Selling my Contract Research Organisation (CRO), with Helen Colquhoun

Gerald Turner:

When you were, just as a sort of technical point, when you have, and there are increasing numbers as you point out, of these hybrids, part Device, part Pharma, if you are either how do you bid on that, if you are a medical device CRO or Pharma CRO how do you go about dealing with that; when you have got something that is neither in effect?

Helen Colquhoun:

You mean in the combination product? Well they are interesting, the first challenge is always to get them categories, so combination product is it going to be regulated as a drug, or is it going to be regulated as a device, once you have that designation then you treat it as a drug or a device study. Interestingly, our experience has been that even if a product is regulated as a drug, if it sort of looks and smells like a medical device, actually the study is better run by the medical device side of the business because one of the difference really particularly with implanted devices is that monitors need to be very comfortable with the logistics of how certain things work in a hospital or in a clinic, and also be prepared to monitor in different places such as an operating room.

So if you have to go into the OR and you are a typical pharmaceutical CRA with a Science background, you are going to be a little bit lost, and you are going to do things that you are not supposed to do, usually touch things, that you are not supposed to touch and everyone gets, hacked off and not very pleased. So in those circumstances even though these combination products may be regulated as a drug, if it is like an implanted device then it should really be run by medical device specialists because of the way the study runs is much more like a medical device study.