The word “3D printing” is both exciting and daunting. It is an enormously disruptive technology that redefines the way a product is designed, prototyped, and developed. However, 3D printing itself is not a novel technology. Actually, the word “additive manufacturing” was created at least 30 years ago for the same process of introducing layer after layer to produce a three-dimensional model of an object.
This disruptive wave of technology has also made an impact in the field of ophthalmology. 3D printing in ophthalmology can be divided into three distinctive categories: optical 3D printing, additive manufacturing of ophthalmic equipment, and biological tissue printing.
3D-Printed Ophthalmic Developments
Bioengineers are making attempts to solve the code for 3D-printing biocompatible clear corneas. A Chinese bioprinting company Qingdao Unique has claimed that it is close to successfully simulating 3D biological structures of the skin and cornea of humans. At the other end of the spectrum, Protos, a San Francisco-based startup, is providing customer-unique spectacle customization via additive manufacturing. The facial metrics of customers are ascertained through 3D scanning and, subsequently, their frames are developed and custom-3D-printed to suit specific customers.
Figure 1. Retinal examination performed with a 3D-printed smartphone retinal imaging adapter
oDocs Eye Care, a New Zealand-based social enterprise, introduced oDocs Fundus — the world’s first open-source 3D-printable smartphone retinal imaging device in 2015. Digital files in a standard tessellation language (STL) format became available on open-source platforms, for example, Github. The files can be easily downloaded and the equipment can be printed locally by users or clinicians, saving both time and money. The new and refreshing concept triggered a wave of openness and innovation in the field of 3D-printed ophthalmic equipment.
Technology in the field of digital design and manufacturing is progressing faster than ever before. For instance, a new app is launched every minute, a new camera module is introduced every few days, and a novel smartphone model is launched every few weeks. Conventional industries like ophthalmology and optometry are not accustomed to this fast-changing speed. Traditional ophthalmic equipment was not designed to handle and combine with these latest waves of technology, but learning and adopting these novel techniques in digital design and manufacturing is part of the solution.
For instance, Welch Allyn, a renowned ophthalmic and medical device producer based in New York, introduced the iExaminer, which rapidly became the first Food and Drug Administration-registered smartphone ophthalmoscope in the world, and grabbed the opportunity to get a share of the mobile ophthalmic imaging market. Yet, when the company did not release new fittings following the introduction of newer iPhone models, the iExaminer rapidly fell out of the race.
Mitigating the Costs
A specialized field, for instance ophthalmology, is a niche market. When compared to common commodity businesses, the supply and demand chain is entirely different. For instance, the cost of the end products is a lot more due to small volume manufacturing and required product certifications and regulatory trials. Injection molding, computer numerical controlled (CNC) milling, and other traditional manufacturing techniques not only need a large upfront investment cost but they also cannot be easily changed to account for any small modifications to the product design.
Figure 2. 3D printing the oDocs Fundus
In order to overcome these barriers, oDocs developed the advanced oDocs Fundus using the crowd solution to innovate and preserve this open-source, community-driven project. To account for the quickly changing mobile landscape, oDocs also selected 3D printing as the chief source of production. Whenever a more recent smartphone model is launched, production and modification can be made within a span of a few weeks rather than months; therefore, this lean process eliminates the need for heavy upfront investment for tooling.
With the help of industrial grade selective laser sintering 3D printing, small-to-medium scale production can also be accomplished, preventing the requirement for large-scale inventory. This production process is unique and can even be simulated at licensed 3D-printing facilities throughout the globe, thereby eliminating other costs associated with import and export activities.
The launch of 3D-printed optical components, for example, lenses compliment current additive manufacturing methods. Luxexcel, a Belgium-based company, was the first to develop the method of 3D-printing clear optical components. Thanks to this technology, custom-made optical lenses have been developed in a fast and low-cost way. The future of intraocular lenses, customized spectacles, and similar individualized lenses is closer than earlier believed.
In spite of all the successes and excitement, the method developed by oDocs may only be relevant in dealing with low-risk medical equipment. Regulatory requested trial and certification is where the key hurdle lies. From a medical device-regulatory standpoint, ophthalmic devices are combined into different categories (for instance, CE class 1, 2, 3) depending on the level of invasiveness and risk.
It is believed that CE class 1 devices are low risk and only require self-certification and declaration, while CE class 2 and above are believed to be moderate-to-high-risk products which had to undergo formal conformity assessment by medical device regulators. It is possible that the regulatory body will request for a safety and efficacy clinical trial based on the risk assessment. It may take months, if not years, for the whole process before a medical device is considered to be safe for distribution in a clinical environment.
Figure 3. 3D-printed no-mydriatic retinal camera
The 3D printing technology is a ground-breaking leap in the design as well as manufacturing industries, and the application of 3D printing in the design and prototyping stage will considerably benefit the development of current ophthalmic devices. This method is not only cost-effective but also saves time. oDocs believes that renowned and multinational conglomerates in the fields of ophthalmology and optometry will ultimately implement this approach to simplify the process of research and development and boost production.
oDocs care deeply about preventing blindness. They have committed to using part of our net profit toward saving sight in the regions where it is needed most. Its time to revolutionize eye health by building accurate equipment that is accessible and affordable. Visual impairment and blindness is a global problem, with 285 million people suffering with this disability around the world, 80% of these cases were preventable or treatable. It is unfortunate that a 90% of those cases are found in developing areas.
Established in 2014 by Dr. Hong Sheng Chiong and Dr. Benjamin O’Keeffe, oDocs Eye Care (formerly OphthalmicDocs) is an innovative company in the field of portable eye care. With thousands of users, our social approach has inspired many others to join the initiative.
oDocs Eye Care’s value is creating quality medical technology to prevent blindness. Their intuitive adapters and smartphone application transform your smartphone into an eye clinic.
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