Good things come to those who wait. Just ask the Korean ultrasoundfirm Medison. The company recently received Food and Drug Administration510(k) marketing clearance for two scanners after waiting 15 monthson one product and ten months on another. The
Good things come to those who wait. Just ask the Korean ultrasoundfirm Medison. The company recently received Food and Drug Administration510(k) marketing clearance for two scanners after waiting 15 monthson one product and ten months on another.
The delays are emblematic of how the medical device approvalslowdown at the FDA has impacted device manufacturers. But ina bit of good news, the FDA seems to have dramatically improvedcommunications with manufacturers, according to Medison.
The FDA in November cleared Medison's SonoAce 88P and SonoAce1500. SonoAce 88P, which took ten months to clear the agency,is a linear-array scanner for obstetric, limited abdominal andsuperficial applications. The product lists at $10,000.
SonoAce 1500, which languished for 15 months, is a gray-scalenon-Doppler linear and convex scanner for full abdominal, ob/gyn,small parts and vascular applications. It lists for $25,000.
Medison holds over 70% of the Korean ultrasound market (SCAN12/30/92). The company is planning to expand in the U.S. witha strategy of offering basic, quality ultrasound at a low price,with an initial focus on in-office practices.
Navigating the logjam at the FDA disrupted the company's marketingplans, however, according to Mark Hayward, president of Medison'sU.S. operations in Fremont, CA.
Medison set up a national sales network last year in anticipationof FDA clearance. While the 510(k) applications for its productswere complete, the products got bogged down due to repeated requestsby the FDA for additional data. Medison had to disband its salesnetwork when approval didn't come rapidly, Hayward said.
"We were guilty of doing too much business activity beforewe could be launched for broad sales," he said.
Medison has since rebuilt its sales network, with 20 independentagents nationwide handling its products. The company has had ongoingmarketing efforts in Latin America and Canada.
Medison's flagship scanner, SonoAce 4800, is still awaitingFDA approval and has been at the agency for 15 months, but communicationswith the FDA indicate that approval should be forthcoming in amonth or two, Hayward said.
SonoAce 4800 is a black-and-white Doppler scanner. Medisonis also developing a color-flow Doppler scanner, Hayward said.
Despite the delay, relations with the FDA have improved dramaticallysince August, Hayward said. After almost a year of silence beginningin August 1992, FDA staffers now accept phone calls and even returnsome calls, Hayward said.
"Something happened in August '93," Hayward said."They've been much better over the past few months."
The FDA started an overhaul of the device approval processat the Center for Devices and Radiological Health last year (SCAN7/14/93). While the product approval backlog at CDRH has yet toshow dramatic improvement, anecdotal evidence suggests that theagency is adopting a more cooperative stance toward industry.