Google Icon

Medical Device Design Consultants - Expert Engineering Solutions

Transform your medical device concepts into market-ready products with Evok's comprehensive engineering solutions. Our 25-year track record in precision injection molding and regulatory-compliant design delivers the quality and reliability medical device manufacturers demand, from initial CAD modeling through FDA-compliant production.

Medical device engineers designing precision components

Our Medical Device Design Services

From concept to production, we deliver end-to-end engineering solutions for medical device manufacturers seeking precision, compliance, and speed to market.

CAD Design & Engineering

Expert SOLIDWORKS modeling and design for manufacturing (DFM) review to ensure your medical device components are optimized for injection molding, regulatory compliance, and cost-effective production.

Rapid Prototyping

Fast-track your medical device development with functional and cosmetic prototypes. Validate design, fit, function, and biocompatibility before committing to production tooling investments.

Material Selection

Navigate complex material science for medical applications. We help you select FDA-compliant, biocompatible materials that meet performance, sterilization, and regulatory requirements.

Tooling & Production

Complete injection mold tooling solutions designed for medical-grade quality. Our production services deliver consistent, traceable parts with full first article inspection and qualification documentation.

Compliant Mechanisms

Innovative living hinge and compliant mechanism design that eliminates traditional fasteners and joints. Ideal for single-use medical devices requiring simplified assembly and reduced part counts.

Parts Qualification

Rigorous qualification protocols including molding trial reports, first article inspection with 30-point critical dimension verification, and process validation to meet medical device quality standards.

Service Process

Our 5-Stage Medical Device Development Process

Concept Feasibility Assessment

We evaluate your medical device concept for manufacturability, regulatory pathway, and market viability. Our team analyzes design intent, material requirements, sterilization methods, and production economics to establish a clear roadmap from concept to compliant product.

Alpha Research & Design Refinement

Beta Development & Tooling

Qualification & Regulatory Documentation

Production Launch & Scale-Up

Proven Excellence

Trusted By Industry Leaders

Over 25 years, we've partnered with Fortune 500 companies and innovative startups to bring complex medical devices to market.

"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

"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

"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

"Great customer service! Paul is super dedicated."

Mo Amin
Mo Amin

"driven with details ... Very impressive"

Lawrence Dathe
Lawrence Dathe

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

Matt Maskell
Matt Maskell

"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

"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

"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

"Great customer service! Paul is super dedicated."

Mo Amin
Mo Amin

"driven with details ... Very impressive"

Lawrence Dathe
Lawrence Dathe

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

Matt Maskell
Matt Maskell

"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

"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

"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

"Great customer service! Paul is super dedicated."

Mo Amin
Mo Amin

"driven with details ... Very impressive"

Lawrence Dathe
Lawrence Dathe

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

Matt Maskell
Matt Maskell
The Evok Advantage

Why Choose Evok for Medical Device Design?

We combine deep engineering expertise with a passion for solving complex manufacturing challenges in the medical device industry.

25 Years of Precision Experience

Quarter-century track record in ultra-clean manufacturing for semiconductor and medical applications, with expertise in regulatory-compliant production processes.

FDA-Compliant Quality Systems

Six Sigma-driven processes with comprehensive documentation, 30-point critical dimension inspection, and full traceability to meet medical device quality standards and regulatory requirements.

Speed to Market Focus

Our streamlined NPD pipeline and rapid prototyping capabilities accelerate your timeline from concept to FDA clearance, helping you reach patients faster while maintaining rigorous quality standards.

Engineering Problem Solvers

Cross-functional team of mechanical engineers, industrial designers, and manufacturing specialists dedicated to optimizing your device design for performance, moldability, cost, and regulatory success.

Meet Our Expert Engineering Team

Industry veterans dedicated to your medical device success.

Paul Dathe, Founder & Chief Engineer

Paul Dathe

Founder & Chief Engineer

Paul founded Evok Polymers with a singular mission: delivering the highest quality injection molded medical and precision components at optimized costs through proprietary technology and deep industry expertise. With over 25 years specializing in engineering, product design, and problem-solving for custom plastic components, Paul brings unmatched experience from the semiconductor, medical device, and consumer products industries. His career highlights include leading new product development at Caliber Products, where he designed and launched 13 products while growing sales 540% and maintaining 100% client retention. At Entegris, he managed a $40 million product line of ultra-clean liquid delivery systems for semiconductor manufacturing—experience directly applicable to medical device quality requirements. Paul's engineering foundation includes roles at Boston Scientific and General Mills, where he mastered packaging and prototype engineering for regulated industries. He holds four U.S. utility patents, earned Six Sigma black belt certification, and graduated from Bemidji State University with a degree in Mechanical Design emphasizing rapid prototyping and 3D modeling. Paul is an active member of the Allied Executives Business Leadership Peer group and the Institute of Packaging Professionals.

Shawn Monitor, Sr. Industrial Designer

Shawn Monitor

Sr. Industrial Designer

Shawn has been instrumental in advancing some of the most sophisticated component design projects over the past two decades. His unique ability to graphically and physically communicate evolving design concepts makes him invaluable for medical device development, where visualization and prototype validation are critical. Shawn excels at building complex mechanical and visual prototypes in various materials, creating photorealistic renderings in Otoy OctaneRender, and developing technical documentation with Adobe Creative Cloud. His expertise in finding moldable part solutions that can be prototyped and validated before tooling has significantly reduced risk in large-scale medical and biotech projects. Shawn's pre-molding design reviews have prevented costly tooling errors and accelerated time to market for numerous medical device clients. He holds several patents and has conducted research across diverse sectors, from consumer products to biotech and medical facilities. His meticulous approach to mechanical design and prototype fabrication ensures that medical device components perform flawlessly from concept through production. Outside of work, Shawn practices photography and enjoys the Twin Cities live music scene.

Daniel D. Hoyt, Ph.D., Business Development Manager

Daniel D. Hoyt, Ph.D.

Business Development Manager

Daniel brings strategic vision and partnership development expertise that transforms how medical device companies approach manufacturing. His specialization in system and process design, combined with his ability to build strategic partnerships, makes him uniquely qualified to guide complex medical device projects from concept to market. At Evok, Daniel leads initiatives that challenge traditional approaches to part design, prototyping, tooling, and injection molding—particularly valuable for medical device manufacturers seeking innovative, cost-effective solutions. His vision extends beyond product development to building collaborative partnerships centered on continuous improvement and mutual success. Daniel's expertise in creating Lean Partnership-Based Organizations empowers medical device startups and mid-sized companies to compete effectively while maintaining regulatory compliance. His proficiency as a facilitator, public speaker, teacher, and coach enables him to translate complex engineering concepts for cross-functional teams and stakeholders. Daniel's commitment to sustainable growth and innovation aligns perfectly with the medical device industry's need for reliable, scalable manufacturing partners. His leadership ensures Evok delivers not just components, but comprehensive solutions that support long-term business success and market growth.

Jason Weber

Industrial Designer

Jason is a seasoned industrial designer whose passion for creating innovative, functional products is informed by his unique perspective on human behavior and ergonomics. Living in a multi-generational household with his wife, two sons, and mother has nurtured his innate empathy—a critical skill when designing medical devices that must be intuitive, comfortable, and safe for patients and healthcare providers. Jason's keen observation of how people interact with products translates directly into medical device designs that prioritize user experience alongside technical performance. His approach balances aesthetic appeal with functional requirements, ensuring medical devices are not only compliant and manufacturable but also delightful to use. Jason's design philosophy emphasizes the importance of understanding end-user needs throughout the development process, from initial sketches through production validation. His ability to bridge the gap between engineering requirements and human-centered design makes him an essential partner for medical device companies seeking products that succeed in real-world clinical environments. In his leisure time, Jason enjoys cooking, gaming, and unwinding—activities that fuel his creative process and inform his holistic approach to product design.

Frequently Asked Questions

What experience does Evok have with FDA-regulated medical device manufacturing?

Evok brings 25 years of precision manufacturing experience, including extensive work with ultra-clean systems for semiconductor and medical applications. Our founder Paul Dathe led product lines at Entegris for high-purity applications and worked at Boston Scientific on medical devices. We maintain Six Sigma quality processes, comprehensive documentation systems, and rigorous inspection protocols designed to support FDA submissions and ISO 13485 compliance requirements.

How do you ensure biocompatibility and material compliance for medical devices?

What is your typical timeline from concept to production-ready medical device components?

Do you provide the documentation needed for FDA 510(k) or PMA submissions?

Can you handle both prototype quantities and high-volume production?

What makes compliant mechanisms valuable for medical device design?

How do you manage design changes during the development process?

What are your pricing models for medical device design and manufacturing services?

Ready to Discuss Your Medical Device Project?

Our engineering team is here to answer your questions and provide a no-obligation consultation on your device development needs.

Certified Excellence

Awards and Recognition

Six Sigma Black Belt Certification

Six Sigma Black Belt

Advanced quality management and process optimization expertise

25 Years of Excellence Badge

25+ Years Experience

Quarter-century of precision manufacturing excellence

Patent Innovation Award

Four U.S. Patents

Innovation leadership in injection molding technology

Transform Your Medical Device Vision Into Reality

Share your project details and our engineering team will provide expert guidance on design, manufacturing, and regulatory pathway. Get a detailed consultation within 24 hours.

Contact Us Today

For immediate assistance, feel free to give us a direct call at +1 612-991-2001 You can also send us a quick email at