Pharmaceutical and medical imaging applications and their challenges for optics and lens manufacturers

A HUGE VARIETY OF APPLICATIONS

• Eyeglasses and contact lenses
• Microscopes
• Endoscopes
• Ophthalmic laser surgery systems
• Surgery guiding systems
• Prothesis measurement systems
• Probe analysis systems
• Body and skin scanners
• Dental scanners
• … and many, many more
   

THE MEDICAL STANDARD

DIN ISO 13485 describes a quality management system for the design and production of medical devices. It is based on the DIN ISO 9001 but differs in several points, e.g. in the concentration on product safety.

For components suppliers like optics manufacturers it is often not necessary to be ISO 13485 certified – however, certain customer requirements may need to be met.
And be prepared for an audit by the customer!

STANDARD COMPONENT

• Short-term availability
• No development costs
• Small quantities available
• Not optimized for application
• No control over product lifetime and product changes
   

CUSTOMIZED COMPONENT

• Long lead-time
• (Significant) development costs
• Often reasonable only for large quantities
• Optimized for the specific application
• Potentially cheaper than standard product
• Control over product lifetime and product changes
   

THE LONGER (LIFECYCLE) THE BETTER

The development and also the certification of medical instruments are often long-term and cost-intensive processes. Product changes during the production lifetime are not desired.

• The optical component should be available over a long period of time (often 10+ years).
• Product changes should be avoided – even though this is not always possible, e.g. in the case of discontinued glass types.

THINK ABOUT PRODUCT AND PROCESS CHANGES

The optics manufacturer needs to understand the impact of product changes on the medical system and the resulting obligations of the system manufacturer (up to a new release by the responsible authorities).

A defined change control process supports the implementation of the necessary measures in the event of unavoidable product changes.

KNOW WHAT YOU BUILD

In the (hopefully rare) event of a product failure, batch traceability is an important tool for risk assessment and root cause control.

Although it may not be legally required for the optics component manufacturer to have batch tracebility, it can be an important argument for the system manufacturer when choosing the optics partner.

MAKE THE PRODUCTS SAFE

• Take care to produce an easy-to-clean – smooth and resistant surface.
• Make them unbreakable – do not use thin, easily breakable glass.
• Use Non-outgasing adhesives in production.
• Produce long-term stability by a rigid mechanics design, ideally without any moving parts for e.g. focus and iris setting.
• Use sealed optics.