Roy T. Tanaka feels hurt when his neighbors refer to his employer, Shiley Inc., as "the heart-valve company." They do so because of the firm's highly publicized problems with a mechanical heart valve that it no longer makes.
Tanaka's pain is understandable. The executive, who joined Irvine-based Shiley in 1989 and was recently named general manager of U.S. operations, is part of a management team that was not around when the company manufactured the fracture-prone valves that have caused more than 200 deaths.
Still, Tanaka finds the ongoing litigation related to the valves distracting. He said it also eclipses in the public's mind the considerable progress that the company has made in other medical technology.
"We are in the business to save lives and at times you can't help but feel people are almost accusing you of taking lives," Tanaka laments.
In fact, Shiley is much more than a heart-valve maker. In recent years, the company has transformed itself through diversification and acquisitions into a multifaceted medical equipment firm with products for blood processing, cardiopulmonary and critical care uses.
That is a long way from the mid-1980s when Shiley lost its footing as the world's leading producer of mechanical heart valves after recalling the popular Bjork-Shiley convexo-concave valves. Between 1979 and 1986, when all manufacturing of the valves ended, doctors implanted about 84,000 of the valves worldwide.
Ultimately, Shiley withdrew from the heart-valve market in the United States. While the company is selling another style of heart valve overseas, it has not won regulatory approval to sell that valve in the lucrative U.S. market.
The company, a subsidiary of drug and medical giant Pfizer Inc., said a decade ago that about half its sales came from heart valves. Today, valves account for about 20% of its $200 million in annual sales. The firm says sales have grown an average of 15% in the past four years. Shiley, part of Pfizer's large hospital supplies division, does not publicly report earnings.
Shiley President Patrice Froidure said the company's strongest growth is in sales of an "autotransfusion" device, which is used during surgery to salvage, clean and recycle a patient's red blood cells. Sales have soared as public concern increases about the risk of transmitting AIDS and other contagious diseases through donated blood.
Shiley entered the surgical blood processing business in 1986 when it acquired Dideco, an Italian company that sold the equipment in Europe. Froidure said sales of autotransfusion equipment has been "phenomenal," rising 20% annually since it was introduced in the United States 2 1/2 years ago. He said autotransfusion equipment now generates 15% of Shiley's worldwide revenue.
"Shiley is not yet the market leader in the U.S.," Froidure said. "Hemonetics is No. 1 in the U.S. and therefore the world. But we are closing the gap very quickly." Hemonetics is based in Boston.
Shiley also has high hopes for a new blood-monitoring catheter. The device, which Shiley plans to start marketing late this year, monitors the blood of critical-care patients in hospital emergency rooms.
Shiley attained a toehold in the blood-monitoring business in 1988 by acquiring Biomedical Sensors Ltd., a British company. "We kept their products and spent quite a bit of money developing the multiparameter catheter," Froidure said.
Most catheters measure only one aspect of blood, such as oxygen level, he said. But Shiley's device can record three blood factors at a time, such as oxygen, carbon dioxide and alkalinity levels. The information is displayed on a screen for easy monitoring.
Froidure said Shiley is a year ahead of competitors in bringing the sophisticated catheter to the market, which some analysts estimate is worth $300 million.
Another important element in Shiley's diversification was its 1983 acquisition of Stockert Instrumente. The company, based in Munich, Germany, makes heart-lung machines used during open-heart surgery.
Current and former Shiley officers say that while diversification has helped Shiley to weather the heart-valve problem, it was a strategy the company adopted long before anyone knew a storm of controversy was about to break.
"It was a good, prudent business practice," said Bob Elliott, president of Shiley from 1970 to 1979.
He said diversification efforts began only a few years after Don Shiley, an engineer, and his wife, Patricia, in 1964 founded the company in the garage of their Tustin home to produce a new kind of heart valve. The firm was incorporated two years later.
In 1968, Elliott said, Shiley brought aboard an engineer to work on design of a tracheotomy tube, used to open air passageways in the windpipe of patients needing help to breathe. Since Shiley began marketing tracheotomy tubes in 1970, it has become the leader in the field.