Prototyping is a learning process, but trials also must be done diligently with attention to detail to avoid extraneous costs that might hinder the product from reaching market mass production. During this time, hundreds of exact replicas may be needed to verify and validate a design. Without proper management, redesigns can become a burden with each respective batch that needs to be reworked. Sterling Medical Devices walks its clients through the design process—from sketches to 3D models to the prototyping stage. Sterling identifies medical device prototypes as necessary requirements needed to move from proof of concept to a physical product not only in your hands, but also to your customers in the clinical environment.
Our capabilities in Prototyping include:
- Photorealistic 3D Renderings
- Human Factor study models
- Show-ready scaled prototype models
- SLA (Stereolithography)
- FDM (Fused Deposition Modeling)
- SLS (Selective Laser Sintering)
- CNC (Computer Numerically Controlled)
- Multiple Urethane Casting
- Fully painted (with logos) functional models
- Silicon & Aluminum quick turn tooling
Specialists Right Within Reach
Sterling has a refined experience with modern medical device prototyping, significantly increasing the efficiency of production. We sift through the research that not only puts you ahead of the game at the onset of the project, but prevents you from derailing along the way or near the end of the process. Our designers and engineers ensure that the prototype is produced at the lowest total cost possible, while still maintaining the most suitable materials for implementation and remaining within compliance. Ergonomic factors can be pinpointed much earlier once prototypes are created which would otherwise be difficult to conceptualize. Computer aided solid models (CAD), computer aided manufacturing (CAM), simulations, and videos are used to present the most precise depiction of both the aesthetic and functionality of the product in terms of hardware and software.
Moreover, our distinguished and well-established network of partners allows our consulting expertise to extend further into specialized disciplines. With this, Sterling is able to further improve medical devices based on the specific needs of the consumer audience and unique functionality of the product in preparation for production. We are also able to determine the standards of existing patents and existing competitors that could require innovative reevaluation. Whether the prototype needs to be made with cardboard, plastic, or metals, our team works to formulate the representation that most effectively communicates the necessary ideas from multiple perspectives.
Prototyping to Verification
Sterling takes into consideration that a prototype—while being a pilot product—necessitates the need for testing to ensure the feasibility of the product. Fault points are reviewed from every angle of the product, especially in prototyping because the model is the closest to what is expected from the final product. Risk management is integrated into every phase of the product development lifecycle so that the end product adheres to ISO 14971 standards. Data & documentation is collected and compiled throughout the entire process to provide proof that all risk factors were considered. An extensive review by our experienced engineers guarantees a reliable and safe medical device. The end goal is to provide a genuinely worthwhile investment that can get the FDA approval to enter the market.