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Where Ideas Become Turning Points


Design, Innovation, and Manufacturing

We leverage our extensive medical device experience to incubate and accelerate market ready products. Watershed can help you with the entire product development process, or only the select phases that you need.

Design, Innovation, and Manufacturing

We leverage our extensive medical device experience to incubate and accelerate market ready products.

Watershed can help you with the entire product development process, or only the select phases that you need.

Additive
Manufacturing

Additive Manufacturing

Additive Manufacturing is increasingly being used in the healthcare industry, and becoming essential to the design and manufacturing of medical devices.

We are fully committed to additive manufacturing. We use our expertise in fabrication and design to guide you in the steps necessary to best utilize this transformative technology.

Design
Services

Design Services

Design for additively manufactured medical devices requires specific expertise, from optimized topologies to designing with regulatory submissions in mind. From the initial patent and competitive product review all the way through to the technical data and visuals for regulatory submissions, we’re here to help you every step of the way.

Regulatory
Guidance

Regulatory Guidance

Producing quality medical devices is in everyone’s best interest and we know what it takes to get there. At Watershed, our team members have commercialized over 10,000 medical devices through the FDA. Whether you need help with initiating FDA required design controls or with drafting regulatory submissions, we’re here to help.

Product Development Process


Whether you’re looking for assistance with concept development, regulatory submissions, or contract manufacturing of your titanium 3D printed medical device… we’re here to help. We offer a completely in-house Product Development Process that incorporates all three parts of a successful product development workflow: Design Support, Additive Manufacturing, and Regulatory & Quality Guidance, to ensure your product goes to market expeditiously and profitably. See the details here.

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We pride ourselves on taking a more personal approach to additive manufacturing and product development.


We offer support and guidance throughout the entire process to create the groundwork for success, including key areas such as:

Proof of Concept
Provide hands-on engineering and manufacturing expertise to turn ideas into proof of concept.

Manufacturing Demonstration
Showcase product and device manufacturing through a variety of technologies including additive manufacturing and CNC machining.

Patent Portfolio Development
Create patent portfolios around specific technologies.

Funding Readiness
Preparing company and products for investment rounds.

Concept to Commercialization
Evaluate and recommend marketplace and commercial opportunities for intellectual property and products, including go-to-market consulting.

Corporate Structure
Consulting around corporate structure and efficiencies for optimal growth, production, and margins.


I was impressed by Watershed’s level of professionalism with our surgeons and their deep understanding of the full development cycle and regulatory filings necessary to commercialize our products.

Biomedical Tech Company
VP of Operations


ISO 9001:2015
Certified

ISO 13485:2016
Certified