2/9/16 Scaling devices from tens to hundreds of thousands or millions sometimes requires a tightrope balancing act of economies of scale and product and process robustness. Micro molding is a proven, scalable and economical process for thermoplastic micro-intraocular implants and devices. Recent developments and new to market intraocular devices and implants have led to the successful treatment of a number of ophthalmological conditions of varying seriousness and complexity such as:
– Retinal detachment
– Diabetic retinopathy
– Age-related macular degeneration
– Dry-eye syndrome
Treatment of these conditions often requires collaboration between ophthalmological surgeons, pharmacologists and micro-specific contract manufacturers. Development of these devices and implants occurs through a large number of highly focused, research-driven specialists (including micro fabrication specialists), such as:
– Small, innovation-support funding programs
– Development companies that easily find a large marketing partner
– Big pharma funding the outsources of the development instead of doing it in-house
To design and build scalable intraocular implants and devices, the design and fabrication plan must include highly precise, micro sized component made from ultra-thin yet strong materials. These materials must be selected and characterized carefully to be robust enough to last for many years in a moist and warm environment.
In order to scale-up a polymer device that may have been born in an academic or laboratory setting, one must first understand the physical characteristics of the eye and how the surgeon will be installing the implant or device. The eye is a complex and sensitive organ with many structures and targets located closely together. These sometimes conflicting structures have significant defense mechanisms (tear film, cornea) that make it difficult for medication to enter. Vitreous fluid is difficult for injected medication to traverse to the posterior of the eye.
Polypropylene glaucoma drain
When designing and fabricating micro molded devices and implants for the human eye, the physical characteristics and material consistency of the components of the eye are critical to understand.
The anatomy and physiology of the eye is one of the most complex and unique systems in the human body. Many of these components of the eye are gelatinous, flimsy, easily punctured, and sensitive. As a result, the implants and devices that are installed must be free of sharp edges, excess material or flash, and have absolutely pristine surface finishes to help ensure both surgeon and patient compliance. The instruments, however, which cut or slice into various components of the eye to install the implants and devices must be very sharp and precisely made to create correctly sized and shaped incisions. Conversely, the instrument to hold or expand the eye open during surgery must be free from parting lines, flash or sharp edges.
Ophthalmologists are meticulously detailed surgeons with extremely good dexterity and their instruments must match their character traits, as their instruments and implants are considered an extension of meticulously planned and executed procedures. The many layers of the eye require the surgeons to switch quickly and accurately from one instrument to another because of the different surfaces they encounter in the eye.
US baseball star Yogi Berra once stated, “I’d give my right arm to ambidextrous.” But having the ability to switch hands and instruments and use both hands during eye surgery enables quick and precise positioning of instruments and safety and efficacy is maintained with instruments designed for the comfort and use in either hand. This requires a look at not only human factors, but also design-for-manufacturability, as the features and tolerances of the device and wall thickness and aspect ratios approach “design challenges” for a particular material selection.
The anatomy and physiology of the eye is one of the most complex and unique systems in the human body. Micro molding is a scalable process with particular design criteria met, including proper size, three-dimensional shape, wall thickness, material selection and surface finish.