How Can You Ensure the Manufacturing of a Medical Device Containing Precision Optical Components?

Define Realistic Tolerances Under Real-World Operating Conditions

One of the most common pitfalls in medical optical projects is defining ideal tolerances that are disconnected from real operating conditions.

In a medical device, optical components must maintain performance despite:

• temperature variations (environmental conditions, sterilization, internal heating),
• vibrations (transport, handling),
• mechanical shocks (clinical use, maintenance).

It is therefore essential to define “real-world” tolerances, both for the optical elements themselves and for optomechanical assemblies.
This approach helps prevent performance drift, costly production adjustments, or—worse—regulatory non-compliance.

Adopt an Iterative Optical and Optomechanical Design Approach

The performance of a medical optical system never depends on a single component. It results from the interaction between:

• optical components (lenses, filters, fibres, sensors),
• optomechanical mounts and supports,
• the chosen assembly process.

An iterative design approach makes it possible to:

• optimize optical performance while respecting volume, robustness, and cost constraints,
• anticipate thermal, vibrational, and mechanical effects,
• validate that the selected architecture is compatible with the intended production volumes.

This approach is particularly critical in medical devices, where repeatability, traceability, and long-term stability are non-negotiable.

When the device includes sensors or acquisition functions, electronics design also plays a key role in overall performance. Noise management, acquisition speed, and signal integrity must be considered from the earliest design stages to fully leverage optical component performance and ensure system robustness under real operating conditions.

Integrate Industrialization from the Design Phase

Ensuring the manufacturing of an optical medical device also requires early consideration of:

• assembly feasibility,
• optical alignment methods,
• performance reproducibility in series production,
• cost of goods sold.

A high-performance design that cannot be industrialized quickly becomes a major project risk.
Alignment between optical engineering, optomechanics, and manufacturing is therefore a critical success factor.

Rely on Proven Expertise in Precision Optics

The development of medical devices incorporating precision optics greatly benefits from experience gained in sectors with comparable—or even more stringent—requirements, such as space and advanced manufacturing.

For several decades, INO has been developing high-precision optical systems for:

• medical devices,
• space applications,
• complex industrial environments.

This experience has enabled the organization to develop proprietary tools and methodologies that:

• accelerate optical component development,
• reduce technical risks,
• simplify the transition to manufacturing.

Conclusion

Ensuring the manufacturing of a medical device that integrates precision optical components requires an integrated approach combining optics, optomechanics, and electronics to guarantee reliable, repeatable performance compatible with clinical and industrial requirements.

It is essential to:

• define realistic tolerances under real operating conditions,
• adopt an iterative optical and optomechanical design approach,
• integrate manufacturing and cost constraints from the outset,
• rely on recognized expertise in precision optics.

This holistic approach—proven in demanding medical, space, and industrial applications—is what enables an optical innovation to be transformed into a reliable, high-performance, and manufacturable medical device.