Healthcare was nowhere to be found between Budweiser and Clint Eastwood Super Bowl commercials. Instead, healthcare systems chose the local route for their 2012 Super Bowl advertising. If you were in California, Minnesota, Ohio, Virginia or other markets you saw local hospitals and healthcare Super Bowl ads.

The Children’s National Medical Center in Washington, D.C. ran a Super Bowl ad in the pregame show promoting the Parents Letter Project. Sheltering Arms, a rehabilitation center in Virginia, also ran a 30-second Super Bowl ad, and Park Nicollet in Minnesota and Cleveland Clinic  ran Super Bowl ads as well.

Local ads are nowhere near the cost of the $3.5 million for 30 seconds the major national Super Bowl advertisers pay. But the cost of local Super Bowl commercials went up, too. In Rochester, New York, for example, a 30-second local Super Bowl ad was up from $15,000 to $20,000.

National campaigns make sense for the Cleveland Clinics and Mayo Clinics of the world, though perhaps not for $3.5 million a spot. But the lower cost for the amount of audience locally is a no brainer for many health systems, who thrive off grabbing a larger share of local patients.

Know of any other local Super Bowl ads from healthcare besides the ones I have listed? Post links in the comments section below.

Healthcare is the economic engine of the United States: one of the few places that shows consistent job growth even in the face of global economic doldrums.

But just because there are jobs doesn’t mean you would want them (no matter how much they pay). Healthcare reform, digital health and a global marketplace have thrown some things into flux. So healthcare has the most jobs and some of the most challenging jobs.

Her are my nominees for people who could take Sisyphus’ place pushing the boulder up the hill: working excruciatingly hard healthcare jobs you may just want to take a pass on.

CEO, publicly funded hospital. You are in a maze with no exit. Most publicly funded hospitals exist to provide care for their region’s uninsured. But with healthcare reform, there won’t be any uninsured. And because everyone in your area sees you as a hospital used primarily by people who can’t afford to go anywhere else, once people get insurance they’ll probably go somewhere else.

Your hospital is funded by Medicaid and Medicare dollars, which continue to get squeezed. You’re also funded through special subsidies to compensate for the uninsured, which will eventually go away. And even though the public subsidy from local government covers an infinitesimal portion of your budget, it opens your books to the general public and gives local politicians license to flog you so they can boost their tough-guy reputation ahead of the next election.

If by 2022, you’re running a public hospital that is profitable and thriving, you should be hired to run Google.

Licensed practical nurse. You are the low person on the totem pole in a critically important profession that seems to never get enough respect. Plus, everyone lies to you. Years of students have been told this is the next great, sure-to-get-hired profession and there aren’t enough nurses to go around. Yet, it looks like there are actually too many nurses at the moment. The nursing shortage never seems to appear and at the moment your peers are getting fired in favor of better-educated registered nurses.

First-year associate, medical device venture capital fund. Welcome to the powerful world of venture capital. Medical device investing is down, the cost of developing medical devices is up and your competition for deals includes most of the major medical device companies in the country. Have we mentioned the medical device tax?

One of the sure paths to acquisition is getting an FDA-approved product. But that pathway has become so murky that some medical device startups don’t even plan for entry into the U.S. marketplace.

So why are there even job openings? Many of your contemporaries are jumping ship to grab bigger multiples in the white-hot digital health space. If your investment focus is not diabetes, cardiology or neurology, you should start sweating.

Pharmaceutical sales rep with 10-plus years experience. One day you woke up and all the requirements for the job had changed. No more free pens. No more buying lunch for medical students. Lead executives of the biggest pharmaceutical companies in the world say pharma advertising has lost its way, the up-and-coming drug firms don’t want your kind anymore, and the startups are building  social networks that create virtual environments in which hospitals can engage sales reps from a distance and maximize their time and money. You’re not even sure what the last part of that sentence means.

On the bright side, Hollywood has taken an increasing interest in working pharma companies and the lives of sales reps into the story lines of its big-budget movies. The down side: it rarely ends well.

This month is MedCityNews.com’s 3rd birthday. Over three years, with your help, we’ve grown from a site focused on healthcare innovation in Cleveland to the leading online portal reporting nationally on innovation and business-to-business insight for leaders in the healthcare and the life sciences.

Knowing what our readers need has been a key to our success. So, please keep supporting us by taking our reader survey. We’ll use these details to better serve you and to reach advertisers who want to reach you, too.

We regularly ask you to take surveys — and for good reason. MedCity News keeps growing and our readers keep changing. Today we have reporters providing exclusive insights from key medical markets like Cleveland, Research Triangle Park, Minneapolis-St. Paul and Philadelphia. Plus, this year we expanded our coverage to write about digital health and emerging companies all across the country. Our online audience will grow by 30 percent in January compared to December. In 2011, our online audience grew 70 percent compared to the previous year.

These are good problems to have. But to make sure we’re meeting all your needs, we need to know more about you. The survey asks for both demographic information as well as what we could be doing more to serve you. I’ve heard feedback that ranges from “Make the e-newsletters better” to “More coverage of startups.”

Please be part of the chorus of readers who have already taken the survey. It will make us an even bigger success this year.

You can take the survey by clicking this link.

[Photo by Flickr user Will Clayton]

A review of life science current events reported by MedCity News this week:

10 cardiologists to follow on Twitter. Some notable cardiologists have embraced Twitter — one even wrote a useful guide to help cardiologists get started on it — and certainly more figure to adopt the technology as it becomes more ubiquitous in the future. So here’s a look at these somewhat early adopters, with a completely subjective list of the top 10 cardiologists to follow on Twitter, in no particular order.

Medical devices: 5 tips for commercialization in China. Getting a bite out of that large and lucrative Chinese market isn’t so simple for small- and mid-sized device firms that lack experience in Asia. With that challenge in mind, here are five tips for commercializing medical devices in China.

St. Jude Medical’s big plans for CRM (and beyond). St. Jude Medical CEO Daniel Starks told analysts that the company will gain a 1 percentage point market share in the global cardiac rhythm market in 2012, and added that the company’s fractional flow reserve technology will be a $1 billion market.

Cleveland Clinic cardiologists: You can die from a broken heart. Intense grief, such as what’s felt at the death of a spouse, can increase a person’s risk of developing cardiac problems that lead to death, according to a new article by two prominent Cleveland Clinic cardiologists. The article — “Can you really die of a broken heart?” — appears in Psychology Today and was penned by Dr. Steven Nissen,the Clinic’s chair of cardiovascular medicine, and Dr. Marc Gillinov, a staff cardiac surgeon at the Clinic.

Gel to treat precancerous skin condition gets FDA nod. A gel to treat a precancerous skin condition has been approved by the U.S. Food and Drug Administration. Picato gel, produced by LEO Pharma is applied to the skin to treat actinic keratosis, a skin condition caused by overexposure to the sun. The condition produces dry, scaly patches or lesions that form on the outermost layer of the skin, a statement from the company said.

[Photo from flickr user: CarbonNYC]

Now here’s the best of what YOU had to say:

Med tech consolidation brings a need for focus. Here are 2 ways to get it. “The medical technology industry has grown quickly and has been concentrated more on top-line, rather than bottom line, growth. With smaller startup companies launching innovation with the sole purpose of being acquired and larger companies eager to take the place of revenue from sun setting products there was a long, frantic period of acquisitions. Now that the industry is maturing you can expect to see even more consolidation and M&A activity.”

Tips for success with electronic medical records. “I cover medical software and health IT for Software Advice, so I was curious to learn about some of the secrets to success when switching to an EMR that might not meet the eye. To find out what is it that separates the health care providers who truly reap the benefits of switching to EMR, from those who don’t, I interviewed representatives of three health providers who use EMRs now:”

How Healthcare is Helping the US Economy. “While some look at the Affordable Care Act as a move in the right direction, others who have not yet had the opportunity to capitalize from it see it from another perspective. All in all, the good things that are springing forth from the healthcare law can improve the economy in the long run.”

Breast implant problems can be stopped with conscientious doctors. “This year began with a breast implant scandal. This one has brought back memories of the one early in my private practice.”

[Photo from photobucket user turhamkey]

I once told a physician friend that he and all doctors would eventually have to give up private practices and be employed by a hospital. “No,” he told me. “I will die with my boots on.”

But do the dreaded hospital acquisitions of private practices actually empower doctors — and in particular, cardiologists?

The Philadelphia Inquirer reviewed the acquisition of private cardiology practices and came up with the usual subjects: a squeeze by payers and the increased costs of running a practice, among others. But the article also pointed out that cardiologists drive new healthcare innovation in hospital systems. Here’s what happened when a pair of cardiologists at Lourdes Health System became comanagers of the hospital’s cardiac services:

• They standardized treatments and started using a cheaper blood thinner.
• They encouraged the hospital to equip ambulances and the emergency department with equipment that diagnoses a heart attack before a patient leaves home. The change cut the time to perform a catheterization by 15 minutes.
• They created units that include nurses with expertise in heart-failure and heart-surgery patients. The measure cut hospital stays and improved patient satisfaction.
• The hospital hired two family physicians for home visits with heart patients.

The theory on why all the changes?  “These doctors are totally engaged in this process. And why? Because they suddenly feel like what they say matters,” Reg Blaber, a vice president at Lourdes, told the Inquirer.

A review of life science current events reported by MedCity News this week:

A life science entrepreneur’s guide to making a great speech. And after talking with some of the entrepreneurs, here are my tips on public speaking to keep you from losing the room (and the opportunities in it).

Is it a drug? Is it a device? No, it’s FDA’s subjective “chemical action” guidance. The agency made an effort to provide guidance on this matter when it released the “Interpretation of the Term ‘Chemical Action’ in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act” six months ago. However, industry experts gathered at a morning panel at the University of St. Thomas, Minnesota on Wednesday believe that the guidance is very subjective and not particularly helpful to companies developing new products.

How will Cleveland Clinic Innovations follow up its best-ever year? So what’s on tap for an encore in 2012? It appears Innovations will have a tough time matching last years’ impressive success, if only because it was such a strong year.

Trekkies rejoice! Qualcomm and X Prize offer $10 million for real-life tricorder. Qualcomm Foundation and the X Prize Foundation are challenging technology and medical innovators to develop a real-life mobile tricorder that can diagnose 15 diseases without any poking, prodding or invasive tests. For those unfamiliar with the tricorder, it’s a scanning device used by the Star Trek characters Bones and Spock in various applications, including detecting health problems noninvasively.

St. Jude Medical launches new MR-conditional pacemaker in India. To capitalize on growing demand from international markets, St. Jude Medical (NYSE:STJ) is launching a new MR-Conditional pacemaker in India that will allow patients implanted with such a pacemaker to undergo a full-body MRI scan safely.

[Photo from HD Wallpapers]

Every week, MedCity News highlights the best of its MedCitizens: syndication partners and MedCity News readers who discuss life science current events on MedCityNews.com.

Now here’s the best of what YOU had to say:

How to facilitate open innovation in the medical device space. “Peter von Dyck was frustrated. When trying to commercialize his latest medical device, it had simply become too inefficient to navigate through various sectors within the fractured medical device ecosystem. So what did Peter do? He created a system to solve this major dilema. In this interview with Peter von Dyck, we learn how e-Zassi is transforming the way medical device companies, innovators, researchers, and investors connect and collaborate in an effort to generate powerful new efficiencies in the development and commercialization of life-saving medical technologies.”

2012 JP Morgan Healthcare’s (wo)men’s club is changing in a good way. “he overall tone of this year’s JP Morgan Lollapalooza was cautiously upbeat, I would say. There are a few promising healthcare IPOs in the pipeline and a lot of opportunity presented by the changing healthcare field. Good companies are getting funded and bankers are busy again. Times are still tough but unemployment is slightly better. Healthcare IT is all the rage and there were even some whispers about early stage investing slowly climbing again. There was so much action around the conference headquarters at the St. Francis Hotel (also known as the worst conference venue on earth unless you love being crushed to death like you were at Altamont for a Rolling Stones concert) that security was even stronger than the airport in Fallujah.”

Medical device startups: Is crowdfunding in their future? “I’m not sure why it has not received more attention in the medical device start-up world, but the Entrepreneur Access to Capital Act (EACA), which recently passed in the U.S. House of Representatives, has the potential to open the door to intriguing fundraising possibilities for individual medical device innovators and start-ups.”

Chief Medical Information Officer’s role becoming more important. “Although I’ve been able to balance these three roles because of the extraordinary IS staff at BIDMC, good governance, and a supportive CEO, it’s challenging for one person to perform all these tasks. Many hospitals and health systems are expanding their management team to include a CMIO. Here are a few thoughts about the role of the CMIO.”

Ethics, disclosure and the FDA: Yaz, Yazmin just the beginning. “My reasoning, like the many consumer organizations which backed a total ban on using conflicted scientists, was that there are plenty of non-conflicted experts at American universities, research institutes or in private practice who are just as knowledgeable as people who sign consulting deals with industry. Moreover, eliminating the whiff of impropriety that appointing scientists with conflicts of interest brings would maintain the public’s faith in the integrityof the process, even if the appointee swears up and down thatis or she isn’t biased by the relationship.”

Taken another way, SOPA and PIPA are like the Internet’s version of the medical device tax. The only difference is that SOPA’s opponents have racked up win after win in their campaign against the legislation. The medical device tax, meanwhile, moves on like a slow steamroller.

The medical device industry could learn a lot from those who have fought against SOPA and PIPA. The legislation approaches a real problem — piracy and copyright infringement — in a sector that is relatively unregulated. But the approaches in the proposed laws are amazingly drastic to solve the problem at hand. Many medical device tax opponents would say the same applies to the tax, which is meant to help fund healthcare reform.

But SOPA’s and PIPA’s opponents have used tactics that are different, more bombastic and — unlike the current battle against the medical device tax — actually working.

Get social and raise awareness. Big-money venture capitalists, eager-beaver entrepreneurs and an assortment of geeks all took to Twitter and put the small but increasingly ubiquitous phrase “STOP SOPA” across their profile pictures. It showed solidarity and raised awareness. Social media is better than a blog entry in Reason magazine and guest columns in the local press.

Align with innovation. Medical device tax critics have been leading with fear first — citing the loss of jobs. The sad problem: The job losses aren’t enough to scare anyone. SOPA was all about the loss of freedom and innovation — the 2012 version of mom and apple pie.

Medical devices are the things that save people’s lives. A better tactic would be to place a greater emphasis on innovation and a focus on the devices that have been created thanks to the current unfettered system. New slogan: “It’s like taxing the Internet.”

Make an example of someone. GoDaddy was among the companies that backed SOPA. So what did the SOPA opponents do? They called for loads of nerds who had their website domain names managed by GoDaddy to transfer them elsewhere. Some did. And GoDaddy caved, reversed its position and scores of other SOPA supporters followed.

So who can the medical device industry make an example of that’s on the same level? Not some poor consumer advocate, but a major company or industry institution that is going the other way on the medical device tax?

Prepare a dramatic moment of civic action. As part of a protest against SOPA, Wikipedia and scores of other sites are going to “go dark” on Thursday. Google is going to use its front page to protest SOPA. That’s the modern version of civil disobedience — and it will get everyone’s attention.

What is the medtech equivalent? A national, one-day furlough for all employees from the c-suite on down to drive home job loss? A sick-out for all doctors who created medical devices?

Make yourself the hero. In all the discourse about SOPA and PIPA, you really feel like opponents are not just callously serving their vested interests, but instead riding to the rescue of something we all hold dear.

Can the medical device industry do the same? It’s a hard sell. The medical device tax proponents say the tax will help provide healthcare for all. And those same people can paint the medical device industry as a sector that’s going to take most of its jobs overseas anyway.

Can the anti-taxers get an anti-SOPA makeover?

I still remember how red-face frustrated one of my seed investors was after hearing my pitch to another investor in Month One of the business. “It’s a process,” he repeatedly said out loud — and I am pretty sure he was talking to himself.

While I’ve always been an adequate-to-solid public speaker, I struggled early boiling down my business in the way many other entrepreneurs easily managed (I got better by watching videos from DEMO).

But I have also suffered as if in a dentist’s chair when listening to entrepreneurs – so good at explaining their molecules, medtech patents and the market opportunity that earns them a $500 million valuation – speaking about themselves, life lessons or other topics that can return just as much value to their businesses as those investor pitches.

These are lost opportunities. And after talking with some of the entrepreneurs, here are my tips on public speaking to keep you from losing the room (and the opportunities in it).

Why are you there? The question is not “What is the subject of the speech?” or “Why did the organization ask you to speak?” or even “What does the audience want to hear?” The question is: What can you get out of it? Why did you or your marketing team decide that this is a strategically valuable place for you to take your time to get up and speak? What is the ROI? Is it a room full of  buyers? Of investors? Of acquirers? Who do you want to reach? I once spoke to a room of 60 people but I only wanted to reach one, and tailored the speech accordingly. Answer the “why” and you have just given the speech the purpose and focus it needs.

Three talking points. Investor pitches are often afflicted by the curse of knowledge. Out of the element of a business meeting and just making a speech, entrepreneurs wind up just rambling. Based off why you are there, develop three points. Introduce yourself and your company, drive home those three points (detail dependent on length of talk) and summarize. Then take questions. People love to ask questions.

Spend just 5 sentences on the science. Unless this is an academic conference, attendees will disappear into their water glasses if the discussion focuses heavily on the research behind the company. Boil it down into five plain-spoken sentences at most.

Never digress and never, ever check your handheld. Every room needs to be owned. And checking your handheld for any reason or making a self-deprecating joke or digression is a sign you are either nervous or disinterested. And, with that, you have lost the room. Plus, going off on a tangent or impromptu only increases the likelihood of saying something awful, off-color or proprietary that you will regret.

You aren’t Steve Jobs. You’re just you… and what does that mean? Not who are you with your kids or who are you behind closed doors with staff. But who are you as the public face of your company? What persona will impress the industry you’re in, inspire people to work for you, get you more press and lead your company to success as you and your investors define it? That doesn’t mean being a charismatic public speaker. It means someone who is genuine.

This is an investor pitch. Well, it’s not, but the principle is the same. The reason you pitch your business well is because you love it, know it and understand the value proposition. Use the same approach that’s made you successful there. Everything else is a digression.

A review of life science current events reported by MedCity News this week:

Klout’s top social media influencers in medicine. We created Klout’s list of the Top 10 social media influencers in medicine after last week’s top KLout healthcare influencers. What’s the difference between that and healthcare? At first glance, the medicine list includes almost exclusively MDs, and it has a decidedly more international flavor.

Canaan new venture fund dedicates $200 million for life science investing. Canaan Partners has announced a new $600 million fund of which one-third will be dedicated to medical device, biopharmaceuticals and diagnostics investing. About a quarter of the investments will likely be outside the United States, primarily Israel and India. Most of the investments will be in early and seed-stage companies.

Time will tell how Medtronic CEO will optimize medical device innovation. At the JP Morgan Healthcare Conference in San Francisco on Monday, Medtronic CEO Omar Ishrak once again laid out his three-pronged effort to rejuvenate medical device maker Medtronic (NYSE:MDT): improving execution, optimizing medical device innovation and quickly expanding its global footprint. Of the three, the biggest challenge will be in optimizing innovation because Ishrak wants to tie it to economic value, and in doing so, will be seeking a major culture change at the company.

Mobile health is dead. Call it digital health every time. I purged one phrase from my vocabulary this year: new media (I now start with “digital”). What’s so new about 10-year-old blogs? Now, I’m nixing another phrase and you should, too. The term is mobile health. Let’s always call the medical revolution digital health, dump the mobile and keep moving forward.

Medtronic pines for medical device innovation in Israel. How important is Israel to Medtronic’s future? Very.

Every week, MedCity News highlights the best of its MedCitizens: syndication partners and MedCity News readers who discuss life science current events on MedCityNews.com.

Now here’s the best of what YOU had to say:

Will Mitt Romney fight healthcare fraud? “There’s a lot more than character at stake when it comes to making false promises or false claims about cleaning up health care fraud. Building on an earlier program that began during the latter years of the Bush administration, President Obama and the Justice Department and Health and Human Services investigators built an admirable record combating malfeasance. But it’s only a start. Romney’s record — he reaped huge rewards by restoring profitability to health care providers purchased during his tenure at Bain, some of whom were caught in the government’s cross hairs — deserves careful scrutiny.”

Hospital health IT tips and tricks: From cloud computing to mobile apps “Last year I started a series of ‘Do’s and Dont’s’ in hospital tech by focusing on wireless technologies. Folks asked a lot of questions about do’s and dont’s in other tech areas so here’s a list of more tips and tricks.”

Are you a medical device or medtech entrepreneur? If so, stop being a problem solver! “In our society, the ability to solve problems is celebrated. In fact, most people would describe themselves as a good ‘problem solver’ in order to get promoted or to land a new gig. But is problem solving overrated? In the world of entrepreneurship, Dr. Arlen Meyers thinks problem solving is a mistake. Instead, he suggests you should become a ‘problem seeker.’ ”

Medify CEO ready to wage war. “The assumption there is that patients don’t understand relevance. We find patients with serious illness often become ‘expert systems’ themselves and when armed with data can have more effective conversations with doctors and, ultimately, the doc makes the call on treatment options, etc. So there is a safety net. Venture capitalists often find it hard to believe patients can educate and empower themselves, but we see their motivation and persistence every day.”

Eager consultant overheard @ #JPM12: “We specialize in putting companies in front of the FDA”

2012 prediction: That consultant is going to be busy.

You can follow all the twitter commentary by following #jpm12.

Canaan Partners has announced a new $600 million fund of which one-third will be dedicated to medical device, biopharmaceuticals and diagnostics investing.

About a quarter of the investments will likely be outside the United States, primarily Israel and India. Most of the investments will be in early and seed-stage companies.

Its most recent life science exit is Advanced BioHealing, which was acquired by Shire for $750 million in 2011. Its healthcare portfolio includes the stroke treatment company CoAxia,  spinal disorder company SpineWave, and pulmonary disease company Elevation Pharmaceuticals.

Canaan will invest at any point in a company’s life, and will dedicate anywhere from $1 million to $20 million to portfolio companies. It describes its biopharmaceuticals investments as:

• Therapeutics and vaccines with a special emphasis on combating infectious diseases
• Companies with drugs that can be repurposed or reformulated
• Sectors with reduced development and commercialization risk
• Platform technologies that address multiple product opportunities

It looks for medical device investments around:

• Novel, next generation devices to treat major diseases
• Devices that target chronic diseases and diseases of aging
• Companies pursuing therapies that are less invasive than current approaches
• Areas where there is strong consumer demand for therapies

It was diagnostics that are:

• Tied to specific, personalized therapies
• Implantable sensors that provide real-time health information
• Technologies that provide ongoing diagnoses for chronic diseases
• From companies with an expedited regulatory path and minimized commercialization risk

[Photo from Flickr user Amagill]

I purged one phrase from my vocabulary this year: new media (I now start with “digital”). What’s so new about 10-year-old blogs?

Now, I’m nixing another phrase and you should, too. The term is mobile health. Let’s always call the medical revolution digital health, dump the mobile and keep moving forward.

We’re days away from the Consumer Electronics Show and its accompanying Digital Health Summit. So it’s the perfect time to build consensus. I also credit this concept to Paul Sonnier and his Wireless Health LinkedIn Group, which helped gather the evidence for this change.

Digital is all encompassing: from big data to apps to electronic medical records to whatever comes next.

Digital health is not tied to platforms. Mobile health, however, is a phrase you associate primarily with phones and tablets. But soon won’t everything be mobile? In a few years virtually every medical device will have an app (maybe we can re-brand the pacemaker the Mobile Health Squared) and we could be facing the concept of “Augmented Reality Health.”

If you listen to people discuss mobile health and digital health, they are talking about the same thing. But it’s not just about semantics. It’s around mindset. People aren’t investing in or creating products that make great iPhone apps, they’re primarily seeking the best solutions to leverage data for everything from genomics to telemedicine. All of those will eventually have an app-based solution (or they may begin there), but the aim is to leverage all things D (as in data and digital).

For the moment, I’m in the minority. “Mobile health” is searched more often than “digital health,” according to the keyword research tool Wordtracker. But it’s also a muddier phrase. When people search for mobile health they’re also looking for “mobile health screenings,” health issues in Mobile, Alabama and health problems associated with mobile homes, according to my research.

Digital health is more distinct — and accurate.

MobiHealthNews — What is mHealth? from ListenIn Pictures on Vimeo.

[Photo from Wikipedia]

The Minnesota medical device company submitted fresh data to the FDA that, if accepted, would be the basis for a premarket approval (PMA) application, CEO Tim Cook said. Uromedica sent the data, which included a clinical analysis of more than 120 men, to the FDA in November. The company hopes to hear back from the agency by the end of January.

The application — while far from the big breakthrough — would be a significant win for the company. The company’s devices are available worldwide, but the FDA in 2010 rejected its PMA application for its female incontinence device, ACT, and the company’s approval efforts in the United States have stalled.

If the FDA accepts the data submitted for the male device, then Uromedica has several big decisions on its plate. At that point, Cook said the company would go ahead with a PMA for its male device, which would likely be completed in the second half of the year. It would also consider resubmitting for its female incontinence treatment and raising additional private capital in order to complete new studies.

The market for male continence products that Cook aims to go after in the U.S. is roughly $200 million, while the one for female incontinence is double the size.

Uromedica has raised $24 million since 1997. The earliest the company could be in the United States with its male device would be 2013.

A go-ahead from the FDA would also be a nice start after a strong 2011. Cook said the company is “right at breakeven.” This year he expects international sales to increase by 33 percent and is projecting profitability this year because the company has won reimbursement approval from the French government for ProACT. Last year, the company implanted more than 1,000 devices taking the total number of devices implanted to more than 10,000.

Uromedica will also expand into new markets this year including Russia and Poland, Cook said. Cook is projecting revenue from both countries in 2012.

That’s Sir Andrew Witty to you.

The CEO of GlaxoSmithKline (NYSE:GSK) was knighted on Dec. 31 for “services to the economy and to the UK pharmaceutical industry.” The honor, among other things, comes with the title of “Sir.”

This year’s list isn’t without its controversial figures — it included a dodgy hedge-fund tycoon and political donor. It was interesting to read how the British press positioned Witty and his “Glaxo turnaround” as reason of the honor.

Sir Andrew joined GSK in 1985, becoming chief executive in 2008.

The year 2011 has been difficult for the firm, which has had to pay £1.6 billion to settle litigation over diabetes drug Avandia, banned in Europe because of a suspected link to heart disease.
Hayley Parsons founded Gocompare.com

In the U.S., it has agreed to pay $3 billion (£1.9 billion) to settle all U.S. investigations into the way the company marketed its products.

But the firm has returned to profit and also saw a pickup in sales in the third quarter of the year.

It also says it has tried to improve access to its medications in developing countries.

In June, several major drugs companies, including GSK, announced big cuts to the amounts they charge for their vaccines in the developing world.

Sir Andrew has also been a keen promoter of GSK’s work in developing a possible malaria vaccine.

As of Tuesday, Sir Andrew was still only Andrew Witty on the GSK website.

Current medical news and unique business news for anyone who cares about healthcare.

Meet Teva’s Jeremy Levin. The former Bristol-Meyers Squibb and Novartis executive will take over the company in May 2012 when Shlomo Yanai retires. The switch means the company will go from an ex-general with no pharma experience to someone better able to integrate the $6.5 billion Cephalon deal and a plummeting stock.

“Investors will like the idea that Shlomo’s replacement is from the industry and someone with knowledge and experience, especially from the innovative side of the business,” Natali Gotlieb, an analyst for Israel Brokerage & Investments Ltd., told Bloomberg.

Brace for culture shock. Clal Finance equity analyst Jonathan Kreizman stated: “We believe that the appointment of a manager from the pharma field, despite the fact that he is not an Israeli, is the correct course to take. Teva will face numerous challenges in the upcoming years. Following the acquisition of Cephalon, its success in innovative drugs will be a decisive factor in its future.”

The best in 2011 years in review. Everyone loves to look back. Some of my favorite “looks back” in healthcare included Medscape’s Worst Physicians of the Year; Washington Post’s year in innovation (which included the idea of hacking DNA); Burrill Report’s nice summary of life science fundraising; the WSJ’s Health Blog’s best posts of 2011 (which reminded me of the CDC zombie alerts); Forbes’ best drug company of 2011; Everything Health’s favorite books of the year; Cardiobrief’s year in review; and The Scientist’s best science mutlimedia of 2011 (example at right).

The best in 2012 predictions. This list won’t be as long, but includes the idea that President Obama will be 2012′s truest conservative; Time’s eight health stories to watch in 2012; Tableau Software’s 10 business intelligence trends to watch; and VentureBeat’s 2012 trends about cloud computing.

What will happen in 2012 healthcare reform. Aside from that pesky healthcare reform Supreme Court case, the big changes in 2012 healthcare reform will include:

• Lowering rebates to Medicare Advantage plans and providing bonus payments to high-quality plans.
• Allowing providers to form accountable care organizations, intended to let them better coordinate care of Medicare beneficiaries. In October, the Obama administration loosened the rules for the program after providers complained about the early version.
• Lowering reimbursement for preventable hospital readmissions. Hospitals have been gearing up for the change, as the WSJ’s Informed Patient column reported earlier this year.

(Hat tip Kaiser Family Foundation)

Speaking of healthcare reform… those with ethics issues are completely ethical enough to decide if they need to ethically not consider the Supreme Court case.

Is the ADD drug shortage… a drug shortage or a natural transition to stop abuse of the drugs?

Healthcare doesn’t do “memes” — at least not as much as the tech industry does.

But 2011 showed that is changing. Amid the tidal wave-sized trends like healthcare reform, innovation in the life sciences and healthcare has started to take to the web. Now more than ever, concepts that will change healthcare forever were starting not just in labs or through clinical trials or tech transfer offices, but online: through healthcare social media, open innovation and digitally minded startups and incubators ready to catch convergence by the tail.

MedCity surfed much of that wave in 2011. Below are some of our  best stories as they played out on our digital pages (based on what you were reading).

The Omar Ishrak Era Begins at Medtronic

Omar Ishrak arrived at Medtronic (NYSE:MDT) and things changed immediately in big ways and small. He embraced social media (somewhat). Then, he quickly told the industry how Medtronic would expand under Ishrak: an aggressive global push with a focus on India, a drive to increase revenue from its emerging health IT operations and a greater factoring of sustainability when developing products.

Ishrak had a largely it-is-what-it-is approach to U.S. healthcare reform. “As far as we are concerned, as long as we work on programs that provide better quality, lowers cost at the same time and provide technologies that improve access, then those are the right strategies to win in any healthcare system,” he said in September. “The specifics of the U.S. are the specifics of the U.S., and it’s complex. But at the end of the day, these three things need to be achieved in the U.S.” But he also said he favors the European approach to regulatory approval: One that seems to be getting products to market much faster.

More Health IT (Every Way Possible)

The mobile health revolution has arrived (even if everyone is still struggling to figure out what’s what). Four top-notch incubators have emerged in Blueprint Health, Rock Health, HealthBox and Startup Health. They are teaming with the likes of Kauffman Foundation and Mayo Clinic and are gathering startups across the country that let doctors answer questions through an app, manage prescription medications and better manage patient stress.

And other areas of health IT emerged: big data, innovations in electronic medical records and the increasing adoption of chief medical information officers.

Will this perspective on the future of healthcare data be a 2012 mantra?

“Organizations should not have information as a basis for competition. We should work to have data shared so [that] data can be assembled into the most complete picture we can get of an individual. Organizations should then compete on how well they serve an individual based on that information.”

A Sneak Peek: Your Job Will be Different Forever

Your job will be gone. Your job will be contracted. Your job will be exported. Your job will be based on your communication skills. Your job will be done online through Web-based products and you won’t ever see another person again. The future of work is not here, but its foundation was being built in 2011.

Cleveland Clinic’s (Business) Innovations

It was a coming-out party of sorts for Cleveland Clinic Innovations, the commercialization arm of Cleveland Clinic. Innovations started the year with the sale of one of its spinoffs to Boston Scientific, which netted the health system $28 million. It also made a groundbreaking commercialization partnership with another hospital system.

It built on its big Boston Scientific exit with big “entrances.” The leader of the Kansas Bioscience Authority joined the Innovations team to expand research collaborations and this month received an $11 million donation to help with its growth.

How has Innovation built its success? We got some insider insight on that this year: Chris Coburn, the leader of Cleveland Clinic Innovations, gets a share of the exits.

Mayo Clinic’s (Social) Innovation

Mayo Clinic’s digital dominance continued this year: It launched its own version of Facebook, a series of Spanish-language social media feeds and took over the healthcare twitter conversation during its healthcare social media conference. If you were linked with Charlie Sheen in 2011, you were, well, #winning.

The impact is bigger than Mayo. The world of content and information is changing because of healthcare social media. More and more, patients are looking to hospitals over traditional media for healthcare information.

Show me the money (NIH style)

Venture capital can’t be the only way to grow a life science business these days. So everyone is on the search for dollars (and who has them). Who has the NIH dollars? States like California, Massachusetts and New York, and institutions like Johns Hopkins, University of Pennsylvania and the University of Washington.

The New Face of a Blockbuster Drug

Benlysta won U.S. Food and Drug Administration approval this year — showing that the definition of blockbuster has changed: “expensive products targeting ever more specific segments of the patient population. And as GSK and other pharmaceutical companies continue working on biologics, expect more of this to come.”

Everyone Loves a Good Rivalry (and Good Doctors)

Everyone loves trash talk. How do we know? The single-most popular story in 2011 was about the storied sports-like rivalry between Cleveland Clinic and its neighbor, University Hospitals that included an allusion that, nowadays, healthcare rivalries nationally and locally may be the hottest ones around.

How’s this for trash talk, hospital style (from the story’s comments section): “I think most in the Clinic see it like this: “UH thinks it competes against the Clinic, the Clinic thinks there is no competition.” On the peds front, I hear the Clinic see’s more peds patients then Rainbow does. The Clinic’s peds specialties have doubled in the last few years. I think Rainbow better watch out.”

But people love something else about hospitals: good doctors, like the lists we ran of the greatest Cleveland Clinic and Mayo Clinic doctors in history.

Here’s to an innovative and feisty 2012.

Benjamin Spock died in 1998 and soon after that, his famous book has had one co-author: Dr. Robert Needlman.

Needlman is a pediatrician at MetroHealth Medical Center and associate professor of pediatrics at Case Western Reserve University. He’s also a graduate of Yale Medical School and worked at Boston City Hospital. He’d been part of a team working on Drspock.com and got the job as the new Dr. Spock when he interviewed with Spock’s widow.

Needlman already was among a team of medical experts developing content for www.drspock.com when he went to dinner with Morgan more than a decade ago to discuss becoming the revising author of the eighth edition of Dr. Spock’s Baby and Child Care.

During the dinner, Needlman suddenly told Morgan he needed to leave.

Morgan was perplexed — until he explained that he had a nightly tradition of reading with his daughter, Grace, then 10, even when he was out of town and had to read over the phone.

He got the job.

“I said, ‘This is the kind of person that Ben would want to carry on his work,’ ” Morgan recalled.

Needlman has been sharing top billing with Spock for years on various books and handled the eighth edition of Spock’s famous book as well. The ninth edition of Dr. Spock’s Baby and Child Care, released Tuesday, adds advice on everything from immunizations and obesity to special needs children and video games.

Needlman had a literary reputation beyond Dr. Spock. His undergraduate degree at Yale was in English literature. While in Boston he helped start Reach out and Read, a  nonprofit that promotes the value of reading out loud to children. He’s also written for Yahoo! and Parent and Child Magazine.

[Photos courtesy of Wikimedia commons and Primrose Schools]

UPDATE: Morgan writes with these addendums.

Cleveland Clinic did what all health systems do in mid-December: send out news-you-can-use, 2012 predictions about better health in the coming year. This one included top medical tests people should get in 2012.

Unfortunately, one of the leading media watchdogs on health news treated the tips like a bad infection. And now the release — which I couldn’t find on the Cleveland Clinic’s website — has become a symbol for a hot-button topic among medical professionals and media types: poor and cheesy medical information.

Gary Schwitzer of HealthNewsReview.org took aim on Dec. 19 at the Cleveland Clinic’s news tips. That critique has popped up across health sites since then and most recently on Dr. Val Jones’ GetterBetterHealth.com.

Schwitzer’s site usually targets news media outlets and is dedicated to improving the accuracy of news stories about medical information with the goal of “helping consumers evaluate the evidence for and against new ideas in healthcare.” Its criteria: accuracy, balance and completeness.

Schwitzer’s takedown of the release was merciless, particularly around the tests for men. He quoted the lists and offered his critique afterward (in red).

• “High-sensitive C-reactive protein — High levels of this inflammatory biomarker are predictive for future heart problems.” But the US Preventive Services Task Force, by comparison, states that “the evidence is insufficient to assess the balance of benefits and harms of using high-sensitivity C-reactive protein to screen asymptomatic men and women with no history of coronary heart disease.”
• “Vitamin D level — Low levels are associated with osteopenia, osteoporosis, breast cancer, colon cancer and heart disease.” But the Endocrine Society, by comparison, published a guideline recommending that doctors “screen for vitamin D deficiency in people at risk for deficiency, including obese individuals, blacks, pregnant and lactating women, and patients with malabsorption syndromes. “We do not recommend population screening for vitamin D deficiency in individuals who are not at risk,” the Society’s task force chair said.
• “PSA level — To screen for prostate cancer.” Do we really need to go through this again? The US Preventive Services Task Force doesn’t make that recommendation. The American Cancer Society doesn’t. This kind of blanket recommendation for men of all ages to be screened for prostate cancer does not reflect the growing call for fully informed, shared decision-making to take place regarding PSA testing.

Schwitzer goes on to take on the women’s side of the health tips, in particular: “Women do not have to have the PSA test, but they should have a routine breast exam and pap smear.”

But, by comparison, the USPSTF states that “the current evidence is insufficient to assess the additional benefits and harms of clinical breast examination beyond screening mammography in women 40 years or older” and the Memorial Sloan-Kettering Cancer Center states that clinical breast exam “adds little to mammography in reducing breast cancer deaths.”

He ends the entry by saying: “We’re going to see a lot of these ‘what to do in the New Year’ health tips columns. We hope more of them are more evidence-based than this one was. And we hope that journalists don’t act on these news tips without doing their own  homework on the state of the evidence.”

Cleveland Clinic didn’t respond for a request for comment.

Health systems are going to be getting more of this scrutiny, which is typically reserved for journalists or academic journals. Cleveland Clinic’s media relations section actually takes you to a section called the Cleveland Clinic Newsroom. That’s a completely appropriate title, by the way, in an era where hospitals are even more trusted than journalistic enterprises like WebMD.

Three people including two Mayo Clinic workers were killed in a Mayo Clinic helicopter crash in Florida on Monday. The cause of the crash and names of the victims are still unknown. But the accident will likely increase the already growing scrutiny on using helicopters for the transport of medical personnel.

The aircraft used in this flight was from a private service and is used for everything from emergency medical services to firefighting to corporate transportation. It’s been identified as a Bell 206. That’s  not unique to healthcare, but it’s also not the “air ambulances” the public associates with medical transport.

It’s been an intense 18 months for the practice of using helicopters for healthcare. Medical helicopter pilots were labeled as flying the “most dangerous missions in aviation” and the “most dangerous profession in America” in a July 2010 article in Popular Mechanics. Some states were using helicopters unnecessarily, the article found, and they have fewer equipment requirements and poorer protocols — around things as pedestrian as weather checks — than other kinds of flights.

Part of the reason for the dangers were from an early era as the practice grew. As of mid-2010, the fatal accident rate on medical helicopters was 1.18 per 100,000 hours. Meanwhile, the rate for all general aviation and air taxi flights is 1.13 per 100, 000 hours, according to the Federal Aviation Administration. For helicopters specifically, the rate can vary between 1 and 1.94 per 100,000 hours.

But there remains a consensus that, in general, helicopters used for medical purposes are not safe enough. The National Transportation Safety Board earlier this year said current helicopter EMS accident records are unacceptable.

More specifically, there’s a big difference in how safe one helicopter is to another. The NTSB pointed out that no matter the cost and makeup of the helicopter — a $800,000 single-engine model versus a $12 million twin-engine autopilot air ambulance — Medicare reimbursement is the same.

Monday’s Mayo Clinic organ transplant flight accident is different than many medical flights. But that won’t stop the safety debate from restarting. And even these flights aren’t without challenges. According to the Associated Press, a surgeon and an assistant flying to pick up a donor heart died in 1990 crash in New Mexico. In 2007, a twin-engine plane transporting a set of lungs crashed into Lake Michigan.

Key questions to be answered about any medical helicopter accident will involve:

• equipment for the pilots
• whether the pilots had scenario-based simulator training and if they had instrument proficiency training
• the kind of autopilot and navigation equipment on the helicopter

It’s unclear what’s happened at the FAA in the past year. The Popular Mechanics article and intensified scrutiny around air ambulances triggered both voluntary safety measures and federal rule proposals. More helicopters came with helmets equipped with night vision goggles, for example. A rule proposed by the FAA in 2010 received final comments in January of this year. It included requirements around pre-flight checks, minimum weather requirements and training — some of which a trade association had already required or implemented.

But the FAA regulation bogged down — due in part to partisan issues around the FAA — and the rule has not yet been implemented.

[Image from News4Jax.com]

Minnesota — the land of a thousand lakes and nearly as many struggling life sciences incubators — has a new early stage facilitator that’s getting its sea legs. The Sister Kenny Research Institute has spent the last few years developing an incubator that leverages its mix of clinicians, innovators, graduate students and a tiny bit of cash to drive nascent medical device companies.

“With thousands of dollars, we can get to a proof-of-concept as opposed to hundreds of thousands of dollars externally,” Lars Oddsson, the director of research at the Sister Kenny Research Center, told the Star-Tribune.

The research center, which is part of the Allina health system, takes equity and also applies what it learns from the startups to improve healthcare delivery. In turn, the center provides some capital, helps with grants, leverages some graduate students and provides access to its network of clinicians. Organizers think it’s the ideal time to build this model because it’s increasingly harder to get early stage dollars in the medical device space.

Their focus is on wellness, prevention and cost containment. The group is setting up a seed fund right now.

The center is different in part because they’re an incubator along the lines of a Rock Health but with a built-in collection of healthcare customers and experts right there that can make it easy for the entrepreneur to access necessary resources and feedback. But they’re not a venturing arm like Cleveland Clinic Innovations.

The Sister Kenny Research Center has at least four products in its portfolio:

• StepWiz, which makes a device that can measure and predict future falling from a patient;
• SKOTEE, a personal robot to help with home healthcare and increase adoption of telemedicine;
• SmartSock, a sock designed to help patients who are at risk of falling;
• Flamingo, a medical device that places stroke patients in a virtual reality environment that teaches them to regain their balance even as they are lying down.

Three of the four companies are the work of Oddsson and none have exited. The next step for the incubator is to scale: draw in additional innovations from outside entrepreneurs, apply the low-cost approach and make it work.

[Photo courtesy of Xandert]

Current medical news and unique business news for anyone who cares about healthcare.

Is the Affordable Care Act finished? Forbes’ Rick Ungar says the federal government’s decision to give states most of the power in deciding what benefits insurance companies must provide to small business is a cynical political calculation. Obama can now says he respects states rights heading into the next election. But that cold political calculation will undermine the most important benefits (in Ungar’s mind) of “Obamacare.”

“I can already hear the sound of state lobbyists revving up their engines and establishing new bank accounts all over America as they prepare to write the state laws that will best serve the health insurance companies to the disadvantage of the consumers in need of good coverage,” Ungar states.

A medical school primer – for innovators. A self-aware and highly organized medical student is most likely to be an innovator.

And prepare for a new kind of residency: “The program is called a longitudinal integrated clerkship – a training model that veers away from traditional clinical block rotations. Instead of studying different disciplines in chunks, students work with physicians in core specialties continuously throughout the year while simultaneously following a panel of patients representing a wide spectrum of medical conditions.”

What patients want, don’t want that much and don’t want at all. In a not-so-shocking-development, patients want better-faster-cheaper: immediate care, the best medications and treatments, and a continuity of care (speaks in my mind to a need for more telemedicine innovation). They care less about conflicts of interest and efficiency. They don’t care at all about things like “real costs.”

A healthcare economy makes you sad. Some of the most depressing places in the United States are elite medical cities including Philaedelphia (most depressing) and Minneapolis (fourth most depressing).

FDA retreat on antibiotic resistance? “The FDA bent to the will of the drug and meat industries.”

One medical clinic’s lesson on humanity. The holidays are about many things. Remembering our humanity is one of them. Alberto Cairo who handles orthopedic rehabilitation for the Red Cross, discusses how their clinic in Afghanistan found a better way to deliver humanity.

I wrote earlier this week that the pro-Occupy Wall Street crowd could mean big trouble for some of the country’s life sciences capitals.

But a few people pointed out that there’s a reason for some med cities to love this development. Specifically, the regions without public policies that fund investors or life sciences startups.

The gist of my earlier piece was that an increasing number of pundits, 1 percenters and even entrepreneurs are attacking the idea that investors and entrepreneurs create jobs. Instead, they argue that it’s consumers who create jobs by purchasing goods. And, they say, the current economic system is undermining the day-to-day consumers, making it impossible for them to create jobs.

Venture capitalist John Hanauer states: “I can start a business based on a great idea, and initially hire dozens or hundreds of people. But if no one can afford to buy what I have to sell, my business will soon fail and all those jobs will evaporate.

“That’s why I can say with confidence that rich people don’t create jobs, nor do businesses, large or small,” Hanauer added. “What does lead to more employment is the feedback loop between customers and businesses. And only consumers can set in motion a virtuous cycle that allows companies to survive and thrive, and business owners to hire. An ordinary middle-class consumer is far more of a job creator than I ever have been or ever will be.”

At first blush, this is bad news for many elite medical cities. Cities like Cleveland, Minneapolis and Philadelphia are in  states that created programs with public dollars that give tax breaks and cash to early stage and institutional investors. This money then trickles into scores of early stage companies. And many of these startups are life sciences businesses.

Legislators (and voters) support this system because they buy the argument that investors and startups create jobs.

So if more people believe in consumers as the No. 1 job creators, the public subsidies for investing and startups would disappear, angel investing would slow down significantly and some of the venture funds that opened offices in states that offered them public dollars would also leave.

But startups are still going to start. Also, research institutions are better than ever at tech transfer and they’re not going to stop doing it even if there are fewer publicly funded angel groups just around the corner. The research institutions still get a return if their startups succeed in another state.

Companies are going to need to follow the money no matter what state they’re in. Early stage investors, generally, will never be comfortable investing in startup companies that are far away. So these life sciences companies — usually made up of only a handful of people, anyway — will  need to relocate. And if it means a CEO must move from one med city to another (which has the same robust customer base and healthcare economy), most startup leaders will be fine with that.

So why wouldn’t a Research Triangle Park or other medical cities that have few to no state incentives for investment welcome such a re-leveling of the playing field?

I believe that in the next few years, the national rivalries and company-swiping will only intensify. There is already a need for human talent and others resources necessary to make startups grow. That talent and capital deficit is going increase dramatically in some medical sectors.

Regions that have human capital — coupled with investment dollars — will be ahead of other markets.

So for some regions, cheering on the 99 percent — while undercutting another regional competitor’s advantage — could be in their best interests.