Medical Balloons
We design & manufacture non/semi-compliant & compliant balloons.
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Medical Extrusions
From single lumen to complex multilumen tubing, we do it all.
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Components
MIS designs and manufactures quality and affordable catheter components. Design your own custom component online or shop our off-the-shelf balloons & extrusions.
Shop off-the-shelf extrusions & balloons
Design your balloon / extrusion with our online designer
Co-Lab
Introducing Co-Lab: our advanced development and rapid prototyping group designed for your early-stage programs.
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Full Product Development
We work as an extension of your design team to take your product from concept to commercialization.
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End-to-end catheter engineering services
With an industry leading team of catheter experts and an optimal catheter manufacturing environment, MIS is your catheter design partner.
Get a quote today
IQueue
Create your own custom extrusion with just
a few clicks and instantly checkout.
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Balloon Designer
Create your own custom balloon in minutes.
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Catheter Designer
Pick from a variety of catheter types.
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Design Tools
Use our easy & quick online design tools to
submit your request to our team.
Get your quote in under 24-hours
Balloon Store
Shop off-the-shelf balloon components
Shop Now
Extrusion Store
Shop off-the-shelf extrusion components
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Online Store
Shop affordable, off-the-shelf balloons & extrusions with 24-hour shipping and only $50 min orders.
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CATHETERÂ DESIGN
Catheter Design &Â Development Services.
At MIS, catheter design services are our specialty. We have built our company around offering a winning combination of industry veterans and in-house technologies to expedite quality product development for medical devices.
Start Your Development Project
Rapid
Prototyping
Product
Development
Testing
Services
DHF
Management
Market
Commercialization
Catheter Design &Â
Development Services
Our minimally invasive medical device experts have decades of experience designing and building complex catheter systems. From balloon catheters to catheter based structural heart delivery systems, our vertically integrated facility opens the doors to catheter design and development.
Thin Wall
Catheters
Minimizing the profile of a catheter is paramount for catheter design and manufacturing. With our vertically integrated expertise and capabilities in catheter tubing, reinforced shafts, and complex catheter assembly, we are experts in thin wall catheters.
Medical Balloons & Balloon Catheters
At MIS we are experts in medical balloon forming. Whether you need balloon components or fully assembled balloon catheters, you can count on our in-house balloon engineers to design and blow your medical balloons.
Medical
Extrusion
Creating reliable catheter designs starts with reliable catheter tubing. From precision single lumen extrusion to complex multi lumen extrusions, our in-house extrusion capabilities makes catheter design and manufacturing faster.
Catheter
Manufacturing
From pilot lines to high volume catheter manufacturing, our ISO 13485 certified facility can handle your minimally invasive medical device manufacturing needs.
Reinforced
Shafts
Our expertise with complex catheter designs makes us experts at developing and manufacturing reinforced shafts. Our in-house braiding and coil reinforced shafts are optimized for your device's exact needs.
Quality &
Regulatory Compliance
We help bring your device to market faster with our in-house quality team and ISO 13485 certified facility. The catheter manufacturing process requires strict regulatory compliance and our quality systems keep you on-track.
Download Our Design Control Process
Discover what the journey to commercialization looks like with our design control process. This is a comprehensive look into the 5 phase process MIS created for catheter development.
Get The Guide (it's free!)Markets Served
Our catheter manufacturing facility serves a wide range of different minimally invasive catheter markets. Our carefully built facility and team give you full control over the catheter design and development process from catheter designs through catheter assembley.
Structural Heart
Complex catheter based systems with multi-directional steerability and multiple catheter shafts for heart valve repair and more.
Explore Structural HeartElectrophysiology
Catheter solutions for EP medical devices such as mapping or ablation catheters with sensor integration. Â
Explore ElectrophysiologyCardiovascular
Catheter solutions for EP medical devices such as mapping or ablation catheters with sensor integration. Â
Explore CardiovascularPeripheral Vascular
Catheter solutions for peripheral vascular including balloon catheters, reinforced shafts and more.
Explore Peripheral VascularNeurovascular
Microcatheter design, development, and manufacturing for tortuous anatomy access, stent deployment, stroke prevention, and more.
Explore NeurovascularVascular Access
Our catheter systems get you where you need to go in the body. MIS designs and manufactures medical devices to give you access to your target anatomy.
Explore Vascular AccessSurgical Robotics
MIS is helping medical device companies build the future of complex catheters and minimally invasive care through precision surgical robotics.
Explore Surgical RoboticsPulse Field Ablation
MIS works with medical device companies to design and manufacture next generation PFA catheters.
Explore Pulse Field AblationA solution for every device
A-La-Carte catheter design & development.
Whether you are in need of low-volume prototypes to prove feasibility, or you are looking for a partner to take you through regulatory submission and commercialization, we meet your needs wherever you are.
Catheter Expertise
MIS has decades of real-world experience in catheter manufacturing across many types of catheters. Our vertically integrated facility and in-house experts make the catheter manufacturing process simple. Ask us about our experience with the following types of catheters.
Steerable Catheters
Meet your exact performance specifications, optimize for bend radius, kink resistance, torqueability and more.
Learn About Steerable CathetersMicro Catheters
Design and manufacture highly flexible microcatheters for neurovascular navigation, designed for high pushability and kink resistance.
Learn About Micro CathetersBalloon Catheters
At MIS we design and manufacture balloon components and integrated balloon catheters. Our in-house balloon forming lowers development costs and timelines.
Learn About Balloon CathetersReinforced Catheters
Reinforced catheter shafts are a core capability at MIS, including braided reinforced and coil reinforced shafts.
Learn About Reinforced CathetersAspiration Catheters
Restore flow and remove embolic material with aspiration catheters. Our experts design and manufacture aspiration catheter systems with excellent performance.
Learn About Aspiration CathetersElectrophysiology Catheters
Electrode and sensor integrated catheters open the door for advanced therapies. At MIS we have years of experience with electrophysiology catheter assembly.
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Off-The-Shelf Catheter Handle
Reach your milestones faster by leveraging our internal handles.
Get through animal studies, first-in-human trials, feasibility studies or whatever milestones you face next with our fast and cost effective internal handles. With a wide range of French support and a variety of built-in features, you can fast-track your catheter system's success.
5-Phase Design Control Process
We follow a proven 5-phase design control process to design and develop your medical device.
Concept development & Optimization.
Develop and evaluate initial designs, design inputs, project requirements, project budget and timeline, and any additional customer requirements.
Establishing target design requirements.
Continuing to develop the product design, the associated manufacturability processes, and the required test methods.
Proving safety and device functionality.
conduct design verification and validation testing to demonstrate that the design outputs meet the design inputs.
Phases 4 & 5, and beyond.
The final phases of the Development Process are Process Validation and Commercialization. The purpose of Process Validation is to establish a manufacturing process that consistently meets all product requirements without the need for ongoing verification testing.
