Saturday, July 30, 2011

Regulatory Smackdown

On Wednesday, July 27th, 2011, the New York Times reported that allies of the medical device industry were waging an extraordinary campaign to discredit an upcoming report by one of the country's pre-eminent scientific groups that is examining possible new regulations on the industry.  As of this posting, the report was released on Friday by the Institute of Medicine (IOM). The report's recommendation is to "scrap" the current system, which elicited reactions from outright rejection by industry officials, to acceptance by patients groups and disbelief from federal regulators, who had commissioned the report.  The report was commissioned by everyone's best friend the Food and Drug Administration on the heels of recent recalls pertaining to metal-on-metal hips, pumps and defibrillators.

The Institute of Medicine is part of the National Academy of Sciences, a widely respected organization. The report goes on to say that it is not immediately clear as to what impact, if any, this report will have, or if it would be adopted.  Industry dissenters included Medtronic, Boston Scientific and Johnson & Johnson.  The mouthpiece for the industry, AdvaMed, immediately weighed in issuing a statement from Stephen J. Ubl, that "this would be a disservice to patients and the public health."  Patient groups and some doctors applauded the panels findings, urging to create a system that examined a device's benefits and harms before patients were exposed to it. On the other hand, FDA officials were caught off guard.

The study in question reviewed the 501(k) clearance process under which moderate risk products are approved by the FDA.  The study DID NOT examine devices that carry the highest risk to patients if they fail.  The study concluded that the 510(k) process lacks the legal basis to be a reliable pre-market screen of the safety and effectiveness of moderate risk devices.  The FDA's immediate response was that it believes that the 501(k) process should not be eliminated but is open to new proposals and approaches in its responsibility as the gatekeeper for device reviews.

As an unknown observer mentioned, "the first commandment of medicine is to protect the consumer from harm."  But what does this say about our value system?  The companies that immediately reacted to this study, have themselves been culpable of numerous recalls.   The Washington Legal Foundation, whose tag line is "Advocate for Freedom and Justice," had fired a preemptive salvo on June 28th, 2011  urging the FDA not to use any advice or recommendations provided by the IOM, claiming violation of the Federal Advisory Committee Act.  The brief was filed with pro bono assistance from Robert Klepinski, an attorney from Minneapolis, Minnesota. Mr. Klepinski is an attorney who counsels pharmaceutical, medical device and biotech companies on FDA policy, in addition to once working for Medtronic as a regulatory attorney.

With the recent controversy swirling around metal-on-metal hips like the DePuy ASR and ASR XL, and the Zimmer Durom Cup, could these scenarios be another example of profits taking precedence over science and technology?  Interestingly, some other industry websites even have links to law firms that are looking for patients interested in participating in class action lawsuits against some of these companies.  So the complex question must be asked of our readers, how does the industry find a balance between corporate sponsorship and science?  Regardless, the fact remains that without clinicians working with companies, and private investment, innovation and technological improvements cease.  And what happens to the patient if government regulations are bought and paid for by corporate interests?

The medical device court of public opinion is waning. The behavior of the insurance industry, a shell game at its best, and the recent public slaughtering of the device industry in the national press has made it evident that the integrity of the and medical device industry is under siege.  Whether our bloggers agree to disagree, the fact remains that those companies that are publicly traded have become slaves to their master, the Street.  What does it say about the medical community when there is such a dichotomy in principles?  Whom does one believe?  The unfortunate aspect of this debate is that there are companies that abide by the rules, and companies that know that the risks are outweighed by the potential profits.  It all comes down to a cost-benefit analysis.  Could it be cheaper to incur the fine or settle a legal claim than it is to properly evaluate the safety and efficacy of a new technology?  Let's be honest, we're all in this to make money, but we're also in this to make the best products that money can buy without compromising the patient's safety.  The current system is not sustainable.  As companies cry out for additional self-regulation, have we learned anything from the most recent crisis in the financial community?  The key to our survival is finding balance and reason in the regulatory oversight process, until then, thrive to survive.


  1. After reading many of the comments from the public on the NYTs article it was clear that the general NYTs reading public wanted to throw the baby out with the bath water not placing any value on the fact that medical innovation has improved the lives of millions of people over the last several decades. Developing a medical technology that actually improves lives is extremly challenging, can cost over $100 million in some cases and takes years of development. Device approvals should be streamlined and the approval process should be made easier, not harder. that being said, I do agree with rigorous post market surveilence so that the therapies that do not work out can be pulled from the market soon after approval. Venture capital from medical device development is already drying up due to the diificulty in getting a therapy FDA approved. If we make it even more difficult, we are basically saying as a society that we would rather not advance science for the improvement of mankind. Oh, but lets keep passing out medical marijana cards like candy; a highly carcinnogenic, mind altering substance that has not been FDA approved, or clinically proven to cure anything, but is now socially acceptable, but a company that is bold enought to try and develop a device to cure uncurable deseases such as heart failure, diabetes etc should be held to a standard that is unatainable; go figure. Without risk there will be no reward!

  2. Just another Obamacare over-reaction, I hope all you Libs out there are happy. Atlas Shrugged, read it!

  3. TSB your a spine guy making comments about a total joint company you know nothing about....? Come on man, keep your nose in your owe shame.

  4. 10:24 no offense, just finished reading the post, where are the comments about total joint companies? Duh?

  5. 10:39...the 5th paragraph...duh on you fool! Maybe thats why you dumb asses should stay in spine sales...cant even tell your head from your asses!

  6. Maybe you should log onto the websites of various law firms that are looking for patients that have had these products implanted, duh! No issues surrounding these products? You live in a vacuum?

  7. oh you arent walking around selling every product in your bag "off label". Give me a break. If you ahve been in the biz for over 5 years, your probalby have sold products off label and how many pat's are now sueing because of the Infuse over use and how many times have you allowed your surgeon to stuff Infuse into "your cage", knowing its off label if its not an LT cage?? So here's your suck on it!

  8. Why is the Lanx rep hanging out for every microdisc and lami trying to get the surgeon to implant an Aspen....pathetic on many fronts.

  9. The 510(k) process is over, and rightfully so. It makes no sense to continue to 'clear' new products based on a substantial equivalence argument that shows the 2011 product to be essentially the same as one in interstate commerce prior to May 28, 1976. If the product still is essentially the same as 35 years ago, it is not worth registering. We all know that industry has abused the system to the max, which is very understandable given the burden of the full IDE/PMA route. Change one word in the labeling, and hope FDA does not notice. Next time, change another word. Next time, omit one. File data that were generated with somebody else's product, which chemically is virtually identical. And so on, and so forth. The cumulative changes have led to products that have surprisingly little in common with their original predicate device.To frustrate industry further, FDA has been extremely inconsistent in how they apply their own rules. In addition, there is no transparency and very little logic to their demands.

    I agree with 7:18 that the whole process should be streamlined and made easier, not harder, and that more emphasis should be placed on post-marketing registries and studies. Almost every time FDA is criticized for letting something pass which it shouldn't have, the incidence of the event is such that most IDE studies would not have caught it.

    The registration process should also be linked to a greater degree with health economic outcomes. In today's market, registration alone does not cut it anymore.

  10. I can't wait to see Globus go BUST!!! What a horribly ran company and weak reps!

  11. The system practiced in the EU is arguably better than the US 510(k) system. It protects patients and enables innovation. Any regulatory move towards an EU-styled system would be hard, but that is because of the uncertainty created by the change. To our benefit, the product recall rate under the 510(k) program has been tiny but certainly not "zero". Also, 5:28 hit the nail on the head with health economics. We need to market products with patient and systemic benefits. Reduce net costs by reducing complications or reoperations or increase outcome durability, etc. If FDA moves to a system with "everything needs clinical evidence to get approval", that will be a dark day for patients and innovation.

  12. 5:48

    Speaking of Globus,, Any idea when this dog might go public?

    Oh, wait, lawsuit, lawsuit, lawsuit.

  13. 510k's aren't going any where. There will be stiffer regulations on reporting and self monitoring once product are 510k cleared - it will have zero impact on all my PODs - Blue Horseshoe loves POD!

  14. Quite the public backlash but not surprising. The public is clueless in regard to their choices. Poor or no education from the hospital or docs for the most part as they have patient contact. With the public outcry they would be happy to have one style of hip and nothing more. Scary thought but it can apply to all devices.

    An interesting comment made in the article was in-regard to the handling during surgery and how the hip was implanted. Seemed everyone glossed over that. At some point we need to come to a realization that often the doc is the weak point. Maybe its not the industry that needs to come to that. The devices must be designed with more robustness to handle the errors and still be able to function.

    Was the company and FDA remiss thinking that just because it was tested the same way that it showed equivalency? I believe so, a key component was changed and the risk analysis glossed over it.

  15. I sense that someone on this blog is getting their Ass handed to them by Globus HaHa.

    It's OK.
    You will leave the business soon like all of the rest.

  16. the only thing that I can use for my ass is some Globus ass paper. That company could ruin a good wet dream. I think its Globus that is going to have their ass handed to them AGAIN, by this lawsuit, again. How many times does the same company need to sue you before you will get it?? Try coming up with your own IP. My surgeons here won’t even touch that shit more less look at it. Heard Globus was pulling their anterior peek innerbody due to failures and screws breaking

  17. What are the top 3 pedicle screw systems you'd want in your back if you needed a 1-2 level fusion.

    What tlif cage at 5/1?

    And what surgeon would you go to if you lived in the:




    consented for: 2 level fusion, tlif @ 5/1, 38 year old non smoker, 215 lbs. Given the option to have MIS or Open...

    Who would you let touch you
    Which screw/company would you want in you
    What TLIF cage
    BMP or crest or flavor of the month biologic (PRP)
    MIS or OPEN


  18. "Anonymous said...
    the only thing that I can use for my ass is some Globus ass paper.
    (that's what I use to wipe up reps like you)

    That company could ruin a good wet dream.
    ( Yes and we will ruin yours)

    I think its Globus that is going to have their ass handed to them AGAIN, by this lawsuit, again.
    (really? When did Globus ever loose a significant lawsuit that made a difference ?)

    How many times does the same company need to sue you before you will get it??
    ( Mr. Mrs. Newbie, lawsuits in this biz are a part of doing business).

    Try coming up with your own IP.
    ( the IP gabage again. Lmfao.)

    My surgeons here won’t even touch that shit more less look at it.
    ( that's because I'm not in your geography DickWeed)

    Heard Globus was pulling their anterior peek innerbody due to failures and screws breaking
    ( OMG ! Screws breaking ? Anyone ever heard of a screw breaking or a story about breakage of a competitive system? You must have less then 1 year in the spine biz. )

    You are a Trip.
    Please respond.
    I find great humor in your words.

  19. Can we go back to the subject at hand? The regulatory environment is just one more big threat to the medical industry as a whole.

  20. The more FDA raises the bar the better. Anything that helps keep out the fly-by-night "companies" with a PO box and a crappy screw is welcome.

    Unfortunately, there are already so many of these crooks (especially in the lone star state) that it may be too late.

  21. Thought provoking idea to think everything is already there and the government can't figure it out.

    Healthcare Economics? How about dual approval. Pointing out the obvious - Why would the government clear something it wont pay for, because CMS doesn't believe in the safety/efficacy of the product?

    Evidenced based medicine? Uh... MedSun anyone??? The infrastructure exists, hospitals already use it, just expand the qualifiers and there's your registry. Double blind the patient qualifiers to encourage participation, and we might have caught Infuse/ASRXL far sooner.

  22. There are no crappy screws anymore, and there would not be so many fly by night companies and crooks if the pricing of screws wouldn't be so high. The margins on screws exceed those on cocaine.

  23. 10:26 I like your questions but they are not as simple to answer as you think. My question is why are you consenting to a TLIF at 5/1 if you are 38, non smoker? Why not an ALIF?

    I have a 360 done on me about 7 years ago here in California. I was 33 years old at the time had a very progressivly bad spondy at 5/1. Being that I was in shape, non smoker and very motivated to heal and get back on my feet to work we decided to go with an ALIF with cages and BMP and sextant in the back. AND NO I am not a MSD rep. At that time, this was the best option out there. If your surgeon can preform an decent MIS, why not go that route? Again, this depends on so many factors, like how much of a decompression you will need to have, if any. Sometimes the ALIF itself can provide either direct or indirect decompression, something you wont see to often with the TLIF.
    The biggest factor here is how motivated are you to get well and get back on your feet? I will tell you, it hurts like HELL and if you are a rep, like me, you gain a different respect for those patients you see laying on the table.
    Wish you luck.

  24. @8:36am

    You don't need 15 sets of instruments, at a cost of $50k-100k each, to snort a line of cocaine. That is the difference. You sound like one of the idiots that run around bad-mouthing Nike for selling a pair of shoes for $110 "when we all know it only costs them $5.00 to make". Are you really that naive?

  25. 10:26 - assuming you are a legit patient,

    You dont choose a surgeon based on which implant they use. You choose a surgeon that's good. And if you dont know someone that has an intimate knowledge of the spine surgeons in your area, then you just dont know if they are good or not. I cringe when i hear people say, "he is supposed to be the best", well, guess what? He isnt, he is a butcher.

    If you could break it down to where exactly you are, or at least the state, then someone here can probably point you in the right direction. Ive steered people away from my own customers before...

  26. "Blue Horseshoe loves POD!"

    You have it wrong. Its "Blue Whore's Shoe" not "Blue Horseshoe"... a lot of people never got the joke.

  27. 10:46, if your costs for instrument sets are that high, you have already built in quite some margin or buy them at Tiffany's. And do you think building a submarine to smuggle the s... is cheap?

  28. Heard there's a lot of unhappy sales people at Nuvasive; What gives? Great products, solid comp plan, Anyone know why there seems to be so much unrest?

  29. 7:13, cause management on all levels sucks. Every rep I hear from has or is ready to jump ship cause management from the local levels is horrible, especially in the Cali areas.

  30. 7:21, speaking of the California market. Do you know what has happend to the local Zimmer Spine rep from Northern California?? Or does anyone else out there know where this rep landed??

  31. 7:21

    Just curious, when you say local level, are you referring to the Area Business Manager position or higher up? Isn't CA mostly distributors for NUVA?

  32. I work for Nuvasive and strongly disagree with your comments about management. I have been a spine rep for 7 years, 3 of them with Nuvasive. The comp plan is solid, the training is fantastic, and we have such unlimited access to cadaver labs/surgeon training/etc. If reps are unhappy it could be that they aren't hitting their numbers. Our quotas aren't for the weak of heart.

  33. The new nuvasive ABM in my territory has nasty slicked-back hair like a used car salesman from the 1950's. Supposedly the guy was in marketing his entire career up until a few months ago and it shows. The surgeons I work with think he's a joke.

    Hook 'em!

  34. 7:57

    Funny. I think I know the guy you're talking about. Wasn't he a product manager or something just before joinning the field as a "manager"?

    I hear that many of the "ABMs" have little to no management experience, same w/ their Sales Directors?

  35. A lot of MBA's in NuVa...Master of Bugger All.

  36. 10:26 --- Unless you're an insider (in the actual surgeries) you'll never know who is among the best in your area. Don't ask us 'cuz we get paid according to how much product the Doc uses (i.e. We're biased beyond credibility.).

    Go get second and third opinions. If your Docs disagree, ask them why.

    Finally, think about taking the most conservative steps first. You can always do more, but once more is done, you cannot do less.

    "Measure twice. Cut once."

  37. Anyone see reps in the field charging "usage fees" for the metrx system? After the local medtronic reps lost the implant biz for a busy surgeon they decided to charge $1500-2000 per case each time surgeon uses their retractor system, in addition to charging for disposables. maybe that is normal but if so i have not seen it.

  38. I'm a former Nuva mgr and I can tell you that the ABM you are speaking of is a very quality individual. He's extremely knowledgeable and a great guy. You are only throwing stones b/c you are afraid of your competition.

  39. 6:59

    Typical Medtronic BS. If you don't use our implants we will charge you to use our retractor. Maybe this made sense a long time ago when Metrx was a unique product, but it's not anymore.

    The Metrx is old technology - just a system of tubes and dilators. A hospital can buy a comparable system outright for a few thousand bucks. Screw Medtronic.

  40. August 1, 2011 6:31 AM: Love your nonchalance regarding screw breakages. I hate to burst your bubble, but that's not a part of doing business either. I'm surprised your device is a failure, though. Did you misread the Synthes prints?

  41. Patients in the US obtain access to excellent technologies and theraputic modalites years and often decades after patients in the EU. This then makes SU comps values inflated 100-fold is they manage to get an FDA approve or even clearance. does this make any sense at all?

  42. for every metal-on-metal hip cleared that perhaps should not have been, rest assured that there are 10 excellent devices that never made it to market due to not getting thru the obstacle course that is the FDA.

  43. 10:17, maybe the balance is slightly different, but the principle is true. For each patient saved from an unsafe device or drug there is at least one that died because a new device or drug is not available (just remember the story of the two cousins with melanoma:

    Another way of looking at this is that absolutely insane amounts of money are wasted on regulatory and compliance activities with as final outcome a zero gain in lives protected or saved. It's just not the same ones that suffer or die.

  44. 7:33 If materials management had a clue they would tell Medtronic and Depuy to take a hike. They can purchase equal quality implants for much less money. Tell the docs they will gain share a portion of savings. No reason to pay Medtronic or Depuy those high screw prices.

  45. Risk Management at hospitals know they'll lose far more in a broken screw litigation by using a cheaper product, than they'll save.

    On an unrelated topic, what's going on with broken screws of Globus? Is there a recall?

  46. Broken screws? Why do you think the products are cheaper? A biomet screw is just as strong as a Depuy screw. No risk there. Do you think only Depuy and Medtronic make "strong" screws? How big is your cup of KOOLADE?

  47. You're saying Biomet still makes screws?

  48. Yes Biomet still does. But you wouldn't know that, would you? You're a little case coverer who fancies himself a rep. But the Big Corporate Product managers get your business for you by signing up Depuy and Medtronic consultancies. Here's a formula you should try. Subtract all business from any customer who has any type of corporate agreement.( Teaching, Royalties, Development, Sponsoring of Education, Fellowship, Donations to a cause, etc) If your territory is able to sustain itself than you are probably earning your pay. Otherwise, you are an overpaid case coverer and lap dance fetcher. Most Depuy and Medtronic reps are.

  49. Geez, you sure seem to have gotten your panties in a knot up your crack over that one. Relax now...

    This is TOO EASY.....

  50. Broken screws are 95+% of the time due to a failed fusion rather than inferior hardware.

    Over the years I have seen/revised broken screws from failed fusions from many manufacturers.

    Infuse certainly helped reduce the # of implant failures due to implant fatigue.

  51. Hey Patient,

    I second the comments before. Definitely get a second and even third opinion, try and consult with friends locally who may be in the business or ask your primary care doc, and don't tell a surgeon what tools he or she should use. You want whatever they are most comfortable with.

    And by the way, not sure what your height is but perhaps lose some weight, especially if your surgery is being considered largely for back pain. At 38 you've got a long life to live with your back, and I'm afraid that for the most part mother nature is still much better at fixing it than surgeons are.

    And remember, recovering from back surgery can be like your dating behavior after a divorce. If you had put that much effort in beforehand, you wouldn't have gotten divorced in the first place.

    Good luck!