Eyeworld

E very new device that we use in sur- gery—and every new drug—began with an idea. The person or persons with the idea had to develop it, per- haps patent it, connect with—or start—a company to further develop it, and then navigate the FDA and other regulatory hurdles before the device could be available for our patients. The process takes many years and tens of millions of dollars. There is no way to know how many times inventors start down this road, but it is safe to say that most give up. Ophthalmology owes a huge debt of gratitude to the innovators who fought through these challenges and have given us so much great technol- ogy. This issue of EyeWorld focuses on innovation. The stories of inventors demonstrate the daunting obstacles they must overcome to bring a new device to market. Without them, we wouldn't have phacoemulsification, premium IOLs—or any IOLs—CTRs, small pupil devices, medical treat- ment for AMD, the hope of new technology for glaucoma surgery, and so on. Innovation applies to every aspect of patient care. We easily recognize innovation in a new surgical device, but we may not be aware of innova- tions in software that help us every day. From the customized phaco set- tings we use in the OR to the ophthalmology apps on our cellphones, software is all around us and the trend line is way up. As EMR becomes standard practice, we are seeing increasingly sophisticated tracking pro- grams for our patients. This will make it increasingly possible to spot de- veloping problems much earlier. The software revolution will dramatically improve patient care. Any discussion of innovation must include the FDA. Virtually every- one associated with innovation—inventors, investors, entrepreneurs, doc- tors, and patients—mentions the increasing burden of FDA requirements. The FDA has set high barriers for proving both safety and efficacy for de- vices. By contrast, the approval process in Europe focuses more on safety and less on efficacy. The result of this difference is that many devices re- ceive approval in Europe years before approval here. For example, the iS- tent from Glaukos was approved in Europe in 2009, but is still awaiting approval in the U.S. The FDA has a laudable goal—protecting patients. But this is a balance issue. For example, glaucoma is a blinding, incurable disease where surgery has high risk and low success. We need to develop better and safer surgical technologies. And once surgeons start using a new device, further im- provements may happen quickly. But if each iteration requires $10 million or more in FDA studies, that has a chilling effect on the process and pa- tients will continue to go blind. Despite the many challenges, innovators continue to invent—defying discouragement. At ophthalmology meetings 15 or 20 years ago the mood was very dark. Medicare cuts and managed care threatened to end oph- thalmology as we knew it. I was struck that year by an absolutely inspira- tional talk from Dr. Howard Fine about new phaco technology. He didn't say a thing about the doomsayers; he was just genuinely excited about these innovations in cataract surgery and what they could do to improve patient care. Innovation begins with hopes and dreams. This issue reviews the process and celebrates the innovators and their stories. Reay Brown, M.D., glaucoma editor Publisher Donald R. Long dlong@eyeworld.org Editorial Editor Stephanie Graham stephanie@eyeworld.org Assistant Editor Stacy Majewicz smajewicz@eyeworld.org EyeWorld Staff Writers Faith Hayden faith@eyeworld.org Jena Passut jena@eyeworld.org Production Graphic Designer Julio Guerrero jguerrero@eyeworld.org Production Manager Cathy Stern cstern@eyeworld.org 703-383-5702 Production Assistant Karen Salerni ksalerni@eyeworld.org Contributing Editors Vanessa Caceres Lakeland, Florida Michelle Dalton Reading, Pennsylvania Rich Daly Arlington, Virginia Enette Ngoei Singapore Matt Young Malaysia Senior Contributing Editor Maxine Lipner Nyack, New York Advertising Sales ASCRSMedia 4000 Legato Road Suite 700 Fairfax, VA 22033 703-591-2220 fax: 703-591-0614 eyeworld@eyeworld.org www.eyeworld.org Advertising Sales Managers Jeff Brownstein jbrownstein@eyeworld.org 703-788-5745 Paul Zelin pzelin@eyeworld.org 703-383-5729 Classified Sales Cathy Stern cstern@eyeworld.org 703-383-5702 EyeWorld Special Projects and Events Jessica Donohoe jdonohoe@eyeworld.org 703-591-2220 ASCRS Publisher: EYEWORLD (ISSN 1089-0084) is published monthly by ASCRS Ophthalmic Services Corp., 4000 Legato Road, Suite 700, Fairfax, VA 22033-4003; telephone: 703-591-2220; fax: 703-591-0614. Printed in the U.S. Editorial Offices: EYEWORLDNews Service, 4000 Legato Road, Suite 700, Fairfax, VA 22033-4003; toll-free: 800-451-1339, 703-591-2220; fax: 703-591-0614; email: eyeworld@eyeworld.org. Advertising Offices: ASCRSMedia, 4000 Legato Road, Suite 700, Fairfax, VA 22033-4003; toll-free: 800-451-1339, 703-591-2220; fax: 703-591-0614; email: eyeworld@eyeworld.org. Copyright 2011, ASCRS Ophthalmic Services Corp., 4000 Legato Road, Suite 700, Fairfax, VA 22033-4003. All rights reserved. No part of this publication may be reproduced without written permission from the publisher. Letters to the editor and other unsolicited material are assumed intended for publication and are subject to editorial review and acceptance. Subscriptions: Requests should be addressed to the publisher. Annual subscription prices: Individual: 1 year, $120; 2 years, $220; 3 years, $320. Institutional: 1 year, $250; 2 years, $330; 3 years, $425. Foreign: 1 year, $240, 2 years $470, 3 years, $700. 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POSTMASTER: Send change of address to EYEWORLD, 4000 Legato Road, Suite 700, Fairfax, VA 22033. Periodical postage paid at Fairfax, VA 22033 and at additional mailing offices. The ideas and opinions expressed in EYEWORLDdo not necessarily reflect those of the editors, publisher, or its advertisers. P U B L I S H I N G   S T A F F November 2011 Volume 16 • No. 11 A S C R S The official publication of the American Society of Cataract & Refractive Surgery World view Innovation: The stories of discovery Reay Brown, M.D., glaucoma editor

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