3D Printing of Ophthalmology Medical Devices and Tools May Be Eligible for R&D Tax Credits

Scientists and doctors have been experimenting with ways to correct vision by way of 3D printing. Additive manufacturing capabilities have proved that 3D printed medical devices can be used in various surgeries of the eye. Businesses, physicians, entrepreneurs and scientists who are involved with 3D printed optometry tools may be eligible for R&D tax credits.

The Research & Development Tax Credit

Enacted in 1981, the now permanent Federal Research and Development (R&D) Tax Credit allows a credit that typically ranges from 4%-7% of eligible spending for new and improved products and processes. Qualified research must meet the following four criteria:

• Must be technological in nature
• Must be a component of the taxpayer’s business
• Must represent R&D in the experimental sense and generally includes all such costs related to the development or improvement of a product or process
• Must eliminate uncertainty through a process of experimentation that considers one or more alternatives

Eligible costs include US employee wages, cost of supplies consumed in the R&D process, cost of pre-production testing, U.S. contract research expenses, and certain costs associated with developing a patent.

On December 18, 2015, President Obama signed the PATH Act, making the R&D Tax Credit permanent. Beginning in 2016, the R&D credit can be used to offset Alternative Minimum tax for companies with revenue below $50MM and for the first time, pre-profitable and pre-revenue startup businesses can obtain up to $250,000 per year in payroll taxes and cash rebates.

Optical Exams

Telemedicine, the remote diagnosis and treatment of patients by means of telecommunications technology, is a recent field that has the potential to grow in the coming years. For developing nations it can be costly to provide optometry tools to those in need. To alleviate this problem, engineers and technicians are developing 3D printed tools that can be utilized in conjunction with smartphone applications to conduct optical exams. Due to the increase in the availability of smartphones, tele-based services can be used for screening ophthalmic diseases and treating patients with known diseases. There has also been a surge in electronic ophthalmic record keeping, wherein images captured by smartphones can be used to better diagnose eye diseases.

New Zealand-based eye doctor Hong Sheng Chiong developed a 3D printed eye testing tool, a device that is readily available for underdeveloped regions around the world. Typically, in order to verify vision loss, expensive and sometimes bulky equipment is used to detect common eye diseases by utilizing a digital retinal camera to take pictures of the back of the eye. Because the retinal cameras are bulky and cumbersome, Dr. Chiong has created a portable eye examination kit to be used with a smartphone camera and an app. Parts of the kit are 3D printed; there is a small biconvex lens that is used to magnify the images to give up to ten times magnification and once the device is assembled it can be clipped into the side of the phone and then used to see the front of the eye. The retina examination is performed with a retina adapter that is 3D printed as well. The parts consist of lenses, nuts and bolts which once assembled can look into the retina of an individual’s eye. These tools are beneficial for doctors when they are conducting eye exams for those who live in developing countries.

Telemedicine is more than just a research tool – it has evolved into a clinical service. Because smartphones are readily available, applications are able to transfer data electronically to those around the globe. In areas where ophthalmologists are rare, a smartphone with a high definition camera can save patients by taking detailed pictures of the front and back of the eye. These images can be sent via email to have the results analyzed within minutes. This proves to be more efficient in rural communities since early diagnosis through accurate screening in a high risk population is critical to prevent loss of vision.

Prevention of Infant Vision Impairment

Premature infants have a higher chance of hyperoxia, commonly known as retinopathy of prematurity due to loss of maternal-fetal interaction. This can also lead to vision impairment due to the lack of oxygen. Identification of these conditions at an early age will try to control the factors from advancing into their childhood. Premature babies are kept in incubators with supplemental oxygen to prevent blindness and in turn death of the patient. A study conducted in New Zealand reported infants with retinopathy of prematurity to be 33%.

3D Printing in Surgery

One solution for becoming vigilant to common eye diseases in premature infants and diabetic patients is an app and a 3D printed lens that can be used on any smartphone device. Sixteen-year-old student Kavya Kopparapu developed a 3D printed lens which can be attached to a smartphone and used with an app to diagnose the preliminary symptoms for people with diabetic retinopathy. The device can spot diabetic retinopathy with similar accuracy to a human doctor. Basically it works by utilizing a smartphone picture of the blood vessels in the eye. Images are then sent over to hospitals’ labs to determine the current eye condition and to determine the diagnosis for the patient. Eye diagnosis results at the Jyot Eye Hospital in Mumbai, India have proven to be successful as it was used on a few patients and potentially increasing going forward. The application and 3D printed lens are reliable ways to treat people with an eye diagnosis.

Many individuals who experience cloudiness or see a film over their eye should be diagnosed for surgery. For cataracts, there is a medical device that is implanted in the eye once the natural lens is removed during the cataract procedure. This lens is placed securely behind the iris and pupil. The tools used include high quality eye instruments that can easily make small incisions into the eye. These instruments include a lid speculum, suture forceps, tying forceps, scissors and blade handles, to name a few. Many of these devices can be 3D printed. At the mechanical engineering school at Kennesaw State University, in the state of Georgia, engineers have developed an eye speculum that holds the eyelids and lashes out during various ophthalmologic procedures. The mechanism is designed to minimize eye pain when the patient is going through a procedure and allows a surgeon to work on the patient without worrying about holding other tools in their hand at the same time.

Scientists and technologists have created a new device that uses high pressure to move an ultrasound and manipulate and destroy objects at cell level sizes. There is a transducer lens that is created by a 3D printer out of clear liquid resin. This is what surgeons implant into an individual’s eye. Eye surgeons are able to use the 3D printed lens in cataract surgery.

With improvements in technology, most cataract surgeries are conducted with a laser, as the laser is highly accurate in determining the area that needs to be surgically removed. Perhaps one day, manufacturers will be able to 3D print a laser machine used specifically in cataract surgery.

Conclusion

Scientists, engineers and doctors are using 3D printing to assist in the ophthalmic industry. From detecting early signs of vision loss to treating patients in developing nations, 3D printing has been providing new solutions for ophthalmology. Businesses that use devices in corrective eye care may be eligible for R&D Tax Credits.

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Charles Goulding and Alize Margulis of R&D Tax Savers discuss 3D printing in the ophthalmic industry.