Medical Device Daily Washington Editor

WASHINGTON Economist Edgar Fiedler is credited with having said, "He who lives by the crystal ball soon learns to eat ground glass." Despite that warning, one of the sessions conducted during the 51st annual conference sponsored jointly by the Food and Drug Law Institute (Washington) and FDA was an attempt to forecast the kinds of medical technology FDA is likely to see in future applications.

Fans of nanotechnology came away from the session with little to cheer about, though, because the speaker played down any hopes for an imminent impact by the "nano" industry on medical devices.

Bill Herman, deputy director for science and strategic initiatives at the Center for Devices and Radiological Health (CDRH), said that this center's current technology forecast is intended "to anticipate the expertise we'll need that we currently do not have" and to establish the kinds of test methods needed.

This kind of forecasting is typically fairly reliable, Herman said, but he cautioned: "You need to engage people in the business" and "you have to constrain their attention to the highly probable" scenarios in order to yield a reasonable forecast.

Any wishing to look into the future "must follow the universes adjacent to yours because it's the implosion of technologies" and ideas that will change one's world, Herman said.

One of the essentials for making such forecasts is knowing what sort of developments are going on at the National Institutes of Health, the National Science Foundation (NSF) and the Department of Defense (DoD), "the three biggest funders of medical device technology research," Herman said, adding that many would be surprised to hear that of these three, DoD is the biggest funder of device research. NSF comes in second.

The portents of things to come are seen in demographic and economic trends, among others, Herman said, noting that "the geriatric population [will require] more sensory aids, more mobility aids and more cardiovascular products." He also cited "the squeezing of the healthcare dollar" and the concomitant "implication [of] home and self-healthcare technology" will become increasingly important.

"Minimal invasiveness is probably the most intense area of interest" in medical circles at present, Herman said, adding that "transdermal surgery is one of the more interesting things." But miniaturized surgical actuators will also make inroads in the operating room. Herman made the case that an equally important trend is that healthcare delivery is becoming less focused on large institutions. "Before 1900, all healthcare was decentralized" by default, but that changed over the course of the 20th century as hospitals grew, and the expense of imaging equipment fed the trend, Herman said, suggesting, however, that the trend is now more towards decentralized care.

Herman took a moment to tip his hat to Silicon Valley. "All the developments associated with the exponential positive feedback of silicon technology ... will drive not just computer science, but also robotics and wireless" communication, Herman said, adding that the law named for Gordon Moore, co-founder of computer processor maker Intel, is still in play, though with limits.

Herman reminded the audience that Moore's Law says that the number of transistors that can be laced into a given area on a silicon chip will double every 12 to 18 months. (Moore also has been quoted as saying, "If Gore invented the Internet, I invented the exponential" in response to extensive use of the doubling principal in other areas of science).

Herman said Moore's law has had "a big effect, but this is going to come to an end when sizes are so small that quantum effects disable" the doubling effect."

All the same, Herman said, "Within the next decade, you're going to see advances in computing power of more than three orders of magnitude" by conservative estimates.

"The most optimistic scenario is 107 increase in power," which would mean that in 10 years, the typical desktop computer might have 10 million times the computing power of the current generation. A potential bottleneck will be software development because software can grow only by hiring programmers to churn out millions of lines of computer code, and the interactions between these chunks of instruction still give programmers fits.

Cellular and molecular biology will enable tissue engineering over the next decade, Herman said. "Tissue engineering was thought a decade ago to be poised for explosive development" but has gone nowhere because "the attitude was that we'll put some cells on a polymer scaffold" and the rest would fall into place.

"It turned out to be more complicated than that."

As for nanotechnology, Herman said the most likely early use beyond the current batch of sunscreens will likely be in vitro diagnostics (IVDs).

"There will be activity" in the areas of coatings and quantum-dot IVDs, he said, but added: "Don't hold your breath over the next decade over nanotechnology."

The problem, he said, is that "if there's even one nanotechnology application, you're into a whole new area with toxicology."

Molecular medicine also came up during Herman's discussion. He said "we're going to see issues that make us see that genomics is a long way from being a deterministic science ... because in the real world, the local environment in which a gene expresses has an important impact on what happens," hence the need for development of epigenomics.

And the resulting flood of information will present a new set of dilemmas, he suggested.

"There are going to be bioinformatics issues. Anyone who tells you they know how we're going to make use of all this information, ask them how."