:
Highly trained, highly skilled team members.
We're positioned perfectly to support pilot manufacturing projects and scale them to full-scale production, or to implement and validate a full-scale production transfer.
ISO 13485:2016 certified
21 CFR Part 820 compliant
Our rapid development strategy maintains quality and design controls through all 5 stages. We employ phase-gates to ensure that requirements are met at the end of each phase.
"We are committed to providing the highest quality devices to our customer's satisfaction, while maintaining compliance with all applicable global and regulatory requirements."
Our Quality Management System is certified to ISO 13485:2016. We believe in the standard's strict design controls and requirements of good manufacturing and documentation practices.
The foundation of our culture at Midwest Interventional Systems is each team member's ownership of, and commitment to the quality of the devices we design and manufacture. Quality is at the core of our business model and paramount to the success of our services and partnerships. Quality is the foundation on which our company stands.
Class 7 Cleanroom
Our cleanroom is ISO 14644-1:2015 Class 7 certified to provide the proper controlled environment for packaging of finished devices. Manufacturing and assembly of components and devices also takes place in the Class 7 environment, where appropriate. Our cleanroom is monitored and maintained per ISO 14644-2:2015.
"Quality tends to fan out like waves. The Quality job he didn't think anyone was going to see is seen, and the person who sees it feels a little better because of it, and is likely to pass that feeling on to others, and in that way the Quality tends to keep on going."
-Robert M. Pirsig, Zen and the Art of Motorcycle Maintenance (1974)
MIS Earns ISO 13485:2016 Cert.
April 6, 2018
Midwest Interventional Systems earns ISO 13485:2016 less than four months after moving into their new facility on East River Road. The certification scope includes Design Controls.
MIS Certifies Class 7 Cleanroom
March 5, 2018
Midwest Interventional Systems completed testing and received certification for their brand new class 7 cleanroom.
MIS Moves to Fridley, MN
December 1, 2017
MIS opened the doors to their new 2500 sqft facility in Fridley, MN. This new facility allows MIS to support design and manufacturing projects of varying scale.
Midwest Interventional Systems is a private contract design & manufacturing company. We specialize in catheters, delivery systems, and other minimally invasive medical devices. We are located in Fridley, Minnesota, USA. We partner with local Minnesotan companies as well as out of state companies, including international companies.
To provide the world with a level of service that is unmatched, with the ultimate goal of enabling medical device companies and inventors to bring their life-changing, innovative products to market with a scaleable and sustainable platform.
Quality is our #1 goal in manufacturing. It is essential for safe devices and consistent business.
We are in business for, and because of, our customers. The key to an outstanding business is maintaining stellar relationships with other businesses. This is achieved through sincere interactions and honest business.
Honesty is essential to a lasting relationship. As a business partner, we promise honesty to our investors, customers, vendors, and all with whom we collaborate. We will resolve difficult issues and adverse circumstances as directly and openly as possible.
Creativity will help propel us into the future. Without creativity a business will eventually fall behind competitors and stagnate. Our wide-ranging experience and penchant for trying new things will enable us to develop creative, innovative, and technologically superior solutions.
The world is bigger than us and the moment we live in. We want to be a valued member of the community. Our good fortune is used to pay it forward to a world that needs positive influence.
Founder & President/CEO
Adam is currently President and CEO of Midwest Interventional Systems. Previously, at CardioKinetix, manufacturer of a novel transcatheter implant (Parachute ventricular partitioning device), Adam held a cross-functional role in the quality group working closely with R&D and manufacturing. There, he gained the perspective of a first class quality manager, working under very strong leadership with a firm commitment to product quality. Prior to that, he was a leader in the Design Services group at Creganna Medical in Campbell, CA. There, he developed a broad understanding of catheter-based technologies while working on over 15 projects in all stages of the product life-cycle. In addition, he developed polymer extrusion engineering skills by working on extrusion lines to enhance the process and improve product quality. Prior to that, Adam worked at his father’s medical device company for 12 years in roles including design, R&D, quality, operations, and manufacturing. He worked on projects designing, developing, testing, and manufacturing many different intravascular implants, including a coronary stent graft and a neuro stent. Adam received his B.S. in Chemistry and Neuroscience from the University of Minnesota in 2010.
Adam enjoys spending time with his fiancé, Kadie. They enjoy traveling, puzzles, reading, and the outdoors.
Founder & VP of Operations
Jeff is the VP of Operations at MIS. Prior to co-founding MIS, Jeff worked for 10 years as a field engineer and trainer for variety of manufacturing and production power houses in North America. He specializes in the use of robotics and automated systems in high-speed manufacturing. He applied his experience with manufacturing to the design and development of training programs and process documentation for internal and external use. Internally, he has trained dozens of service engineers, novice through veteran. Jeff has delivered on-site training to over 100 technicians and service team members. His experience in automated systems, manufacturing, technical training and documentation makes him a valuable member of the MIS team.
Jeff is a life-long Minnesota resident and husband to his high school sweetheart, Molly. Jeff enjoys spending his winters on the ski slopes and summers mountain biking through the numerous trails throughout the twin cities.
5155 East River Road Suite 415, Fridley, MN 55421, USA