She was probably a little more than 5-feet-tall... and close to 160 pounds of pure muscle. On a day unlike any other, I crossed the path of this 60-year-old woman (though she doesn't look a day over 40) who is an avid bodybuilder, at the gym I often work out in.
We were both headed to a piece of equipment to do pull-ups - I was by myself, she was with a cadre of women that she was training. As I was about to get on the machine she cut me off rather quickly and hopped on it before I got the chance.
"Hey," I told her. "I was just going to get on that."
She gave a quick glance back toward me and rolled her eyes. She then proceeded to do about 50 pulls ups before stepping away from the machine.
No doubt physical fitness is a main priority for her as it is for a great deal of enthusiasts at the gym, but are they focused on their mental fitness or their brain health? Shortly after I had my encounter with her, I had the chance to talk to a company called SharpBrains, a firm that serves as an advocate for brain health.
It was amazing to me that in my discussion with SharpBrains CEO Alvaro Fernandez, that there is a cultural shift regarding neurological diseases and that many companies are developing programs and techniques to prevent these diseases from setting in.
The market for this concept is rapidly growing – expected to jump from the current level of $1 billion to about $6 billion in 2020 – according to the SharpBrains newly released study, the Digital Brain Health Market 2012-2020.
The 211-page market report tracks developments at more than fifty public and private companies offering fully automated applications designed to assess, monitor and/or enhance cognition and brain functioning, and provides industry data, insights and analysis to help executives, entrepreneurs, technology/health innovators and policy makers navigate the opportunities and risks of the rapidly growing Digital Brain Health field.
In summary, he said that patients are going to be doing more and more to preserve their brain health alongside their physical health. So the next time I see my 60-year-old workout nemesis, it might be worth a mention to her to look into what the company is doing - that is if I can muster up the courage to look her in the eye after our last encounter.
Earlier this week, I had the privilege of attending the Southeastern Medical Device Association's (SEMDA) annual conference. It was a tremendous opportunity to meet the players in the med-tech space that are located close to the office where Medical Device Daily is published.
I would have to say that this conference did not disappoint. The presentations were lively; the speakers were great and the topics were very relevant to the med-tech industry. Perhaps one of my most favorite speakers was Jon Ellenthal, a partner and President of TEDMED, a company focused on innovation and breakthrough thinking across all of health and medicine.
Ellenthal's speech was my favorite - not simply for the humor - but because he approached the problem of healthcare with new eyes. He looked at the issue as if he was an outsider and it put a whole new perspective on the industry and the practice of healthcare in this country.
The two day conference provided just enough information to not feel crowded. Going forward I wonder if it will expand to an extra day. It should be pointed out that in years past the event was only a day and a half. Perhaps that's a query I should be sending to the organizers of the conference.
I will say this, if you're a med-tech company out there in the southeast and you're not attending this conference - you're missing a great wealth of information.
ATLANTA - With a substantially strong turnout the Southeastern Medical Device Association (SEMDA) kicked off its 2013 conference earlier today. Hosted at the Georgia Institute of Technology Global Learning Center, the organization's annual conference featured speakers ranging from Medical Device Manufacturers Association President/CEO Mark Leahey to Jeff Shuren, MD, director of the Center for Devices and Radiological Health (even though he was speaking from an offsite location).
SEMDA seemed to have its finger on the pulse of med-tech firms' concerns even more so than last year. As in past years the themes seemed to center around dealing with strained funding and going through intense regulatory procedures, but this year's conference was a bit different and offered speakers seemed to echo to attendees that there was hope for the industry.
One example of this came from Leahey, who urged device makers to get out stories on their successes and urged device makers to encourage patients who benefited from med-tech innovation to speak out about the technology. He said that the med-tech industry has a compelling story and that story needs to get out. He also said that he was confident that progress was being made in repealing the medical device tax.
Not to be outdone, FDA's Shuren gave positive news and presented data showing that after a decade of lagging services when it comes to approving devices, there seems to be a slight uptick in FDA getting devices out of the door.
While the med-tech industry has gone through changes and faces challenges, it was refreshing to see presenters focus on the bright spots in the industry.
A clumsy attempt to address the Medicare Part B physician fee problem has nagged at Washington for a decade, but it appears Congress is ready to put a doc fix in play. Whether it’ll happen depends on politics and, as a skeptic might argue, some accounting sleight-of-hand, but it appears this is a now-or-never moment.
As has been widely noted, the Congressional Budget Office recently released a report proposing a lower figure for the budgetary effects of a repeal of the sustainable growth rate (SGR) mechanism than has been calculated for some time.
Instead of the average figure of $30 billion a year that had been floated a few years ago, CBO claims the figure now stands at roughly $14 billion a year over 10 years. A recent hearing in the House Energy and Commerce Committee makes clear the bipartisan support for a repeal of SGR is as intense as it has ever been, and one has to assume a bill will at least make it through committee.
Among the potential flashpoints in the House is the question of offsets. Rep. Frank Pallone of New Jersey resurrected the idea of using cuts to military spending in Iraq and Afghanistan as an offset, but we should acknowledge that the pay-for question might come across as background noise. Congress may simply resort to the path of least resistance.
Two sources of fudged numbers
There are a couple of points to consider. One is that the current low rate of growth in Medicare expenditures is an anomaly and will vanish as the economy recovers, which means the historical cost growth of 5-6% will resume. This tells us the fiscal claims underlying the current push rely heavily on a bookkeeping convenience, but that’s how accounting is routinely (ab)used.
The second point is that as physicians increasingly become tied to hospitals under accountable care organizations, some spending that has been treated as a Part B expense will fall into Part A, the Medicare hospital silo. This, too, suggests that any easing of physician fee spending could be more apparent than real. It also means Part A is almost certain to balloon and become the new problem child on Capitol Hill.
Perhaps most interesting for physician specialists – beyond the recent Part B fee schedule that shifts resources to primary care at the cost of specialty care – is the rumor that an SGR repeal bill will call for permanent zero updates to the Medicare physician fee schedule (MPFS) within two or three years of that bill’s passage. The message there is clear to specialists and primary care docs alike: Get on board with ACOs or get out of Medicare altogether, because you’d starve under Part B fee-for-service.
So what does it mean if this happens? Basically it’s one item off a hefty to-do list where Medicare spending is concerned. Getting rid of the loathed SGR will remove a perennial headache for both sides of the political aisle and will once again “prove” that Congress can act in a bipartisan fashion, but repealing SGR will do pretty close to nothing to “bend the cost curve.” Not by itself, anyway.
Ask anyone in the med-tech field, or any other manufacturing field for that matter, where the largest majority of emerging markets for their businesses reside and chances are they will say somewhere in Asia, with China being the first country to likely cross their lips.
With more than 600 billion people and a combined GDP of $2.3 trillion, the ten nations that make up the Association of Southeast Asian Nations (ASEAN) are already experiencing dramatic economic growth. This is especially true of the medical device market, which in 2012 was worth more than $4 billion. Roughly 65% of the $4 billion comes from Asia’s new tigers: Malaysia, Indonesia and Thailand.
And then there is China, with a $9 billion medical device market i. It is now the sixth largest medical device market in the world, and analysts estimate it will grow between 15%-20% annually over the next five years.
The country is home to nearly one-fifth of the world’s population. With 1.3 billion people and a burgeoning middle class, China has witnessed an unprecedented rise in healthcare consumption. More citizens are spending more money on healthcare, including sophisticated medical devices.
Numbers like the ones above are impossible to ignore for any company that fancies itself to be an international player. With that in mind, Medical Device Daily has joined forces with Pacific Bridge Medical, a well respected consulting firm that helps companies doing business in the medical market, to bring our readers more timely and informative news about this critical area of the world.
The inaugural story provided a comprehensive overview of the Chinese market. Pacific Bridge Medical president and founder Ames Gross outlined the opportunities in China, noting the need for larger international medical companies to have a direct manufacturing presence in China. He also said that Chinese made products have improved greatly in quality and are starting to give Western made devices some stiff competition that will only increase in the next decade. Gross said that to compete with these Chinese companies, international companies will need to offer basic, low-cost versions of their A-line products. To do this, some of them have set up their own China-based manufacturing facilities. Others have acquired Chinese companies with broad product portfolios and decent market shares.
Look for a story in tomorrow's edition of Medical Device Daily on the aforementioned new tigers of Asia.
[caption id="" align="alignnone" width="500"] His ideas aren't the only ones that are all wet[/caption]
It has been said there are shortages in this world, but there has never been a shortage of bad ideas. In fact, the opposite seems to be true. Here are three really crummy ideas we should all hope end up thoroughly debunked.
FDA does comparative effectiveness research
We’ve tackled this idea before, but unlike fine red wine, this one isn’t improving with age. The Institute of Medicine released a report recently stating that FDA should “have a more rigorous approval process for new technologies,” arguing that med tech firms “tend not to do comparative-effectiveness studies and, compared to the pharmaceutical industry, invest much less in research and development.”
Aside from the enormous difference in market capitalization between the largest drug makers and the largest device makers, the comment blithely ignores the huge difference in the per-patient cost for device trials and drug trials, the latter of which often require the doctor do nothing more than give the patient a pill. Beyond that, a CE trial for devices would have to be much larger and more expensive, and hence most would never see the light of day.
But let’s not forget this is the same IOM that recommended FDA scrap the 510(k) program and replace it with … well, with who knows what? They never said. They did say, however, that the replacement might employ the notion of a predicate device, which was just brilliant! And let’s not forget that Bill Vodra, one of the boy wonders of the IOM report on 510(k)s, said at a conference that the 510(k) program would have cleared a jumbo jet with a camel as the predicate.
What this says about FDA is unclear, but one thing all this makes clear is that anyone with enough time and money on their hands can get a JD or a PhD and sit on a blue-ribbon IOM panel. I’d rather have a blue-plate special, thanks very much.
Blame the environment for breast cancer
Well, the U.S. government is again bent on destroying cancer by any (absurd) means available, including by spending money on hypotheses such as that breast cancer is caused in significant part by the environment.
Anyone familiar with the term “endocrine disruptor” knows what I mean. There has been an ongoing ruckus over these chemical compounds, a list that includes bisphenol A (BPA). All I can say about BPA is that if you ingest enough of anything, it’ll make you sick. The data behind BPA and other endocrine disruptors has been largely inconclusive at best. But let’s not let that trouble us. Heck, it’s only tax money!
By the way, have you or a loved one been diagnosed with a brain tumor you can blame on your cell phone? Just call 1-800-AmbulanceChaser for a free consultation.
Assume healthcare reform will fix the Medicare cost issue
This is one of those “I have a hunch” observations based on our collective past experience as much as anything else. The problem with this assumption is that similar past assumptions have almost always proven false. For instance, Medicare was projected in 1965 to incur a cost of between $12 billion and $15 billion per year by 1990. The number came in at about ten times that.
At some point, healthcare overhaul might “bend the cost curve” to sustainable levels, but this outcome is a lot more likely to require help from other quarters, such as tort reform, allowing people to go on Social Security without going on Medicare, and means-tested eligibility.
Most people will say none of these ideas is particularly obnoxious, but you’d be surprised at how they’re greeted in some quarters. Still, I predict means testing will be applied to both Medicare and Social Security at some point. It won’t fix either, but I can’t see how either can be fixed without it.
In October of last year, Medtronic made headlines when it reported that it was going to acquire Changzhou holdings, a China-based company that is a provider of orthopedic devices, for $816 million.
Now the acquisition, in my opinion was perhaps the loudest shot fired in the battle to maintain a dominant presence in China one of the fastest growing emerging markets.
Last month, Stryker responded in kind with its plan to acquire Trauson Holdings, a China-based firm that specializes in products for the spine for $764 million.
After listening to a webinar from Millinneum Research Group, about the Top 10 trends to watch out for in med-tech, the shift in focus to emerging economies came in at number two on the list. But the interesting thing is, the topic of acquisitions into China was also a part of the seventh trend to watch out for, which was Merger & Acquisition Activity Increasing.
In a sense one could argue that the topic was big enough to take up nearly two slots on the trend list. But what this really signifies is that the shift in thinking for firms is starting to become action.
Companies are eager to dip into new markets and in 2013 and I think we're going to see an explosion of firms investing in emerging markets, especially China.
The rules, however, are going to change, and it's not going to be business as usual when vying for regulatory approval. There are going to be cultural differences, and a different approach on securing clearance for a product to get to market.
It's going to be a far different ride, but this presents a new frontier for med-tech companies to explore.
[caption id="attachment_2137" align="alignleft" width="300"] Who said January's a dull month?[/caption]
The new year is underway and a few things of interest to med tech firms have already cropped up. Here are three of the more interesting developments in the world of medical devices (and it’s only for the month of January).
Duval files petition to stay substantial equivalence guidance
I’ve never filed a citizen’s petition, but something tells me it entails more work than making a cup of coffee, so I’ll assume that regulatory consultant Mark Duval thought he was on to something in filing a petition to have FDA stay its 2011 guidance on substantial equivalence.
Duval indicated that stage-gated reviews of 510(k) applications have morphed into a mechanism for forcing applicants into the de novo route, but Duval also told me that while managers at CDRH seem to have struck a more realistic tone in their approach to the device clearance process, many of the staff at the Office of Device Evaluation are acting as though they didn’t get the flyer.
Duval explained that stage-gated reviews have turned into an excuse for administratively determining a device not substantially equivalent, a determination that is supposed to be made only upon a review of the merits of the application.
One presumes there will always be at least some conflict between regulator and regulated, but it appears the conflict has ebbed only mildly since the change in administration at CDRH in 2009. We’ll see how this develops going forward.
OIG signs off on single-vendor agreement
Device makers are not always fond of group purchasing organizations (GPOs), but agreements between doctors and hospitals that restrict the range of devices available in the cath lab are not eyed benignly by industry, either. Still, the decision by the Office of Inspector General to step aside and allow a group of interventional cardiologists to sign just such an agreement with a hospital does not seem to have provoked much response from device makers, at least none that is audible.
As described in the Jan. 10 edition of Medical Device Daily, the cath lab in question would be stocked with drug-eluting stents provided via only a single vendor, which probably means a GPO has just shouldered aside at least one new entrant to the DES market. Less surprising is that the cardiologists have agreed to implement “certain measures to reduce costs attributable to lab procedures,” which purportedly accounts for 60% of the pay-for-performance compensation program in the agreement.
With all the emphasis on cost containment, however, this may a blueprint for how things are done going forward. Have device makers concluded this is no longer a fight worth fighting?
Stage 3 meaningful use: Providers cry Uncle
Both doctors and hospitals pleaded with the Centers for Medicare & Medicaid Services not to jam more meaningful use standards down their throats until the meaning of stage 2 meaningful use standards emerges.
A representative of the Federation of American Hospitals told me that not only have providers not had time to fully digest the utility of stage 2 meaningful use, they’re also feeling the camel’s back sag under the aggregation of quality initiatives coming out of CMS for the past decade or so. Quality might usually trump quantity, but it appears that a certain quantity of quality … oh, nevermind.
Suffice it to say that stage 3 meaningful use is not going to come into force this year.
Looking forward, it does not appear that the Supreme Court has scheduled the hearing of the Myriad gene patenting case. One assumes they’ll hear arguments this term, but as of now, the Court has published its schedule to the end of March, and there’s no mention of Myriad.