Services
Prototyping Services
Not every medical device program is at the same stage, and not every prototype needs the same level of tooling, inspection, or flexibility.
Three Prototyping Options
MTD offers three micro injection molding prototype options, each using custom hardened-steel tooling and production-intent molding processes, to deliver high-fidelity micromolded components in the material required for your application.
Depending on where you are in the development process, you may need:
- molded parts to evaluate an early-stage concept
- dimensional data to compare parts to a drawing
- a bridge tool that can ultimately transition into production
Our in-house metrology lab can provide one-piece First Article Inspections (FAI) for your prototype design
Examples of High-Fidelity Prototypes
bioabsorbable implant prototype
overmolded prototype of fully-encapsulated medical circuit board
Which Prototyping Option Is Right for Your Program?
Compare the three options at a glance, then scroll for more details.
| Prototype Tool | Prototype Tool + FAI | Bridge Tool | |
|---|---|---|---|
| Best for | Early-stage evaluation | Defined designs requiring dimensional feedback | Programs progressing toward production |
| Hardened Steel Tooling | |||
| Drawing Required | |||
| One-Piece First Article Inspection (FAI) | |||
| Steel-Safe Areas | |||
| Dimensional Fine-Tuning | |||
| Potential Path to Production | Limited | Limited |
1
Prototype Tool
Best for early-stage programs that need molded parts quickly and do not yet have a finalized drawing.
MTD builds custom hardened steel tooling, molds the requested prototype parts, and ships them to you for evaluation.
This streamlined option is intended for programs where the primary objective is getting representative molded components into the hands of your engineering team for fit, function, assembly, or other early-stage evaluations.
Includes:
- Custom hardened steel prototype tooling
- Production-intent injection molding
- Customer-specified material
- Molded prototype parts
- No steel-safe areas
- No dimensional inspection or FAI required
- Drawing not required
Consider this option when:
Your design is still evolving and you primarily need molded parts to evaluate your concept before establishing final dimensional requirements.
2
Prototype Tool + FAI
Best for programs with an established drawing that need molded parts and dimensional feedback.
This optiThis option adds dimensional verification to the prototype process. MTD builds a custom hardened steel mold and produces prototype components, followed by a one-piece First Article Inspection (FAI) using our in-house micro metrology capabilities.
A drawing is required so our metrology team can evaluate the molded component against the specified dimensions and tolerances.
Includes:
- Custom hardened steel prototype tooling
- Production-intent injection molding
- Customer-specified material
- Molded prototype parts
- One-piece FAI metrology inspection
- No steel-safe areas
- Drawing required
Consider this option when:
Your design has progressed to a defined drawing and you want dimensional data along with your molded prototypes, but you do not yet require tooling designed for dimensional fine-tuning or future production.
3
Bridge Tool
Best for programs approaching design maturity that want to preserve a path from prototyping into production.
Our most comprehensive prototyping option is designed for customers who want to use the prototype phase as a true bridge toward production.
MTD builds a custom hardened steel mold with strategic steel-safe areas, allowing certain dimensions to be fine-tuned based on molding results and metrology data. Prototype components are molded and a one-piece FAI is performed to evaluate the part against the customer drawing.
As the design progresses, the tooling can be adjusted where appropriate and potentially continue into development, validation, and production — reducing the need to start over with an entirely new tool.
Includes:
- Custom hardened steel tooling
- Production-intent injection molding
- Customer-specified material
- Molded prototype parts
- One-piece FAI metrology inspection
- Strategic steel-safe areas for dimensional fine-tuning
- Drawing required
- Tooling designed with future production in mind
- Pathway to development and validation activities
Consider this option when:
Your program is progressing toward production and you want prototype tooling that provides greater flexibility for dimensional refinement and can support the next stages of development.