There are only 70 or so days left in 2012, but that doesn’t mean there isn’t a lot of critical activity still in play. Here are a couple of things to keep track of.
November 6: Who will choose the new faces on the Supreme Court?
Several members of the Supreme Court are approaching retirement, which makes the upcoming presidential election even more important. Justice Ruth Bader Ginsburg is 79 and nearly certain to vacate her seat before 2016. Justices Scalia and Kennedy are both 76, while Justice Breyer is 74. How many of these last three will hang it up over the next four years?
A second Obama administration will bring in a demonstrated liberal to replace Ginsburg, although the flame-out of the nomination of Goodwin Liu to the Ninth Appeals Court in 2010 suggests the White House will try a candidate who is less extreme than Liu. A Romney administration would no doubt nominate a reliable but not radical conservative.
If Obama wins, the balance of power on the Supreme Court will look much the way it does now assuming Ginsberg is the only retiree, while a Romney win would shift things in a way that could be meaningful to life science patents despite the outcome in Prometheus.
Making a forecast becomes dicier if you go beyond Ginsberg. There’s a decent chance Breyer would try to hold out ‘til 2016, especially if Romney wins, but Kennedy and Scalia would have to stick around to the age of 80 to pull that off.
Why is this important? Anyone who thinks the Myriad case will close the book on life science patent law is badly mistaken. Myriad may or may not become something of a template for gene patents, but what then of proteomics? What of the software used in medical devices and electronic health records?
If there’s one thing on which I’d bet everything I have, it’s that we’ve seen only the beginning of life science patent lawsuits here in the 21st Century, and if you think the stent patent wars have been intense, just wait. This isn’t over by a long shot, folks, which makes these Supreme Court retirements – and by extension the election – critical.
Supreme Court and Myriad
Will the Supreme Court agree to hear Myriad at long last? We’ve discussed it before, so there’s no point in rehashing the basics.
Those who assume the Supremes will take a crack at Myriad think the nine justices weren’t impressed with the decision rendered earlier this year by the Court of Appeals for the Federal Circuit, especially given what was widely thought to be an instructive decision in Prometheus. We should also bear in mind that Breyer’s views in Prometheus echoed his dissent in Classen, which include that the Court should not be influenced by the prospect that invalidation of a patent might wipe out an entire industry.
Those in the life sciences will not be encouraged if the case snares a writ of certiorari but for what it’s worth, Chief Justice Roberts won’t try to duck a conflict between Republicans and Democrats in this lawsuit, as he clearly was attempting to in the healthcare reform case.
It’s sometimes tough to predict Kennedy’s vote, but Scalia, Alito and perhaps Thomas can be relied on to at least consider the huge sums invested in these areas, although Thomas’s vote in Wyeth v. Levine might make him seem something of a wild card. Ginsburg, Sotomayor and Kagan are guaranteed to march in lockstep with Breyer.
I wouldn’t bet a nickel on the outcome of a Supreme review of Myriad, but it’s a cinch the courtroom will be packed and a lot of people are going to be outraged at the outcome and call for the Court’s collective neck. Pardon the cliché, but you definitely will want to stay tuned to this one.
We have been hearing a lot about the death of innovation in the field of medical technology for the past few years, a victim; it would appear, of a sluggish worldwide economy and more stringent regulation and reimbursement policies. However, a closer look reveals that medical device innovation is still very much alive, and will continue to thrive both in the U.S. and overseas.Medical Device Daily’s “Med-Tech on a Mission: Strategies to Drive Innovation” addresses the status, prospects and challenges that epitomize this market and identifies distinctive research agendas and tactical business development approaches that have the proven records, or the potential capacity, to drive this sector through its ongoing transformation into a market for the new millennium.
This report is designed to provide a unique insight into the complex and complicated world of med-tech innovation, the lifeblood of the industry that is threatened on both the funding and regulatory fronts. Finding financing, securing partners and distinguishing market opportunity has become more problematic in the ongoing economic downturn, so this report is designed to identify trends, potential partners and innovative companies that can facilitate the subscriber’s corporate strategies.
One chapter of the book is dedicated to a stellar panel, moderated by Jim Stommen, Medical Device Daily’s former executive editor, which includes innovators, executives and investors who have made unique contributions to the med-tech sector. Panelists include Thomas Fogarty, MD, PhD, president of Fogarty Research & Development; Perry Genova, PhD, founder and CEO of medical device start-up firm Oncoscope; Arlen Meyers, MD, president/CEO of the Society of Physician Entrepreneurs; and Kevin Schulman, MD, professor of medicine in the Duke University School of Medicine.
This incredible lineup of med-tech talent expressed optimism that innovation can continue to thrive in the U.S., but expressed a concern that more rigid regulation and pricing pressure may drive much of that exploration overseas, which would be a disaster.
Fogerty noted that probably a third of the information being presented at major medical meetings is coming from people who reside outside the U.S. “When I first entered this field 40 years ago, probably 90% of what was presented in the way of valuable new information came from the United States. Not anymore, and I don’t think that is a welcome direction by any means.”
Schulman cautioned investors from looking at the overseas market as the ultimate panacea. “I think we’re seeing strategies that are not predicated solely on the U.S. market. Obviously everyone in the medical device industry is looking at emerging markets in hopes that they are the Holy Grail, but they may prove to be even more challenging; we’ll wait to see. And in terms of venture capital, it’s going to go where it can get the best return. As investment funding goes away from social networking, I think it will come back to healthcare, but it’s still going to be asking tough questions before they put money down.” He added that in the U.S. “Innovative funding mechanisms will replace old models: Crowd funding, superangels, possible government funding of technology transfer offices, state and local support for SBIR recipients, proof of concept funds, super accelerators.”
In addition to the one-of-a-kind roundtable panel, “Med-Tech on a Mission” features a wealth of singular interviews conducted by Stommen with individuals who are truly representative med-tech movers and shakers that comprise a wide range of aspects of the market.
There is also a chapter on strategic data that highlight trends in financing, innovation and business development practices that have characterized the market during its most recent 12 months are displayed in graphics that depict an aggressive market that has averaged more than two industry deals per day by medical technology companies and investors, financiers and business partners
The book also contains interviews with innovative new companies and delves into how these companies continue to find funding and conduct clinical trials in the face of difficult financial and regulatory challenges.
For more information on this new insightful report,and to order your very own copy, please go here .
[caption id="attachment_1958" align="alignleft" width="300"] Hotline to FDA, but should we use it?[/caption]
Most of the entries here at the MDD Perspectives blog address med tech, but I’m going to go off topic and address the compounding pharmacy issue, because it is at risk of becoming an FDA issue.
As we all know, the New England Compounding Pharmacy (NECP) is said to be the source of the tainted methylprednisolone injections that led to the multiple cases of meningitis, and now the predictable cry has gone out to have FDA regulate compounding pharmacies. The idea is understandable, but let’s find out what’s involved before we let our patella tendons get the better of us.
How many more inspections can FDA really handle?By some accounts, there are 7,500 compounding pharmacies in the U.S., roughly 3,000 of which produce sterile drugs. If one presumes that only the 3,000 operations processing sterile drugs present a sufficient risk to be routinely inspected, that’s 1,500 pharmacies every year.
I’ll go out on an limb and say FDA’s Center for Drug Evaluation and Research is in no position to suddenly manage 1,500 additional inspections a year, let alone more than 3,700. At a time when the agency is struggling to keep up with its current domestic inspection load and catch up to all the foreign facilities making finished drugs and active pharmaceutical ingredients, another 30 inspections a week are flatly out of the question.
Another question is whether FDA oversight would have prevented this episode. It’s tempting to say unequivocally yes, but it’s not entirely clear how long it took NECP’s operations to fall into such a state of disarray. If the decay set in starting less than two years ago, FDA oversight wouldn’t have changed a thing if you’re counting on inspections to do the trick. I would point out there are other factors that torque the inspection argument as well.
Regulation on the cheap? Don’t bet on it
The ramifications of FDA regulation of compounding pharmacies are not exactly benign, either. Can you imagine batch testing in a compounding pharmacy? No, of course not. The alternative? One imagines it would be the use of analytical equipment characteristic of the quality-by-design program instituted several years ago by CDER. In other words, plenty of mass spectrometers and liquid and gas chromatographs.
Now maybe compounding pharmacies already use that kind of equipment, but it’s a cinch they’d need a lot more. And they’d still have to validate all kinds of processes for each small batch of drug. I think it’s pretty safe to say the typical compounding pharmacy’s cost of doing business would double under an FDA regime.
Anyone ready to tell patients they have to pay double when there’s no certain benefit to be had?
The final damning fact for those who want FDA to take this over is the absence of a systemic problem. There have been other episodes of problems with compounding, but even FDA’s data do not indicate a tsunami of bad drugs coming out of compounding labs. Furthermore, this problem is the result of bungling by the authorities in the Bay State, and a bit more vigilance by the administration of Governor Deval Patrick wouldn’t hurt, but nobody’s calling him out, curiously.
I’m not minimizing the deaths and the illnesses, but there is no evidence at all that putting FDA in charge of compounding pharmacies would have prevented this episode.
Furthermore, this business of running to the federal government every time something untoward happens carries another risk, one that may dwarf what just happened. If budget issues – such as sequestration – clip FDA’s budget dramatically and the states stop keeping tabs on compounding pharmacies, who’s watching out for the patients then?
As the saying goes, be careful what you wish for.
[caption id="attachment_1946" align="alignleft" width="300"] Some collectives work. Others discuss interoperability consensus[/caption]
Trekkies and non-Trekkies alike will recognize the expression “resistance is futile” as a favored saying among the drones of the Borg collective of Star Trek fame. Obviously I’m paraphrasing with the title of this essay, but let’s ask ourselves a question: Is it a big deal that the Department of Health and Human Services still does not have an agreed-upon standard for electronic health record (EHR) interoperability?
HHS has been yakking about this since 2005, when Mike Leavitt ran the department. Now we have Kathleen Sebelius and still no standard for EHR interoperability. Seven years and a few agreed-upon components, but no complete standard. Just for a little perspective, let’s look at some things that have been accomplished in seven years or less.
On September 12, 1962, President Jack Kennedy delivered his go-to-the-moon speech. On July 20, 1969, the recently departed Neil Armstrong delivered the first human footprint on the lunar surface along with the famous remark about a giant leap for mankind. Elapsed time? Just a bit less than seven years. And it was a government job.
China’s Great Leap Forward was an attempt to industrialize agriculture and resulted in the forced starvation of as many as 45 million people. Chairman Mao Zedong undertook a process he knew from the history of Russia would cost millions of lives. How long did it take? A mere three years were required to force 45 million people to starve to death. This, too, was a government job.
Construction began on the newest holder of the title of the world’s tallest building, the Burj Khalifa, in September 2004 and the building opened for business in January 2010. The cost of the building has been estimated at $1.5 billion, which is a lot less than the U.S. government has plowed into EHR bribes to doctors and hospitals. Elapsed time? Six years.
On the other hand, let’s acknowledge one advantage the builder of Burj Khalifa had over government. Construction workers – most of who probably held no better than a high school diploma – did the building whereas bureaucrats with MDs and PhDs are tasked with doing EHR interoperability. Maybe it’s not a fair comparison.
So there you go. After seven years and tens of billions of dollars, Washington is still playing games with interoperability standards after more time than it took to put a man on the moon or build the world’s tallest building, and more than twice the time it took to starve tens of millions of citizens of China to death. Bravo, HHS, bravo.
Now for HHS’s next act of persistent futility: ICD-10.
[caption id="attachment_1919" align="alignleft" width="150"] Mike Dunford of Covidien is a mentor in AdvaMed's new military veteran program[/caption]
One of the many lessons I have learned as an Army wife is that in the military, if you’re not at least five minutes early to an appointment, you’re late. So I had to laugh when Mike Dunford, senior VP of human resources at Covidien (Dublin, Ireland and Mansfield, Massachusetts), told me that in a room full of military veterans, “by 7:40 everybody was in their chairs and ready to go” for an 8 a.m. meeting Monday.
Dunford, a former Marine, is a mentor in the first Medical Technology Veterans Program (MVP) Boot Camp for Returning Heroes, which kicked off this week at AdvaMed in Boston. Veterans from all military ranks and branches from around the U.S. have spent the past three days learning about opportunities in the medical device industry and attending career development workshops that explore military skill translation, resume writing, networking techniques, and interviewing tips.
It’s that sense of work ethic and being on time, among other important traits, that make military veterans a good fit for careers in medtech, Dunford said. Each of the 25 veterans in the year-long program has been assigned a mentor. Like Dunford, the program mentors are all veterans themselves who currently work in the med-tech industry at companies such as Abiomed (Danvers, Massachusetts), Boston Scientific (Natick, Massachusetts), Haemonetics (Braintree, Massachusetts), and Covidien. The mentors’ role is to guide these veterans during their career transition.
The program fulfills an important need in this country as the latest jobs report shows a nearly 11% unemployment rate for veterans of Iraq and Afghanistan, that’s 50% higher than the U.S. average unemployment rate.
Dunford said another important character trait that veterans bring to the med-tech table, in his experience, is adaptability. In this industry, he says, “we’re changing everyday.”Those changes come both from within a company through acquisitions, as well as outside of a specific company, such as changes in the way new products are approved or reimbursed.
“Knowing that you can get folks into the organization that can adapt to their environment is important, not everybody can [adapt],” Dunford said. “This is a pool of talent that we need to leverage across the industry because they’re out there. That’s what I really want these folks to understand is that we want them as much as they want opportunity.”
Michael Minogue, president/CEO and chairman of Abiomed and an Army veteran himself, helped establish the MVP after speaking with wounded service members at last year's AdvaMed meeting. Minogue said he has also noticed many similarities between the military and the medical device industry. First and foremost, he says, is the sense of a mission and a dedication of helping and serving others, closely followed by the ability to constantly adapt to a changing environment.
The new program is designed to give military veterans an idea of how to package themselves so that they can get a full-time job after they separate from the military, Minogue said. Of the 25 veterans selected for the MVP boot camp, 25% are women and 52% are wounded or disabled.
In addition to the MVP boot camp at AdvaMed, another component of the program is the creation of a professional networking website, www.medicaltechnologyveterans.org, which Minogue says will be the industry’s version of LinkedIn for military veterans. “That’s going to be a huge win,” Minogue said, because it will have a broader reach than the boot camp.