INNOVATION IN OPHTHALMOLOGY
How Three Companies Navigated the FDA Approval Process
Interviews with representatives of three companies provide readers with a sneak peak into the arduous FDA approval process. The main hurdle with a first-of-its-kind product? According to Dr. Tarantino, it is that development and regulatory testing follow parallel trajectories. The best time to initiate interaction with the FDA? Early, says Dr. Sawhney, in order to build a relationship that can help to smooth out forthcoming difficulties. Anything that can contribute to a quicker FDA approval? The answer may be in sound clinical science, offers Mr. Burns.
You Don’t Have That in Your US Practice?
Trifocal, toric phakic, extended range of vision, and sulcus-fixated spherical and toric IOLs; CXL; and various laser platforms top the list of products and procedures that are available outside but not inside the United States. In particular, although much has been published on the effectiveness and safety of CXL, “it is really high time that US patients had access to this treatment,” Dr. Cummings says.
Get Over It
The inevitable groan over the transition to electronic health records (EHRs) is twofold:
(1) it can cost a lot of money up front, and (2) it can initially slow a physician and his or her practice down. But, as Dr. Goldman points out, implementation of a good EHR system can equate to cost savings over the long term. Other advantages of EHRs include faxing of electronic notes as soon as a patient exam is completed and availability of patient records, scans, and letters on one’s smartphone.