ATLANTA — A company develops what it says is an innovative product, gets FDA approval and brings it to market. Then all of a sudden — nothing happens. Zero, zilch, nada — nothing. The device just doesn’t catch on. It leaves some companies collectively scratching their heads and asking what happened. The process can be maddening with millions of dollars lost and a considerable amount of time wasted.
“Sometimes having a better mouse trap isn’t good enough to be successful,” said Bruce Smith, executive VP, strategy and business development, for Theragenics (Buford, Georgia).
Smith was one of several panelists speaking on the Innovations in Georgia during the Georgia Life Sciences Summit 2007 held at the Georgia World Congress Center last week. He said that intense focus and the ability to really market a product contributes to one being a veteran player in the med-tech game.
And he should know.
Theragenics is one of Georgia’s oldest med-tech companies, having received its start in 1981 in the basement of a radiological center. Its primary focus is on developing products for cancer treatment.
Its specialty is in brachytherapy, a form of radiotherapy where a radioactive source is placed inside or next to the area requiring treatment. Conversely, external beam radiotherapy, or teletherapy, is the application of radiation that has been externally produced by a linear accelerator.
The company was publicly traded in 1986 and in 1987 it released its first product offerings which included the palladium-103 TheraSeed device, as well as I-Seed, an iodine-125 device. Physicians implant these brachytherapy “seeds” during a one-time, minimally invasive procedure, usually performed on an outpatient basis, to treat patients with cancer confined to the prostate gland.
From its humble beginnings the seeds of the future were planted for a company to be a successful mainstay.
Those seeds bore fruit in the form of two subsidiaries.
The first is CP Medical (Portland, Oregon), which manufactures wound closure systems, needles, cardiac pacing cables, and other surgical products used in diverse markets including the general, dental, cosmetic, and veterinary surgery markets.
Its second subsidiary, Galt Medical (Garland, Texas), develops disposable devices used for vascular access, primarily serving the interventional radiology and interventional cardiology markets. Galt’s current products include guide wires, micro-introducer kits and tear-away introducer sets and kits, and hemostasis valved introducer sets and kits.
“We learned early on that no one is going to care as deeply about your product than you do,” he said. “Get behind and in front of your product.”
The success of the product, he said, depends on several key elements. Those include the FDA, reimbursements, manufacturing and marketing.
“Putting them together [successfully] can be and often is overwhelming,” he said.
He added that all too often, start–up med-tech companies are trampled coming out of the gate because of a reluctance to try and “address” these four elements.
Other panelists hammered down on the need to look for innovations that are reasonable and can be accepted by the public.
“Start ups need to focus on products that are practical or those that are in a white space,” said Henry Grage Jr., co-founder and president of Reperfusion Therapeutics (Alpharetta, Georgia). “They also need to keep costs down.”
Grage’s company is taking a chance on a device that would lessen reperfusion damage or damage to tissue caused when blood supply returns to the tissue after a period of ischemia. The absence of oxygen and nutrients from blood creates a condition in which the restoration of circulation results in inflammation and oxidative damage through the induction of oxidative stress rather than restoration of normal function.
“At first physicians were very skeptical of our procedure,” he said. “That was our biggest barrier. But now they are really starting to come around.”
And in some cases, panelists said that when the situation looks impossible, patience and focus are all that are needed to get the product successfully over the hump.
“We’re excited about our products,” Smith said. “And we believe the products each provide opportunities for growth. You have to have that and focus. If you don’t have focus then you better have buckets of money. And sometimes it doesn’t hurt to have both.”