Forgive me for ripping off Dickens, but a good headline is priceless. This posting, however, is about two tales of an agency (located near Washington) with which we are all familiar.
For the first tale, FDA recently re-classified diagnostics for the Yersinia genus of bacteria (Bubonic plague, just in case you were wondering) as covered in the Nov. 18 edition of Medical Device Daily, and FDA stated in the Nov. 17 edition of the Federal Register that an advisory committee had recommended such a change back in 2002.
This is not the only example of a request for a device down-classification that lingered at the agency for close to or all of 10 years. The agency's Center for Devices and Radiological Health needed 10 years to reclassify a couple of catheter types last year after a request was filed in 2000 by Cook Medical (Bloomington, Indiana).
These are conspicuous delays, but I have to admit I have no recall of hearing anyone in industry complain about laggardly device re-classification requests, so I'm assuming they're none too numerous.
I asked around at FDA to find out what the explanation might be for the delay in the reclassification of Yersinia diagnostics. Here's what I heard:
CDRH's Office of In Vitro Diagnostics has been continuously working on this for some time and has at all times remained committed to the reclassification's completion. During this process a series of other issues have emerged, such as SARS, H1N1, HIV waiver, setting up a structure to deal with CMC emergency use preparedness, issues with laboratory developed tests and others that have needed to be made Office priorities. Many of these priorities have required the use of the same subject matter experts that were working on the reclassification.Additionally, we have experienced significant personnel changes (which are natural for any small-to-mid size organization) during the reclassification effort and have been working within the usual clearance processes for these actions, which include many steps.
Whether that's good enough for anyone in industry I don't know, but it fits in with my (admittedly preconceived) notion that the resource crunch at FDA has created a lot of headaches for industry and agency alike. It'll be interesting to see how FDA fares in fiscal 2013, but I get it if some are pessimistic.
FDA, industry, docs all in cahoots?
The second tale has to do with a dinner my wife and I had recently with some friends, who'd invited several other friends over. My wife and I were not that familiar with the general views of many of the other guests, but that made for a great opportunity for opinion gathering.
I asked everyone at the table what they thought of FDA, and the answers were uniformly less than flattering … a lot less. They ranged from remarks to the effect that FDA is in bed with industry to the view that FDA is utterly incompetent and not to be trusted with anything. For what it's worth, some of the opinions were that doctors are also in bed with industry, making for an eerie healthcare ménage à trois.
Much of the suspicion regarding FDA and device makers had to do with the implications of user fees, but my dinner mates who felt the user fees were the problem were also unaware of how long the user fee program has been in place and hence could not say whether their suspicions pre-dated the onset of that program.
Whatever the case, there apparently is a strain of thinking which holds that FDA, industry and doctors are some sort of unholy trinity seeking to hoodwink patients into bad devices. I have no idea how widespread that kind of thinking is, but there may be tens of millions of Americans who see it that way. FDA, docs and device makers perhaps ought to ask themselves whether it's particularly smart to allow that kind of thinking to go unaddressed.
But we'll talk more about that later this week.
[caption id="attachment_1118" align="alignleft" width="133" caption="Kris Shah, VP - Technical Division Manager, Baylis Medical, discusses one of the companys solutions, with the help of a skeleton model."][/caption]
[caption id="attachment_1119" align="alignleft" width="238" caption="A representative of Tornado Medical Systems demonstrates the benefits of the companys MRI products"][/caption]
So far I’ve chronicled my visit to Canada by focusing on what I’ve learned so far about the country’s focused efforts on growing its medical device industry – which is, of course, the primary purpose of the Advanced Medical Devices Media Tour, organized by the Ontario Ministry of Economic Development and Innovation (MEDI).
But in addition to learning about the many incentives Ontario provides med tech companies to set up shop in the province, I’ve also had the rare opportunity to interact with other journalists from all over the globe. I am certain that my overall experience here in Canada has been enriched by the diversity of the group I am touring with.
After two days of meeting with the CEOs of Toronto-based medical device companies, our group is now in Thunder Bay, Ontario where we will tour a local research institution and more medical device companies.
My travel companions include journalists from France, Germany, India, Japan, China, and London, in addition to our Canadian representatives from MEDI. I am actually the only U.S.-based journalist in the group. Here in Thunder Bay there are 18 of us all together, including the two MEDI representatives and one MEDI photographer. Last night at dinner I joked that because of our widely diverse backgrounds, the 18 of us in the group could probably rule our own country if we had to. One of the MEDI reps quipped back that we could call ourselves the G18 – a nickname I liked so well I borrowed for the title of this blog post.
But on a more serious note, it has been a highly educational experience to not only learn about the Canadian medical device industry but also to engage in conversations with my fellow journalists about what healthcare is like in their country and what challenges their medical device companies face. Although I was already aware of some of these issues – like how long Japanese patients have to wait for new technology because of the rather slow time to market in their country – hearing about the problem from the perspective of a Japanese reporter somehow had more impact for me than just reading about it.
Earlier this year GE Healthcare established its first global Pathology Imaging Centre of Excellence (PICE) in Toronto, Ontario.
GE and its digital pathology joint venture, Omnyx, will invest $7.75 million along with a $2.25 million grant from the Health Technology Commercialization Program created by Ontario’s Health Technology Exchange and funded by the Ontario Ministry of Research and Innovation. Planned collaborative R&D partnerships are expected to bring an additional $7.2 million, for a total investment of $17.2 million over the next three years.
Considering GE is a massive global corporation with locations all over the world and its JV Omnyx is based in Pittsburgh, it’s only natural to ask: Why Canada?
“Why Canada? It’s GE – we could have put it on the moon if we tried,” Luigi Gentile, executive director of GE’s PICE told Medical Device Daily and about 14 other journalists participating in Ontario’s advanced medical devices media tour. Gentile listed several factors that supported the company’s choice to make Toronto the home for its new pathology center. Some of those factors include: the high quality of pathology that happens in Canada; the experience and early adoption that the country has had in digital pathology; great pool of experts in both molecular and digital anatomical pathology; and the fact that the large geographic area of Canada creates an opportunity to develop a model in Canada that is very exportable to countries like Brazil, Russia, India, and China that are all facing the same challenges.
And of course the money that the Canadian and Ontario governments kicked in for the center may have influenced the decision a bit too. More than just providing funding, the government has brought together all the partners of industry, government, and clinicians to one central location in Toronto’s MaRS Discovery District.
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Hockey isn’t the only thing our northern neighbors do well. Canada – Ontario in particular – knows innovation.
While the U.S. has struggled in recent years to find ways to maintain its leadership position in medical innovation – Ontario has its own strategy that seems to be working out quite well for the Canadian province. More than $13.9 billion in industrial and university-based R&D is performed in Ontario every year.
So, what’s their secret? Ontario offers all the key ingredients for attracting life sciences companies: the right people, the right cost, and a healthy research environment.
Let’s start with the people part of the equation. Ontario has more than 100,000 researchers in its talent pool. Thousands of young researchers and technicians graduate from the province’s 44 universities and colleges every year. Ontario attracts top scientists from around the world with generous funding programs, top-notch lab facilities and the opportunity to work on leading-edge projects in a collaborative environment.
The next ingredient – cost – is particularly impressive, given the troubles U.S. medical device companies are facing with the recent medical device tax. Canada’s R&D tax incentive program is one of the most generous in the world. The after-tax cost of $100 R&D expenditure can be reduced to roughly $56 or even less than $37 for small businesses. A survey of international business costs last year showed that Canada offers the lowest R&D costs among the G7. That same survey reported that the country’s overall business costs were the lowest in the G7 for R&D intensive sectors – including medical devices.
Finally, Ontario encourages business and economic growth by creating the right environment for innovation. The province has partnered with the private sector to invest nearly $3 billion over an eight-year period to support research and commercialization at its universities, hospitals and research institutes. In addition to the generous federal R&D tax program mentioned above, Ontario tops that up with additional tax incentives such as its Ontario Research and Development Tax Credit, the Ontario Innovation Tax Credit, and the Ontario Business-Research Institute tax credit.
As part of the media tour I’ll be participating in today, organized by the Ontario Ministry of Economic Development and Innovation, I will be getting a first-hand look at some of the incredible medical technology being developed here. Check back tomorrow to find out how it went!
Long-time observers of FDA's regulation of therapeutic medical devices will note an oscillation over time, and we are now in a period in which the pendulum has reached as far as it can in one direction and is now headed the other way. The only question is how far.
It's not tough to find parties that have a hand in this. Congress finds it difficult to keep a steady hand because there are two parties with their different worldviews. Ditto those in the executive branch. Perhaps there is an inevitability to the back-and-forth at FDA's Center for Devices and Radiological Health.
Still, those on the Hill and at 1600 Pennsylvania Avenue might want to consider whether their excesses are the problem. After all, a sense of modesty is tough to come by if you work at FDA, hold an extreme point of view and are egged on by the administration or someone in Congress.
Other actors on this stage have their own agendas, such as those who authored the letters to Congress and the White House in 2008 and early 2009 alleging managerial malfeasance at CDRH. Let's not forget the prattle by the Union of Concerned Scientists about alleged suppression of dissent at CDRH. This part of the noise factory suggests there are a lot of people in this town who think that the possession of a post-graduate degree confers the right to rule unfettered over device applications.
There are other holders of those degrees, though, and they don't all agree. If your boss tells you you're wrong … well, get over it. Not everyone gets to be the boss (I know, what a creepily hierarchical assertion, right?).
The problem is that we as a society spend an inordinate amount of time and money hashing out issues that needn't cost so much. Was there really any reason to bring 510(k) applications to a near stand-still when David Kessler was the FDA commissioner in the 1990s? And yes, the CDRH of Jeff Shuren is undergoing a pretty interesting overhaul that his predecessor should have undertaken. Still, Shuren and the current commissioner have clearly gone too far as the current spate of FDA-related legislation demonstrates.
It's easy to be glib about all this in my line of work. One muses that of course the pendulum swings, and what good is a pendulum that spends all its time at bottom dead center? Can't make a clock tick that way. And it must seem peculiar for a loud-mouth like me to urge others to tone it down, but nobody has been denied a perfectly good device – or was implanted with a bad one – because of my rhetoric.
But that's all the more reason for reason to prevail. We're obviously in trouble if someone in the media has to argue for not hitting the pendulum so hard that it oscillates madly the way it has these past two decades. That, however, is apparently what it's come to.
Recently I posted a blog here about my observations of the medical device space over the last five years and how it has changed during my five-year tenure at Medical Device Daily. Like the industry, we too have changed a great deal since I joined the MDD staff in October 2006.
The first big change during that timeframe is the launching of Medical Device Daily Perspectives, our free, weekly e-zine, MDD Perspectives offering viewpoints on developments within the med-tech industry. In that, we aim to go beyond the news to provide you with a fresh outlook on the companies, trends, people and events taking place in the industry today. It goes beyond the who, what, where, when, how, and why to help you see understand how it affects you and why you should care.
Not long after MDD Perspectives launched, we saw an opportunity to bring you news as it is still developing, giving you a sneak peak at what to expect in our next daily issue of MDD. With that, the Medical Device Daily Midday Report was born. It's an email sent to our subscribers typically once a day (more in the event of late breaking news) offering a snippet of what we are working on for the next day’s issue. We figured we owed our subscribers that little heads-up on what to look for the following day.
As social networking has rapidly taken on a life of its own over the past couple of years, we knew we needed to engage our readers through sites like Facebook and Twitter in an effort to interact with you and also give you yet another venue of finding out what is happening at that very moment – tomorrow’s headlines today, so to speak, in 140 characters or less!
Earlier this year we launched the Medical Device Daily Perspectives Blog site. Similar to the weekly e-zine, this site brings you critical news, analysis, debates, commentary and camaraderie related to the med-tech industry.
We have worked hard over the last half a decade to keep up with the way information technology has changed and to deliver the news to you more immediately than ever before.
Of course there is always room for improvement and we do challenge ourselves on a regular basis to do better.
More blogs. More tweets. More breaking news alerts.
We’re always open to new ideas, so if there is something you would like to see more of, less of, or just think we should try doing differently, don’t be shy! Drop us an e-mail, Facebook message, Tweet to us, or simply post a comment here on our blog site.
[caption id="attachment_1071" align="alignleft" width="296" caption="Being there first: Who can resist it? Who can afford it?"][/caption]
I don't directly invest in med-tech, but attending Transcatheter Cardiovascular Therapeutics for five years makes me wonder how an investor separates winners and losers. I know TCT 2011 has both, but which are which?
Asking about the patient population is just the start of the investor conversation, but in an age in which indications for use are becoming increasingly narrow, it's probably the last question, too. After all, we have radio-frequency ablation devices approved for paroxysmal atrial fibrillation, but not for persistent or long-standing afib.
I have no clue how different an ablation device has to be to treat these different conditions – it's all in the wrist for all I know – but its clear that a stent designed to address a branched coronary artery is a different animal than a single-axis stent.
It's not hard to top that, either. Just add the question of whether the patient is diabetic and you have a whole new world. What if the efficacy of elution drugs is different for type 1 versus type 2 diabetes?
You see where I'm going. We are supposedly headed for an era of personalized medicine, but when the cost of device development is rising and reimbursement is tightening, who can afford to sweat a patient population of 5,000? At the moment, Edwards Lifesciences can. The conventional thinking about the Sapien TAVR aortic valve is that the U.S. market offers about 5,000 patients per annum. I haven't the foggiest what Edwards is charging for these things, but I guarantee they're not cheap.
Edwards' CEO Mike Mussallem is no dummy. If Edwards can't make its money back in five years, it will in 10 when the Sapien XT and more patients are available. Still, you can't discount the possibility that someone will invent some amazing biotech goo that can be dabbed onto the aortic valve to dissolve the calcium, shrink the stenosis, and prove that pixie dust really does exist.
That's quite speculative, but what if FDA tells Mike, "you need a new PMA for these patients who are less sickly and less stenotic"? We're all aware that Wall Street likes a sugar buzz a lot more than it likes real food these days, and while we understand why, that doesn't change the windsock behavior of stock traders. Don't think they wouldn't get the news about FDA and those somewhat different indications for use.
Sean Salmon of Medtronic said something at TCT 2009 that stuck with me. He was discussing bioresorbable stents and said "it's not compelling to be the first in this technology," although he also said it's a good idea to assemble a developmental program "in case you're wrong." But someone has to be the first on the dance floor or Mom and Dad never meet and get married and all that rigmarole.
I don't pretend to have any answers other than "a healthy economy" and "investors with nerve." I'm not sure how much we have of either of late, though, and the troubles in Greece and Italy make me wonder if this global malaise will persist.
I can say this, however: If the bigger ideas of the future apply only to ever-smaller numbers of patients, we're going to need some fundamental technological advances to make devices cheap, or the effort to expand indications will have to be a bit more seamless than I believe it is at present here in the U.S. Otherwise, Wall Street will join venture capital in the 510(k) game and leave the PMA-type stuff to other nations, and being there first will entail being there, not here.
Medtronic has the potential to be a trend setter with its attempt to have drug eluting stents (DES) treat erectile dysfunction (ED).
The device maker recently moved one step closer in this effort as it reported that it had completed its ZEN (Zotarolimus-Eluting Peripheral Stent System for the Treatment of Erectile Dysfunction in Males with Sub-Optimal Response to PDE5 Inhibitors), feasibility study.
The device, which hasn't been named yet, will be inserted into the pelvic area of the body. More specifically the stent is delivered using a catheter threaded up to the pelvis, where the pudendal artery is located. It was placed in the artery, opening the vessel and allowing for better blood flow.
In a large number of cases, ED is caused by vascular disease due to the deterioration of the endothelium. The company said that its DES is ideal because it preserves endothelial function of the native vessels.
The theory behind the stent treatment is that, ED could be thought of as a sort of penile angina and could in fact be treated much the same way the heart is treated by DES.
But not all ED stems from the same causes. Sometimes there are confidence and psychological issues associated with the condition. In order to totally corner this market Medtronic is going to have to do some hefty research and really drill down to determine what the patient population would be. That’s going to bethe company's greatest challenge.