Mechanical Engineering of Diagnostic Device Design

As specialists in mechanical engineering of diagnostic device design and fabrication, prototype molding is an integral part of our development process.

Molding Proves the Design. Our job is not complete until we have molded your device in low volume, tested it against all product requirements and implemented any needed design improvements. This process proves the design, along with the manufacturability and assembly methods before transfer to manufacturing. We like to call it “accountability in design”.

Low Volumes, Production Quality. While we are not a manufacturer, if you need production quality units to support user studies, internal testing, or clinical trials, we can help. Our medical device fabrication, injection molding, and assembly equipment is identical to the machines used in production, allowing us to supply you with hundreds to thousands of actual devices, not just prototypes, while still in development. This allows any issues to be discovered and corrected well before transfer to manufacturing.

Prototype Tooling Fabrication. We fabricate prototype molds using a proprietary process we developed that has several advantages over traditional aluminum prototype tooling (or ‘soft tooling’) and molded prototype service providers.

  • Transferable. Our tooling uses standard steel MUD (master unit dye) frame mold bases, making them readily transferable to any production molder in the world. This means that your manufacturer can use them as bridge tooling to produce parts during the weeks or months that your production tooling is in process. This also provides the manufacturer with valuable learning that is applied to the fabrication of production tooling, significantly reducing risk during scale up to higher volumes.
  • Fast Fabrication and Iterations. Our highly efficient machine shop and proprietary tooling design allows us to fabricate molds in as little as one week and make mold modifications in just one day, saving significant time and cost. The ability to quickly and inexpensively iterate the tooling design is critical to efficiently achieving all product requirements.
  • High Quality Parts. Our prototype molds are mostly steel, allowing the parts we produce to replicate those made in production and making them of a significantly better quality than parts made by molded prototype service providers. In addition, we can easily modify our molds and they last far longer than those of service bureaus, holding tolerances over tens of thousands of shots, instead of hundreds.
prototyping process

In-House Machine Shop

Our on-site machine shop allows us to fabricate quickly and with a high degree of quality.  Our engineers talk directly with the machinists to communicate the design intent and ensure critical features are made right, the first time. Rather than keep our machine shop busy 24/7, we maintain excess capacity so we can quickly meet the needs of our engineers, and ultimately our customers.

Our machining capabilities are vast and expertise is top notch. Anything that can be made in a machine shop, we can fabricate:prototype molds, test and assembly fixtures and prototypes made of metal or machinable plastics. We have five Hass CNC (Computer Numeric Control) machines, two CNC lathes and well-rounded set of supporting tools and equipment.

Additional Benefits of In-House Injection Molding

  • Speed and Quality. Communication between the engineer and machinist is best when they are both in the same building as it minimizes iterations and errors that lead to delays. Once we fabricate your prototype tooling, we immediately produce your device using one of our two manufacturing grade Arburg injection molding machines. These factors allow us to meet aggressive project delivery dates while maintaining high quality.
  • Learning. The process of mold fabrication and molding provides us with critical learning that is applied to the design of the production molds. We communicate critical part and mold design elements to the production mold maker, reducing risk and saving our customer time and substantial expense when transferring the project to manufacturing.
  • Stocked Materials. We maintain a stock of over 150 different types of the injection molded materials, which allows us to quickly sample, test and evaluate potential material candidates. In addition, our relationships with material suppliers and custom compounding companies allows us to source prototype quantities of any of the thousands of materials available on the market. Learn more about our Material Selection services
Molding Area Image

Our Injection Molding Equipment

Manufacturing Grade. We use injection molding machines made by Arburg, a German company well known in the industry for high quality molding machines. You will find Arburg injection molding machines used by many high volume manufacturers throughout the world. This choice allows us to replicate the manufacturing environment while still in the development phase and resolve any design or manufacturing issues far before transfer to manufacturing.

Closed Loop System for Faster Design Solutions. Our molding equipment uses a closed loop system, which retains the molding process settings electronically. With this feature, when we mold parts and then perform a mold modification, we can have confidence that the only variable in the next set of parts is the mold modification, rather than a change in the molding process. This enhances our ability to quickly complete a design with a minimum of iterations.

We have three injection molding machines: a 66 ton electric, 38 ton hydraulic and a 55 ton vertical hydraulic