In medical device development, prototyping is the critical bridge between concept and mass production, allowing engineers to test form, human-machine interaction, and the assembly feasibility of key components before committing to production tooling. The approach is intended to reduce the risk of costly design changes later in the process.
HemoSonics, developer of the Quantra blood coagulation analysis system, worked with Proto Labs in 2018 to produce prototype housings for the device. The exercise gave the development team a way to assess the structural strength of the housing and the fit of internal components before final molds were cut.
Medical device prototyping typically draws on several manufacturing processes, each with different trade-offs in precision, material properties, and cost. The methods below are among the core services used in the industry.
| Technology | Application focus |
|---|---|
| 3D printing | Validation of complex geometries and rapid iteration |
| CNC machining | High-precision machining of metal or plastic parts |
| Injection molding | Low-volume functional validation before mass production |
| Sheet metal fabrication | Production of housing structures and support frames |
3D printing is often used to validate complex geometries and support rapid iteration. CNC machining is suited to high-precision metal or plastic parts, while injection molding allows low-volume functional validation before mass production. Sheet metal fabrication is used for housing structures and support frames.
Process selection should follow the purpose of the prototype. When only appearance needs to be checked, 3D printing offers the fastest route. When mechanical strength or assembly accuracy must be tested, CNC machining is more dependable. When production material characteristics need to be evaluated, injection molding is the appropriate option.
Prototype housings do more than establish physical dimensions and internal space. They also help teams evaluate how a device will be operated in a clinical setting and whether cleaning and disinfection procedures are feasible.
