Life Science & Medical Device Prototype Development

From concept to manufacturing, we streamline your end-to-end product design journey with expert regulatory and documentation support.

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Start Developing Your Medical Device Prototype

Bergman Prototyping can help take your device from concept to prototype and beyond with our innovative solutions for complex medical device technologies.

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Innovating Medical Solutions from Concept to Market

With extensive knowledge and proven expertise across the entire product design cycle, Bergman Prototyping excels in medical device prototyping, R&D, and prototype development. Equipped with an in-house CAD design station and CNC machining, along with a network of local vendors for fast turnaround, we streamline design for manufacturability (DFM) and design for assembly (DFA). From research and design to testing, manufacturing, and compliance, we deliver innovative solutions for the medical and life sciences industry with efficiency and precision.

Specialized Expertise in Medical Device Development

Medical Device Development

Product Development

Sketching and concepting different designs to explore all possible solutions and trade-offs for the best path forward. ➝ Specialties: InVivo Catheter, Benchtop Capital Equipment, Concepting, Manufacturing Processes
Best Documentation Practices

Minimizing waste and ensuring manufacturing quality through proper risk analysis and requirement specifications. ➝ Specialties: Risk analysis, Requirements & Specifications, Validation & Verification
Enclosure Design

Bringing industrial design visions to life with a focus on manufacturability and cost-effectiveness. ➝ Specialties: Design for manufacturability, Design for Human Factors, Design for Ingress Protection, Lean & Six Sigma
Plastic Design

Optimizing plastic components for efficiency and high-quality production. ➝ Specialties: Injection Molding, Structural Foam & RIM, Thermoforming, Cast Urethane, Blow & Rotational Molding
Sheet Metal Design & Welding

In-house prototyping for faster results and robust manufacturing. ➝ Specialties: CNC Milling & Turning, Aluminum Extrusion & Casting
Manufacturing Tools & Fixtures

Creating precision tools and fixtures to streamline production and reduce waste. ➝ Specialties: Laser & UV curing stations, Thermal & Fluid applications, Test Fixtures, Cutting Fixtures

Proven Expertise in
Medical Device Prototyping

With over 20 years in the medical device industry, Bergman Prototyping blends technical expertise, design precision, and regulatory knowledge to create prototypes that seamlessly transition into manufacturable solutions. Through innovative problem-solving and a patient-focused approach, we’ve contributed to breakthrough medical products now in widespread use.

From Prototype to Production

Extensive experience in design, assembly, and engineering to develop functional prototypes that lead to scalable, manufacturable solutions.

Regulatory Expertise

Over 20 years in the medical device industry, ensuring compliance with regulations while prioritizing patient safety and risk management.

Precision-Driven Design Specifications

Ensuring every product meets rigorous medical requirements, patient needs, and end-user expectations through well-documented design specifications.

Proven Track Record

Contributions to successful medical innovations, including projects like the Venclose generator bezel, now in use for 100,000+ treatments annually following its acquisition by BD in 2022.

Creative Problem Solving

A dynamic and open approach to exploring multiple solutions, finding unique ways to bring ideas to life while meeting strict industry requirements.

Healthcare markets we serve

Bergman Prototyping excels in medical device prototyping and life science manufacturing, delivering innovative, high-precision solutions that drive cutting-edge product development.

> Cardiovascular

> Biotechnology

> Otolaryngology

> Endoscopy & Minimally Invasive Surgery

> Gynecology

> Oncology & Radiation Therapy

> Dental

> Gastroenterology

> General Surgery

> Orthopedics & Trauma Devices

> Laparoscopy

> Wearable Medical Devices

Value Added Services

Bringing new healthcare products to market is a complex process, and Bergman Prototyping is here to streamline every step. From concept development to commercialization, we help accelerate your journey by balancing performance, quality, and cost to create a market-ready solution. Acting as an extension of your team, we provide expert guidance and hands-on support to ensure your product’s success. Our services include:

Product Engineering & Innovation

Controlled Environment Manufacturing & Sealed Packaging

Original Equipment Manufacturing (OEM) Compliance & Oversight

Compliance & Regulatory Strategy

Regulatory Filings & FDA Approval Process

Strategic Sales & Supply Chain Coordination

Program Oversight & Execution

Testimonials

Wade Bantz, Technical Program Manager

"I have had the opportunity to work with John in the Advanced Programs group since he started at BAE Systems. I found him to be a very creative and conscientious engineer. When faced with writing test plans for a third party on a development platform he was able to establish a very strong relationship with the team and create a quality set of documents. Our group has given John some “of the wall” assignments and he has been very clever at coming up with solutions. He is an excellent engineer for any mechanical design team."

Dave Dolfi, Research Fellow

"John was an excellent worker at Avago. Even though he was only just finishing his undergraduate studies as an ME, he had very good lab skills, was a very good machinist, and required a mimimum of supervision. Even though his experience with optical measurements was minimal when we hired him, he learned very quickly and was quite dependable at making rather sophisticated optical measurements for us. I recommend him without reservation."

Marty Larsen, Project Manager

"I've managed John for just under a year. He was new to the company when he started, and I was impressed with how fast he came up to speed and became a contributing member of the team. John is very willing and able to contribute by trying things he hasn't done before, or establishing a relationship with someone he doesn't know in order to get things done. John's persistant style, great work ethic, and focus on achieving his goals has made him a highly valuable member of the team."