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


For pharmaceutical and medical imaging applications there are unique challenges for optics and lens manufacturers. Starting from product lifecycles to DIN ISO Norms. 

By Steffen Mahler

INDUSTRIAL VS. MEDICAL IMAGING APPLICATION


 

INDUSTRIAL OPTICS APPLICATIONS

  • Surface inspection (e.g. glass inspection)
  • Dimensional measurement (e.g. car parts)
  • Robot guidance system (e.g. parts handling)
  • Color analysis (e.g. printing)
  • Fluorescence (e.g. security)
  • Hyperspectral imaging (e.g. agriculture)
  • … and others
     

MEDICAL OPTICS APPLICATIONS

  • Surface inspection (e.g. skin)
  • Dimensional measurement (e.g. prothesis)
  • Robot guidance system (e.g. surgery)
  • Color analysis (e.g. tongue)
  • Fluorescence (e.g. bioanalysis)
  • Hyperspectral imaging (e.g. brain activity)
  • … and others
     

Industrial and medical applications are often very similar in terms of technical requirements.

Medical devices with optical components


 

Symbol of a person in bed over a close-up of different coloured optical filters

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
     

 

ISO 13485


 

ISO 13485 book icon over a background with optical filters

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 vs. customized optical components


 

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
     


STANDARD Lens VS. CUSTOMIZED LENS


 

Standard component

 Black lens with C-mount for medical technology

Customized Component

 Customised lens from Schneider Kreuznach in an adapted housing


Lifetime requirements


 

 Icon of a heart above a close-up of optical filters in different colours

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.


change control process


 

 Change control process icon over a background with optical filters

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.


traceability


 

 Magnifying glass icon over a close-up of optical filters in various colors, symbolizing traceability

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.


special requirements for optical components


 

Icon of an aperture above a close-up of optical filters in different colours, symbolising special requests

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.
Get in Touch

Please do not hesitate to contact us if you have any questions. Our dedicated team is here to help you every step of the way. Whether you need assistance with product selection, technical specifications, or general inquiries.

Jos. Schneider Optische Werke GmbH
Ringstraße 132
55543 Bad Kreuznach | Germany

Tel: +49 (0) 671 601 205
isales(at)schneiderkreuznach.com
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