The Advanced Medical Technology Association (AdvaMed; Washington), the largest medical technology lobby group in the U.S., held its annual meeting last week in Washington DC. The meeting offered an excellent snapshot of all the exciting developments occurring in this critical sector of the healthcare field.
While the med-tech market has encountered some challenging headwinds over the past few years on the regulatory and reimbursement fronts as well as in the venture capital markets, there are signs that the sector is headed for a dramatic rebound. A report released at the meeting provided by EvaluateMedTech forecasts the industry approaching $455 billion in global sales in 2018.
Ian Strickland, a product manager at EvaluateMedTech and author of EY's report, said that the in vitro diagnostics market is expected to be the world’s largest med-tech segment in 2018, with sales of nearly $58 billion. "Within the industry, the leading segment of in vitro diagnostics continues to grow more strongly than the med-tech market as a whole, thanks
[caption id="attachment_2838" align="alignleft" width="150"] Medical Device Daily is Blues Brother-approved[/caption]
to advances in molecular diagnostics and drugs becoming increasingly linked to diagnostic tests," Strickland said.
Another report released at the meeting by Ernst & Young noted some key ways in which the med-tech industry is expanding its offerings.
Companies are offering services and solutions to improve outcomes and drive costs down. The report also noted the increasing use of prevention and remote monitoring to improve outcomes more efficiently through real-time management of health conditions. Additionally, med-tech companies are increasingly enabling patients to manage their conditions at home without frequent, costly interventions.
It was apparent in listening to the many panel sessions at the meeting that companies that can find a way to successfully transform themselves into effective providers of value-based medical technology in the U.S.and in international markets have the potential to thrive in a dramatically changing healthcare environment that is rapidly leaving behind the traditional fee-for-service model.
Glen Giovannetti, Global Life Sciences sector leader for EY, told me that 80% of healthcare costs are people with the top five of chronic diseases. "There’s a real patient management challenge at that level. And so you begin to think about opportunities to help hospital systems more efficiently manage this. It could be an intervention, it could be a device but it could also be about the patient’s journey and how we help them. Let’s talk about when they might need a health intervention before they show up in the emergency room."
I also learned that not only is my smartphone fun to play with, but it can also save my life. One session that I attended at the meeting noted that there are more than 97,000 healthcare-related applications available for these phones, and that healthcare organizations are trying to help their customers determine which of these products are effective in helping to save time and money. In the presentation, Manasai Patwardhan, a consultant at PA Consulting Group, noted that nearly 500 million smartphone users will have healthcare apps by 2015.
There were quite a few celebrity sightings at the meeting including U.S. senators Orin Hatch (R-Utah) and Amy Klobuchar (D-Minnesota). Additionally, Marilyn Tavenner, adminstrator for the Centers for Medicare and Medicaid Services and Margaret Hamburg, MD, commissioner of the FDA, made presentations. Morning Joe co-hosts Joe Scarborough and Mika Brzezinski brought there unique brand of commentary to the meeting as well.
We too had a special celebrity sighting at our booth, with the Blues Brothers stopping by to admire our awesome array of products and to promote next year's AdvaMed event that will take place in Chicago.
On a more personal note, AdvaMed was the first conference that Medical Device Daily has covered since our acquisition by Thomson Reuters, and we really enjoyed playing up the benefits of our new ownership to current and potential customers at the meeting, Who knows, maybe we can get Elwood and Jake to promote new product roll-outs in the future.
[caption id="attachment_2829" align="alignleft" width="150"] A patient receives a chiropractic thoracic adjustment[/caption]
Until recently I, like most people, was under the misconception that chiropractic care was for people who have been involved in an accident or suffer from chronic neck or back pain. And, like most people, I never considered going to a chiropractor until I had a reason to.
I first went to see Dr. Dean Jacks at Chiropractic Associates in Niceville, Florida, in July when I began having pain in my neck and upper back. Having never been to a chiropractor before, I really wasn’t sure what to expect. I thought I’d have a few adjustments and the pain would go away and that’d be that. Little did I know I would end up committing to three adjustments a week, therapeutic exercises twice a day, and lifestyle changes to improve my overall health, far beyond the pain that prompted that first visit.
I also had no idea that within two months not only would the pain be gone but I would no longer be suffering from three or more headaches a week, or that I would see noticeable improvements in my chronic digestive problems. It really made sense once I stopped to think about it. Our brain communicates to the rest of the body through the nervous system sending messages through the spinal column to vital organs. So naturally spine health should be closely related to a person’s overall health.
But I didn’t want to invest in a long-term chiropractic care plan without committing to the lifestyle changes necessary to realize the full benefit, and to reach my true health potential.
The biggest change I’ve made since starting chiropractic care has been a drastic increase in physical activity. I went from getting hardly any exercise at all to practicing Taekwondo three to four times a week. That alone has made an incredible impact on my health.
I’m also making dietary changes that Jacks has recommended and becoming more particular about what goes into my body. I’m watching my sugar intake, eating more protein and fiber, and avoiding partially hydrogenated oils and fried foods. I still have a lot to learn in the way making smarter food and supplement choices, but I feel like I’m on the right track.
I know there is a lot of controversy surrounding chiropractic care and I too was skeptical of the philosophy behind chiropractic methods. But if it hasn't done anything else for me, going to Jacks has at least given me the incentive I needed to make positive lifestyle changes and I've received a type of personal care and attention from him that is very rare in the current healthcare environment.
That pain in my neck a couple months back might have been the best thing that ever happened to my health.
The playwright George Bernard Shaw is credited with having said, “the single biggest problem in communication is the illusion that it has taken place,” a remark device makers might apply to their interactions with FDA and the Centers for Medicare & Medicaid Services.
Those two agencies might have similar observations about device makers, too.
Still, we’ve all discovered it’s not always easy to communicate clearly, especially when complex matters are at hand. So let’s dig into the story behind a recent development at FDA and a long-standing communication hurdle between CMS and device makers.
FDA recently issued a draft standard operating procedure for its communiqués with device makers regarding how recent evidence might affect the agency’s expectations of device applications. The draft SOP is interesting in two ways.
One of these is that it is a re-draft of a 2011 version that described two types of communications, the notice-to-industry (NTI) letter and the immediately-in-effect (IIE) letter.
The NTI letter – which would have functioned to communicate an emerging consideration rather than an immediate change – does not appear in this latest draft. To make matters more interesting, the agency does not explain the omission. Will FDA take up the NTI letter in a separate draft SOP? It’s not clear.
What we do know, however, is that FDA will use the IIE letter to let industry know when the existing standards for safety and/or efficacy for a device/indication simply don’t cut it. Industry would have 60 days to argue, but the terms of the IIE letter would go into force 90 days after the comment period closes.
The second reason this new draft SOP is interesting is that the often-contentious relationship between industry and agency makes one wonder why FDA opted to let the NTI letter slide, especially since it’s a vehicle for giving device makers the heads-up when such changes might be in the offing.
As matters stand, the net effect is that FDA has restricted its options to an 11th-hour approach to informing device makers that the regulatory standards for device applications have changed – to the complete exclusion of something more proactive.
Defining your terms; substantial clinical improvement
The new technology add-on payment mechanism has been in play at CMS for nearly a decade, and device makers generally like the program because it gives them a reason to innovate, including when that innovation carries a higher price tag than the current standard of care. The benefit for patients is that they have access to devices that do the job a lot better than that standard of care. One of the things a device maker has to demonstrate to qualify for a new tech add-on payment is that the offering renders “substantial clinical improvement” over the current suite of offerings.
Device makers will say this term of art is sufficiently fuzzy that it’s tough to plan trials around it. So a device maker might ask why there’s no standard metric for “substantial clinical improvement.”
We might assume there are a couple of obvious reasons for this. One is that poorly met needs will always draw more leniency from both FDA and CMS. The same goes for patients in dire straits.
Another problem is that it’s no mean feat to come up with a rubric that works across device types and across disease states. There’s also this question of a “level playing field.” By that I mean device makers might react badly if CMS told industry that one device type has to offer a 15% reduction in morbidity (to pick a number out of thin air), then propose an entirely different standard for another device type.
Like it or not, CMS and industry are stuck with the task of making up the meaning of “substantial clinical improvement” as they go along. It’s ugly and messy, but it’s probably the least obnoxious of their options.
A routine physical turned out to be a nightmare for me last year when it was discovered that my white blood cell count was significantly low. It was also the catalyst behind my drive to make sure that any physician I go to now can get overnight if not instant results from a lab once my sample is being tested.
At the time, I was just getting over a severe cold that I had received from my now 2-year-old daughter - which was the ultimate culprit of the white blood cell shortage. However, at the time, when I questioned the nurse (who politely told me that I needed to come back in for more tests) about the potential cause of the shortage.
The first words out of her mouth were, "Have you ever been exposed to HIV?" I can tell you that at the time I heard that my heart stopped and I was an emotional wreck. Thousands of questions ran through my head - mostly . . . how could this even be a possibility? I was told that I needed to be tested to rule it out.
A few days passed and I went to the physician's office for my test. I inquired about what type of test I was actually taking and the person drawing my blood politely told me that she was testing for AIDS. I dejectedly went back home to anxiously await the dreaded call from the lab.
For nearly two days I was on pins and needles waiting for the results to come back. Then while I was at work, I received a phone call. "Your test is clear Mr. Ford. Your results came back negative." That's all.
I said thank you and quickly hung up. For a week I had been on an emotional roller coaster. Waiting for the test results to come back over the weekend was also extremely stressful. Physicians ought to push for more point of care diagnostics. There ought to be a stronger focus on getting patients test results to remove this anxiety.
[caption id="attachment_2748" align="alignleft" width="300"]Mid-20th Century Europe meets Asia; no med tech arms race yet [/caption]
Developments in the world of medical devices vary by region, but a few recent stories from the pages of Medical Device Daily give a good sense of just how turbulent the global market is. MDD has beefed up its OUS coverage of late, providing a lot of detail on some vital markets, including Asia and Europe.
For instance, a story from last month by our correspondent Kristine Yang states that the China Food and Drug Administration (CFDA) released a new set of regulations in July that could boost costs for homegrown device makers, which may benefit those that export to China, a reversal of the usual pattern whereby local device firms have a pronounced edge where Beijing's policy-making is concerned.
Yang noted that the market in China is expected to grow from $14 billion in 2009 to $38 billion in two years, adding that imported devices are “often seen as offering better quality.” The reputation for devices shipped to China now seems poised to benefit (in the short run at least) by an effort to “to update outdated rules, raise the quality of domestic manufacturing and better protect patients,” Yang wrote.
However, other nations need not be complacent. Yang’s article states that two official policy papers have emerged that discuss the need “for the government to provide more support for research and industrialization of implant devices.”
The following day, Yang filed another story for MDD describing a period of consolidation of device distributors, a trend she said “lags a similar process in the pharmaceutical industry and is well behind a similar consolidation in the U.S. or Europe.”
Yang points out that the largest multinational device maker in China is Johnson & Johnson (New Brusnwick, New Jersey), which has a quarter of the market, about four times the share enjoyed by GE Healthcare (Chalfont, UK).
However, once again Beijing is getting involved, drafting a five-year plan intended to create “up to 10 medical device groups with annual sales of $800 million,” Yang’s article states. Running parallel to this is a trend for larger Chinese device makers to set up their own distribution arms. The market in this nation is clearly going to be more competitive in the intermediate run, even if Western nations will enjoy robust trade in the near term due to quality considerations.
And for those of a patent frame of mind, John Brosky wrote in the Aug. 28 edition of Medical Device Daily that Edwards Lifesciences (Irvine, California) has posted the bond needed to enjoin sales of Medtronic’s (Minneapolis) CoreValve device in Germany.
The two companies have been in a legal tussle in several jurisdictions over whether the CoreValve infringes on the design of the Sapien, Edwards’ blockbuster entry into the catheter-based aortic valve market. Edwards informed Brosky that the ruling “not only prohibits the sale of the CoreValve systems, but further ordered a recall of these products.”
This is a big development because not only does Germany pay generously for cardiology devices compared to most other EU jurisdictions, but also because “Germany is Europe’s largest market with 90 implanting centers, accounting for 26% of the total in 2011,” Brosky reported.
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