Skip to main content

Fully Customizable

Product Development Process

We fully customize our product development process based on the specific needs of your project. Where others may be bogged down by overly complex and rigid processes, the VitalPath team understands the need to be flexible and responsive to keep timelines on track to meet key milestones.

Feasibility & Initiation

Rapid Prototyping iterative design builds with testing of concepts to meet performance. User needs are established.

Design & Development Planning

User needs are refined, design inputs established.

Design Input

Selected concept is further developed & characterized.

Design Output

Final product design is statistically verified as meeting design inputs.

Design & Manufacturing Transfer

Processes are validated and human use studies conducted, if needed.

Commercialization

Product Release Authorization releases product. Product life cycle is continuously managed per the routine quality system.

Download Brochure

We use a responsive, problem-solving approach to

Rapid Prototyping

Our expertise, capabilities, and streamlined process allow us to quickly build complex catheter and delivery solutions.

  • Custom prototypes—FAST
  • Rapid design, build, and test prototype cycles
    • Typically, 2–3 runs of 10–20 samples each are needed before design freeze
  • In-house component capabilities enable quick turnaround

Our Engineers will act as

An Extension of Your Team

Our experienced engineers have the deep technical knowledge needed to take your challenging concept and deliver a manufacturable device.

We collaborate with you to:

  • Improve your design to meet manufacturing capabilities
  • Verify manufacturing processes are capable
  • Validate repeatability and reliability
  • Execute per our mature ISO 13485 quality systems

We offer a wide range of secondary operations in house, saving time and streamlining your supply chain.

Our custom, complex component capabilities include:

  • Complex device assemblies
  • Braiding & coiling
  • Curved & steerable catheters
  • Complex extrusions
  • Laser welding and cutting
  • Wire forming & ablation
  • Nitinol forming

Support through ramp

Flexible, high-mix manufacturing

We can handle all your manufacturing needs, from pilot production through volume manufacturing.

Specializing in high-mix manufacturing, we have the flexible people, processes, and systems to meet the challenges of manufacturing scale-up.

Benefits of high-mix manufacturing include:

  • Accommodates design changes typical with launching new technology
  • Lot-release quality systems speed time to clinical trials and market launch
  • Supports customer during growth, as important new technologies may spend years in low-volume production
  • Provides a manufacturing pathway supporting all phases of growth

Once we build your shaft or delivery system to your specifications and it performs as intended, we can manufacture your finished device in our FDA-registered facility. Or, we can hand it back to you for the finishing touches, whether that’s loading a stent or adding a handle.

Our production manufacturing services include:

  • Process development
  • Verification
  • Validation
  • Scalable QA systems

Contract Manufacturing

Volume Manufacturing and Finished Device Assembly

Over 90% of our work is volume subassembly and finished device production including dock to stock agreements with Tier 1 OEMs.
We assemble complex catheter devices including fine wire assemblies, testing, packaging and labeling.

ISO 13485:2016 Certified

FDA Registered

300+ Employees

3 Minneapolis Locations

ISO 7 & 8 Cleanrooms

Company Updates

Videos & Resources

Ensuring a braided shaft meets very tight tolerances

VitalPath manufactures catheter components with very precise tolerances. In this QA inspection process, a team…
Company News
VitalPath Operations Delivers for Customers by Driving Efficiencies, Lowering Costs, and Improving Yield
Press Releases
Maplewood Facility Expands by Nearly 70% to Support Microcatheter Growth