INTRODUCTION
REASON FOR STUDY AND ITS IMPORTANCE
This study was begun in order to help define the field of nanobiotechnology and its utility in creating devices of enhanced sensitivity or function that are useful in biomedical research, drug discovery and clinical therapy. Nanotechnology, a buzzword since the 1980s, is now coming of age. Discoveries and inventions are building on one another in ways that can scarcely be anticipated. As future-guru Ray Kurzweil is fond of pointing out, technology advances in an exponential fashion. Nanotechnology is now approaching the steep part of the curve. At the same time, it is being combined with a relatively mature biotechnology. The result is a cornucopia of new ideas, inventions and commercial products.
With this report, we hope to identify companies and products in this emerging field, and to sort out those with bright prospects from the not-so-likely contenders. We feel that this will be a valuable contribution to all those with an interest in biomedical devices.
INTENDED AUDIENCE OF THIS REPORT
This report is intended for entrepreneurs, venture capitalists, CEOs, business and product development officers, R&D directors, intellectual property lawyers and research scientists and bioengineers looking for an overview of biomedical applications of nanotechnology and the potential for commercialization of this technology.
SCOPE AND CONTENT OF THE REPORT
This report covers biomedical nanoscale devices, i.e. any biomedical contrivance in which a critical component is measured in nanometers (nm). One generally accepted definition of nanotechnology is that it involves engineering objects with dimensions of less than 100 nm. In this report, we are somewhat more liberal. We take it as given, for instance that microelectromechanical systems (MEMS) are evolving into nanoelectromechanical systems (NEMS), even as microfluidics are already advancing to nanofluidics.
Biomolecules all have dimensions in the nanometer range, but there is nothing to be gained by re-classifying all of biotechnology as nanotechnology. Only when biomolecules are combined with manufactured nanoscale items or are significantly re-engineered are they considered in this report. Likewise, some semiconductor chips now have features with dimensions smaller than 90 nm but it does no good to consider the entire semiconductor industry under the heading "nanotechnology." We do not discuss general-purpose semiconductor chips here, even when incorporated into a medical device.
Devices that are covered in this report include things such as: bioassays that use nanoscale components, including thin films and nanoparticles; nanotools that are applied to life science research including atomic force microscopes and accessories; drugs and drug delivery systems that use nanoscale capsules, fullerenes or MEMS; fullerene objects, such as nanotubes, as applied to medical devices; and quantum dots as applied to bioanalytical systems. Also covered, in a prospective sense, are artificial cells, artificial organs and artificial organisms.
METHODOLOGY AND INFORMATION SOURCES
The information reported herein has been gathered from a variety of industry and other sources. The 10K forms and other SEC filings from public companies have been examined along with annual reports, catalogues, press releases et cetera. The World Wide Web is a rich source of information, as almost every commercial concern now has its own web page. Product literature and trade journals have been monitored, including BCC's own Nano/Bio Convergence News and proceedings of BCC Conferences, including the Nanoparticles Conference-2002 and Nanotech and Biotech Convergence-2002, for which the author of this report is program chairman. Where appropriate, medical literature and scientific literature have served as a research source.
We have also gathered information from the U.S. government, the European Commission and private foundations and organizations, including the Rand Corporation and the Institute of Nanotechnology.
Armed with the industry and statistical information garnered above, market participants have been interviewed to fill gaps in understanding.
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