Optik im Blick: Optisches Design ist integraler Bestandteil moderner Medizinprodukte

The challenges of optical system design for medical equipment

When it comes to designing optics for medical applications — such as medical image devices used in microscopy, endoscopy, ophthalmology, or diagnostic settings — unique expertise in design and manufacturing is required, as well as specialized tools. This level of experience and skillset is crucial, as specifications for medical devices are highly demanding.

Without optics expertise, medical product companies could encounter a range of challenges related to:

• Optical performance
• Robust design and engineering
• Performance repeatability in manufacturing
• Cost management
• Product design preparedness and manufacturing yield
• Quality control and testing

It is imperative to be able to achieve high reliability, mechanical and electrical tolerance limitations, heat dissipation, optimized human factors, and other requirements. For example, during the design phase of a medical device, having the right blend of expertise and capabilities enables optimization techniques to ensure the balance of various technical constraints, resulting in a miniaturized, manufacturable, reliable, and cost-effective product that meets safety standards.

Another example of optics technology is the use of lasers, which are integral to many surgical procedures and tissue treatments. These platforms produce high-power, high-density laser beams, often delivered through a disposable fiber optic.

In some applications, free space optics — which transfer light beams through the air instead of through fiber optics — can also be considered as an alternative mechanism for beam shaping and steering. The laser type may vary depending on the application’s characteristics, such as power density, penetration depth, and wavelength.

Because of the level of complexity inherent in designing with the right laser based on application in a medical setting, the design and engineering teams must have the knowledge to Design für die Fertigung. This requires dedicated expertise in areas such as tooling design, special test equipment implementation, and optimization of manufacturing processes — skillsets that may not be readily available in house.

Ever-evolving design requirements for optics in medical devices

Within the Gesundheitsindustrie, design requirements for optics will change depending on the product type and application. Medical devices are known for special design processes and requirements, so leading companies often turn to manufacturing partners with the expertise, tools, and capabilities to accelerate time-to-market, better manage risk, provide greater scalability, and meet sustainability objectives, among other benefits.

Based on Flex’s decades of experience in the healthcare industry, we have identified some critical nuances within optics design requirements for different medical devices.

IVD devices

IVD devices require creative sensing and illumination solutions. Two common examples are the bright field or oblique illumination solutions for imaging or the spectral excitations for spectroscopy and fluorescence readings. In both examples, proper design is required to ensure precision, miniaturization, and low-cost manufacturing.

Point-of-care devices

Mit point-of-care sites shifting to clinics and patient homes, these devices are now smaller, price sensitive, and manufactured in high volumes. Most point-of-care devices combine electronics, mechanics, software, and miniaturized optics. The key to achieving a reliable and miniaturized optical solution for these systems is implementing a multidisciplinary approach backed by a team of experts in several engineering categories including new product introduction (NPI).

Medical spectroscopy devices

Medical spectroscopy is the study of the absorption, scattering, and emission of light by tissues. This allows the ability to perform complex diagnostic and therapeutic applications, such as in the identification of cancer tissue. Spectroscopic solutions can be integrated into laboratory microscopes or medical devices such as endoscopes or other surgery equipment.

Design teams must find the optimum solution for optics in medical spectroscopy devices, whether it is mechanical or signal-to-noise constraints, illumination and imaging requirements, or electronic design.

Key capabilities for optics design in medical devices

Medical device companies should seek key expertise and capabilities in areas such as optomechanical design and optimization, optical component manufacturing and supply chain, and active alignment for high-precision optics to successfully bring their products to market. At Flex, our teams are equipped with the knowledge, skillsets, and tools to help companies integrate optics into their medical devices in a way that enables manufacturability, scalability, and faster time-to-market.

Optomechanical design and optimization

Within the healthcare industry, optomechanical engineering is a unique area of expertise, especially for miniaturized and cost-sensitive products such as point-of-care products, ophthalmic home use devices, and more.

Flex converts precise optical requirements to optomechanical design and component manufacturing, and then partners with MedTech companies to achieve the desired specifications efficiently.

We also perform error-budget simulations to verify high-system performance and high-production yield to ensure that the optomechanical tolerances meet precise optical constraint requirements.

In one real world case, a MedTech customer turned to Flex for optomechanical design expertise to resolve yield issues in the development of a miniaturized diagnostic device for small clinics.

Flex helped the customer develop a robust design for the device that was optimized for manufacturability and provided dedicated tools for manufacturing to meet the customer’s production plan.

Optical component manufacturing and supply chain

Flex specializes in optical component manufacturing for optical prototyping and mass production for medical devices. This ensures meeting technical performance and quality standards and allowing long-term agreements with suppliers.

Solutions provided for optical system assembly and integration including various components:

• Sensoren
• Illumination sources
• Spherical and aspheric lenses
• Mirrors and prisms
• Standard and special coatings
• Lens injection
• High precision optomechanical manufacturing

Active alignment for high-precision optics

Active alignment is one of the most advanced approaches for high-precision optics manufacturing. It provides an automatic solution, or semi-automatic solution for miniaturized and high-precision assemblies at low costs and high yields.

We provide active alignment solutions at the manufacturing line for existing products, or provide a robust design for new products, tuned to the unique requirements of the alignment tools.

Engaging an end-to-end partner for optics in medical devices

The rapidly growing medical optics market is revolutionizing healthcare by integrating advanced optical technologies into various medical applications. From diagnostics and point-of-care solutions to endoscopy and surgery devices, optical solutions like imaging, lasers, and sensors are enhancing patient care and enabling healthcare companies to innovate and differentiate their products. This progress demands specialized expertise in design, manufacturing, and regulatory compliance to meet the stringent requirements of medical devices.

Medical device companies can design, build, and deliver products with integrated optics at scale by engaging a manufacturing partner with specialized end-to-end capabilities and expertise in optimizing and streamlining the product lifecycle for the healthcare industry.

That’s where Flex comes in.

By leveraging end-to-end optical capabilities, our customers optimize product development, reduce costs, and ensure high-quality outcomes. We help you reach your end goal of transforming healthcare and improving the lives of patients and practitioners.

For more information on Flex’s optics capabilities for medical products, click here