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.
The Future of Medical Device Design
Watershed capitalizes on Additive Manufacturing’s unlimited design freedom to produce parts that are highly complex and enhanced for things such as biomimicry, mass customization, and surface optimization for osseointegration. All of this while also being designed for printability and for post-print operations, safeguarding costs and repeatability.
Design for Additive Manufacturing (DfAM)
By controlling the additive manufacturing process, we have created a symbiotic relationship with our designs. Surface textures on specific surfaces, multicomponent assemblies, uniquely latticed bodies, fully printed threaded features, etc., are all possible with proper DFAM.
Working with Watershed on the daily basis has really accelerated our product development process. Having an instant extension of our R&D department has allowed us to focus on new product development instead of trying to find and interview multiple candidates for weeks or months.
Clinical Designs for Patient Outcomes
The design of 3D printed devices presents a unique opportunity to gather pre-clinical in vitro or in vivo data to support marketing claims.
We help design for a 510(k) submission, while avoiding a full clinical trial, with proper claim construction and a complementary hazard analysis that feeds back into the design process.