Design and Prototyping

Unlocking Innovation: Revolutionize Medical Device Prototyping with Cutting-Edge 3D Printing

We understand that time is of the essence in the medical industry, where groundbreaking ideas can save lives. That’s why we offer a game-changing solution that accelerates your path from concept to reality, while ensuring precision, quality, and cost-effectiveness every step of the way.

Why choose us? Our team is a powerhouse of expertise, with a deep understanding of both medical technology and advanced 3D printing techniques. By harnessing the potential of additive manufacturing, we empower you to swiftly iterate and refine your designs, revolutionizing the prototyping process. Our cutting-edge 3D printers allow for intricate details, complex geometries, and customizability, enabling you to create medical devices that align seamlessly with your vision.

But it doesn’t stop there. We pride ourselves on our commitment to collaboration. When you partner with us, you gain access to a dedicated team of skilled professionals who will work hand-in-hand with you, providing invaluable insights and guidance. From brainstorming innovative solutions to troubleshooting design challenges, we are here to make your vision a reality. With our combined expertise, we ensure that your medical device prototypes meet the highest standards of functionality, durability, and safety.

Embrace the future of medical device prototyping. Join forces with Prime Path Medtech and harness the transformative power of 3D printing. Experience shorter lead times, enhanced design capabilities, and significant cost savings. Let’s revolutionize healthcare together, one prototype at a time.

Have an idea, however, you aren’t sure where to begin?

Schedule a complimentary 30-minute call with us get started

Why Choose Us

ISO 13485:2016

Why not begin your journey on the best foot with a certified quality partner from the start? As a full-service manufacturing provider, we believe in quality. Being ISO 13485:2016 and FDA registered demonstrates that commitment.

3D Printing Experts

We have been recognized by EOS as a “premier” partner in North America. EOS is the leading technology provider worldwide for industrial 3D printing of metals and plastics and offers integrated solutions in additive manufacturing.

Budget Friendly

As a small business, we understand the importance of capital preservation. We are always trying to find creative ways to keep the costs low both in prototyping and manufacturing.

Services

PRODUCT DEVELOPMENT PLAN CREATION

Have an idea, but not sure where to start? Or don’t know if you can identify all the regulatory requirements for a project? Do you just need some help getting a project off the ground? Our team of medical device engineers have been successfully launching devices for more than 20 years. Let us help you understand the overall and detailed plan and how to get from day one to product launch with practical, business-focused insight and planning.

USER AND PRODUCT SPECIFICATION DEVELOPMENT

FDA and ISO both require user and product specification development, an important step ensuring the development team understands the requirements for the product. Our team of medical device engineers understand the practical and regulatory aspects of this process, and we can help lead your marketing and development teams to establish concise, well written, and easily understood requirements and specifications. Starting projects on the best footing is important, let us help.

DATA ANALYSIS

Do you have an overwhelming amount of data from a test? Or do you just have too much to do and not enough time to organize, analyze or synthesize data from a test? Let us help you move your project forward. We have PhD level medical device engineers with years of experience conducting, analyzing, and assessing testing data, and statistical resources to make the data understandable and useful to your team. We can compile all your data into a report with recommendations and conclusions as needed.

PROJECT MANAGEMENT

Utilizing our proven Product Development Process or your internal product design process, our experienced, Biomedical Engineer project managers can guide your project team from day one to product launch. Each of our project managers has led multiple successful Class I and Class II projects to market and we understand all aspects of product development. This real world, practical experience and total process understanding leads teams to obtain goals in a timely manner with successful results.

REPORT WRITING

Do you have a team of talented engineers whose time is monopolized with writing reports to satisfy regulators when they could be working on new, innovative projects? Let us help you free up some resources. We have a team of technical writers and medical device engineers, who work together to create solid, professionally written documents for your projects. Hand us the data and we will prepare the report.

Design and Prototyping

Why Choose Us

ISO 13485:2016

3D Printing Experts

Budget Friendly

Services

PRODUCT DEVELOPMENT PLAN CREATION

USER AND PRODUCT SPECIFICATION DEVELOPMENT

DEVICE CLASSIFICATION

DATA ANALYSIS

3D PRINTED PROTOTYPES

PART OPTIMIZATION

FILE REPAIR AND OPTIMIZATION

PROJECT MANAGEMENT

SOFTWARE DESIGN CONTROL DOCUMENT CREATION

RISK MANAGEMENT ASSESSMENT

BIOCOMPATIBILITY TESTING REQUIREMENTS

REPORT WRITING

CAD MODELING

PART REPLICATION

Looking for a partner