In the development of a new glaucoma surgery, a fundamental group of conditions must be met in a timely fashion to achieve success. The new procedure must address the fundamental cause of a problem such as increased resistance to aqueous outflow at the level of the trabecular meshwork. The technique or device should not spend health care resources to an excessive degree in terms of expensive supporting instrumentation or equipment. Moreover, the surgery or device to be developed should fully integrate into the current execution of surgical care of the general ophthalmic patient. Finally, it should provide a platform for future improvement and the development of other devices.
Even if the fundamentals are correct, for an idea to reach clinical application, certain realities must be addressed. First of all, to achieve funding, the idea must have a firm foundation of intellectual property rights. The surgery or device must also have supporters champion it in terms of the finances necessary to develop and test it and to secure its FDA approval. In the case of the iStent Trabecular Micro-Bypass Stent (Glaukos Corporation), initial support came from Olav Bergheim, the founder of Fjord Ventures. Olav is a modern-day Viking who has chosen to make war on glaucoma, and his ideological and financial support were fundamental in propelling the development of this device and others.
A second reality is a need for technical support. The iStent is currently the smallest implantable medical device in the history of medicine. Its development and production required a very high degree of technical expertise, which thankfully was found in Professor Morteza Gharib, vice provost for research, and Hans W. Liepmann, professor of aeronautics, at the California Institute of Technology. This technical support continued with David Haffner of Glaukos Corporation. He provided an outstanding level of expertise in biomedical engineering as well as the patience needed to study more than 200 prototypes.
Finally, all of these parts must come together and be furthered in an organized way through the considerable FDA journey. This task was performed by the CEO of Glaukos Corporation, Thomas Burns (Figure). Without the timely convergence of these many factors, new devices cannot be developed, successfully tested, and approved for use so that they may affect the care of patients.
Richard Hill, MD, is a founder of Glaukos Corporation and Orange County Glaucoma in California. He is also an associate professor of ophthalmology, emeritus, at the University of California, Irvine. Dr. Hill may be reached at ocg@mac.com.
