February 11th marks the second anniversary for TSB. Contrary to some blogger's opinion our blog continues to pick up momentum. Last month we had 85,000 viewers and over 50,000 unique visitors. Our forecast for 2011 is over 1 million viewers and at least 650,000 unique visitors. A tremendous thank you must go out to everyone involved in being our eyes and our ears allowing us to keep an honest hand on the pulse of the industry. For those that criticize our honesty and truthiness freedom of speech is the greatest right provided under the U.S. Constitution. Unlike other platforms our objective was, is, and always will be to provide you with an open forum enabling your voices to be heard whether in dissent or affirmation.
What we have learned over the past two years is that we have provided our readers with a realistic analysis of the industry along with an honest expose of the personalities involved. As we move into a new year, our focus will be on the market, how healthcare will continue to shape industry policies and strategies, and how POD's continue to threaten every salespersons right to earn a living in this industry. Once again, thank you.
Thank God for that federal judge in Florida, a Ronald Reagan appointee I might add. Prediction: Obamacare goes down in flames after 5-4 vote in the Supreme Court! all together now, Hip Hip Hooray!
ReplyDeleteKudos to the Spineblogger. No one else has the balls to shine some light on the dark heart of our troubled industry. Don't let the bullshit threats from losers typing away in their mom's basement get you down.
ReplyDeleteBy the way, you should start to accept advertising. There are many companies who would like to reach your unique audience. If you play your cards right, you might even be able to quit your day job.
9:06 do you know anything about internet advertising? there are numerous statistics available that show you need 1million+ visitors/month to generate any meaningful revenue via advertising. this includes niche subject areas. idiot
ReplyDeleteI feel lots of love here today.....nope, sorry I take that back after reading 9:22.
ReplyDeleteGREAT JOB MM - keep it up even though I'm just one of a few and not many of a million.
9:22 - It's quality vs quantity ( I tell my wife that every night).
Dammit Men...Tough Crowd, but FUNNY
ReplyDeleteCongrats TSB. Love the forum- have for years now!
ReplyDeleteHappy Birthday TSB! I really enjoy the blog. Thanks for the forum.
ReplyDeleteI really enjoy reading what the TSB writes and do so everyday, but I sometimes disgusted by the lack of professionalism by the people who comment. If the posters weren't able to be anonymous, I'm not sure they would make some of the comments face to face or in front of their colleagues.
ReplyDeleteKeep up the goodwork. Glad to see that someone is carrying over to the 21st century the spirit of Upton Sinclair...
ReplyDelete10:36
ReplyDeleteTake the good with the bad idiot. Just kidding.
Many of the comments you find "professional" are made BECAUSE they're anonymous. You can still glean the truth if you pay close enough attention!
Happy reading and Happy anniversary TSB.
Even if you forced someone to register a name, what forces them to use a real one?
ReplyDeleteThe anonymous postings are fine. Take everything with a grain of salt.
We Americans live in a nation where the medical-care system is second to none in the world, unless you count maybe 25 or 30 little scuzzball countries like Scotland that we could vaporize in seconds if we felt like it.
ReplyDelete- Dave Barry
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ReplyDeleteCongratulations TSB, who ever you are, on your successful 2nd anniversary. The stories and insight into our industry make us all stop and think. Unfortunately some don't stop to think before they respond. I'm sure this blog spot takes time and effort to post. How many readers would contribute say $10 per year for the ability to review the entire post?
ReplyDeleteGreat reading and I enjoy the anonymous BS!
ReplyDelete-Nature Boy
Thanks TSB. Congrats on 2 years...would love to somehow fast forward 2 years and see what topics we'll be "bloggin bout"
ReplyDeleteI read the blog daily, mostly while in traffic to/from my hospitals. Been in the industry for 11 years, funny how many times I've asked a competitive rep if he/she has ever read thespineblogger---Many say yes, those that haven't, I've encouraged them to check it out.
At the very least, it's a nice wakeup call/lesson for the newbies to the spine industry that this job is no longer the mecca. And for us "old timers", it's a nice reminder of the good old days and from what I gather, if things do go south with my current employer, I can simply get a new name tag to wear in the OR in less than 3 months (only by going thru an executive recruiter tho)
Happy B-day TSB
Medical Device Makers Shun U.S.
ReplyDeleteBy ANDREW POLLACK
Late last year, Biosensors International, a medical device company, shut down its operation in Southern California, which had once housed 90 people, including the company’s top executives and researchers.
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Peter DaSilva for The New York Times
Marti Conger, a business consultant in Benicia, Calif., went to England in October 2009 to get an implant of a new artificial disk for her spine developed by Spinal Kinetics of Sunnyvale, Calif., a short distance from her home.
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The reason, executives say, was that it would take too long to get its new cardiac stent approved by the Food and Drug Administration.
“It’s available all over the world, including Mexico and Canada, but not in the United States,” said the chief executive, Jeffrey B. Jump, an American who runs the company from Switzerland. “We decided, let’s spend our money in China, Brazil, India, Europe.”
Medical device industry executives and investors are complaining vociferously these days that the industry’s competitive edge in the United States and overseas is being jeopardized by a heightened regulatory scrutiny.
The F.D.A., they and others say, appears to be reacting to criticism that its approvals for some products had been lax, leading to a spate of recalls of some unsafe medical devices, like implanted defibrillators and hip replacements.
Now, executives of device companies say the F.D.A. has gone too far in flexing its regulatory muscle, and they worry that a slower, tougher approval process in a weakened economy could chill investments and cripple innovation.
In addition, they say that American patients are being deprived of the latest technology because companies routinely seek approval for new devices in Europe first. For instance, heart valves that can be installed through a catheter instead of open-heart surgery have been available in Europe since 2007 but will not be available in the United States until late this year at the earliest.
“Ten years from now, we’ll all get on planes and fly somewhere to get treated,” said Jonathan MacQuitty, a Silicon Valley venture capitalist with Abingworth Management.
ReplyDeleteMarti Conger, a business consultant in Benicia, Calif., already has. She went to England in October 2009 to get an implant of a new artificial disk for her spine developed by Spinal Kinetics of Sunnyvale, Calif.
“Sunnyvale is 40 miles south of my house,” said Ms. Conger, who has become an advocate for faster device approvals in the United States. “I had to go to England to get my surgery.”
Stenum Spine Hospital in Germany has performed disk surgery on 1,000 Americans over the last eight years, said Jim Rider, the hospital’s American marketing agent.
Acknowledging industry concerns, the F.D.A. on Tuesday proposed creating an “innovation pathway” aimed at speeding regulatory reviews of a small number of groundbreaking devices. And last month the agency announced measures it said would make the regulatory process more predictable for the vast majority of devices.
“A consistent and predictable review process will stimulate investment here at home and keep jobs from going overseas,” Dr. Jeffery Shuren, the director of the agency’s medical device division, told reporters.
But Dr. Shuren did not say the F.D.A. would relax its standards, arguing that Europe’s system might be too lax. He said that a breast implant, a lung sealant and an implant for elbow fractures were approved in Europe but not in the United States, and then had to be taken off the market in Europe for safety reasons.
“We don’t use our people as guinea pigs in the U.S.,” he said
Medical device executives said they welcomed the steps, but continued to express concerns. Consumer advocates, like Dr. Sidney Wolfe of Public Citizen, however, said that device regulation was already much less stringent than for drugs and that the F.D.A. was caving in to industry demands rather than ensuring consumer safety.
Dr. Charles Rosen, a spine surgeon who is also president of the Association for Medical Ethics, said that the newest devices were not always best. He said he had at least 50 patients who had suffered serious problems from an older artificial disk. Many of those patients, he said, had gone to Europe to get them before they were available in the United States.
Just since November, three reports — two sponsored by device industry trade groups and one conducted by the consulting firm PricewaterhouseCoopers — have raised concerns about the F.D.A. approval process. One report found that the rate of recalls in Europe was similar to that in the United States, suggesting faster approvals overseas were not hurting patients.
ReplyDeleteThe complaints are driven in part by financial pressures. Venture capitalists, because of the financial crisis and their own poor returns, have less money and need quicker returns on their investments from the companies they back.
Bigger device companies also complain about the F.D.A., but not as much as struggling start-ups. “The F.D.A. is asking for larger trials, more thoughtful trials, all in the interest of the American public,” said Dr. Stephen N. Oesterle, senior vice president for medicine and technology at Medtronic.
To be sure, the United States remains the clear world leader in medical device innovation, according to the report by PricewaterhouseCoopers. Some 32 of the 46 medical technology companies with annual sales exceeding $1 billion are based in the United States, the report said.
Still, the report said the United States’ lead was slipping.
Device companies have been seeking early approval in Europe for years because it is easier. In Europe, a device must be shown to be safe, while in the United States it must also be shown to be effective in treating a disease or condition. And European approvals are handled by third parties, not a powerful central agency like the F.D.A.
But numerous device executives and venture capitalists said the F.D.A. has tightened regulatory oversight in the last couple of years. Not only does it take longer to get approval but it can take months or years to even begin a clinical trial necessary to gain approval.
Disc Dynamics made seven proposals over three years but could not get clearance from the F.D.A. to conduct a trial of its gel for spine surgery, said David Stassen, managing partner of Split Rock Partners, a venture firm that backed the company. “It got to the point where the company just ran out of cash,” Mr. Stassen said. Disc Dynamics was shut down last year after an investment of about $65 million.
Some companies and investors are even contemplating forgoing the American market completely.
“We never intend to spend a nickel in the United States for clinical trials,” said William Starling, who runs Synecor, a device company incubator in Raleigh, N.C., and who is a venture capitalist.
Mr. Starling is an investor in Spinal Kinetics, whose artificial disk was implanted in Ms. Conger in England.
ReplyDeleteThe company began working with both the F.D.A. and European regulators in early 2005. It won approval in Europe in 2007 after testing its device in 30 patients and spending $4 million. Since then, thousands of the disks have been implanted.
Only last May did it receive approval for a final trial for F.D.A. approval that would involve about 250 patients. But hard-pressed investors are not willing for now to put up the $50 million or so the trial would cost, Mr. Starling said.
In the meantime, Spinal Kinetics is moving its manufacturing to Germany and has already laid off 20 people in Silicon Valley. One reason for the move, Mr. Starling said, was that some countries in Asia and Latin America allowed use of devices that have been approved in the country in which they are made. So moving manufacturing out of the United States opens up those markets.
Totally forsaking the lucrative American market could be difficult. While approval in Europe is easier, health care systems there tend to spend less on medical devices. Some companies, however, are trying to generate some sales in Europe in an effort to be acquired by a bigger company, which could then afford to deal with the F.D.A.
Dr. Shuren of the F.D.A. said in an interview that there had been “no conscious effort” to make device approvals tougher. “We are dealing with increasingly more complex devices coming to market,” he said.
But numerous executives say agency reviewers seem to be more cautious as Congress and others criticize the agency for being too lenient. Critics cited two recent examples: the DePuy hip implant recalled last year and an instance in which top agency officials approved a knee repair implant, made by ReGen Biologics, over the strenuous objections of their scientific reviewers.
Pharmaceutical executives are also complaining about how tough the F.D.A. has become. But they are not forsaking the American market, in part because there is not a big disparity in the regulatory system for drugs between the United States and Europe.
Some figures bear out a toughening in devices. The F.D.A. last year granted 19 premarket approvals — the type of clearance required for the most highly regulated devices — down from 48 in 2000.
The average time required to win an approval through the less stringent 510(k) pathway, which is used for most devices, rose to 116 days in fiscal year 2008 from 97 days in fiscal year 2002. Agency figures show there have been increases in the proportion of applications rejected or withdrawn.
Investment by American venture capitalists in the medical device sector has fallen 36 percent since 2007 to $2.3 billion last year, according to the MoneyTree survey from PwC, the National Venture Capital Association and Thomson Reuters. That is steeper than the 27 percent drop for all venture capital investing.
Last year, total venture capital investing increased 19 percent while investment in medical devices fell 9 percent.
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If TSB took ads from spine companies he would have to change his name to Robyn Young. Let's keep TSB from the business relationship conflicts that Robyn has. Lord knows we don't want TSB doing an awards show for "the best products that pay for awards gala tables and ads on TSB".
ReplyDeleteCharge an annual subscription fee to get a log in and keep ripping people's asses. Those with torn butts will still pay you an annual subscription fee. Heck, I'd even expense it to my company as I can stay on top of what's really going on.
Congratulations Spine Blogger!!! I wish you all the best for 2011.
ReplyDeleteThank you Spine Blogger for a great 2 years...please keep it up!
ReplyDeleteKeep on rockin in the free world!!!!
ReplyDeleteCan you please explain how the pod model is set up and works?
ReplyDeleteCongrats TSB! @ years of the GOOD, the BAD, and the UGLY . . . I'll let everyone assign their own respective companies to each of the three categories!
ReplyDelete6:27 - i get a kick out of that comment everytime it appears in a blog comment . . . at least say congrats first . . . a little social lubrication if you will!
What a great way to celebrate your 2-year anniversary....go 6 days without any new posts worth reading! Nice!
ReplyDeleteTSB,
ReplyDeleteI am responsible for building a business by developing relationship, increasing revenue and increasing market share. In the end if you have done just that, your followers have increased and comments have also increased (unfortunately both good and bad). Congrats and I enjoy the site.
Joe Independent
No cake? WTF
ReplyDeleteYes, fight those PODs. Surgeons making money on both sides = Huge consumer fraud story, that no one is talking about. Let's get this looked at at a federal (FBI) and state (AG) level. Go spineblogger! Name names.
ReplyDeleteWouldn't pay to read TSB. Quite playing fantasy football 10 years ago and never looked back. Felt good not having to think about it every week. TSB I could easily do without too. Maybe not for the rest of you addicts.
ReplyDeleteI had a F5 fusion and they used LDR Cage. I had the surgery done in April 2010. I have had a CT that shows the fusion worked however, I am in more pain now then I was before the LDR Cage was put in. I wondering if there has been other complaints or other people who may have experienced similar pain with the device.
ReplyDelete10:57
ReplyDeleteHow ridiculous do you sound and silly at that why are you even on this site
@4:59 Feel for you, but don't get hung up on the cage. It's a tool, and you implying that the cage has anything to do with your pain is like saying the nail didn't go in straight because of the hammer. If you don't like what your doc is saying, see a different one. If they tell you the same thing, it's probably true. There are a whole slew of reasons for pain after a fusion, and much of it depends on what kind of pain you're having. Neck, arm, shoulder, back, leg, etc all have different reasons. And you don't have an F5 fusion, it's a two number combo (e.g. 4/5, 5/6) and it's either C, T, or L. Finally, assessing how solid a fusion is, especially with a cage, is difficult, and would be the first thing to verify. Aside from the CT scan, having your "flexion-extension" X-rays sent to Medical Metrics in Houston for analysis (and no, I don't work for them, or LDR for that matter) is one of the best ways to assess it.
ReplyDeleteGood luck.