Mark Logan @ Visx, Inc

Abstract

Since 1986, Visx had been guiding several procedures to treat corneal pathologies and refractive eye disorders through the multistage FDA approval process. The costs associated with submitting clinical trial information to the FDA were taking a toll. Problems increased dramatically in September 1994, when Visx's stock price fell 26% with the news that FDA approval was delayed because of compliance irregularities found at some clinical testing sites. And that same year, its revenues dropped by 19%. Getting FDA approval was extremely important to Visx, as it would have its foot in the door and be able to sell its excimer laser system in the United States. The persistent sentiment among the management team was that even though Visx had a technologically superior laser system, which consistently received top ranking from the world's leading ophthalmologists; Visx's competition was going to win the race to gain FDA approval by virtue of being relentlessly aggressive and street smart. Excerpt UVA-G-0620 Rev. Aug. 18, 2010 MARK LOGAN @ VISX, INC. On January 7, 1995, Mark B. Logan, the newly appointed chairman and CEO of Visx, Inc., sat in a brightly lit conference room at the Chaminade Resort & Spa in Santa Cruz, California. The off-site strategy meeting Logan had scheduled a month before had started, and the mood among the attendees, most of whom were members of the company's senior management team, was grim. Visx, of Santa Clara, California, was one of two major players in the emerging laser vision-correction market in the United States; the other one was Summit Technology, Inc., of Waltham, Massachusetts. The two competitors developed and manufactured excimer laser systems for ophthalmic applications. Although their systems were being successfully used worldwide, Visx and Summit were awaiting U.S. Food and Drug Administration (FDA) approval to sell them in the critically important U.S. market. Since 1986, Visx had been guiding several procedures to treat corneal pathologies and refractive eye disorders through the multistage FDA approval process. The costs associated with submitting clinical trial information to the FDA were taking a toll on Visx, but the problems increased dramatically in September 1994, when Visx's stock price fell 26% with the news that FDA approval was delayed because of compliance irregularities found at some clinical testing sites. That same year, revenues dropped by 19% to $ 17,896,000, from $ 22,074,000 in 1993, and the company recorded a net loss of $ 6,264,000 or 60 cents per share. . . .