Diabetes: Europe, the U.S. and the medtech pendulum’s swing

GlySure CEO Christopher Jones has a career spanning more than 2 decades and 2 continents, during which he’s seen the medtech regulatory pendulum swing from the Europe to the U.S. and back. 

In an exclusive interview with MassDevice.com, Jones told us about being an American executive in the U.K., changing regulatory timelines and challenges to look for with a Europe-1st strategy.

MassDevice: You have a career that has spanned work with regulators in the U.S. and abroad.  Tell us about your background. 

Christopher Jones:  I’ve got 20-plus years in medical devices and diagnostics, starting in the U.S.

The biggest part of my career was at Nellcor, which eventually, through acquisition, became part of Tyco Healthcare, which is Covidien (NYSE:COV) today. I left a bit before they turned into Covidien.

There we had products – critical care, pulse accelerators, tube tracts – that we were selling globally and that we were putting through for approval in the U.S., Europe and in Japan.

From there I went onto Tensys Medical which was a continuous non-invasive blood pressure company. There we were really focused on the U.S. market and had U.S. approvals.

Now I have come over to the U.K., where I’m running GlySure. GlySure is developing a continuous glucose monitor for use in the hospital. The reason I ended up here is because the U.S. is the biggest market for this product and when they got to the point of reaching proof of concept, they really wanted to have a U.S. focus to the company.

Which is why they first brought Bill Moffitt, who is our chairman and who is based in Chicago, who was CEO of i-STAT and CEO of Nanosphere. And then they recruited me.

We’ve firmly got our eye on the U.S., but at the moment we are absolutely driving forward with a Europe-1st strategy, because the regulatory path for CE Mark is a bit clearer right now. In fact we’ve seen several of our competitors coming over to Europe looking at the same approach.

MassDevice: The Europe-1st strategy is a popular one these days.  How long has it been that way?

CJ: What I find interesting is throughout my career I’ve seen the regulatory timelines and the differences in timing between U.S. and Europe change and go back and forth.

There was a time back in the early ’90s where you could get to Europe faster. We were launching 1st in Europe with devices and systems at Nellcor.

Then all of a sudden things came around and the FDA got faster and we realized all of a sudden that there wasn’t any delay anymore. We were basically doing everything in parallel back then and able to get through FDA approvals on pretty competitive timelines with Europe.

What’s become really obvious over the last 4-5 years is that those timelines between U.S. regulatory and European regulatory have diverged once again. You’re seeing more and more companies go to market 1st in Europe, because they can get the CE Mark faster, then go to the U.S. when they are able to get the data to satisfy the U.S. requirements.

To be fair, there are different focuses. The European system is much more focused on just demonstrating the basic baseline safety of the device, as opposed to performance. They are much more focused on ensuring the device is safe and they put it out in the hands of the doctors to figure out how to use it.

The FDA has a challenge in that they’re responsible for both device regulation and also for overall patient safety and health. They’ve got a role that the European regulators don’t have. That causes them to take a different approach sometimes.

MassDevice: In dealing in both arenas, are there certain experiences that you had with either body that were particularly telling?

CJ: That is a challenging question to answer. I think if you look right now at the market that I’m in, continuous glucose monitoring for the hospital, there have already been 2 companies that have gotten CE Marks for early prototype systems in Europe.

One was Edwards Lifesciences (NYSE:EW) and the other OptiScan (ASX:OIL).  In fact Edwards submitted to the FDA for approval and wasn’t able to get it and eventually backed off.

I won’t get into the details because it’s another company, but if you look at their quarterly earnings you can see the CEO make comments about the challenges they ran into and what the FDA was asking for. In my understanding from looking from his comments, the FDA was looking at usability and asking for usability trials. They made the decision to go on to a 2nd-generation device.

The FDA in June just held a public comment in which they pulled in feedback from the clinical community to get advice on what the performance metrics should be, what testing should be done in order to clear a continuous glucose monitor for use in the U.S.

We think it was a really important step because it provided the FDA with a lot of good feedback. Hopefully they can take that and incorporate that into their thinking, be able to share that with the industry to provide everybody with some direction on approvals. But that’s definitely a different approach than what we’ve seen in Europe.

MassDevice: With that meeting, do you feel that the FDA has been taking steps to fix the diverging timelines?

CJ: I do. I think it was a very important step to go get feedback from clinicians in the clinical community to guide their decision making. To me that was a very positive step in the right direction. I am eager to get back and talk with them some more about our proposed trials and the feedback they got from the clinicians.

MassDevice: In the medtech community, there’s sometimes a tendency to romanticize the European regulatory environment. Are there obstacles there that device makers sometimes underestimate?

CJ: I think that’s a challenge that we are clearly aware of. While you can get the approval quicker it doesn’t necessarily mean that you then have all of the clinical proof that clinicians are going to want in order to get widespread adoption. But what you do is go out to the early adopters and start to work them to then build that further clinical evidence to create support for the device.

MassDevice: On the other side of the pond, are there benefits to the FDA pathways that device makers sometimes take for granted?

CJ: I think the answer to that is absolutely yes. When you talk to VCs that are looking at funding companies and if you look at exiting companies, they have a huge premium that they put on FDA above CE Mark.

The CE Mark on its own without data, without usage, confers a small amount of benefit to a startup company. It really is when that CE Mark is backed up by clinical usage and data and opinion leaders that can talk about product performance that it becomes valuable.

Whereas the FDA approval is more rigorous, that on its own, in talking to people, is recognized as such tends to confer for the bigger bump in evaluation to the company.

MassDevice: What do you think are some of the most important cultural differences you’ve see in dealing with the FDA versus dealing with European regulators?

CJ: I’ll talk about the one that fascinates me the most, because it’s 1 of those that I view as just a difference. Not necessarily 1 being better or worse than the other.

When you go and talk with the FDA about studies and patient numbers, many times the FDA is looking to make sure you’ve got enough patients in your study to get a very representative sample, to ensure that there aren’t outliers out there that you’ve missed that could be safety risks. While you probably can never touch enough patients to eliminate any risk, there is certainly a value in pushing for more patents to minimize the risk.

The European regulators almost take the opposite approach. When they are looking at study design, they are pushing it down to get the smallest number of human subjects possible, because there are ethical concerns in Europe about doing studies on critically ill patients in hospitals. There are 2 very valid opinions.

One approach, which is, "What testing is possible to minimize risk once the product is a launched?" And the other one which says, "Let’s minimize the human testing in order to reduce the risk to the subjects of the test."

Both take the regulators in very different direction in terms of number of patents required for approval.

MassDevice: A lot of companies are looking to the European market as a launching point. Do you have any tips or warnings for them when they are coming to Europe?

CJ: I think it’s really obvious, but Europe is a very large place and very diverse – much more diverse than the U.S. It’s really important to take a country-by-country approach because there are stark differences between Northern and Southern Europe and Eastern and Western Europe. You need to get some local experts to help you figure out which markets you want to tackle first, which country is best served by direct sales, which country can be best served by distribution.

There are a lot of differences in the healthcare system from country to country. It takes some time, some planning and a whole lot of local knowledge before you want to jump in. As a small company I think it’s probably wise to pick a few markets and start an approach without trying to go too broad too quickly.

MassDevice: In terms of the CE Mark not conferring an immediate bump in sales, any words of warning or temperance for startups coming that way?

CJ: That’s an interesting question. I think my personal belief is that the value of the CE Mark lies in what you do with it next in being able to build a network of key opinion leaders and build a credible sales platform.

A lot of companies are coming over to get experience in the market, and it’s important to have local experts on the ground in the countries where you want to go to market. That way you can get the result, the customer updates, the feedback that you’re looking for.

MassDevice: Last but not least, lets switch topics just a little bit. I know GlySure doesn’t yet have any products for sale in the U.S. Is the medical device tax on your radar?

CJ: I think the short answer is not yet, because we are not on the market yet. In many ways I think it’s probably more of an issue for existing companies because their pricing is already set in the market. A company launching a brand new product is just going to look at that device tax and take it into account when they figure out what their plans are for marketing the product in the U.S.