With an investment almost equal to the size of his company and what he calls ``a leap of faith,'' Steve Richter has doubled the size of his medical testing lab. The move gives his medical-device-making customers the ability to move their drug-interactive products to market faster.
Richter's $7.5 million investment in new and expanded laboratory testing, clean room and analytical services for MicroTest Laboratories Inc. includes a $1 million virology lab for the expected onslaught of testing that will be required under pharmaceutical good-manufacturing guidelines established by the Food and Drug Administration.
``It pretty much doubles the size of the company from 50 people to 100 people,'' and to more than $10 million in sales, said Richter, president and chief executive officer of MicroTest, in an interview June 6 at Medical Design and Manufacturing East in New York. Richter founded the company in his home in 1984 before turning his full attention to the business three years later.
MicroTest customers include medical industry giants Johnson & Johnson of New Brunswick, N.J.; Boston Scientific Corp. of Natick, Mass.; and Medtronic Inc. of Minneapolis, among others. Sales growth averaged 15-20 percent from 1996-2000, and now is on a 40 percent growth trend.
The company also formed a partnership earlier this year to set up an in-house testing lab for global contract manufacturer Symmetry PolyVac of Manchester, N.H., a manufacturer of plastic surgical instrument delivery trays and cases for the sterilization market. The in-house lab is expected to reduce the time needed to test plastic products for sterilization standards and deliver them in two to four weeks, compared with the typical 10 to 12 weeks.
MicroTest also has struck a deal to conduct testing for a combination drug product - one in which the drug is combined with a new delivery system - for a large, undisclosed pharmaceutical company that will be launched later this year. Richter did not reveal the product but said that it has ``huge market potential'' and that by not having to build its own infrastructure, MicroTest's customer will be able to bring the product to the market three years earlier.
Richter said his company's expansion - which includes a small-batch contract manufacturing facility - gives MicroTest the ability to provide dedicated product management from testing to manufacturing.
``We took our medical-device laboratory and married it to contract manufacturing. We can do all the testing necessary to release a product, including stability testing,'' he said.
Looking ahead, Richter has set aside an additional 5,000 square feet of space for expansion.
``We expect to be expanding in the hospital side,'' as companies expand testing to comply with increasingly strict FDA regulations, he said. MicroTest will be adding services, such as clean room and pharmaceutical products testing.