The continued evolution of medical technologies is making it increasingly difficult, almost moot, to distinguish a medical device from other therapeutics. In Science Translational Medicine November 30, 2009, Harvard scientists report on the use of a polymer disc that stimulates an immune response that in turn shrinks tumors:
In a new approach to fighting cancer, scientists from Harvard University have engineered an implantable disc designed to attract immune cells and prep them to attack tumors. Mice with melanoma tumors were much more likely to survive if they’d been implanted with the device, and tumors disappeared in up to half of the vaccinated animals, according to research published today in the journal Science Translational Medicine. Researchers believe that the implant elicits a broader immune response than traditional vaccines, and may therefore prove more effective. A startup called InCytu, based in Lincoln, RI, is now developing the technology for human testing.
One might call this a device for the fact that it is implanted, but the response it engenders is more a drug delivery, which would indeed be a device except for the fact that this device does not delivery drugs. One might also consider that this could be viewed as a drug — a solid drug — except for the fact that it is not metabolized like a drug. It could be considered gene therapy, since the polymer contains fragments of genetic material designed to mimic bacterial DNA. It could be considered an autologous cell therapy treatment, since the polymer also contains fragments of the patient's own tumor.
As far as I am concerned, the definition is moot, since the principal criteria for judging the implant is its safety and efficacy in treating tumors. The most important consideration here is that, as evidenced by this definitional challenge, there is a merger of multiple scientific disciplines taking place that is resulting in very unique therapeutics. The advances in cell biology, materials technology, gene therapy, chemistry and other sciences are proceeding rapidly and synergistically to yield products that will most importantly challenge the device industry AND the drug industry (and many others) by producing results that compete with any and all of them.
Posted via web from medmarket's posterous
