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Medical Grade Plastic Parts Manufacturing | FDA-Compliant Components

Evok Polymers specializes in precision-engineered medical grade plastic components that meet stringent FDA compliance standards. With over 25 years of injection molding expertise and a proven track record serving medical device manufacturers like Boston Scientific, we deliver biocompatible, sterile-ready parts with documented traceability. Our Six Sigma-certified processes ensure consistent quality for critical healthcare applications, from surgical instruments to diagnostic equipment, while maintaining cost-effective production cycles.

Precision medical grade plastic components in sterile manufacturing environment

Our Medical Grade Plastic Manufacturing Services

Comprehensive injection molding solutions for FDA-compliant medical components, from initial design through high-volume production.

Medical Part Design & Engineering

Specialized CAD design services for medical-grade components with focus on biocompatibility, sterilization compatibility, and regulatory compliance. We optimize designs for FDA submission requirements while ensuring manufacturability and cost-effectiveness.

FDA-Compliant Material Selection

Expert guidance in selecting USP Class VI, ISO 10993 certified, and FDA-approved resins including medical-grade polycarbonate, PEEK, polypropylene, and silicone. We navigate material science to ensure biocompatibility and performance for your specific medical application.

Medical Device Prototyping

Rapid prototype services using medical-grade materials for functional testing and regulatory submissions. We provide biocompatible prototypes that accurately represent final production parts for validation, sterilization testing, and FDA 510(k) documentation.

Cleanroom Mold Design & Tooling

Precision mold design and production tooling engineered for medical manufacturing environments. Our molds incorporate features for minimal particulate generation, easy cleaning validation, and consistent part quality to meet ISO 13485 standards.

Medical Parts Qualification & Validation

Comprehensive qualification protocols including First Article Inspection, process validation documentation, and statistical process control. We provide IQ/OQ/PQ documentation, dimensional reports with Cp/Cpk analysis, and material traceability for regulatory compliance.

High-Volume Medical Production

Scalable production capabilities for medical components with lot traceability, process monitoring, and quality documentation. We maintain controlled manufacturing conditions, implement change control procedures, and provide Certificate of Compliance for each production run.

Medical device manufacturing process flow in controlled environment

Our FDA-Compliant Development Process

Medical Design Feasibility & Regulatory Planning

We begin by evaluating your medical device concept for manufacturing feasibility, regulatory pathway, and material biocompatibility requirements. Our team assesses sterilization method compatibility, tissue contact classification, and FDA submission strategy to establish a compliant development roadmap from the start.

Biocompatible Prototype Development & Testing

Design Validation & Process Development

Production Tooling & First Article Qualification

Validated Production & Continuous Quality

Proven Medical Manufacturing

Trusted By Industry Leaders

Delivering precision medical components for leading healthcare and life science companies with documented quality and regulatory compliance.

"driven with details ... Very impressive"

Lawrence Dathe
Lawrence Dathe

"Great expertise and people!"

Rick Chen
Rick Chen

"Evok provided exceptional service! Paul and the studio team demonstrated amazing expertise and professionalism throughout the process. They exceeded expectations with precision and timely execution. Highly recommend for any project requiring top-notch design solutions."

Jason Salveson
Jason Salveson

"Great customer service! Paul is super dedicated."

Mo Amin
Mo Amin

"Paul is very knowledgeable and passionate regarding all facets of plastics manufacturing."

Matt Maskell
Matt Maskell

"Amazing business and amazing person to work with.Paul and I grew up together he has always had attention to detail in everything he has ever done,my company has used him a couple times now and are so pleased with the outcome I would recommend the company to anyone, once again..."

Kevin Nattress
Kevin Nattress

"Had a Great to work with Paul and it has been great! Has a plethora of knowledge and was great to learn from."

Landen Pool
Landen Pool

"driven with details ... Very impressive"

Lawrence Dathe
Lawrence Dathe

"Great expertise and people!"

Rick Chen
Rick Chen

"Evok provided exceptional service! Paul and the studio team demonstrated amazing expertise and professionalism throughout the process. They exceeded expectations with precision and timely execution. Highly recommend for any project requiring top-notch design solutions."

Jason Salveson
Jason Salveson

"Great customer service! Paul is super dedicated."

Mo Amin
Mo Amin

"Paul is very knowledgeable and passionate regarding all facets of plastics manufacturing."

Matt Maskell
Matt Maskell

"Amazing business and amazing person to work with.Paul and I grew up together he has always had attention to detail in everything he has ever done,my company has used him a couple times now and are so pleased with the outcome I would recommend the company to anyone, once again..."

Kevin Nattress
Kevin Nattress

"Had a Great to work with Paul and it has been great! Has a plethora of knowledge and was great to learn from."

Landen Pool
Landen Pool

"driven with details ... Very impressive"

Lawrence Dathe
Lawrence Dathe

"Great expertise and people!"

Rick Chen
Rick Chen

"Evok provided exceptional service! Paul and the studio team demonstrated amazing expertise and professionalism throughout the process. They exceeded expectations with precision and timely execution. Highly recommend for any project requiring top-notch design solutions."

Jason Salveson
Jason Salveson

"Great customer service! Paul is super dedicated."

Mo Amin
Mo Amin

"Paul is very knowledgeable and passionate regarding all facets of plastics manufacturing."

Matt Maskell
Matt Maskell

"Amazing business and amazing person to work with.Paul and I grew up together he has always had attention to detail in everything he has ever done,my company has used him a couple times now and are so pleased with the outcome I would recommend the company to anyone, once again..."

Kevin Nattress
Kevin Nattress

"Had a Great to work with Paul and it has been great! Has a plethora of knowledge and was great to learn from."

Landen Pool
Landen Pool
The Medical Manufacturing Difference

Why Choose Evok Polymers for Medical Manufacturing?

Over 25 years of injection molding expertise focused on quality, compliance, and cost optimization for medical device manufacturers.

Regulatory Expertise

Six Sigma certified processes with comprehensive documentation to support FDA submissions, ISO 13485 compliance, and medical device quality system requirements.

Medical Industry Experience

Proven track record serving medical device manufacturers including Boston Scientific and Entegris, with deep understanding of biocompatibility, sterilization, and cleanroom manufacturing requirements.

Quality & Traceability

Statistical process control with Cp/Cpk analysis, complete lot traceability, material certifications, and documented change control procedures for every production run.

Cost-Optimized Solutions

Transparent pricing model focused on minimizing total cost of ownership through optimized design, efficient tooling, and high-yield production processes while maintaining medical-grade quality standards.

Meet Our Medical Manufacturing Experts

Experienced engineers and designers dedicated to your medical device success.

Paul Dathe, Founder and Chief Engineer at EVOK Polymers

Paul Dathe

Founder

Paul Dathe founded Evōk Polymers with a singular mission: delivering the highest quality injection molded components at the lowest possible price through proprietary technology and deep industry expertise. With over 25 years specializing in engineering, product design, and solving complex injection molding challenges, Paul brings unparalleled depth to every project. He holds four U.S. utility patents and earned Six Sigma black belt certification, applying rigorous process optimization to mold design engineering. Prior to founding EVOK, Paul led new product development at Caliber Products, launching 13 products while growing sales 540% and expanding from 25 to 144 customers with 100% retention. His responsibilities spanned tooling design, functional assessments, 3D modeling, prototype fabrication, tolerance analysis, and mold flow studies. Earlier, as Senior Mechanical Engineer at Entegris, Paul managed a $40 million product line of ultra-clean liquid delivery systems for semiconductor applications. He began his career at Rollerblade in design and prototyping before serving in senior engineering roles at General Mills and Boston Scientific. Paul earned his Bachelor of Science in Mechanical Design from Bemidji State University with emphasis in rapid prototyping and 3D computer modeling. He's an active member of Allied Executives Business Leadership Peer group and the Institute of Packaging Professionals.

Jason Weber, Industrial Designer at EVOK Polymers

Jason Weber

Industrial Designer

Jason is a seasoned industrial designer with a passion for creating innovative and functional injection molded products. His design philosophy is deeply influenced by his life within a multi-generational household with his wife, two sons, and mother, which nurtures innate empathy and keen observation of human behavior—qualities that translate directly into user-centered design excellence. Jason brings creative vision to EVOK's engineering projects, balancing aesthetic refinement with manufacturing practicality. His ability to understand how people interact with products ensures that every component he designs not only meets technical specifications but also delivers intuitive functionality and ergonomic comfort. Jason's multidisciplinary approach bridges the gap between pure engineering and real-world application, helping clients create products that resonate with end users. Outside the studio, Jason finds inspiration through cooking, gaming, and relaxation, activities that fuel his creative process and problem-solving abilities.

Shawn Monitor, Sr. Industrial Designer at EVOK Polymers

Shawn Monitor

Sr. Industrial Designer

Shawn Monitor has been an instrumental creative force on some of the most advanced injection molded seating and component projects of the last two decades. His particular expertise lies in graphically and physically communicating evolving design concepts and intricate part features through complex mechanical and visual prototypes built in diverse materials. Shawn creates photorealistic renderings using Otoy OctaneRender® and develops professional layouts, diagrams, and logos with Adobe Creative Cloud, providing clients with clear visualization of engineering concepts before tooling commitment. His deep involvement in pre-molding design reviews has significantly reduced risk on numerous large-scale projects by identifying and resolving potential manufacturing issues early in the development cycle. Shawn excels at finding mechanical molded part solutions that can be prototyped and validated prior to expensive production tooling, saving clients time and money while ensuring design intent is maintained. He holds several patents reflecting his innovative approach to injection mold component design. Beyond his professional achievements, Shawn practices photography and enjoys the vibrant Twin Cities live music scene, interests that sharpen his visual communication skills and creative thinking.

Daniel D. Hoyt, Ph.D., Business Development Manager at EVOK Polymers

Daniel D. Hoyt, Ph.D.

Business Development Manager

Daniel brings exceptional expertise in system and process design engineering, coupled with strategic partnership cultivation that sets EVOK apart in the injection molding industry. His passion for innovation and collaboration drives initiatives that challenge traditional norms in part design, prototyping, tooling, and injection mold manufacturing. Daniel's vision extends beyond disruption—he's building a community centered on continuous improvement, mutual benefit, and genuine partnership that empowers small and mid-sized businesses to compete at the highest levels. His leadership focuses on creating Lean Partnership-Based Organizations that optimize engineering processes and deliver sustainable growth. Daniel's proficiency as a facilitator, public speaker, teacher, and coach, combined with exceptional team-building and mentorship abilities, accelerates EVOK's mission to transform industry standards. Under his guidance, EVOK establishes new benchmarks for collaborative engineering success, ensuring clients receive not just technical expertise but strategic insights that drive their competitive advantage in demanding markets.

Natalie Weber, Operations Officer at Evok Polymers

Natalie Weber

Operations Officer – LIV

Natalie is a dedicated apprentice in product design and management who embodies the harmonious blend of creativity and sustainability in injection mold engineering. Possessing innate curiosity and a discerning eye for innovation, she tirelessly explores where design converges with environmental consciousness—bringing fresh perspectives to material selection and dematerialization strategies. Immersed in intangible design principles since childhood, Natalie grasps the profound impact injection molded products can have on the planet, driving her commitment to infusing eco-consciousness into every project facet. Her education in sustainability, combined with hands-on mentorship from seasoned professionals, accelerates her mastery of product design intricacies. Natalie investigates diverse materials, manufacturing techniques, and emerging technologies, always evaluating their ecological footprint and lifecycle implications. Her journey extends beyond creating aesthetically pleasing components—she's shaping a future where injection mold design engineering seamlessly integrates sustainability principles, leaving a positive legacy for generations while meeting demanding performance specifications.

Julie Young, Accounting and Finance Manager at Evok Polymers

Julie Young

Accounting and Finance Manager

Julie Young has been an integral part of Evok since its inception, bringing meticulous attention to detail and thorough financial expertise to the organization. As an experienced accounting professional, she excels in organizing and categorizing transactions, reconciling accounts, and producing clear, concise financial reports that enable informed business decisions. Julie's proficiency in accounting software ensures streamlined processes and timely delivery of financial information, maintaining compliance with all regulatory requirements. Her dedication to professionalism and confidentiality provides the financial backbone that supports Evok's operations and growth. Beyond standard bookkeeping, Julie plays a critical role in vendor relationship management, ensuring all partners are paid promptly and maintaining the trust-based environment that is central to Evok's values. Her reliable financial services support both the team's effectiveness and customer satisfaction by ensuring resources are properly allocated to deliver exceptional injection molding solutions.

Frequently Asked Questions

What plastics are medical grade?

Medical grade plastics include materials that meet FDA, USP Class VI, and ISO 10993 biocompatibility standards. Common medical-grade resins include polycarbonate (PC), polypropylene (PP), polyethylene (PE), PEEK, polysulfone (PSU), liquid silicone rubber (LSR), and certain grades of ABS and nylon. These materials are specifically manufactured with controlled additives, documented purity, and consistent lot-to-lot performance. At Evok Polymers, we work with certified medical-grade material suppliers and provide complete material traceability documentation including resin certifications, lot numbers, and biocompatibility test reports for every production run.

Is medical grade plastic safe?

What is medical grade PVC?

What are medical plastics?

What plastic material is FDA approved?

How long does medical device prototype development take?

What documentation is provided for medical parts production?

Can you help with FDA submission documentation for medical devices?

Need Medical Manufacturing Guidance?

Our team of medical manufacturing experts is ready to discuss your project requirements and regulatory pathway.

Certified & Trusted

Awards and Recognition

Six Sigma certification logo

Six Sigma Black Belt Certified

Advanced process optimization and statistical quality control

Institute of Packaging Professionals member badge

Institute of Packaging Professionals

Professional membership and industry expertise

Manufacturing excellence badge

25+ Years Manufacturing Excellence

Proven track record in precision injection molding

Ready to Discuss Your Medical Device Project?

Complete the form below and our medical manufacturing specialists will contact you within 24 hours to discuss your requirements, regulatory pathway, and project timeline.

Contact Us Today

For immediate assistance, feel free to give us a direct call at +1 612-991-2001.