It’s interesting (and even comforting) to note that issues with the FDA, or the governing body of whatever country you happen to be in, appear to be universal. At least that’s the case in Japan, with its PMDA, or Pharmaceuticals and Medical Devices Agency. The leaders of two different groups acknowledged that the PMDA is a conservative, slow-moving organization that’s reluctant to change.

But there is certainly no shortage of “lobbyist” groups, or associations that act in a fashion similar to a lobbyist group. For example, the Japan Association for the Advancement of Medical Equipment (JAAME) is working closely with the automotive industry to align medical device technology with automotive technology. One such application of the union would put sensors into the car’s steering wheel. Such sensors could detect blood pressure, heart rate, etc., keeping a close eye on the driver. Not surprisingly, the funding for JAAME and groups like it come mainly from industry.

Another key issue that’s rankling many is the split, or more importantly the non-split, of the PMDA into two separate groups, one to deal with the pharmaceutical industry and one to deal with medical devices. Proponents of the split say that the limited crossover between medical devices and pharmaceuticals, combined with the increasing number of devices looking for approval, makes the split a no-brainer. It’s a discussion that’s been taking place for quite a few years, and finally appears to be on the agenda. But even the most optimistic estimates say it’ll be at least a few years before there’s any significant action taken.

Richard Nass