NDH Medical Inc. makes its money extruding tubing and making catheters as a contract manufacturer, using time-tested technologies and procedures. The small, 10-person Florida company isn't well-suited to the risks and expenses of research and development.
But when a new medical company came in the door with an idea for a catheter tube that would collapse in a blood vessel, NDH President Geary Havran decided it was worth putting some time into. The new firm had no clear plan for manufacturing, but Havran decided to take a chance and do what amounted to unpaid research.
Eighteen months later, it seems like the gamble has paid off.
The tubing is about to hit the market and NDH has applied for patents for its new manufacturing process. Havran thinks it could ultimately mean at least a 25 percent increase in business for the St. Petersburg, Fla., company.
NDH is patenting the extrusion head and control system that allows it to make the multilumen, polyurethane tubing.
The key, Havran said, is that the process can vary the wall thickness of one of the passageways along the length of the tube, so that it can collapse in the body when the tube is not being used. That's better for the patient because a thinner catheter means less risk of blood clots and other complications, like sluggish blood flow, that can occur when catheters are left in the body.
``This is probably the most difficult of the projects that we have taken on,'' said Havran, who started the company in 1994 with partner Scott Nicora, who he said was instrumental in developing the technology. ``Normally when someone comes to us with a custom tubing application, we're talking about making tooling. This involves literally developing a new process.''
The company revealed the new product at the Medical Design & Manufacturing West show, held Jan. 6-8 in Anaheim.
NDH developed the process for FlatCath LLC, an Atlanta joint venture between product development firm Hatch Medical LLC and the inventor of the tubing, Dr. Aubrey Palestrant. Palestrant patented the tubing, but NDH's patent covers the manufacturing process.
The first application will be the hemodialysis market, where the products will be marketed by Medical Devices Technology Inc. in Gainesville, Fla.
Havran said there are many other applications in areas like vascular access. That's part of the reason NDH decided to develop the manufacturing process, at its own expense, Havran said.
``We were convinced that the product concept had significant value and we felt reasonably confident it was a project we could be successful at,'' he said.
Havran said it was relatively easy to make the prototype, but much more of a challenge to figure out how to manufacture it.
``We made a couple of prototype pieces and said, `Gee, that's not that difficult,' '' he said. ``Then you say, `I need to make this day in and day out in the manufacturing environment.' That's where the challenge came in.''