ATLANTA – The Society for Biomaterials (Mount Laurel, New Jersey) Translational Biomaterial Research conference, titled "Advancing Discoveries from the Laboratories to the Clinic," addressed the role of med-tech innovation in the future of healthcare.

Such was the case for the keynote address, delivered by both Scott Bruder, vice president and chief technology officer of BD (Becton Dickinson; Franklin Lakes, New Jersey), and Jennifer West, director of Nanospectra Biosciences (NBS; Houston), a company that was spun out of research conducted at Rice University (also Houston).

"It's probably not surprising that most of the money spent on healthcare is spent in the U.S.," Bruder said to an audience of several hundred.

Nearly $5 trillion are spent worldwide on healthcare, according to graphs and information Bruder presented. Of that amount, "only" 8%, or $382 billion, was spent on medical devices and diagnostics. And of the $382 billion, nearly one-third goes solely toward medical devices.

The remaining 92% is spent on healthcare services, pharmaceuticals, hospital charges and other miscellaneous items.

"This country spends $7,000 per person a year for healthcare costs," he said. "Third-world and developing countries spend less than $1,000 a year on people and they are [in] the areas that are going to be growing the fastest."

He added that this situation puts the U.S. in a position where all eyes will be on it for changes in health reform over the next few years.

Part of the shift will have to come from paying close attention to changes and policies that are being developed to shape the healthcare industry.

Specifically, Bruder was questioned about one potential shift that could have immediate impact and that is the possibility of Congress giving FDA more power after the Supreme Court's ruling in Riegel v. Medtronic (Minneapolis).

Sens. Edward Kennedy (D-Massachusetts.) and Patrick Leahy (D-Vermont) introduced a companion bill to H.R. 6381, which has 62 co-sponsors in the House (Medical Device Daily, Aug. 14, 2008). That bill was introduced to ensure that individuals are not prevented by the Food, Drug and Cosmetic Act (FDCA) from suing device makers under state tort laws. It could potentially give FDA more far-reaching powers.

"I think if you work with [FDA], they'll have the ability to help you go through the regulatory path, Bruder said. "But if you overstep your bounds, they're going to come down on you hard."

While FDA loomed large in the keynote address, some questioned how to better work with the agency and when was the right time to take a product into commercial development. It is a process that West said she is all too familiar with.

She was part of the research team at Rice University that led to the formation of Nanospectra Biosciences in 2000. The company's main goal is to help with the commercilazation of the AuroLase Therapy, which utilizes the unique "optical tunability" of a new class of materials developed at Rice.

These AuroShel particles (also known as nanoshells) can be designed to absorb different wavelengths of light, including the near-infrared wavelengths that can penetrate human tissue. The particles are delivered intravenously to the tumor and then the area is illuminated with a near-infrared laser. The particles will selectively absorb this near-infrared energy, converting the light into heat to thermally destroy the tumor and the blood vessels supplying it without significant damage to healthy tissue.

"I would argue that we started the company a little too early," West said. "We started it about two years earlier than we were supposed to."

She said that the company had to deal with the dry financing period of 2001, which forced it to look toward the government for funding. West added that there needed to be more research on the therapy before the company was founded.

But NBS has had a happy ending, with an IDE approved for AuroLase Therapy and a Phase I clinical trial beginning this year.

And in some cases, according to Bruder, it helps to get an early start. The road to product approval "is a long, arduous path," he said, "but success depends on advantage point. You just have to be proactive."