Prototyping

Prototyping medical device mechanical sub-assemblies is a critical step in the development process of medical devices. It involves creating functional or semi-functional models of individual components or subsystems that will eventually be integrated into a complete medical device.

Key Aspects of Prototyping Medical Device Sub-Assemblies

Design Validation – confirm that the sub-assembly meets its intended function (e.g., a pump delivering precise fluid volumes or a sensor detecting biological signals).

Feasibility Testing Assess whether the design can be manufactured and integrated into the larger system.

Risk Mitigation Identify flaws or failure points early, especially critical in medical devices where malfunctions can harm patients.

Types of Prototypes

Proof-of-Concept (PoC)

Basic models to demonstrate core functionality, often rough and not fully refined.

Functional Prototypes

More advanced versions that mimic the final sub-assembly’s performance.

Pre-Production Prototypes

Near-final designs used for regulatory testing and manufacturing setup.

Process

Design Phase

Starts with CAD (computer-aided design) models or simulations to define the sub-assembly’s specifications.

Material Selection

Biocompatible materials (e.g., medical-grade plastics, titanium, or silicone) are chosen based on the device’s application (e.g., implantable vs. external use).

Fabrication Techniques

Common methods include 3D printing (for rapid iteration), CNC machining (for precision), or injection molding (for scalable parts).

Assembly and Integration

Sub-assemblies are built and tested standalone before being combined with other components.

Testing

Rigorous evaluation for performance, durability, and safety (e.g., stress tests, sterilization compatibility, or electrical safety).

Prototyping medical device sub-assemblies is both an art and a science—balancing innovation with the stringent demands of healthcare.

It’s where theoretical designs meet real-world constraints, paving the way for devices that can save lives or improve quality of life.

If you’ve got a specific sub-assembly in mind, we look forward to hearing from you.