Should Medical Device Companies Pursue Regulatory Approvals in Europe Before the US?


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It’s a constant debate. Pursue a medical device regulatory approval in the US? Or does it make more sense to seek a European approval first? Is there a definitive answer? According to Marc Sanchez, Founder of Contract In-House Counsel, medical device companies would be wise to take a step back and consider the business ramifications first.

In this interview with Marc, we learn more about this hotly debated issue as well as a host of other interesting medical device regulatory trends. Okay, so who is Marc Sanchez? He’s the Founder of Contract In-House Counsel and Consultants. His law practice focuses on building a regulatory strategy for start-ups and small to midsize companies in the medical device field. This strategy includes both pre-market approval and post-market surveillance matters.

These are Your Options:

1) You can listen to the interview with Marc Sanchez right now:

2) You can also download the mp3 file of the interview by clicking here.

3) Don’t forget – you can listen to this interview and all of the other Medsider interviews via iTunes.  And if you get a chance, leave us an honest rating and review on iTunes. It really helps out.

4) Read the following 7 Action Points from my interview with Marc Sanchez. (If you don’t have time to listen to the entire interview, this serves as your unofficial cheat sheet.)  Also, feel free to download the 7 action points by clicking here.

5) Lastly, scroll down even further and read through the actual raw transcripts of the interview.

The 7 Action Points:

If you don’t have time to listen to the entire interview, these 7 action points will serve as your unofficial cheat sheet. Also, feel free to download the 7 action points by clicking here.

Choosing Between a FDA Approval and a CE Mark is a Strategic Business Decision

While deciding between a FDA approval and a CE mark, Marc advises his clients to analyze the situation from a business perspective, rather than a regulatory perspective. Getting a CE mark in no way expedites the FDA approval process. Therefore, if a company decides to go to Europe first, it should be solely because it has an established marketing and distribution network there, along with the capabilities to manage these resources from an entirely different continent. Not because it wishes to speed up the FDA approval process later.

Conducting Thorough Research on your Product and the Applicable Regulatory Procedures is the First Step if you are Seeking Approval

Marc feels that it is imperative for every business manager to identify whether his medical device falls under the exempt category or under Class I, II, III, and thereafter understand the regulatory procedures applicable. For Class I and II devices, one needs to concentrate on finding a predicate device and can then follow the 510(k) procedure. However, for Class III devices, the way forward is almost always a PMA, and will involve a panel review.

Raging Debate Over Innovation vs. Regulatory Process

The recent PIP breast scandal has exposed the loopholes in the European regulatory procedure where a company was selling unapproved breast implants for about 10 years in France before being detected by post-market surveillance. The FDA had banned the implants of this very same company after it inspected the manufacturing conditions in Europe. While the FDA is being hailed for its watchful eye pertaining to the PIP scandal, many argue that the FDA’s tight regulations stifle innovation in the medical device industry. If fact, some consider Europe to be ahead of the US in terms of medical device technology, due to its less stringent regulatory procedures.

FDA Has Been Increasing Focus on Post Market Surveillance

There is an increased focus on safety within the FDA, especially since many medical devices are now imported from China, Europe, etc. Therefore, the FDA is increasing its inspections in these places to determine that the correct manufacturing, labeling practices, etc. are being followed. In case of any discrepancy, the company is issued a Form 483. According to Marc, the fact the FDA has been ramping up its post market surveillance is evident from the fact that a record ten thousand 483 citations were issued in 2011.

CDRH has Issued New Guidelines in Order to Maintain Continuity Between Reviewers

The PMA timeframe is generally four years due to the amount of clinical trials and data needed by the FDA for approval. Due to the high turnover at CDRH, there has been a problem in the continuity of reviewers because of the difference in the standards of approval. However, very recently, the CDRH has issued set guidelines in order to maintain continuity between reviewers, which will hopefully make the review process smoother.

Reading the Fine Print in your Employee Agreement Document is an Absolute Must

The recent case of whistle blowing involving FDA reviewers who reported information to the Congress, but were having their e-mails monitored by the FDA, brings to light the importance of knowing and understanding workplace policies. Most agreements mention that the employee’s computer will be monitored, which implies that private emails are also monitored. Therefore, any information which the employee wishes to keep private must never be accessed from the workplace.

Implementing Social Media Policies at the Workplace is the Need of the Hour

Marc advises all his clients to have strict social media policies in place, which would imply everything the employee does on the work machine, on the work servers, and on the work cell phone…is monitored and not private. However, along with such strict policies, Marc feels that employers should provide their employees with some breathing space, and not take offence at things said on social media sites provided they are done off duty hours and do not include any sensitive company information.

Read the Interview with Marc Sanchez:

Scott Nelson:    Hello, everyone.  It’s Scott Nelson, and welcome to another edition of Medsider, home of the free personal med tech MBA, and for those of you who are new to the program, this is where I bring med tech and medical device stakeholders onto the show and we dig into their background and we dig into their current work and really try to suck as much wisdom out of them as possible so we can learn something and apply it to what we’re doing in order to experience various successes along our path within this space.  And today’s guest is Marc Sanchez, he’s the founder and principal of Contract In-House Counsel and Consultants.  They’re in the Southeast, Atlanta, Georgia area.  So, welcome to the call, Marc.  Appreciate you taking some time to come on the show.

Marc Sanchez: Thank you for having me.

Scott Nelson:    Alright.  So Marc, we’re going to dig into a couple of different topics here but it’s going to be mainly focused around kind of the regulatory environment, the 510(k) versus PMA, should companies focus on US regulatory approval first versus a CE mark in the EU.  We’re going to get into some FDA trends, and then maybe into some mistakes that you see some of your clients make in that typical regulatory process.  But let’s get started with one of the topics that I mentioned in that if it’s a newer medical device technology, should companies consider getting a US approval first or a CE mark in the EU first?

Marc Sanchez: Well, I get this question a lot and, you know, I like to backtrack with my clients and say, “Let’s not let the regulatory issue be the deciding factor here,” and I like to step back and say, “Is your business ready to be in Europe?  Are you ready to find a distributor, marketing sales?  How will you manage that from a continent away?”  And, you know, the answer to that question is going to depend on are you relatively a new startup, mid-sized or a really well-developed company?  So that’s really the first question I try and start from, and once they’re comfortable with, “I’m ready to be in Europe” or “I’m ready to be in US, tell me what to do.”

What I often find clients looking to answer in asking that question of “Should I be in Europe first?” is really they’re asking, “If I go to Europe first, if Europe is easier, will that make when I come back to the States, when I come back to the FDA process, will that make the FDA process faster because I have EU clearance?”

Scott Nelson:    Mm-hmm.

Marc Sanchez: And that’s kind of the nugget I think clients are asking.  They’re kind of looking for that really quick approval in Europe and a really quick approval in the US.  And from a regulatory standpoint, Europe is going to be softer.  Europe generally has a different standard than the FDA.  The FDA’s caught a lot of flak for being slower with new technology, but it isn’t going to affect the FDA process.  If you are able to go to Europe and get a faster process, faster approval, you’re still not going to be able to come back to the US and get an expedited process because of that.

Scott Nelson:    Gotcha.

Marc Sanchez: And, you know, it’s up for debate whether the standards in Europe are easier and will allow newer technology [00:03:11] in in a way that is still safe or whether the FDA process, which is a little bit slower, actually allows products into the market only when they are truly proven safe?  I think that’s still a question that needs to be looked at.

Scott Nelson:    Gotcha.  So you’re saying first and foremost that companies should look at it mainly from a business perspective, not just focused simply on the regulatory aspect.  I like how you put it, “Are we ready to do business a continent away?  Have we identified distributors that can effectively sell or market our products?”  That’s a great point.  Do you find that a lot of companies get caught up too quickly or too much with that topic of the regulatory environment versus looking at it from a business standpoint?

Marc Sanchez: Absolutely, you know.  I find a lot of companies that will take a lot of time and develop a really thought-out business plan and all of a sudden they toss that to the wayside and they want to know regulatory questions.  And regulatory questions are important and they may impact your business plan, but you always want to make sure that you’re sticking with the business plan and the model of growth that you know is sustainable and that you know is something you can execute and manage before running it to the regulatory issues.

Scott Nelson:    Okay, and you’re saying in your experience, taking a step back and looking at it from a business standpoint, beyond that, if I’ve got XYZ device and we make the decision as a company to pursue a CE mark in Europe, you’re saying that just because we have a CE mark, that’s not going to necessarily expedite the process of obtaining a 510(k) or even a PMA in the US?

Marc Sanchez: You know, I think people often confuse a CE mark with something like an ISO certification.  It doesn’t have that same level of oomph that the ISO certification has with the FDA.  If you’ve gone into and you’ve gotten a CE mark, the FDA is still going to ask you, “What’s your device like? How safe is it?  What’s the classification?”  They still want that scientific evidence to show that it can be marketed safely and effectively.

Scott Nelson:    Gotcha.  Okay.  But to that point, a company can use data that they have collected in Europe in order to help facilitate a 510(k) approval in the US, correct?

Marc Sanchez: Absolutely, and it’s going to depend on the classification of device.  If it’s a class III device and could be the most risky type of device, something like an implantable device, you may be able to use that evidence but there still may be a need for clinical data that is within FDA regulation.  But  for the most part, you know, if you’re able to safely market a device in Europe, you’re going to be able to use that data in a 510(k) application.

Scott Nelson:    Gotcha.  Okay.  Very good.  I want to ask you about that recent news about the PIP breast implant scandal in EU and the potential ramifications of that in the US.  But before we go any further, I think it might help if we kind of take a step back and kind of, I’ll have you briefly explain the differences between a 510(k) approval and a PMA here in the US, just for those in the audience that are listening and have heard those buzzwords, heard that terminology but maybe don’t quite understand the differences between the two.

Marc Sanchez: Yes.  You know, I think it’s important anytime you have a medical device to take a moment to understand what is your device in the regulatory scheme that you’re in, and what I mean by saying that is you have to identify whether your device is exempt, it falls outside in regulation, and you still have to be careful to make sure that it meets the exemption that’s in the statute, or if you have a class I, a low risk, class II, which is a medium/moderate risk, or a class III, which is a high risk.

And you may also have this completely new device, something’s that’s not on the market, and depending on that classification, you’re either going to go through a 510(k) and I describe these as a sort of a regulatory pathway—and 510(k) is the most common.  You’re just looking for substantial equivalence to a predicate device, something that’s [00:07:08] already locally manufactured and sold versus a PMA, which is an acronym for pre-market approval, and those are for the really high-risk or even the in vitro diagnostic devices.

And those devices are going to go through a panel review, kind of similar to what you’d see for a new drug where the FDA wants clinical data, then wants it to go through a series of tests starting with maybe lab mice and then going on to other mammals, and eventually to a full human trial before they allow it on the market.

Scott Nelson:    Okay.  And you said the difference classes, the class I, class II, class III.  So, class I, and correct me if I’m wrong, with class I devices you don’t even have to get a 510(k) for class I, but for the class II and class III devices you do need a 510(k), and sometimes even a PMA?

Marc Sanchez: For a class III, it’s almost always going to be a PMA and the 510(k) will not be available.

Scott Nelson:    Uh-huh.

Marc Sanchez: Class II and I, that’s going to vary depending on the device.  For the most part, if you can identify a device that’s already on the market, if you’re a substantial equivalent, so you’re pretty much making the same device with a few minor changes that don’t affect it, you can go through the 510(k) process.  And for those devices that don’t meet the 510(k) requirement, you are able to sell without going through that regulatory pathway. I still find a lot of clients that kind of think, “I can skip right to, you know, pass go and keep on going.”  But you do need to make some time to look at your device, look at the definition in the statute.  There are technological requirements.  There’s a whole bunch of stuff in the statute that you have to meet.

And the other thing I see clients do is incorporate two devices.  They’ll come up with a class I or an exempt device, and then they’ll incorporate in a class II device, so kind of as a combination device.  Once you incorporate that 510(k) device, then you have to do something different.

Scott Nelson:    Okay.  Okay, I gotcha.  And so a class I device, can you think of an example off the top of your head?

Marc Sanchez: Yeah.  You know, I’m working with a client now that does an ostomy bag, and it’s outside the body, it doesn’t necessarily interact with the body in any way, it just needs to be a sterile bag but it’s outside the body.  And so the FDA doesn’t regulate those in the same way they would, say, a lung [00:09:31] or something like that.

Scott Nelson:    Okay, and then like a class II would maybe be like a knee or hip implant, maybe something like that?

Marc Sanchez: I think if you get into the implantables you’re probably going to get into more the class III.  I’m trying to think of a good example of a class II device.  Nothing’s coming off the top of my head, but anytime you get into an implantable, you’re more likely than not going to be into the class III.

Scott Nelson:    Okay, gotcha.  Okay, that makes sense.  Very good.  Okay.  And then, the whole issue of predicate devices, it seems like that’s such a gray area, and that’s partially to blame for like the hype of the whole 510(k) process.  You know, are letting unsafe devices kind of scoot by by giving them a 510(k) approval?  So can you speak to that issue at all?

Marc Sanchez: You know, it’s a difficult question to answer because there’s a little bit of wiggle room that the FDA gives you in looking at a predicate device, because you have to show substantial equivalence and so, you know, big changes to a device are going to not be substantial equivalent.  You’re really changing the technology.  You’re changing the material that it’s made out of.  And those sorts of changes aren’t going to get caught but the question is, when does the FDA screen those out?  Because if you’re not going through the 510(k) process, then it’s going to come on to the post-market enforcement and it’s going to take some time for the FDA to find out that you’re selling a device because you thought you were exempt and you didn’t go through a 510(k) process, and it turns out you actually did enough change in the materials to warrant more examination of whether or not it’s safe.

Scott Nelson:    Gotcha.  Okay.  Okay.  That’s a segue into the whole PIP breast implant scandal because using that as an example, some people that would like a more stiff or more rigid regulatory process would argue that that issue in Europe, that’s something that we could experience here in the US if we’re letting too many companies scoot by with a 510(k) approval when really a PMA should have been required.  So let’s dig into that PIP issue.

Marc Sanchez: Yeah, well, [00:11:50] the PIP scandal is one that’s just come out in Europe but the company had been selling breast implants in Europe and really across the world since about 1991.  So if you think about it, from 1991 until 2010 they were selling a device that wasn’t approved, and it turns out that instead of medical-grade silicone in the breast implants they had what they called a [00:12:12] home mix, which was both industrial- and agricultural-grade silicone in these implants.  So, for a period of, you know, 1991 till 2010, they were able to market and sell this illegal device across the world in places except the US.  So that to me kind of speaks to the US system that this product was banned only in the US and really able to be sold everywhere else.

Scott Nelson:    Gotcha, and I don’t think I realized that that was…I mean, I obviously read into that, and that story had received a lot of attention in the news, but I don’t think I [00:12:49] that close.  So that was 10 years?  They’ve been selling those for 10 years?

Marc Sanchez: Yeah, and there’s a question of when they started to change the formula because there’s a question of whether they started out selling truly a medical device, a medical-grade silicone device.  But at some point, and some believe very early on, they decided to skip the pre-market approval process, you know, a question of fraud, and because they could make it cheaper do this [00:13:17] home mix of silicone, and for a period of time and we can’t really understand for how long, they were selling those devices that were really, you know, who knows how dangerous.

Scott Nelson:    Right.  And you know, when I first heard that story—because I probably would lean, I mean, granted, it’s just one guy’s opinion, but I would lean maybe towards really trying to make the regulatory process more efficient, and if that means we’ve got to make some changes that would be a little bit more risky, I would maybe potentially think that we should look at those.  But this story I would venture to think would cause a lot of people to say, “Look, see this is why we should take things slower.”  So, which side of the fence do you fall on?

Marc Sanchez: Well, I think the PIP scandal is a hard one to use as an example because anytime you look at medical devices you have two sides of a coin.  You have the pre-market approval process – you know, did they gain proper approval for their device?  And then the other side of this coin is the post-market surveillance – did they manufacture it in a way that has maintained its safety and its effectiveness?

Scott Nelson:    Mm-hmm.

Marc Sanchez: And on the pre-market side it’s a clear case of fraud.  They didn’t try and get French approval and EU approval for the device, and so it’s hard to say that on the pre-market side something should have changed.  On the post-market side, it’s kind of awe-striking that French authorities could have the manufacturer on their soil for a period of 11 or 12 years with no inspections, and I think that’s the side of the coin that I try and focus on, is really there should have been someone within the first year or two years of manufacturing who went into the facility, looked at what they were doing and said, “Wait a second, you’re doing something that isn’t right.”

And if you look at the history of it, they try to come to sell in the US I think around 2002 or 2006, and the FDA banned those silicone breast implants but allowed them to sell saline implants.  As soon as they started selling saline implants, they became under FDA authority.  FDA sent an agent to inspect their facility in Europe and found a horrible manufacturing condition.  They deemed their silicone implants adulterated and banned from sale in the US.  Despite that, there were still another four or five years before French authorities did anything.  So really, I look at it on the post-market surveillance side that really something there needs to change.

Scott Nelson:    That’s fascinating.  Again, you’ve obviously done a ton of research.  You can speak very well to this topic, which is awesome.  But that’s fascinating.  So wouldn’t that have triggered the French authorities to look into this a little bit further if the FDA’s saying, “No, we’re banning this?”

Marc Sanchez: Well, that’s the question that everyone is asking right now, is how did the French authorities not know about this?  There were FDA agents coming into their country looking at one of the manufacturers, and that’s one of the things that’s more likely than not to change.  The FDA always inspects foreign facilities and they’re starting to do on the drugs side is they’re starting to share inspection data with the EU.  This year is the first year of the formal launch of the program.  The past four years they’ve been doing a pilot program to see how that information sharing would go, and my guess is that after this scandal that information sharing is going to happen on the device side.

Scott Nelson:    Uh-huh.

Marc Sanchez: Because there’s just no excuse for how an FDA agent can come in, deem these adulterated, find the conditions that they found and not share or have the French authorities ask about that.

Scott Nelson:    Very good.  So, in essence, that would probably help that information sharing process.  I guess we’ll see that maybe come to fruition a lot more faster on the medical device side than we would have otherwise, is that safe to say?

Marc Sanchez: You know, we’ll probably see a pilot program launched pretty soon.  And it’s not just that the US didn’t know about it, but even though it was a French manufacturer [00:17:25] didn’t question or try to inspect the facility.  They were sold all over Europe and there were instances of patients coming in because of the higher rate of rupture with these breast implants and doctors not reporting these to the Ministry of Health, and the Ministry of Health of say Ireland reporting that to France.  So, it’s going to be better coordination within the EU as well.

Scott Nelson:    Gotcha.  Okay.  So beyond that, what do you think are the other consequences or ramifications that we’ll see, I guess mainly looking at the FDA here in the US?  Is there anything that comes to mind, kind of looking at the back end of this PIP fallout?

Marc Sanchez: You know, I think the FDA has kind of maybe taken a moment of relief to say to the industry, “Our way works.  We may be a little bit slower but we are safer.”  And I think that’s the stance that’s going to be here in the US because there’s a lot of talk in Europe to say, “Well, why don’t we replicate the FDA system?”  And of course there’s some pushback there because the question is, does it kill innovation?  Does it slow down innovation?

Scott Nelson:    Mm-hmm.

Marc Sanchez: But, you know, here I think the sense is that we’ve got it right.  And it’s not just the PIP scandal.  There are some other examples.  There’s a lung [00:18:44] that was approved in Europe before it was approved in the US, and before it gained US approval it was already being withdrawn off the market in Europe.  There was an elbow fracture, like a process, that went through in Europe, and then when it was about to gain approval in the US it was withdrawn from the market.  You know, there are lots of examples where the FDA process has shielded the public from being…and I know a lot of people are using the word “guinea pig,” and I’m not sure if that’s quite the word to use, but it is shielding and helping patients from unnecessary procedures or procedures that may actually complicate their lives a little bit more.

Scott Nelson:    Right.  You know, in hearing you even explain those stories, I’m almost wondering if the FDA would do themselves some good if they actually bring to attention more stories like that where people even like me would say, “You know what?  That’s a good point.”   “This device, we did not approve it here in the US but it was approved elsewhere, and look at what happened.”  Do you see what I’m saying?  It would probably…

Marc Sanchez: Yeah.

Scott Nelson:    Maybe that’s more of a [chuckles] marketing aspect to the FDA, but that would probably do them some good.

Marc Sanchez: I think it definitely helps the FDA when they bring out legislation or new rules because the industry lobby of course wants to have devices out there faster because that’s when you can start making the money.  But this really helps the FDA say, “We hear your argument.  We really want to get the device out there faster.  But look at our case history of what we’ve shielded the US consumer from.”

Scott Nelson:    Right.  You know, on the flip side though, I will tell you this.  An interventional cardiologist told me this that after recently going over to Germany to do some training on I believe it was the sapien percutaneous heart valve by Edwards—you know, I was asking him how that training went, and he said it was good.  He said one of the big disappointments, though, is that whenever we actually do get to implant that in the US, we’re going to be implanting the first generation of that valve where in Europe, but I can’t…I mean, don’t quote me on this, but they’re on their second, third generation of that same technology.

So, theoretically, they’re getting a lot better technology in that second or third iteration than US patients will.  And so, you can see the other side of the coin when a tighter regulatory process does impede innovation and the end result is patients sometimes don’t get that technology soon enough, right?

Marc Sanchez: It’s an incredibly difficult balance to strike…

Scott Nelson:    Mm-hmm.

Marc Sanchez: …because you really do want that, you know, the best technology that’s available on the market as quick as possible.  But the unfortunate thing is, you know, when we get into something like heart valve or any sort of implantable, the clinical trials really take time because the FDA wants to see over a period of years or I think maybe even over a five-year period what the effect is of having a new foreign object in the body.

Scott Nelson:    Mm-hmm.  Right.  So, I definitely want to talk about other trends beyond the scandal that you’re seeing or that you think we’ll see, but before we get into that…I tell you what, let’s get into that now.  I guess this might serve as a good segue into that, other trends that you’re seeing, and then I kind of want to backtrack and ask you a little bit about that recent news that we’ve heard about the FDA reviewers and the FDA kind of spying on the reviewers that were somewhat whistleblowing to some of the things that were going on behind the scenes.

Because I know that you’ve done quite a bit of work in regard to social media within kind of this environment, and so I do want to ask you about that, but are other trends that you’re seeing in regard to the FDA?  Or maybe I should just ask you, what do you personally think we could do right now to improve that—I know you mentioned the balance that needs to take place between the necessary research and then also getting devices to market quicker, but do you think there is one or two things that can happen now to further improve that process?

Marc Sanchez: Well, you know, I think one of the things that’s happening in the US has been a shift in focus on the pre-market side to a focus on the post-market surveillance.  I think the FDA shows like it has a very firm grip and a firm sense of how the pre-market approval process works, you know, 510(k)s, PMAs and all those.  I think that has a very established process.

What the FDA’s starting to do is starting to look at how these devices are actually manufactured in the US, and not only in the US.  We receive a lot of medical devices from abroad manufactured in China, Europe, a lot of places, and what the FDA is doing is increasing inspection into these facilities no matter where they are.  And to step back the way the FDA does this is they come into your facility, and once they’re in your facility they have the right to look at everything.  Everything is fair game, and if they find anything that doesn’t meet the good manufacturing practices from labeling to how you track your supplier, everything, they’ll issue what’s called a Form 483.

And this is kind of a measure to see how active the FDA is in enforcement, and normally this number is very low and you kind of see a consistent trend in it, but over the past year, in the past two years, there’s been a big spike.  Last year there was a record set of over ten thousand 483 citations issued.  So not all of that is medical device.  Some of it is food and some of it is drugs, but I think that shows that the FDA is really in full gear looking at enforcement and looking at how these devices are manufactured and ensuring that they’re manufactured in a way that is clean, is labeled accurately, is marketed fairly, is manufactured with the same materials [00:24:32] or better in the 510(k) or the PMA, all sorts of things like that.

Scott Nelson:    That was the Form 482, right?  And what increase was that did you say over the past year?

Marc Sanchez: That’s a Form 483, and last year there was a spike that went all the way up to 10,000 Form 483 citations issued.

Scott Nelson:    Ten thousand plus.  Wow, that’s a fascinating [00:24:53].  Okay, so what do you think is driving that?  I mean, why the record level of Form 483s this past year?  Any ideas?

Marc Sanchez: I think there are a couple of things, and to me it’s truly telling to what’s going on in Congress.  Every agency is looking at its budget being cut.  I mean, nothing is sacred in Congress right now in terms of deficit slashing, but the one thing that has survived if not seen a [00:25:17] increase has been the FDA.  The FDA has stayed at or increased its current budget, and what that means is that it’s actually trying to bring on more inspectors, and it really is focusing on that goal of ensuring—I think we’ve had some really high-profile recalls, you know…

Scott Nelson:    Right.

Marc Sanchez: …on the food side, some things in China, but not necessarily on the food side in terms of recalls from China, other suppliers, foreign countries, have had their products recalled, and I think that’s been on the FDA’s mind and I think that’s one of the things driving that.

Scott Nelson:    Okay.  So within the FDA you there’s just an increased focus on safety, and so hence we need more inspectors to improve on that post-market safety.  That’s interesting.  Behind that…beyond that issue, I should say, are there other trends that you’re seeing in regard to the kind of the regulatory culture and environment?

Marc Sanchez: Well, you know, not too many trends here in the US at the moment but I think we know everyone’s keeping their eye on Europe because, you know, before the PIP scandal there was a look to recast the medical device directive, which is the main medical device legislation in Europe.  And now, in light of PIP, I think those changes are probably going to be more emotionally driven than they were before, and so in the spring we’re going to see the final set of rules on the recast there.

And so I think that’s what everyone’s looking at right now, is, how is that going to impact Europe?  And, what’s my timeframe before those rules are fully in effect?  And I think you’ll see a lot of device manufacturers, a lot of people that have ideas or have the potential to gain approval in the US versus Europe, they may try and get into Europe while the rules are the old rules, before the new rules are in effect.

Scott Nelson:    Gotcha.  Yeah, that’s an interesting point.  One quick question before we move on in kind of that recent news about the FDA reviewers and kind of the whole social media of that topic.  You know, I’m going to lose my train of thought here.  I wanted to ask you one question in regard to these trends.  Yes, the regulatory timeframes.  I think I recently read an infographic that the PMA timeframes are something in the neighborhood of four-plus years now, and I can’t remember exactly the average timeframe for a 510(k) approval but…

On that same topic, it seems like the turnover within at the CDRH is extremely high.  And so I’m just curious, do you think that’s a big issue in regard to these regulatory timeframes?  Do you think it’s really more to do with other factors like just a more focus on the safety of approving devices and that kind of thing?

Marc Sanchez: You know, I think that the timeframe really is set by the standard that you have to show for a riskier device like something that would warrant a PMA.  The clinical trials just take time.  It’s something that’s really hard for clients to understand sometimes that FDA wants that much data, but they really do.  To meet the scientific evidence requirement, they want a lot of data.

I think the issue that you see though with the CDRH turnover is the continuity between what one reviewer is telling me to do, and then all of a sudden, two years later, the reviewer switches and now you have new hands and they want different things and have a different attitude towards approval, and that’s where you can kind of run into some issues.

Scott Nelson:    Right.

Marc Sanchez: CDRH is very sensitive to that and they have issued some new guidance documents, I think it was just in December or January, about how that continuity between reviewers is going to be handled.  And I think that will smooth things over and it may take some time off the process, but I think generally the process is going to be dictated by the riskiness of the device.

Scott Nelson:    Gotcha.  Okay.  So definitely, I mean, that will most likely help but there’s going to be a high likelihood of determination being made by how risky the device is.  That makes sense.

Marc Sanchez: Yeah.  You know, I think a low-risk device, it can be as quick as 90 days, but if you have something like a heart valve, you know, look at a longer period of time.

Scott Nelson:    Gotcha.  Okay.  Moving beyond kind of the whole social media aspect as it fits under the same umbrella, you’ve done a lot of work, I know in doing some research on your background in regard to kind of social media and its impact and what’s allowable, what’s not, but there is some recent buzz about some positions inside the FDA that were kind of playing sort of a whistleblower role and reporting information to Congress people.  The FDA then was sort of monitoring their emails and, you know, that’s sort of a [chuckles] noteworthy topic within the past weeks.  But what’s your take on that whole aspect to maybe just speak to social media, as I mentioned, under this kind of umbrella?

Marc Sanchez: Yeah.  This is a really [00:30:24] topic and unfortunately for the FDA reviewers I think they were in a very weak position, and here’s why.  We all have computers at work and it’s very familiar for us, and we all know what we should know, that our work email is monitored.  We probably have signed some sort of policy that says whatever@companyemail is monitored and we kind of just have that in the back of our heads, but I think what we have forgotten is that easiness, and for the most part there are not blocks at work.  I can check my Gmail.  I can check my Yahoo mail.  I can check my Facebook.  Do those same privacy policies that apply to my work email apply to my Gmail account?  You know, that’s a private account.  I need a password to get in, you know.  That’s my password.

Scott Nelson:    Mm-hmm.

Marc Sanchez: And what the court had said is, you know, what is your reasonable expectation of privacy to that information?  [00:31:19] the FDA did and I think we can all relate to an employer that has done this, and especially a government employer.  Every time that you logged into an FDA machine there was a warning that came out of the dialog box, and I don’t remember the exact words but to the effect it said, “Everything done on this computer is not private and is monitored,” and you agree to those terms, and you click “OK” to finish the startup process and see your desktop.  And that’s really what’s going to be the kick in the pants for the FDA reviewers, is that they agree to that every time, and they still check their Gmail or still check their private messages.

It’s a different story if I go into an employer, they tell me, “Your work email is private,” or, “Your work email is public and monitored,” but they don’t mention anything about my Gmail account, and then it comes down the road that they have been taking snapshots of my inbox, they have retrieved my password, they’re reading my email messages.  That becomes a different situation because you didn’t tell me you were going to read it, so I kind of thought it would be private.

Scott Nelson:    Right.

Marc Sanchez: And kind of the thing I always tell clients is, “You know, just remember what your employer tells you really is true and don’t look at anything at mails at work that you don’t want anyone to really know about.”

Scott Nelson:    Sure.  So, is the take on that that these whistleblowers should have been bringing in their own laptop or [chuckles] bringing in their own tablet to fire off these emails?

Marc Sanchez: Well, you know, it gets into this nuanced questions that are hard to answer because…

Scott Nelson:    Right. [Chuckles]

Marc Sanchez: You know, for example, if I bring in my tablet and it has 3G capability and I check my email and I shoot emails across the 3G network…

Scott Nelson:    You’re fine, right?

Marc Sanchez: I’m completely safe because I am not using my employer email network.

Scott Nelson:    Okay.

Marc Sanchez: But if I bring in my own laptop, and then I connect through the Wi-Fi at work, it’s sort of a proxy of going through the employer’s network, and so…

Scott Nelson:    Sure.

Marc Sanchez: …it gets under the kind of crazy questions that I think catch people off guard because they’re just so used to using the technology and they just don’t think about whether they’re at work or whether they’re at home.  It’s just [00:33:25] but for legal purposes there are different statutes that apply when you’re in your private email than when you’re in your work email.

Scott Nelson:    Gotcha, and the reason I mention this is kind of a side topic beyond the 510(k)/PMA regulatory environments, but it’s interesting nonetheless, and I know this is part of your practice, right?  Is helping clients that have gotten into trouble in a workplace via personal email, Facebook, Twitter, etc., correct?

Marc Sanchez: You know, it’s something that it touches everyone of us, and even though I deal heavily on the medical device side of regulatory issues, I am on a ground level with these startup companies and it’s easy for a startup or a small-sized company to kind of say, “I’ve got my FDA clearance.  I’ve got my CE mark.  Let’s get to selling and marketing,” and they start to grow without a plan, and that’s kind of where I come in and say, “You’re starting to add on employees.  It’s important to have social media policies, employee policies in place to proactively prevent these issues from happening.”  So I feel like it’s kind of a value-added service that I can bring to my clients because it is an issue that they need to think about and it’s sometimes off their radar because they’re just ready to go and sell the device.

Scott Nelson:    Right. [Chuckles] No, that’s interesting.  So, I know this is probably somewhat of a…I should say vague, but somewhat of a blanket question, but do you generally advice companies to just completely admonish in all social media, “Don’t let your employees use social media?”  Or, I guess, if you had to give them a piece of advice, what is it typically?

Marc Sanchez: So it’s two pieces of advice that I give.  The first is have a social media policy that governs all the work-related activity and basically would be a policy like the one the FDA had that said, “Everything you do on the work machine and on the work servers and on the work cell phone is monitored and is not private.”

And then the second thing that I advise them to do is to have a tough-skin approach to everything that happens outside of work because a lot of the cases that you see in the social media is, “I go to work, the boss says, ‘You really don’t meet your sales goals.  You’re horrible and [00:35:41] rangy with not meeting your sales goals.’”  You’re fuming, you leave work, you go home and you log in from home into your private Facebook, and you call your boss every name in the book…

Scott Nelson:    [Chuckles]

Marc Sanchez: …and you have some some Facebook friends that are also work colleagues who like and comment.  Now your employer finds out about it and wants to fire you for what you did at home.  That’s why I advise the employers that everything that happens off the clock, unless it’s something that’s really, you know, releasing patent information or releasing customer lists, ignore it.  Just say, “I have to take a tough-skin approach and just let my employees vent.”

Scott Nelson:    Okay.  That’s interesting.  So I would’ve expected you to say, for the employees, “Don’t take it personal.  Don’t post that kind of stuff.”  But you’re saying actually to the employers, “Let them vent.  That’s personal stuff.  Take a thick-skin approach.”  I like that.  I like that approach. [Laughs]

Marc Sanchez: It’s going to get you in a lot less trouble because you see a lot of cases that come out where they try and take like a measured response, and each time the courts have said, “You went just a little too far,” and so it’s better just not to even try it.

Scott Nelson:    Right, right.  No, that’s great stuff.  So, I know we’re kind of reaching the end of our conversation, but this has been really good.  I mean, I can tell that, Marc, you’re really, really knowledgeable in regard to a lot of these topics and have some really well-thought-out opinions and takes on a lot of these issues.  So, anyway, thanks a ton for coming on.  But I want to give you the opportunity to talk briefly about your practice and how people in this audience can get a hold of you should they want to work with you.

Marc Sanchez: Yeah, I appreciate that.  I spend a lot of time in the medical device field.  I come on as contract in-house counsel, as you mentioned, for startups, small and medium-sized companies, and a lot of the information I talked about today you can find on my main blog, which is foodct, F-O-O-D-C-T dot com, and that will give you the latest news on some of these issues.  And if you really are curious about the 510(k) versus the PMA or how does the regulatory process work in Europe or Japan, I have process charts on my main website that should give you a 30,000-foot-level view of how that works in those different countries, and that’s sanchezmarc, S-A-N-C-H-E-510(k)-M-A-R-C dot com.  And you know, I encourage people just to go there and read the information, and they can always get in touch with me through this.

Scott Nelson:    Okay.  So your main blog is at foodcourt.com?

Marc Sanchez: Yeah, Food Court, and it’s not spelling out Court.  It’s F-O-O-D-C-T dot com.

Scott Nelson:    Okay.  Okay, gotcha.  So F-O-O-D-C-T dot com.  So that’s the main blog, foodct.com.  And then your main website, should people want to learn a little bit more about you and to check out some of those charts that you mentioned in regard to the FDA regulatory process, sanchezmarc. That’s S-A-N-C-H-E-Z-M-A-R-C dot com.

Marc Sanchez: That’s right.

Scott Nelson:    Alright, cool.  Cool.  Well, thanks a ton, Marc, for coming on.  Really do appreciate it.  Is there anything else that you wanted added in that we didn’t get to at all?

Marc Sanchez: No, I think we covered a lot of ground.

Scott Nelson:    Yeah, yeah.  I know we got a lot of the topics that we had discussed previously kind of checked off in a hopefully relatively short amount of time.  So, anyway, thanks again, Marc.  I’ll have you hold on the call, but to you listening, if you like what Marc had to say, you can obviously tell that he’s really knowledgeable in regard to a lot of these topics, go check out either his blog or his website, Food Court, that’s F-O-O-D-C-T dot com, or sanchezmarc, S-A-N-C-H-E-Z-M-A-R-C dot com, and I’ll link those up when the interview is posted on medsider.co, but go reach out to Marc should you want to partner with him.

Alright, but thanks again for listening, and just real quick, if you’re listening to this on the website or listening to this through another avenue, you can download the podcast via iTunes.  Just go to iTunes and do a search for Medsider or medical device, it’ll come up, and that way you could subscribe to the podcast for free.  All the new interviews would be automatically downloaded to your iTunes account.  You don’t have to do anything.  It automatically syncs with your iPod, your iPhone, etc.  It’s an efficient way to get these interviews should you be interested.  So, anyway, thanks a ton for listening everyone.  Until the next episode of Medsider.  Take care.

[End of Recording]

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