Nawana: The company commented on this some time ago in terms of financial outlay required to do the adjunctive clinical studies for products that have been in market for a period of time, but now need further clinical evidence to continue their marketing. Now, the EU has come—there’s a little bit of to and fro with the EU on the timing of when compliance needs to occur. In the grand scheme of things, what it means for us is a deployment of some cash to do more clinical trials.

And as a big company, we’re in a good position to go and do that work. We will take the opportunity to be very selective about which products continue, and we’ve got such a broad portfolio, we will do the extra work for the products that we want to continue for a good period of time. Now, if you take that another step back and you say, what does the European marketplace look like, there’s a whole bunch of technologies from smaller competitors that probably don’t have the clinical evidence at all, and are not likely to gather the evidence that would be required. So I think that this will reshape in the medium term the number of players and the type of players that we see in the European marketplace.

Net-net, I think Smith & Nephew is in a good position. Up front, there’s a little bit of cash deployment to really just do some of the clinical studies that are now required. Again, the time horizon has been pushed out, because the European folks have realized that they just can’t get all the work done, to even monitor it. But regulatory reform, that’s part of what we do, right?

When you’re a 160-year company, that’s your job, is to anticipate, shape, and then comply with the regulatory environment and changes. And so for us it’s just, that’s our normal course. We should be good at that. And one of the reasons I actually brought QA/RA on to my executive committee, it wasn’t previously an executive committee role, is because it’s a really important thing, for us to always be in front of quality. But it’s also a really important thing to shape the regulatory environment and to make sure that we’re leading. If you spend all this money innovating, then that last mile with the regulators, you actually need to be up front with that as well.

And so again, Melissa Guerdan is our new head of QA/RA, someone that I’ve worked with prior, who’s just an out-and-out specialist in this field. So I feel confident that we’re in a good position there.

Exec Chat: New Smith & Nephew CEO Namal Nawana Outlines Growth Strategy At JP Morgan

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