Physicians in the US are increasingly worried that innovation in the US has taken a bad turn. This has stemmed partly from two topics we've discussed before: the purportedly strict FDA approval process and the fact that many new devices released in the US have been brought under fire most notably, metal-on-metal hip implants.
Now, at the recent Transcatheter Cardiovascular Therapeutics conference, this topic has been raised again. Most notably, companies have brought up the fact that it's tough to make a business case for developing improved drug-eluting stents (DES). This is because the current-generation stents are already very good and feature low rates of complications, meaning that trials to show the conclusive superiority of new stents would have to be extremely large and therefore expensive. In fact, one panellist argued that the development cost could range from half a billion to a billion dollars, and it would therefore be challenging to recognize any returns. For patients, this unfortunately means that the rate of adverse events may never reach lower levels than what it is now. For the market, this means that it is unlikely to be expanded by the release of new premium-priced technologies.
Is innovation in the US really in such bad shape though. One article in the Economist indicated that innovation in the US is still way ahead of other countries, such as Germany; the US received a score of about 7 in terms of medical technology innovation while Germany and the UK scored just above 5, representing the second-highest scores. The article also emphasized that the regulatory process in the US is still much better than say China's or Japan's. Nonetheless, the US did show a slowdown in innovation from 2005, while China, Brazil, and India all showed notable improvements. Consequently, while the situation in the US may not be as bad as the industry is painting it, action will certainly need to be taken to keep the US at the head of the pack.