Medical Device Prototyping Solutions

Empire group: your partner in high-quality, cost-effective medical device prototyping

For critical industries like healthcare, moving quickly from concept to prototype to final product can be vital. At Empire Group USA, Inc., we provide end-to-end medical device prototyping services that blend innovation and quality with speed and cost efficiency.

Benefits of Rapid Prototyping for Medical Device Development

Rapid prototyping medical devices is advantageous for:

  • Increasing speed to market. By accelerating design cycles, rapid prototyping enables medical device manufacturers to quickly produce and validate design iterations. Rapid prototyping not only helps in outpacing competition but also in responding swiftly to the ever-evolving needs of the healthcare sector.

  • Evaluating designs before full-scale production. Supporting innovation, prototyping allows you to test your product for functionality and manufacturability. Designers have the chance to refine and perfect products to better align with project requirements and end-user needs.

  • Cost efficiency. Identifying design flaws early on through prototyping reduces overall development costs, minimizing the risk of expensive design alterations and rework once you've started production runs.

  • Safety and compliance. Creating accurate prototypes for preclinical testing is invaluable, helping to ensure that devices are safe for human use and adhere to all medical industry regulations before market introduction. Prototyping products for compliance testing can facilitate the approval process.

Premium Medical Device Prototyping Services From Empire Group

We specialize in full product lines, single runs, and everything in between, assisting our medical clients with short-run prototyping for medical devices and components. Our design, fabrication, and finishing capabilities for medical device prototype development include:

  • Design and engineering support

    Empire Group's design for additive manufacturing (DFAM) analyzes support optimized product design within the framework of 3D printing's capabilities and constraints. Our team will work closely with you to evaluate your component or assembly design based on the following:

    • Additive manufacturing feasibility

    • Cost-effectiveness and reductions

    • Ideal material construction and wall thickness

    • Complexity and required angles/weight support

    • Potential for part consolidation and topology optimizations

    • Overall expected performance

    By incorporating DFAM into our design process, we're able to make suggestions and help ensure your 3D-printed product will be fully functional and financially viable.

  • 3D printing

    This additive manufacturing technique allows us to quickly create prototypes with complex geometries that traditional manufacturing processes struggle to achieve. As Empire Group's smallest-scale process to date, our Micro DLP 3D printing capabilities offer exceptional accuracy and resolution in the emerging microfabrication market. These 3D printing services are ideal for manufacturing precision medical devices.

  • CNC machining

    This fabrication method combines speed, automation, and cost-effectiveness with high-quality, precision manufacturing. It's an optimal choice for rapid prototyping and design validation, excelling in the creation of looks-like prototypes that also demonstrate the function and feel of the final product. The fast process also allows for easy design modifications.

  • RTV casting

    Room temperature vulcanization (RTV) casting is a prototyping option that, while economical, generates complex and tight-tolerance parts. It's useful for scaled looks-like prototypes, working components of production quality, and everything in between. We work with an array of medical-grade silicones, resins, urethanes, epoxies, foams, and more to achieve the desired mechanical, electrical, or thermal properties in your prototype.

  • Custom finishing and assembly

    To ensure that prototypes deliver the functionality and aesthetics you desire, Empire Group's custom finishing and assembly services add the final touches that make your prototypes presentation-ready. From sanding and specialty surface treatments to myriad painting and coating options, our team can customize your prototype's surface finish to deliver almost any appearance or effect. We'll also handle anything from threaded insert and hardware installation to complex assemblies with fit and tolerance checks.

Quality You Can Trust — Our Certifications

Empire Group's commitment to quality and security is reflected in our stringent adherence to industry standards. Our ITAR-registered company maintains ISO 27001:2013 and ISO 9001:2015 certifications, and we have Fortune 500 and defense companies testing our quality systems to ensure complete customer satisfaction and data protection.

ISO 9001 Certified
ISO 27001 Certified
ITAR Certified
Empire Group USA

Featured Customer Success Story: Medical Device Prototyping for Cogmedix

Cogmedix, a medical and clinical device manufacturer, needed rapid prototyping services to speed up product development and the FDA validation process. By combining our rapid tooling technologies with our 3D printing capabilities, our team was able to deliver prototypes made from end-use materials within a matter of days. 3D printing allowed us to quickly make design iterations for the client, resulting in prototypes that Cogmedix could utilize for sterilization testing and product validation.

Read the Full Case Study

Contact Empire Group for FDA-Approved Medical Device Development Solutions

Choosing Empire Group as your medical prototyping and design partner will give you access to cutting-edge technology and over two decades of experience in innovative, quality craftsmanship. With comprehensive in-house prototyping services covering everything from rapid prototyping to finishing and assembly, as well as our DFAM approach to product optimizations, our expert team will help you bring your medical device vision to life. Contact us to discover how we can transform your ideas into impactful medical solutions, or request a quote today.