Eyeworld

EW FEATURE 40 by Vanessa Caceres EyeWorld Contributing Editor Pushing surgical device innovation through the system Inventors share their experiences with product development Creativity. Persistence. Collaboration. T hese are all traits that come in handy if you're looking to create an ophthalmic de- vice, according to those who have worked firsthand with inventing devices. EyeWorld got the story behind several surgical devices—the Henderson Capsular Tension Ring (CTR; FCI Ophthalmics, Marshfield Hills, Mass.), the Malyugin Ring (MicroSurgical Technology [MST], Redmond, Wash.), and the iStent (Glaukos, Laguna Hills, Calif.). The physician–inventors share how they came up with their ideas, how they got their ideas to the market, and what others who are looking to in- novate can do to move forward. Henderson Capsular Tension Ring Bonnie An Henderson, M.D., part- ner, Ophthalmic Consultants of Boston, and EyeWorld cataract editor, found the original CTR (Morcher, Stuttgart, Germany) to be useful, but with a challenge. "I noticed that the most difficult part of using a CTR was removing the residual cortical material after the CTR was im- planted," she said. "This difficulty stems from the compression by the traditional CTR of the residual mate- rial against the capsular bag." Dr. Henderson began to devise alternate designs for a ring that would not compress the cortical or lens material. Her ideas built on the original CTRs, which had been tested for efficacy and biocompati- bility. "The challenge was to be able to introduce indentations without compromising the strength of the ring. A second challenge was to en- sure that a modified CTR would be implanted by the available injector systems," she said. Dr. Henderson approached Morcher with her idea. "After several discussions about the dimensions and several illustration drafts, we made a prototype. I used the proto- type in animal eyes in a wet lab and provided feedback about changes," she said. Morcher engineers helped to fix the product's challenges and made changes to the product based on the experience in the wet lab. Similar to the original CTR de- sign, the Henderson CTR stabilizes the capsular bag before, during, and after cataract surgery. However, the Henderson CTR also features eight equally spaced indentations that span the circumference of the ring, according to FCI Ophthalmics. This helps to remove nuclear and cortical material more easily. Although the device was ready to use in Europe only a year after the prototype, obtaining U.S. FDA ap- proval for the Henderson CTR took a few years, and it was finally ap- proved in 2009. Dr. Henderson encourages other ophthalmologists to pursue their in- novative ideas and work with an ethical company or investor. "Sign two-way non-disclosures and have discussions about expectations for the product before any work is done," she said. This can include discussions about the product's fi- nancial projections, naming rights, marketing, and distribution. She also said that honesty about the product is crucial. "If the inventor or com- pany finds the original design is not effective, either alter it or scrap the idea and start over," she said. Malyugin Ring The Malyugin Ring was "discovered" in a film—an ophthalmic film, that is. Boris Malyugin, M.D., Moscow, featured the ring in a film he made called "Russian solution to small pupil phaco and tamsulosin floppy iris syndrome," which won first February 2011 Innovation in ophthalmology November 2011 T his survey shows some very interesting trends. For the cataract/IOL group, an accommodating IOL with power- ful near vision was the landslide winner, showing a robust desire for improvement in the presbyopia-correction arena. A device for continuous monitoring of IOP won over the three surgical devices—although if added to- gether, the surgical devices won handily. The strong showing for depot glaucoma meds and topical anti-VEGF agents shows the critical need for these treatments. –Reay Brown, M.D., glaucoma editor F eedback from clinicians is valuable in directing research efforts toward areas of greatest patient need. Despite recent advances in IOL technology, there is a clear desire for an IOL with improved accommodative ability. The need for a better glaucoma operation was identified as a priority by 338 of 492 (69%) respondents, but there was no consensus on the best surgical approach. Difficulty with adherence to glaucoma medical therapy and the need for repeated intravitreal injection of anti-VEGF agents prompted significant interest in alternative drug delivery systems for these therapeutic agents. –Steven Gedde, M.D., glaucoma editorial board Monthly Pulse Keeping a Pulse on Ophthalmology AT A GLANCE • Physicians who are inventing new surgical devices often rely on creativity, collaboration, and determination • Challenges to innovation include designing the prototype, obtaining regulatory approval, and meeting the product demand • Physicians who want to introduce a new surgical device should focus on product quality and find a company or person who backs their idea Henderson Capsular Tension Ring Source: Bonnie An Henderson, M.D. The iStent device Source: Glaukos

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