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inquiries@meddux.com
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Monday – Friday: 9AM – 5PM

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6165 Lookout Road
Boulder, CO 80301 USA
+1 (720) 675-7154

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Resources

Resources

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Blog

17/9/26

Polymer Material Selection in Medical Devices

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Case study

8/13/26

Minimally Invasive Electrosurgical Device

Electrosurgical device company needing technically diverse CDMO partners with Meddux to help drive product development to manufacturing transfer.

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White Paper

10/10/25

Predictive Modeling of Laser-Cut Hypotubes

A validated computational model that predicts how a laser-cut hypotube will bend and stretch — before the first prototype is cut.

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Blog

06 Jun 2024

Understanding the Phase Gate Process in Medical Device Development

How the concept phase sets technical requirements and de-risks a device program early.

All Resources

A Pragmatic Approach to Quality

17 Sep 2026

Polymer Material Selection in Medical Devices

Materials are the physical backbone in every product, andadvancement in materials science and chemical engineering have been a drivingforce behind many of the technological innovations in medical devices.

Critical Parameter Management

06 Jun 2024

Understanding the Phase Gate Process in Medical Device Development

How the concept phase sets technical requirements and de-risks a device program early.

Critical Parameter Management

03 Jul 2024

Equipment Qualification, Process Validation, and Test Method Validation

Equipment qualification, process validation, and test methods that make a line ready.

Critical Parameter Management

11 Jun 2024

Mastering the Design and Development Phase in Medical Device Production

Inside design and development: component processes, tooling, controls, and early testing.

Critical Parameter Management

08 Jul 2024

Component Qualification, Process Performance Qualification, and Design Transfer

Component qualification, PPQ, and design transfer: the gates to manufacturing readiness.

Energy Therapeutics

09 May 2024

Energy Therapeutic Technologies – A Primer

RF, ultrasound, cryo, and laser: how each modality affects tissue and where it is used.

Critical Parameter Management

08 Jul 2024

Critical Parameter Management, Sustaining Engineering, and Continuous Improvement

How CPM, sustaining engineering, and continuous improvement keep devices in control.

Critical Parameter Management

21 Jun 2024

Ensuring Quality in Medical Device Design Verification and Validation

Test strategy, safety and performance testing, and the evidence needed before launch.

Innovation in Healthcare

25 Jun 2024

Maximizing our Impact

Why Meddux exists: how medtech funding and provider pressures shaped a different CDMO.

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Case Study
White Paper
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A Pragmatic Approach to Quality

09 Sep 2024

The Importance of Risk Management in Medical Device Development

Identifying, assessing, and mitigating risk across the whole development lifecycle.

User-Centered Design

08 Aug 2024

The Role of Ethnographic Research in User-Centered Design for Medical Devices

What observing clinicians in real settings reveals that interviews and surveys miss.

User-Centered Design

08 Aug 2024

The Importance of Journey Mapping in User-Centered Design for Medical Devices

How journey mapping exposes the real clinical workflow that surrounds your device.

User-Centered Design

08 Aug 2024

The Role of Prototyping in User-Centered Design (UCD) for Medical Devices

How prototypes, from paper sketches to functional builds, surface use problems early.

User-Centered Design

08 Aug 2024

Integrating User-Centered Design in Medical Device Regulations and Compliance

Aligning user-centered design with IEC 62366 and FDA human factors expectations early.

User-Centered Design

08 Aug 2024

Effective Risk Management in User-Centered Design for Medical Devices

How use-related risk fits into UCD: frameworks, common gaps, and practices that hold.

User-Centered Design

05 Aug 2024

Balancing User-Centered Design with Development Constraints in Medical Devices

How to hold on to user-centered design against deadlines, budgets, and tech limits.

User-Centered Design

24 Jul 2024

Introduction to User-Centered Design

What user-centered design covers, which tools matter, and why it makes devices safer.

User-Centered Design

24 Jul 2024

The Critical Role of Early and Continuous UCD in Product Development

Why user research belongs at the start of development, and why iteration never stops.

Handheld RFA device for ENT applications with a shapeable shaft and deployable micro-electrode array.

cAse study

August 9, 2026

RFA Device for ENT Applications

A startup contracts Meddux to accelerate an innovative radiofrequency ablation (RFA) therapy from concept to clinical trial.

Surgeon wearing a surgical headlight performing a minimally invasive procedure in the operating room.

cAse study

August 13, 2026

Minimally Invasive Electrosurgical Device

Electrosurgical device company needing technically diverse CDMO partners with Meddux to help drive product development to manufacturing transfer.

Cath lab monitor displaying coronary angiography images during an interventional procedure.

cAse study

August 13, 2026

Interventional Cardiology Instrument

Multinational medical device firm partnered with Meddux to rapidly prototype and refine an innovative cardiology instrument, confirming design feasibility.

Physicians performing a minimally invasive procedure in the operating room.

cAse study

August 13, 2026

Interventional Ablation Device

An energy therapeutics company partners with Meddux to design, develop, and manufacture its soft tissue ablation catheter.

Meddux technicians assembling medical devices in a cleanroom.

cAse study

August 13, 2026

Scalable Manufacturing Development

Medical device company partners with Meddux to execute design controls, validate critical processes, and establish scalable cleanroom manufacturing for FDA-registered commercialization.

cAse study

August 13, 2026

Critical Parameter Management

Global medical technology OEM contracts Meddux to conduct manufacturing analysis and apply critical parameter management approach for product quality optimization.

Electroporation delivery system handpiece prototype resting on engineering sketches.

cAse study

August 13, 2026

DNA Therapeutics Electroporation Device

A biotechnology company focused on developing DNA-based therapeutics partners with Meddux to develop a delivery system for First-In-Human Clinical Trials.

3D render of a braided neurovascular microcatheter with active electrodes at the distal tip.

cAse study

August 13, 2026

Microcatheter with Active Electrodes

Startup company contracts Meddux to develop novel neurovascular catheter with integrated energy therapy delivery.

Cover of the Meddux white paper on predictive modeling of laser-cut hypotubes.

white paper

October 10, 2025

Predictive Modeling of Laser-Cut Hypotubes

A validated computational model that predicts how a laser-cut hypotube will bend and stretch — before the first prototype is cut.

white paper

July 22, 2024

New Product Development and Critical Parameter Management

A structured path from initial concept to manufacturing excellence in a highly regulated environment.

white paper

August 19, 2024

User-Centered Design in Medical Devices

How user-centered design shapes medical device development — from intuitive, safe devices to design controls and compliance.

white paper

Insights for More Efficient Braided Catheter Development

A joint study with MSI comparing CathCAD-predicted and empirical catheter performance, and how braid pattern affects both performance and manufacturing cost.

Contact:

inquiries@meddux.com

Capabilities

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Medical Device Development
Finished Device Assembly
Steerable Devices
Electrode & Sensor Integration
Laser-Cut Hypotubes
Catheter Braiding
Catheter Coiling
Catheter Lamination

Markets

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Advanced Endoscopy
Cardiovascular
Electrophysiology
Endobronchial
Energy Therapeutics
Interventional & Delivery Systems
Interventional Spine
Neurovascular
Oncology
Ophthalmology
Structural Heart
Surgical & Endoscopic
Targeted Drug Delivery
Urology

Our Approach

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User-Centered DesignProduct DevelopmentCustom Process DevelopmentContract Manufacturing

About Us

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About MedduxMeet the TeamQuality & CertificationsEventsCareersConnect

Resources

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White PapersCase StudiesBlogVideo & Webinars

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