Sunday, January 10, 2010

Geff Yielding: Going, Going, Gone!

It was announced on Sunday, January 10th, 2010 that Geff Yielding of Jacksonville, Arkansas was sentenced to 78 months imprisonment for his role in a healthcare fraud scheme that involved his now deceased wife Kelley (who died mysteriously the day before she was to testify before a convened Federal Grand Jury) in connection with the sale of ORTHOFIX bone stimulators and OSTEOTECH allograft bone graft to Baptist Health Medical Center, North Little Rock, Arkansas between 2003 and 2004.

Mr. Yielding was employed as a physicians assistant for Richard Jordan, a prominent Baptist Neurosurgeon. Yielding was able to dictate what products were ordered for use in surgery performed by Jordan. The commissions during that period totaled $380,000. Hopefully, this will send those scrub technicians, physicians assistants and operating room nurses a stern message. "You play, you will pay." Come on ladies and gentlemen, you know who you are. As this drama continues to unfold TSB and our readers await for the day that the DOJ elevates their commitment to clean up this industry by throwing some surgeons into jail.

Yielding will serve a minimum 80% of the 78 months since he was convicted of federal charges. Yes sirree, for those of you playing in this space any federal conviction requires a mandatory 80% of the sentence. In addition to jail time, Yielding is required to make restitution in the amount of $944, 995.84 (OUCH!) The sad part to this saga is that there is a child that not only was left motherless, but will be fatherless come March 10th, 2010.

TSB has to ask the FBI and DOJ what is taking you so long to put the other criminals behind bars. Stop pandering to the surgeons that continue to behave that they are beyond reproach starting their own distributorships while collaborating with other industry professionals. You know who you are, start looking over your shoulder. A double standard by the judicial system, TSB wants to know what our readers think?


Friday, January 8, 2010

Applied Spine launches New Website!

"Stabilimaxx is a very sophisticated device, but unless deconstructed, it is challenging to explain."
- Ed Durkin, Marketing Consultant -

Hey Ed, this has to be the quote of the year. Not only is Stabilimaxx challenging to explain, it is challenging to manufacture, and it may be challenging to implant! You gotta love our industry. Press Release: Applied Spine Launches New Website. After how many years? 5 ? Applied Spine is at the point of announcing it has launched a new website. Panjabi needs to find the right people to get this product to the market. Thirty Days in the Hole. Could it be possible that by getting the patient involved in an interactive questionnaire, the patient will be able to convince their spine surgeon that they are a candidate for Stabilimaxx. Isn't that the surgeon's job? Oops! TSB forgot, consumer driven healthcare, the future of spine care in America.

Is the spine industry ready to take the next step in advertising where we become like the pharmaceutical companies listing the potential side effects of having back surgery with some of these devices? TSB wants to know what our readers think?

PS: The animations are nice.

Thursday, January 7, 2010

World Renowned Surgeon(s) named Co-Medical Directors at Vertiflex

On January 6th, 2010, in an unprecedented self-serving promotional press release, Vertiflex a leading innovator (huh) of minimally invasive and motion preservation spinal technologies (totally delusional) announced that "two world renowned surgeons" were named as co-medical directors of the company. Scott "I've never seen a deal I didn't like" Blumenthal and Nick Shamie were named to this co-position to assist in the on-going trial of the Superion Interspinous Spacer designed for spinal stenosis.

Interestingly enough, not only has Dr. Blumenthal been a consultant for many a spine companies, he is now also a spine consultant for the Dallas Mavericks, God love the Blog Maverick. Of course a press release of this magnitude is always entertaining especially when someone, an authority no less, makes a blanket statement that Superion is generationally advanced over other alternatives. Can we have a little more depth and substance than that. Where is the evidence? Even Heidi Fleiss has more credibility.

TSB always finds self-promotion an art that can be practiced by some within the industry to unfathomable heights. It's interesting that no one in the industry has ever heard a public statement by any of these surgeons about Superion until they were hired to lend credibility to the product. Is it world renowned or is it another clown, TSB wants to know what our readers think?

Tuesday, January 5, 2010

Shiny Happy People - Where is the Creativity?

Recently, TSB and a few colleagues were discussing how much spin goes into marketing many of our "me too" products. Yet, when we analyzed the visual quality of industry ads and websites we started to wonder where did we get all those "Shiny Happy People laughing meet me in the crowd......" Michael Stipe of REM must feel relief that our industry has built its marketing platform and websites on one of his songs.

Is there any creativity and originality in this industry? Considering the low cost of goods sold, general and administrative costs, along with cost of sales, this industry is quite profitable and provides a respectable ROI for investors. Yet, when it comes to creativity in marketing spine, the only grade that can be given is a big fat "F."

So why does this exist? An old mentor of mine once said, "imitation is the greatest form of flattery." If there is any truth to that comment most marketing people and companies cannot develop an innovative platform when it comes to selling product or creating a website. It seems most are "bogged down" in following the same formula. The Legacy companies or Spine Cartel are sterile in their presentation, and the early-growth stage companies are terrible. Shiny happy people smiling......... come on, you can't tell me that the result of back surgery is happiness. Maybe to some, but if I were a gambling man I would bet that the reason pain management has become such a huge industry is because unlike the subliminal message that these websites attempt to send, there are many people that have back pain. One of the smartest surgeons that TSB ever worked with said; "Once you have back pain, you'll always have back pain." So where is all this happiness emanating from? I'm just waiting for the day when someone has an elderly person doing a cart-wheel on their website. Hand-stands anyone? Skate-boarding?

Does anyone think that one day we will emerge from the "Still Life" genre of marketing in spine and start spending some of those profits on some real marketing? Can we enlist some real talent outside the industry when it comes to developing websites? My grand-daddy's favorite expression was, "cheap is expensive." TSB is awaiting for the day when some marketing genius finally starts to think out of the box. Isn't that what marketing is all about? Can anyone explain why there is so little innovation in spine marketing?

TSB wants to know what our readers think?






Biodegradable Magnesium, Could We be looking into the Future of Spinal Implants?

Biodegradable polymer implants have exhibited some success especially in small joints. Many researchers believe that magnesium has emerged as a primary candidate for biodegradable metal implants. Considering the magnesium is the eleventh most abundant element by mass in the human body, its ions are essential to all living cells where they play an important role in manipulating biological phosphate compounds like DNA , RNA and ATP. The only challenge that magnesium has presented is that it produces hydrogen which can prolong the healing process and could potentially harm the body. The advantage of biodegradable implants is that they dissolve upon fulfillment of their intended function. Obviously this minimizes the long-term problem like inflammation, or in the case of stents, restenosis.

The way magnesium works is that it offers greater strength than polymers and as it corrodes it releases inert ions. The Swiss (who else) Federal Institute of Technology in Zurich has developed a magnesium based glass that has not exhibited the release of hydrogen during its clinical trials. Jorg Loffler and his colleagues have identified a way to circumvent this challenge by adding zinc to the magnesium to form a magnesium based metallic glass. Herr Loffler has developed a rapid cooling process that permits more flexibility in the process quickly cooling the molten material resulting in an amorphous structure that he compares to that of window glass.

By exhibiting no hydrogen , the biocompatible metallic glass could actually serve as the basis for the next generation of biodegradable thickness, as much as 5mm in thickness. This could possibly be used for bone implants. It's like Alice in Wonderland peering through the looking glass. Could this be the future? TSB wants to know what our readers think?

Sunday, January 3, 2010

Will the Doctor and Patient Lose Under a New Healthcare Plan? You Decide

Recently, the WSJ ran the article "What Doctors and Patients have to lose under Obama Care." Since this summer, the current healthcare reform bill has been inspected, injected, detected, and rejected, by every special interest group and lobbyist along K Street. Yet the question still remains how does the U.S. manage to contain the cost of delivering medical care when it is forecasted that by 2012 we will be spending $4 trillion dollars annually on delivering it.

Depending on your tenure, cost containment in healthcare has been a concern for a minimum of thirty years if not longer. This article touches upon salient arguments made about the penalties and regulations that are aimed at surgeons in the current bill. A major concern is whether the Center for Medicare Services (CMS) should be given the ultimate authority in deciding when and how medical devices and drugs should be used and dispensed with, and how they should be priced on Medicare patients. Contrary to what some commentators have written, TSB is not a socialist considering that no government agency should have the right to dictate what the surgeon can do, but considering that CMS is the federal agency responsible for Medicare, they should have a right to say how much they are willing to pay for products, especially commodity products that really are not bettering the outcomes. It comes down to supply and demand. The economic model of price determination concludes that a competitive market price will equalize the quantity demanded by consumers, and the quantity supplied by producers, resulting in equilibrium of price and quantity. Quod erat demonstratum (QED).

What is disconcerting in this article is that the government is attempting to absolve itself from the same protection that it advocates for subscribers of private healthcare insurance, the appeals process. Obviously, Hays vs. Sebelius sets a precedent that Medicare cannot unfairly deny a patient if the treatment in question is deemed "reasonable and necessary." So the question must be posed to our readers whether the government should have the right to control which medical devices spine surgeons can use on Medicare patients? And, if the device does not improve the outcomes, does the government have the right to decide how much it will pay for these devices? Will this discourage innovation? Or, will it create an environment where inventors and investors will be conservative in how they choose to identify real innovation versus pure marketing before investing their capital? Let's use an example, if TSB launched a pedicle screw that really doesn't improve the outcomes, but offers the surgeon some "intra-operative flexibility" can the manufacturer justify charging more than the competition for the screw, considering that most operating room time is a fixed cost? Many of our readers cry out for free-market enterprise, isn't a by product of commoditization lower pricing? That's the free-market at work.

For years the general public has complained about the insurance industry, but what most Americans fail to understand is that United Healthcare, Cigna, Aetna, Oxford, et al, are not in the business of providing healthcare, they are in the business of risk management. Risk management involves the assessment, identification and prioritization of risks followed by coordinated and economical applications of capital to minimize the probability of unfortunate events, or to maximize profitability. Today, much to our chagrin, the government is attempting to address the healthcare crisis like the insurance industry, looking to minimize its risk.

If the author, Dr. Gottlieb of the American Enterprise Institute truly believes that we will inhibit innovation, all he has to do is look at our industry. Some of the small changes in innovation that he does speak of really amount to nothing more than pure marketing in spine. Innovation means introducing something new, but it also can mean introducing something that truly affects the clinical outcomes. Has the glut of "me too" products really changed the outcomes? We constantly hear people ask the question whether is it new, is it true and will it make a difference? Maybe, only one question needs to be asked; "Will it make a difference?" Because that's what really matters. In closing, Dr. Gottlieb makes it sound that the government will be the impetus for private insurers to take its cue from Medicare, yet, haven't private insurance companies behaved in this manner all along? TSB wants to know what our readers think?






Saturday, January 2, 2010

Is it Leadership or Management That You're Looking For?

Recently Drue DeAngelis wrote an article on his website pertaining to Building Management Teams in Orthopaedics. Kudos to the new Orthopaedics and Spine News platform. The article is quite informative, yet, TSB believes that what he failed to discuss was that there is a distinction between what constitutes a great leader and a good manager. Whether you are hiring a CEO, Regional Sales Manager or Product Manager, leadership is important, especially in a start-up or early growth stage company. Leadership can make things happen at an accelerated rate if the right scenario exists. The culture and business model at these companies is different than being employed by an established organization.

Many start-ups have succeeded, yet, there have been many that suffer from what TSB calls the, "I can't get out of my own way syndrome." It's the endless enigma, Ego. The primary reason this occurs is because the individual(s) that started the venture does not have the necessary skills to run a company. There is a difference between developing a product and motivating people to execute. One takes engineering, scientific and listening skills (hopefully), while the other takes someone with a defined vision, knowing how to engage and inspire people, create accountability, build a plan, generate ideas and produce results. Essentially, it takes team work and empowerment. Resistance in a leader seriously compromises one's ability to embody the character traits and perform the functions of a leader and manager. What you learn in the spine business is that many times the job really doesn't go to the most qualified person. It can be argued that the best leaders are those that truly have the ability to think out of the box. Why? Because life's experiences have built a box around most of us. You become more fixed in your beliefs, habits, reactions and behavior. Most people are too busy, distracted, stressed out, unfocused and ungrounded. We are too mired in the past or the future. But it takes more than just thinking out of the box, it takes someone with integrity, clarity, transparency and the ability to be open-minded. The problem in most of these small companies is that the person(s) that started the company usually resists other ideas.

With that said, why do investors and board of directors look for people outside the industry? Could it be that they lack the ability to really gauge someone's skills? These individuals usually come from finance with no industry or people experience, or are even surgeons from our industry. As TSB has written on numerous occasions, it seems that we can't get out of the box in this industry because we are constantly rewarding people that bring the same tired principals and experience to the game. What once worked at a DePuy, Danek, or Medtronic fifteen years ago, or even one year ago, is not going to necessarily work at an early growth stage company because of the difference in culture, dynamics and minimal product portfolio. In addition, a leader at a small company is not a leader per se, but a worker bee. An early growth stage company needs leaders that have the capacity to wear multiple hats in the course of building the business. Just look at some of the companies that we have profiled over the last year. Seven layers of senior management for an organization that generates ten to fifteen million in revenue? Tell me that this isn't Einstein's definition of insanity.

So the next time you are looking for a candidate to fill a position ask yourself the following questions:

Does the candidate know their values and beliefs?

Is the candidate self-defined?

If hired, can the candidate develop a vision for the organization? Remember at that point the candidate may not even know what you have in the Intellectual Property pipe line.

Can the candidate connect their vision to a strategy and execute?

Is the candidate flexible and forward thinking?

Will the candidate be inspiring and credible, meaning do they know the business?

Is the candidate focused?

Do you think the candidate will be accountable yet be willing to take risks?

Will they facilitate personal growth to the team and its members by empowering them?

Can they be a thought leader?

Can they create a collaborative environment?

Does the person have a genuine interest in people?

Are they eager to learn and lead?

Do we ourselves know what we are looking for?

Do we ourselves have a defined strategy?

TSB is sure that our readers can come up with some more questions, but let's face facts, this isn't brain surgery, or, for that matter spine surgery. All it takes is a little time and preparation to find the right person for the job. Maybe Drue is right, you're better off letting someone with the DeAngels' experience handle the search for you. TSB wants to know what our readers think?