Intricon Contract Development & Manufacturing Organization
Intricon is a leading contract development and manufacturing organization specializing in integrated solutions for medical device miniaturization, precision engineering, and advanced microelectronics for biosensors.
Our vertically integrated approach allows us to streamline the entire product lifecycle, from concept and design through to scalable production. With decades of expertise in micromedical device innovation, we help bring your product to market efficiently.
Our Approach to Contract Development
Collaborative Design Process
We take a partnership-driven approach to product development, working closely with you to transform your ideas into functional, market-ready medical devices.
Our multi-disciplinary team of engineers and regulatory experts collaborates at every stage to refine designs, improve manufacturability, and ensure optimal performance of your device while remaining within a predefined project budget.
Design for Manufacturability
Involve us early in your development process to optimize costs, improve efficiency, and mitigate production challenges. By integrating Design for Manufacturability (DFM) principles from the start, we ensure seamless scalability and superior performance from prototype to production.
Our approach focuses on optimizing materials, refining assembly processes, and selecting advanced components to support scalability from prototype to high-volume production while maintaining a high standard of quality and performance.
Regulatory Expertise
We are 100% focused on medical devices and deeply understand the regulatory landscape. Intricon provides comprehensive support to ensure compliance with FDA, ISO 13485, and other international medical standards, helping you navigate complex requirements with confidence.
Core Manufacturing Capabilities
Custom EM Sensors & Assemblies
What we do: Custom electromagnetic sensor designs to address EM performance and size requirements.
Why it matters: Meet induction, resistance, sensitivity, and localization goals while seamlessly integrating within interventional devices.
Precision Molding
What we do: Fully-automated high-volume capabilities, best-in-class needle and insert molding capabilities
Why it matters: Reduces production costs, avoids costly setbacks, improves part quality, and accelerates time to market.
Microelectronics
What we do: Microelectronic assembly and circuit design, incorporating ultra-fine pitch circuits with components down to .01005in.
Why it matters: Improve performance, reduce cost, and scale efficiently.
Microcatheters and Access Sheaths
What we do: Precision-engineered microcatheters and access sheaths designed for enhanced navigation, trackability, and compatibility with interventional devices.
Why it matters: Improves procedural efficiency, ensures patient safety, and supports next-gen minimally invasive medical treatments.
Automation
What we do: Design and integrate custom automation into our processes and workflow.
Why it matters: Reduces assembly steps, speeds up timelines, and lowers costs for efficient market entry.
Polymer and Metal 3D Printing
What we do: High-precision additive manufacturing for both polymer and metal components.
Why it matters: Accelerates development timelines, reduces material waste, and enables design for intricate medical device components.
Vertically Integrated Services
Prototyping & Rapid Iteration
Our contract development and manufacturing services accelerate product development timelines with in-house prototyping capabilities. We provide rapid iteration cycles, enabling you to refine your designs efficiently before committing to full-scale production.
Scalable Manufacturing Solutions
Our scalable solutions are designed to support high-volume production and adapt to your evolving needs. With advanced automation and lean manufacturing processes, we ensure efficiency, consistency, and cost-effectiveness throughout the entire product lifecycle.
Professional Project Advice & Guidance
We provide expert guidance throughout the entire product development lifecycle. Our team of engineers and regulatory specialists offers tailored advice on material selection, design optimization, and compliance strategies to ensure project success.
Quality Assurance & Compliance
Stringent Quality Control Measures
Quality is at the core of everything we do. We adhere to rigorous quality control measures, including in-line testing, automated inspection systems, and statistical process control to ensure that every product meets or exceeds industry standards.
Our commitment to quality translates to reliable and safe medical devices that perform consistently in real-world applications.
Compliance with Global Standards
As a trusted medical device manufacturer, Intricon adheres to globally recognized quality and regulatory standards, including ISO 13485, FDA regulations, and EU MDR compliance.
Our dedicated compliance team continuously monitors evolving regulatory requirements to ensure that our products meet the highest industry benchmarks.
What Our Customers Are Saying
I feel lucky to have had such a great supplier for the past 3 years. We accomplished so much together, and I am very appreciative of Intricon’s hard work and commitment to us. Their collaboration and support, especially during the rough times, did not go unnoticed.
Senior Supplier Quality Engineer
Leading Medtech Company
Intricon was identified as our component supplier based on their reputation in the medical device industry, over molding capability, ISO-8 clean room manufacturing capacity, automation ability, and the expertise offered by their team. As an Intricon client, you immediately understand that they are a multifaceted supplier with systems designed to support the full breadth of medical device manufacturing, ranging from material sourcing to finished device assembly, packaging, and labeling.
External Manufacturing, Associate Director
Medical Therapeutics Company
Since the onset of our partnership, Intricon has applied their extensive engineering knowledge and Quality Systems rigor to ensure the components manufactured will be of the highest quality and comply with the associated FDA and ISO requirements. Intricon’s staff are truly what makes the company so impressive and such a valued partner as illustrated via organization of project teams, effective inter and intra organizational communication, strong root cause investigations, and unsurpassed medical device manufacturing knowledge.
Associate Director, External Manufacturing
Gastrointestinal Enzyme-Based Product Company