ATLANTA — Several med-tech CEOs were the center of attention during this week's South Eastern Medical Device Association (Norcross, Georgia) annual conference at the Georgia Aquarium. However the spotlight didn't include heavy grillings from senators regarding bonuses, pay or flying in expensive private jets.

Instead the tone was a lot more down to earth and dealt with topics that many start-ups in the med-tech industry struggle with constantly. Rick Haury, VP of economic development of MACOC, served as the moderator. Roundtable members included Rick Randall, CEO of Trans 1 (Wilmington, North Carolina); David Field CEO, Trimax Medical Management (Macon, Georgia); Omar Latouff, MD, founder of TransCardiac Therapeutics (Atlanta); Steve Johnson, CEO, CreatiVasc Medical (Greenville, South Carolina); and Chris Rowland, president of the Americas Region for Given Imaging (Yokneam, Israel).

The CEO roundtable is a new feature for the three-year-old conference and had one of the largest turnouts in the day-long event.

"The financial demands in this environment are great, but we've seen a 20% increase in registration for this conference," Haury told the audience before firing off a barrage of questions to the group.

One of the first topics that came up was how to build a positive relationship with the FDA.

"If you're a start-up company you're going to live by the FDA and die by the FDA," Latouff told the audience. "Get to know the FDA. Before you send your proposal meet with them in Washington and talk to them."

He added that such a visit would unveil the mystery of the organization and help companies get their product to markets much faster.

Latouff founded TransCardiac Therapeutics in 2003 and develops intellectual properties that he had patented in 2001.

Johnson, whose company creates solutions for the growing hemodialysys market, said that a key in maintaining strong relationships with the FDA is to be extremely proactive.

"Communication, trust and no surprises I have to say that those are key in fostering that strong relationship with the FDA," Johnson said. "Take advantage of the informal pre-IDE process and send the FDA sections at a time from your proposals. Let them comment on the proposal before you formally submit it."

Another topic that came up was how to grow as a med-tech firm in this troubled economy.

Johnson said the difficulty for his company was that it hit its stride in the regulatory path soon after the company was founded.

"Our fear was that when we got FDA Phase I approval that our investors weren't going to come back in so quickly with their funding," Johnson said. "But they wound end up coming back in with 100% participation."

Trans-1's CEO spoke of how the sagging economy changed the shape of the med-tech landscape.

Randall has been at the helm of Trans-1 since 2002 and helped usher it through what has been called med-tech's last big IPO. The company raised nearly $90 million in an IPO in 2007, making the CEO the first SEMDA alumnus to go public (Medical Device Daily, Oct. 22, 2007).

"The current environment has changed things," he said. "I wouldn't want the company to run out of money in this environment nor would I want to go back to the public to raise that money."

As a result, Randall said that today's CEO has to think conservatively about spending money and manage growth appropriately.

One of the toughest areas stems from keeping existing talent in the Southeast, especially when it comes to those with a specialty of navigating through the FDA's regulatory path.

"You really have to preserve your capital to retain your good people," Field said. "It costs a lot to replace someone who has been in the company with you for years."

The CEOs admitted that this is a much different environment than last year and that executives are in a more difficult position than ever before. In some cases they said the key question that it comes into play is the cost of growth or the growth of cost.

No Comments