Monday, May 18, 2009

The Changing Directives in the EU Medical Device Market

Another missed free webinar. But, the topic deserves some investigation.


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Thursday, April 30, 2009 from 1:00 to 2:00pm (EST)

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Nerac will hold a FREE, online event titled:

The Changing Directives in the EU Medical Device Market

Are You Prepared for the March 2010 Deadline?

The European Union(EU) has revised their Medical Device Directive, which regulates how products are approved for sale within any of the 27 EU member nations. With a rapidly approaching March 2010 deadline to comply with the revised Medical Device Directive, many medical device manufacturers are faced with an enormous amount of work to complete in a short period of time in order to obtain a CE mark for sale of their products.

At stake is maintaining or increasing share in the growing $86 billion market that accounts for a significant percentage of most U.S. medical device companies’ profits. With nearly 8,000 devices on the EU market, it is possible that a backlog of applications could bottleneck approvals, with serious implications for sales and profits.

Many products that used to rely on substantial equivalence will now require a clinical literature review. Clinical literature reviews constitute an effective alternative to time-consuming and costly clinical trials. In addition, post-market surveillance will now be required for CE mark approval. Companies need to analyze product data now to make certain that they have initiated the required procedures to prevent disruptions to their sales pipelines.

We invite you to attend a free webinar hosted by Nerac which will provide an overview of the changes to the Medical Device Directive and discuss what Notified Bodies are expecting when they receive a clinical literature review or post-market surveillance report.

Be sure to register to attend and mark your calendar!

Thursday, April 30, 2009 | 1:00 to 2:00pm (EST)

There are many questions surrounding the implications and requirements of the new Medical Device Directives. Webinar attendees will learn:

  • What are the changes to the EU Medical Device Directive and how do they impact my company?
  • How do clinical literature reviews address the new requirements? What are the benefits of using a clinical literature review?
  • What other options are available to address the requirements?
  • What are the Notified Bodies expecting to see from a clinical literature review?
  • What are some common pitfalls in performing a clinical literature review?
  • How does the approval process work? How can I streamline the process and maximize our chances for success?

Ensure that your company is positioned to comply with the new requirements before March 2010--Join experts from Nerac and TUV-USA for a powerful discussion designed to give you answers to these questions and more.

Who should attend?

· Engineers, Regulatory and Clinical Medical Device Professionals.

Speakers & Topics

Upcoming Changes to EU Medical Device Directive and Use of Clinical Literature Reviews
Deb Schenberger, Ph.D.
Nerac Analyst

The Clinical Evaluation Process
Jennifer Bromm
Medical Products Manager
TUV-USA

The webinar will be interactive, with the opportunity to submit your questions throughout the presentation. Don't miss this exciting, informative event...register here.

To learn more about this topic, read the Nerac Analyst Report "Clinical Literature Reviews | Changes in EU Medical Device Directive require Immediate Steps." Click here to read the report.


Wednesday, May 6, 2009

Implementing Personalized Medicine

Another missed free webinar. But, the topic deserves some investigation.

NERAC WEBINAR SERIES | Industry Insights and Analysis
on Business Challenges, Trends and Opportunities

Sign Up Today - Space is Limited!

Thursday, April 30, 2009 from 1:00 to 2:00pm (EST)

Click here to register.


Nerac will hold a FREE, online event titled:

The Changing Directives in the EU Medical Device Market

Are You Prepared for the March 2010 Deadline?

The European Union(EU) has revised their Medical Device Directive, which regulates how products are approved for sale within any of the 27 EU member nations. With a rapidly approaching March 2010 deadline to comply with the revised Medical Device Directive, many medical device manufacturers are faced with an enormous amount of work to complete in a short period of time in order to obtain a CE mark for sale of their products.

At stake is maintaining or increasing share in the growing $86 billion market that accounts for a significant percentage of most U.S. medical device companies’ profits. With nearly 8,000 devices on the EU market, it is possible that a backlog of applications could bottleneck approvals, with serious implications for sales and profits.

Many products that used to rely on substantial equivalence will now require a clinical literature review. Clinical literature reviews constitute an effective alternative to time-consuming and costly clinical trials. In addition, post-market surveillance will now be required for CE mark approval. Companies need to analyze product data now to make certain that they have initiated the required procedures to prevent disruptions to their sales pipelines.

We invite you to attend a free webinar hosted by Nerac which will provide an overview of the changes to the Medical Device Directive and discuss what Notified Bodies are expecting when they receive a clinical literature review or post-market surveillance report.

Be sure to register to attend and mark your calendar!

Thursday, April 30, 2009 | 1:00 to 2:00pm (EST)

There are many questions surrounding the implications and requirements of the new Medical Device Directives. Webinar attendees will learn:

  • What are the changes to the EU Medical Device Directive and how do they impact my company?
  • How do clinical literature reviews address the new requirements? What are the benefits of using a clinical literature review?
  • What other options are available to address the requirements?
  • What are the Notified Bodies expecting to see from a clinical literature review?
  • What are some common pitfalls in performing a clinical literature review?
  • How does the approval process work? How can I streamline the process and maximize our chances for success?

Ensure that your company is positioned to comply with the new requirements before March 2010--Join experts from Nerac and TUV-USA for a powerful discussion designed to give you answers to these questions and more.

Who should attend?

· Engineers, Regulatory and Clinical Medical Device Professionals.

Speakers & Topics

Upcoming Changes to EU Medical Device Directive and Use of Clinical Literature Reviews
Deb Schenberger, Ph.D.
Nerac Analyst

The Clinical Evaluation Process
Jennifer Bromm
Medical Products Manager
TUV-USA

The webinar will be interactive, with the opportunity to submit your questions throughout the presentation. Don't miss this exciting, informative event...register here.

To learn more about this topic, read the Nerac Analyst Report "Clinical Literature Reviews | Changes in EU Medical Device Directive require Immediate Steps." Click here to read the report.

Monday, May 4, 2009

Five Ways that Team Members Build Trust with Each Other

Another missed free webinar. But, the topic deserves some investigation.

NERAC WEBINAR SERIES | Industry Insights and Analysis
on Business Challenges, Trends and Opportunities

Sign Up Today - Space is Limited!
Thursday, April 30, 2009 from 1:00 to 2:00pm (EST)

Click here to register.

Nerac will hold a FREE, online event titled:
The Changing Directives in the EU Medical Device Market
Are You Prepared for the March 2010 Deadline?
The European Union(EU) has revised their Medical Device Directive, which regulates how products are approved for sale within any of the 27 EU member nations. With a rapidly approaching March 2010 deadline to comply with the revised Medical Device Directive, many medical device manufacturers are faced with an enormous amount of work to complete in a short period of time in order to obtain a CE mark for sale of their products.

At stake is maintaining or increasing share in the growing $86 billion market that accounts for a significant percentage of most U.S. medical device companies’ profits. With nearly 8,000 devices on the EU market, it is possible that a backlog of applications could bottleneck approvals, with serious implications for sales and profits.

Many products that used to rely on substantial equivalence will now require a clinical literature review. Clinical literature reviews constitute an effective alternative to time-consuming and costly clinical trials. In addition, post-market surveillance will now be required for CE mark approval. Companies need to analyze product data now to make certain that they have initiated the required procedures to prevent disruptions to their sales pipelines.

We invite you to attend a free webinar hosted by Nerac which will provide an overview of the changes to the Medical Device Directive and discuss what Notified Bodies are expecting when they receive a clinical literature review or post-market surveillance report.

Be sure to register to attend and mark your calendar!

Thursday, April 30, 2009 | 1:00 to 2:00pm (EST)

There are many questions surrounding the implications and requirements of the new Medical Device Directives. Webinar attendees will learn:
· What are the changes to the EU Medical Device Directive and how do they impact my company?
· How do clinical literature reviews address the new requirements? What are the benefits of using a clinical literature review?
· What other options are available to address the requirements?
· What are the Notified Bodies expecting to see from a clinical literature review?
· What are some common pitfalls in performing a clinical literature review?
· How does the approval process work? How can I streamline the process and maximize our chances for success?
Ensure that your company is positioned to comply with the new requirements before March 2010--Join experts from Nerac and TUV-USA for a powerful discussion designed to give you answers to these questions and more.
Who should attend?
· Engineers, Regulatory and Clinical Medical Device Professionals.
Speakers & Topics
Upcoming Changes to EU Medical Device Directive and Use of Clinical Literature Reviews
Deb Schenberger, Ph.D.
Nerac Analyst
The Clinical Evaluation Process
Jennifer Bromm
Medical Products Manager
TUV-USA
The webinar will be interactive, with the opportunity to submit your questions throughout the presentation. Don't miss this exciting, informative event...register here.

To learn more about this topic, read the Nerac Analyst Report "Clinical Literature Reviews | Changes in EU Medical Device Directive require Immediate Steps." Click here to read the report.

Wednesday, April 8, 2009

Soros says US banks 'basically insolvent'

http://uk.reuters.com/article/bankingfinancial-SP/idUKN0638646120090406?pageNumber=3&virtualBrandChannel=0&sp=true

NEW YORK, April 6 (Reuters) - The U.S. economy is in for "a lasting slowdown" and won't recover this year, while "the banking system as a whole is basically insolvent," billionaire investor George Soros told Reuters Financial Television on Monday.

While nationalization of banks is "out of the question," he said stress tests being conducted by the U.S. Treasury could be a precursor to a more successful recapitalization.

But he warned about the danger of watering down mark-to-market accounting rules, saying this creates conditions for prolonging the life of U.S. 'zombie' banks.

Soros also said the U.S. dollar is under pressure and may eventually be replaced as a world reserve currency, possibly by the IMF's Special Drawing Rights, a synthetic currency basket comprising dollars, euros, yen and sterling.

China recently proposed greater use of Special Drawing Rights, possibly as an eventual global reserve currency.

"In the long run, having an international accounting unit other than the dollar may be to our advantage," Soros said.

He added that the system that has allowed the United States to spend more than it earns has to be reformed. "That is coming to an end and it will not be allowed to recur. There will have to be some change."

While a global recovery is possible in 2010, Soros said the timing will ultimately depend on the depth of the recession. China, he said, will be the first country to emerge from recession, probably this year, and will spearhead global growth in 2010.

He said world policy-makers are "actually beginning to catch up" with the crisis and efforts to fix structural problems in the financial system.

The system was "fundamentally flawed, and there is no returning to where we came from," he said.

EURO-ZONE NOT IN DANGER OF CRACKING

In Europe, he said the crisis provides an incentive for countries that use the euro to remain inside the monetary union, though countries on the periphery still face serious problems.

Soros said the euro has been "a tremendous advantage" to countries that use it, adding there's "no question of a weaker country dropping out."

While additional resources for the International Monetary Fund will help it stabilize struggling Eastern Europe, he said the Baltic states still face "serious problems" and Ukraine is not far from default.

Widespread use of credit default swaps has worsened the risks for Europe, he said, though he added that Germany, the euro zone's biggest economy, is becoming more open to offering help.

"Germany, which has been the most reserved about being the deep pocket of the rest of Europe, has recognized that it too has a responsibility toward the new member states," he said.

Germany has been one of the most reluctant major economies to meet U.S. calls for more fiscal stimulus spending to boost the global economy and fight the financial crisis.

(Editing by Chizu Nomiyama)

((steven.c.johnson@reuters.com; Tel: +1 646 223 6346; Reuters Messaging: steven.c.johnson.reuters.com@reuters.net))

((Multimedia versions of Reuters Top News are now available for: * 3000 Xtra: visit topnews.session.rservices.com

* BridgeStation: view story .134 For more information on Top News: topnews.reuters.com)) Keywords: USA ECONOMY/SOROS

(C) Reuters 2009. All rights reserved. Republication or redistribution ofReuters content, including by caching, framing or similar means, is expresslyprohibited without the prior written consent of Reuters. Reuters and the Reuterssphere logo are registered trademarks and trademarks of the Reuters group ofcompanies around the world.nN06386461

Monday, April 6, 2009

The Little Engine that Could

The Little Engine that Could

Delivered to the Canadian Club, Toronto
Prof. Heather Munroe-Blum
March 30, 2009

Thank you, Helen, for that kind introduction, and thank you to Enna Kaplun and Brett Abernethy of Manulife Financial, which sponsored this event.

I am delighted as well to see so many Toronto leaders here amongst you, and many of McGill’s dedicated campaign volunteer leadership including Senator Michael Meighen of Ogilvy Renault LLP, Eugene McBurney of GMP Securities, Donna Hayes of Harlequin, Tim Casgrain of Skyservice Investments, and Stephen Halperin of Goodmans.

The global meltdown has become a near-obsession, and with good reason. Shrinking revenue streams and bleak investment statements have triggered gut-wrenching anxiety. Yet the downturn is not the biggest crisis Canada faces, though it may be the most publicized. The issue we need to confront is our stubbornly poor performance in building the economy of the future: the Innovation Economy — the creation and marketing of ground-breaking knowledge, and value-added goods and services.

Canada is “the little engine that could” puffing its way up a mountain, and our old “I think I can” optimism is no longer enough. It can be done. But only through strategic, concerted and coordinated action. We need a coherent plan, a coherent vision — and we lack one currently.

First, I will quickly survey Canada’s innovation performance, to demonstrate how businesses, universities and governments are inextricably linked when creating innovation. Then I will propose a new framework of partnership across those sectors essential to drive social well-being with future prosperity. I’m going to talk today about tough challenges, but everything I say stands on a foundation of confidence that Canada has the talent and the resources to make it to the top of that mountain.

Canada’s Innovation Landscape

Established and emerging nations alike are in a race to create meaningful economies in a civil society, and the only ones that succeed will be the Innovators. How is Canada performing? Canada’s innovation scorecard is as uneven as our geography, full of peaks and valleys. Internationally, we’re respected — we’re seen as safe, honest and trustworthy. Our quality of life draws talented people from across the world. At the same time, few of our brands and institutions have global recognition. And we lack transformational international networks — networks that span sectors to strategically mobilize private sector, government, university and community resources.

Our higher education system has developed quality institutions with varied missions: from those focused on a regional agenda to internationally ranked universities driving national and international innovation. Having just returned from France, and seeing the Herculean struggle France faces to reform its undiversified and paralyzed higher education system, has only strengthened my determination that we must nurture Canada’s sometimes serendipitous and underleveraged diversification.

With respect to education, Canada leads OECD countries in those aged 25 to 64 who have completed some form of higher education. Great news, until you look closely. Our college graduation rates rank first in the OECD, but only 24 per cent of our working-age population holds a university degree, a rate that lags fully 10 per cent behind the U.S. Canada ranks second-last amongst 17 peers in terms of PhD graduates – the talent pool that dominantly drives the Innovation Economy, in all sectors. Visionary investment over the past decade at federal and provincial levels has helped Canada to attract, attract back and retain international stars, and to give a shot of adrenalin to university research and scholarship. At McGill alone, we have attracted more than 900 outstanding new professors, over 500 of these recruited from outside Canada, including more than 150 repatriated Canadian stars.

But the times they are a’changing — look south. The new U.S. administration has a vision for higher education, research and innovation and the will to achieve it. Paradoxically, the influx of superb new talent to Canada has had the effect of stretching thin operating funding for research and discovery, and we could quickly face a new brain drain. For those of us who saw Canada lose top talent with the cuts to research of the mid-1990’s, it is clear that we cannot afford to revisit that scenario.

Momentum is hard to build, and to lose it is tragic. Noted American Science Policy Advisor, James Duderstadt, claims that it takes, on average, a decade to build a research program of significance, but only two to three years for neglect to destroy it.

Economically and creatively, new federal and provincial initiatives have mapped a way forward to support vibrant regional clusters: energy in Alberta; aerospace in Quebec; biotech and life sciences in Quebec, Ontario, Saskatchewan and B.C.; information and communications technology in many provinces, to name just a few. But isolated initiatives do not reflect a strategy that builds on the best of the best and propels us to win internationally.

According to your own Toronto guru, Richard Florida, 10 mega-regions, which have only six per cent of the world’s population, “account for 43 per cent of the planet’s economic activity and more than half of its patented innovations and star scientists.” And none of these are in Canada. We are still struggling to create mega-regions out of isolated population clusters. Our business demographics are similarly fragmented — Canada has a huge proportion of smaller businesses, many successful nationally, but relatively few remaining companies large enough or innovative enough to achieve and sustain a stable global profile. Canada’s large number of small- and medium-sized enterprises, or SMEs, tell another story; one of an entrepreneurial people who roll up our sleeves and start businesses wherever we see a niche. Canadian companies also have a good track record in creating new-to-market products. The next move is for these talented individuals with their smart ideas, new products and small businesses to compete internationally.

And to move Canada into a 21st-century Innovation world, business expenditures on R&D, or BERD, must grow dramatically. Canada’s BERD sits at just 1 per cent of Canada’s GDP, two-thirds of the OECD average and about half the U.S. rate. And it has been in decline since 2001. The innovative knowledge emanating from our internationally ranked university research has not been accessed to create a similar surge, in value-added benefits to business and the economy.

What does this add up to? Well, the mountain that the little engine of Canada faces isn’t just the rubble from the global economic crisis. We’ve got one mountain of an innovation problem, and we’ve had it since long before Freddie Mac hit the skids. The Conference Board of Canada scores Canada a “D” in innovation, ranking us 13th of 17 countries. And this at a time when it is essential that we move Canada away from our 19th-century manufacturing and commodities-based economy, to a superbly educated citizenry and a 21st-century innovation-led society. To put Canada’s per-capita income on par with the U.S. in 15 years, if the U.S. stays constant, Canada will have to quadruple its productivity growth.

Not problems, but problem, singular

So how do we fix this? First and foremost, we need to start thinking of innovation as a single system — one formed by the interconnected yet unique contributions of businesses, universities and governments. To get on track, we need a coherent plan to create a system of profound linkages and to analyze and boost innovation productivity across sectors.

Take for example, the troublingly low rate of business investment in R&D. I’ve noted that Canada has a high proportion of SMEs, and SMEs have scant resources to conduct research and development — so it’s just a private sector problem, right? No, it’s a government problem, and a university problem, and a community problem and a business problem.

If we view low BERD as a big-picture “system” problem, we get a very different view, and we see why the government’s attempt to boost private-sector investment with R&D tax credits yields very disappointing results. In fact, more direct government investment in business R&D, rather than tax credits, would allow the best alignment of government and industry goals to strategic investment in targeted and basic university research, and graduate level talent development. The shared platform for building the Innovation Society would provide a sense of common purpose for industry-university-government partnerships. We are missing the opportunity to forge strategic partnerships that would integrate cutting-edge knowledge, talent and research from universities into business and government in a way that creates and sustains results.

As another example of working at odds: Canada’s procurement policies. New “Made-in-Canada” procurement practices would foster a more integrated national market for advanced technologies, furnishing incentives for new industry support for research and development. I don’t advocate protectionism here, but instead advocating that we take selfish advantage of the room we have within our WTO and NAFTA frameworks — as our competitor countries are already doing to their significant benefit. In turn, a bigger market and more business R&D would galvanize demand for graduates with advanced degrees, helping Canada to catch up to its peers and fueling the loop of: education --> talent --> societal impact.

So let’s look at the big picture. Our assets are considerable, but they are fragmented. The various sectors driving innovation are riding on different tracks. Our economic clusters are not as connected or as effective as they could be, within our regions, within our nation or out in the world. Our approach to diagnostics and solutions isn’t stimulating real economic growth and social well-being. There has never been a time when we needed to pull together more than we do now, to preserve our fine Canadian social values as we grow the life amenities for which we are known worldwide. Yet we don’t seem to have a plan. Let me propose one.

I know we can

Basically, to innovate, we must integrate. Canada’s unique ratio of small population to big geography means that Canada is not big enough to accommodate one country, 10 provinces and three territories acting in isolation, hoping to capture the attention of institutions and regions we are all courting around the world. We need a coordinated critical mass of quality and innovation to make a difference at home and abroad. We must commit to being full partners in our innovation system. We must connect. To explain this, I’m going to sketch out five points:

First, having made essential strategic stimulus investments in infrastructure supporting science, technology and innovation, and international graduate students, Canada and its provinces now need to increase investment in the full spectrum of basic research. We need to keep pace with the direction of our peers. Why? Because the seedbed of innovation lies in the curiosity-driven fundamental research that creates the opportunity for applied research and practical and commercial benefits. That’s how Silicon Valley was born. To create a new vaccine, you have to know how the virus’s defences work – that’s basic research from which companies and research teams can convert this knowledge into innovation, by developing new processes and products – for example, a new vaccine.

Second, businesses need to invest substantially more in hiring highly educated talent and in supporting applied R&D. We cannot let the economic crisis scare us into retreating to our comfort zone: that is, “local” perspectives, focusing on traditional economic strengths of manufacturing and the sale of raw commodities. Regardless of economic or political pressures, we have to continue to invest in internationally competitive talent, research, products and services. To build on its existing excellence and reputation, Canada needs system-wide solutions for our low rate of business R&D, one of the most stubbornly persistent causes of our underperformance in innovation and economic productivity.

Third, to attract and fill new knowledge-intensive jobs, we must dramatically raise the percentage of the Canadian population who are university graduates, particularly those with master’s- or doctoral-level education. Roughly 70 per cent of new jobs created in the new economy worldwide require a university degree. Currently only 24 per cent of working-age Canadians hold a degree. That’s a big gap.

Fourth, while we focus on constructing our national system of innovation, we cannot go off the rails internationally. We have to act strategically and in systems, not as individuals, in order to connect Canada to the most innovative regions of the world, and to raise our international profile. Canada has a multitude of individual international partnerships — professor to professor, company to company, government to government, and even professor to company. And these “one-off” partnerships contribute incrementally and sometimes meaningfully.

But the future of high-impact international partnerships, I believe, lies in a new model: one where high performers in the key innovation sectors in Canada — from industry, government and universities — work in targeted partnerships with the key sectoral players in peer countries in those fields; where closest competitors will also be closest collaborators. Strategically targeted, these new partnerships can connect our fragmented clusters into golden mega-regions — Canada-California, or Boston-Montreal-Toronto (and the new accords of collaboration between Québec and Ontario are most encouraging), and create the critical mass needed to complete globally in the Innovation Economy.

And they will do so in a way that reflects a new reality that we must integrally intertwine our social and human values with our means of advancing economic productivity and success, not see one in conflict with the other.

My fifth recommendation is ultimately the most important. We all need to shift away from what the Canadian Council of Chief Executives called “a culture of complacency...a sense that good is good enough.”

The world has changed, and Canada, its provinces and its people must change. We need to recognize that innovation will be the engine of success, and governments must have the courage to invest in highly successful businesses, cities, and institutions. All policies cannot be equalization policies. Regional equity is not a substitute for innovation excellence — as the main event, equalization is a recipe for disaster. Excellence in talent and product, whether from universities or businesses, boosts our reputation abroad. It’s called “free advertising”. With the global economic shakedown and a Canadian productivity and innovation gap that refuses to go away, it’s do or die time.

I titled this talk “The Little Engine that Could,” as a favourite metaphor, that prompted me to think of another defining moment in our nation’s history: the creation of the transcontinental railway. In the 19th century, railways were the defining symbol of progress and technological advance. At the birth of our nation, Canada faced a jumble of unconnected and uncoordinated regional railways, run by a patchwork of different companies on different gauges of track. Even time-keeping wasn’t standardized, making scheduling impossible. Yet somehow, all the different players, fighting for their own interests, in an increasingly enlightened self-interest, began to see the vision of what Canada could become. And they acted on that vision. The fragmented regional lines began to connect.

In October 1873, workers changed the broad gauge track from Montreal to Stratford to the standardized narrow gauge that would allow this line to link to the national system — and they did it in one weekend. Four hundred and twenty-one miles of track changed in just three days. The building of the transcontinental railway wasn’t pretty: there were squabbles and corruption and the shameful shadow cast by the poor treatment of those who laboured to build it. But it was completed, and the new railway was the foundation of Canada’s prosperity and cohesiveness as a nation in the making. They didn’t let short-term greed get in the way of long-term greed.

Our current innovation system is the 21st-century equivalent of Canada’s railways just before the great transcontinental railroad. It’s fragmented and regional. It isn’t fully and effectively connected to the world outside our borders. (How much less valuable would our national railway have been if we never got around to connecting it to the U.S. railroad system?) Often, our different sectors seem to be running on different gauges. But Canada holds incredible promise. A new nation-wide innovation system is, ultimately, what we need to bring us into the new age of enlightenment.

And, like Canada’s first “national dream,” we need a strategy to carry it out, and a broad, distributed leadership with the will to act on it. Canada is filled with talented, skilled and entrepreneurial people — and you, and me, the leaders in this room, are many of the chief creators of change. A pioneering spirit formed Canada into a great nation, and we are still moved by that pioneering spirit. Working together, pioneering strategically, we can meet the new challenge. Whether we like it or not, the train is leaving the station. We can miss it – or, we can get on board.

Thank you.

Sunday, April 5, 2009

At 3M, A Struggle Between Efficiency And Creativity

http://www.businessweek.com/magazine/content/07_24/b4038406.htm



BusinessWeek
JUNE 11, 2007 INSIDE INNOVATION -- IN DEPTH
At 3M, A Struggle Between Efficiency And Creativity
How CEO George Buckley is managing the yin and yang of discipline and imagination


Not too many years ago, the temple of management was General Electric (GE ). Former CEO Jack Welch was the high priest, and his disciples spread the word to executive suites throughout the land. One of his most highly regarded followers, James McNerney, was quickly snatched up by 3M after falling short in the closely watched race to succeed Welch. 3M's board considered McNerney a huge prize, and the company's stock jumped nearly 20% in the days after Dec. 5, 2000, when his selection as CEO was announced. The mere mention of his name made everyone richer.

McNerney was the first outsider to lead the insular St. Paul (Minn.) company in its 100-year history. He had barely stepped off the plane before he announced he would change the DNA of the place. His playbook was vintage GE. McNerney axed 8,000 workers (about 11% of the workforce), intensified the performance-review process, and tightened the purse strings at a company that had become a profligate spender. He also imported GE's vaunted Six Sigma program—a series of management techniques designed to decrease production defects and increase efficiency. Thousands of staffers became trained as Six Sigma "black belts." The plan appeared to work: McNerney jolted 3M's moribund stock back to life and won accolades for bringing discipline to an organization that had become unwieldy, erratic, and sluggish.
Then, four and a half years after arriving, McNerney abruptly left for a bigger opportunity, the top job at Boeing (BA ). Now his successors face a challenging question: whether the relentless emphasis on efficiency had made 3M a less creative company. That's a vitally important issue for a company whose very identity is built on innovation. After all, 3M is the birthplace of masking tape, Thinsulate, and the Post-it note. It is the invention machine whose methods were consecrated in the influential 1994 best-seller Built to Last by Jim Collins and Jerry I. Porras. But those old hits have become distant memories. It has been a long time since the debut of 3M's last game-changing technology: the multilayered optical films that coat liquid-crystal display screens. At the company that has always prided itself on drawing at least one-third of sales from products released in the past five years, today that fraction has slipped to only one-quarter.

Those results are not coincidental. Efficiency programs such as Six Sigma are designed to identify problems in work processes—and then use rigorous measurement to reduce variation and eliminate defects. When these types of initiatives become ingrained in a company's culture, as they did at 3M, creativity can easily get squelched. After all, a breakthrough innovation is something that challenges existing procedures and norms. "Invention is by its very nature a disorderly process," says current CEO George Buckley, who has dialed back many of McNerney's initiatives. "You can't put a Six Sigma process into that area and say, well, I'm getting behind on invention, so I'm going to schedule myself for three good ideas on Wednesday and two on Friday. That's not how creativity works." McNerney declined to comment for this story.

PROUD CREATIVE CULTURE

The tension that Buckley is trying to manage—between innovation and efficiency—is one that's bedeviling CEOs everywhere. There is no doubt that the application of lean and mean work processes at thousands of companies, often through programs with obscure-sounding names such as ISO 9000 and Total Quality Management, has been one of the most important business trends of past decades. But as once-bloated U.S. manufacturers have shaped up and become profitable global competitors, the onus shifts to growth and innovation, especially in today's idea-based, design-obsessed economy. While process excellence demands precision, consistency, and repetition, innovation calls for variation, failure, and serendipity.

Indeed, the very factors that make Six Sigma effective in one context can make it ineffective in another. Traditionally, it uses rigorous statistical analysis to produce unambiguous data that help produce better quality, lower costs, and more efficiency. That all sounds great when you know what outcomes you'd like to control. But what about when there are few facts to go on—or you don't even know the nature of the problem you're trying to define? "New things look very bad on this scale," says MITSloan School of Management professor Eric von Hippel, who has worked with 3M on innovation projects that he says "took a backseat" once Six Sigma settled in. "The more you hardwire a company on total quality management, [the more] it is going to hurt breakthrough innovation," adds Vijay Govindarajan, a management professor at Dartmouth's Tuck School of Business. "The mindset that is needed, the capabilities that are needed, the metrics that are needed, the whole culture that is needed for discontinuous innovation, are fundamentally different."

The exigencies of Wall Street are another matter. Investors liked McNerney's approach to boosting earnings, which may have sacrificed creativity but made up for it in consistency. Profits grew, on average, 22% a year. In Buckley's first year, sales approached $23 billion and profits totaled $1.4 billion, but two quarterly earnings misses and a languishing stock made it a rocky ride. In 2007, Buckley seems to have satisfied many skeptics on the Street, convincing them he can ignite top-line growth without killing the McNerney-led productivity improvements. Shares are up 12% since January.

Buckley's Street cred was hard-won. He's nowhere near the management rock star his predecessor was. McNerney could play the President on TV. He's tall and athletic, with charisma to spare. Buckley is of average height, with a slight middle-age paunch, an informal demeanor, and a scientist's natural curiosity. In the office he prefers checked shirts and khakis to suits and ties. He's bookish and puckish, in the way of a tenured professor.

Buckley, in short, is just the kind of guy who has traditionally thrived at 3M. It was one of the pillars of the "3M Way" that workers could seek out funding from a number of company sources to get their pet projects off the ground. Official company policy allowed employees to use 15% of their time to pursue independent projects. The company explicitly encouraged risk and tolerated failure. 3M's creative culture foreshadowed the one that is currently celebrated unanimously at Google (GOOG ).

Perhaps all of that made it particularly painful for 3M's proud workforce to deal with the hard reality the company faced by the late '90s. Profit and sales growth were wildly erratic. It bungled operations in Asia amid the 1998 financial crisis there. The stock sat out the entire late '90s boom, budging less than 1% from September, 1997, to September, 2000. The flexibility and lack of structure, which had enabled the company's success, had also by then produced a bloated staff and inefficient workflow. So McNerney had plenty of cause to whip things into shape.

GREEN-BELT TRAINING REGIMEN
One of his main tools was Six Sigma, which originated at Motorola (MOT ) in 1986 and became a staple of corporate life in the '90s after it was embraced by GE. The term is now so widely and divergently applied that it's hard to pin down what it actually means. At some companies, Six Sigma is plainly a euphemism for cost-cutting. Others explain it as a tool for analyzing a problem (high shipping costs, for instance) and then using data to solve each component of it. But on a basic level, Six Sigma seeks to remove variability from a process. In that way you avoid errors, or defects, and increase predictability (technically speaking, Six Sigma quality has come to be accepted as no more than 3.4 defects per million).

At 3M, McNerney introduced the two main Six Sigma tools. The first and more traditional version is an acronym known as DMAIC (pronounced "dee-may-ic"), which stands for: define, measure, analyze, improve, control. These five steps are the essence of the Six Sigma approach to problem solving. The other flavor is called Design for Six Sigma, or DFSS, which purports to systematize a new product development process so that something can be made to Six Sigma quality from the start.

Thousands of 3Mers were trained as black belts, an honorific awarded to experts who often act as internal consultants for their companies. Nearly every employee participated in a several-day "green-belt" training regimen, which explained DMAIC and DFSS, familiarized workers with statistics, and showed them how to track data and create charts and tables on a computer program called Minitab. The black belts fanned out and led bigger-scale "black-belt projects," such as increasing production speed 40% by reducing variations and removing wasted steps from manufacturing. They also often oversaw smaller "green-belt projects," such as improving the order fulfillment process. This Six Sigma drive undoubtedly contributed to 3M's astronomical profitability improvements under McNerney; operating margins went from 17% in 2001 to 23% in 2005.

While Six Sigma was invented as a way to improve quality, its main value to corporations now clearly is its ability to save time and money. McNerney arrived at a company that had been criticized for throwing cash at problems. In his first full year, he slashed capital expenditures 22%, from $980 million to $763 million, and 11% more to a trough of $677 million in 2003. As a percentage of sales, capital expenditures dropped from 6.1% in 2001 to just 3.7% in 2003. McNerney also held research and development funding constant from 2001 to 2005, hovering over $1 billion a year. "If you take over a company that's been living on innovation, clearly you can squeeze costs out," says Charles O'Reilly, a Stanford Graduate School of Business management professor. "The question is, what's the long-term damage to the company?"
Under McNerney, the R&D function at 3M was systematized in ways that were unheard of and downright heretical in St. Paul, even though the guidelines would have looked familiar at many other conglomerates. Some employees found the constant analysis stifling. Steven Boyd, a PhD who had worked as a researcher at 3M for 32 years before his job was eliminated in 2004, was one of them. After a couple of months on a research project, he would have to fill in a "red book" with scores of pages worth of charts and tables, analyzing everything from the potential commercial application, to the size of the market, to possible manufacturing concerns.
Traditionally, 3M had been a place where researchers had been given wide latitude to pursue research down whatever alleys they wished. After the arrival of the new boss, the DMAIC process was laid over a phase-review process for innovations—a novelty at 3M. The goal was to speed up and systematize the progress of inventions into the new-product pipeline. The DMAIC questions "are all wonderful considerations, but are they appropriate for somebody who's just trying to...develop some ideas?" asks Boyd. The impact of the Six Sigma regime, according to Boyd and other former 3Mers, was that more predictable, incremental work took precedence over blue-sky research. "You're supposed to be having something that was going to be producing a profit, if not next quarter, it better be the quarter after that," Boyd says.

For a long time, 3M had allowed researchers to spend years testing products. Consider, for example, the Post-it note. Its inventor, Art Fry, a 3M scientist who's now retired, and others fiddled with the idea for several years before the product went into full production in 1980. Early during the Six Sigma effort, after a meeting at which technical employees were briefed on the new process, "we all came to the conclusion that there was no way in the world that anything like a Post-it note would ever emerge from this new system," says Michael Mucci, who worked at 3M for 27 years before his dismissal in 2004. (Mucci has alleged in a class action that 3M engaged in age discrimination; the company says the claims are without merit.)
There has been little formal research on whether the tension between Six Sigma and innovation is inevitable. But the most notable attempt yet, by Wharton School professor Mary Benner and Harvard Business School professor Michael L. Tushman, suggests that Six Sigma will lead to more incremental innovation at the expense of more blue-sky work. The two professors analyzed the types of patents granted to paint and photography companies over a 20-year period, before and after a quality improvement drive. Their work shows that, after the quality push, patents issued based primarily on prior work made up a dramatically larger share of the total, while those not based on prior work dwindled.

Defenders of Six Sigma at 3M claim that a more systematic new-product introduction process allows innovations to get to market faster. But Fry, the Post-it note inventor, disagrees. In fact, he places the blame for 3M's recent lack of innovative sizzle squarely on Six Sigma's application in 3M's research labs. Innovation, he says, is "a numbers game. You have to go through 5,000 to 6,000 raw ideas to find one successful business." Six Sigma would ask, why not eliminate all that waste and just come up with the right idea the first time? That way of thinking, says Fry, can have serious side effects. "What's remarkable is how fast a culture can be torn apart," says Fry, who lives in Maplewood, Minn., just a few minutes south of the corporate campus and pops into the office regularly to help with colleagues' projects. "[McNerney] didn't kill it, because he wasn't here long enough. But if he had been here much longer, I think he could have."

REINVIGORATED WORKFORCE
Buckley, a PhD chemical engineer by training, seems to recognize the cultural ramifications of a process-focused program on an organization whose fate and history is so bound up in inventing new stuff. "You cannot create in that atmosphere of confinement or sameness," Buckley says. "Perhaps one of the mistakes that we made as a company—it's one of the dangers of Six Sigma—is that when you value sameness more than you value creativity, I think you potentially undermine the heart and soul of a company like 3M."

In recent years, the company's reputation as an innovator has been sliding. In 2004, 3M was ranked No. 1 on Boston Consulting Group's Most Innovative Companies list (now the BusinessWeek/BCG list). It dropped to No. 2 in 2005, to No. 3 in 2006, and down to No. 7 this year. "People have kind of forgotten about these guys," says Dev Patnaik, managing associate of innovation consultancy Jump Associates. "When was the last time you saw something innovative or experimental coming out of there?"

Buckley has loosened the reins a bit by removing 3M research scientists' obligation to hew to Six Sigma objectives. There was perhaps a one-size-fits-all approach to the application of Six Sigma as the initial implementation got under way, says Dr. Larry Wendling, a vice-president who directs the "R" in 3M's R&D operation. "Since [McNerney] was driving it to the organization, you know, there were metrics established across the organization and quite frankly, some of them did not make as much sense for the lab as they did other parts of the organization," Wendling says. What sort of metrics? Keeping track of how many black-belt and green-belt projects were completed, for one.

In fact, it's not uncommon for Six Sigma to become an end unto itself. That may be appropriate in an operations context—at the end of the year, it's easy enough for a line manager to count up all the money he's saved by doing green-belt projects. But what 3Mers came to realize is that these financially definitive outcomes were much more elusive in the context of a research lab. "In some cases in the lab it made sense, but in other cases, people were going around dreaming up green-belt programs to fill their quota of green-belt programs for that time period," says Wendling. "We were letting, I think, the process get in the way of doing the actual invention."

To help get the creative juices flowing, Buckley is opening the money spigot—hiking spending on R&D, acquisitions, and capital expenditures. The overall R&D budget will grow 20% this year, to $1.5 billion. Even more significant than the increase in money is Buckley's reallocation of those funds. He's funneling cash into what he calls "core" areas of 3M technology, 45 in all, from abrasives to nanotechnology to flexible electronics. That is another departure from McNerney's priorities; he told BusinessWeek in 2004 that the 3M product with the most promise was skin-care cream Aldara, the centerpiece to a burgeoning pharmaceuticals business. In January, Buckley sold the pharma business for $2 billion.

Quietly, the McNerney legacy is being revised at 3M. While there is no doubt the former CEO brought some positive change to the company, many workers say they are reinvigorated now that the corporate emphasis has shifted from profitability and process discipline to growth and innovation. Timm Hammond, the director of strategic business development, says "[Buckley] has brought back a spark around creativity." Adds Bob Anderson, a business director in 3M's radio frequency identification division: "We feel like we can dream again."

By Brian Hindo

Saturday, April 4, 2009

Japanese scientists try to record people's dreams

Japan's dream machine
(02:02) Report
Apr 3 - Japanese scientists try to record people's dreams.

A Japanese science lab is developing technologies to visualise images and dreams - and eventually read people's minds.

http://uk.reuters.com/news/video?videoId=101445&videoChannel=-9992

Wednesday, April 1, 2009

Collaborative Innovation in Biomedicine


Drivers, Best Practices and Strategies for Pre-Competitive Consortia June 22-23, 2009 Marriott at Metro Center Hotel Washington, DC

Co-Organized with The Critical Path InstituteFinal Agenda Now Available!* View a PDF of the brochure * Register Today and Save! Early Registration Discount ends this Friday, April 3rd.



As the pharmaceutical industry moves closer to what has been described as a "Revenue Cliff", as a number of key patents expire on major drugs, at the same time as the industry confronts the additional challenges of a dramatic decline in pipeline productivity, declining availability of R&D resources, and increased regulatory and business practice pressures, new models for drug discovery and development become critical to the industry's future. Pre-competitive consortia are becoming an important alternative model for accelerating drug discovery and development, while sharing resources and costs. Current consortia have produced some notable successes and provide a valuable approach for better understanding where the best opportunities for collaboration may exist, what strategies to employ and how to win support for such efforts.

This important program will explore pre-competitive, multiple party, consortia-based collaborations in drug discovery and development, examining key questions and issues, including:

  • How should equal partners be brought together?
  • What if the partners are not equal in size or contribution?
  • What is the impact of creating and communicating a compelling Vision and Mission for such consortia?
  • What are the Best Solutions for data contribution and sharing?
  • What Organizational Models work most effectively in which situations?
  • What are the current Best Practices for how such consortia should be organized and managed?
  • What New Models are proven to generate higher levels of IP?
  • How can IP be shared effectively, while being protected?
  • How to move from Collaborative Consortia back into competitive programs.

This leading-edge conference will feature key speakers from pharmaceutical companies and non-profit organizations, with first-hand experience in setting up and managing successful consortia, as we explore the most important new models, key issues, challenges and best practices of Collaborative Innovation in Biomedicine.


Agenda-at-a-Glance:
SUNDAY, JUNE 21, 2009

PRE-CONFERENCE SHORT COURSE:

The Architecture of Collaborative Innovation
Course Leader: Robert Porter Lynch, Chief Executive Officer, The Warren Company; Chairman Emeritus, The Association of Strategic Alliance Professionals, Inc. (ASAP); Author of 5 Books on Strategic Alliances, including "The Architecture of Trust" (to be published in 2009)

MAIN CONFERENCE

MONDAY, JUNE 22, 2009 - DAY ONE

The Power of Collaborative Innovation and the Architecture of Trust
Robert Porter Lynch



Defining Characteristics of Successful Models of Collaborative Innovation
William Mattes, Ph.D., Director, Toxicology, The Critical Path Institute



Revising the Role of Intellectual Property - From Exclusivity to Partnership
Richard Gold, Ph.D., Professor and Director, Center for Intellectual Property Policy, McGill University



Information Flows and IP Control in Pre-Competitive Collaborations
Mark Anthony Mersereau, Esq., PTC Intellectual Property Law, LLC



"Radical Collaboration" - How IBM Transformed the Semiconductor Industry through Pre-Competitive Collaborative Innovation - A Hi-Tech Industry Case Study
Bernard Meyerson, Ph.D., IBM Fellow and Vice President, Strategic Alliances and Chief Technology Officer, Systems and Technology Group, IBM



How Collaborative Innovation Aids the Regulatory Process and Vice-Versa
Bruno Flamion, MD, Ph.D., Professor of Physiology and Pharmacology, University Of Namur, Belgium,and Chairman, Scientific Advice Working Party, The European Medicines Agency (EMEA)


FACILITATING DATA SHARING


Keynote Address
Speeding Research and Development through a Collaborative Ecosystem
Ken Buetow, Ph.D., Associate Director for Bioinformatics and Information Technology and Director of Center for Biomedical Informatics and Information Technology, National Cancer Institute (NCI); Co-founder, caBIG(TM) and The BIG Health Consortium(TM)

Taking a Pre-Competitive Approach to Defining Standards and Leveraging Best Practices to Enable Basic Research Collaboration
Martin Leach, Ph.D., Executive Director, Basic Research & Biomarker IT, Merck & Co., Inc.
Gaining Efficiencies through Open Innovation
Susie Stephens, Ph.D., Principal Research Scientist, Lilly Research Labs, Eli Lilly and Company
Customer Perspective on Pre-Competitive Software Development (tentative)
The Value of and Standards for Facilitated Data Sharing- Collaborative Activities in Research and Healthcare
Rebecca Kush, Ph.D., Founder, President and CEO, Clinical Data Interchange Standards Consortium (CDISC)
Jessica Nadler, Ph.D., AAAS Fellow for Policy and Technology Policy, Department of Health and Human Services


Breakout Round-Table Discussions
Issues of Shared IP from Consortia Research
Moderators: Richard Gold, Ph.D., and Mark A. Mersereau, Esq.
Solutions for Facilitating Data Sharing in Collaborative Research
Moderator: Martin Leach, Ph.D.
Overcoming Resistance to Sharing Drug Safety Results
Moderator: Arthur Holden
Governance, Organizational Management and Trust Building Issues for Consortia
Moderator: Robert Porter Lynch
Shared Development of Tools and Technology
Moderator: Erik Kuja and Catherine Oyler
Working to Enable Regulatory Changes
Moderator: Bruno Flamion, Ph.D.
Information Infrastructure for Collaborative Therapy Development
Jay "Marty" Tennenbaum, Ph.D.

TUESDAY, JUNE 23, 2009 - DAY TWO

Round-Table Reports

CONSORTIA CASE STUDIES

The Innovative Medicines Initiative: Driving a New Paradigm in Pre-Competitive Research
Jackie Hunter, Ph.D., Senior Vice President, Science Environment Development, GlaxoSmithKline


Successes and Renewal of the Dundee Signaling Consortium
Malcolm M. Skingle, Ph.D., Director, European Academic Liaison, Genetic & Discovery Alliances, GlaxoSmithKline


Where No One Has Gone Before - A Collaborative Model to De-risk Discovery and Development of First-in-Class Therapies (How Non-Profits can use their Mission to be a Unique Convener of Pre-Competitive Collaborations)
Russell "Rusty" Bromley, Chief Operating Officer, Myelin Repair Foundation


Enlight Biosciences and Related Examples: Pre-competitive Collaboration to Ensure Development and Acceptance of Critical New Technology
Erik Kuja, Strategic Alliances, Pfizer Worldwide Business Development
Catherine Oyler, Senior Director, Emerging Technologies, Corporate Office of Science and Technology, Johnson & Johnson

DRUG SAFETY CONSORTIA


The Serious Adverse Event Consortium, Ltd. [SAEC] - Formation and Current Status of an International Effort to Understand the Genetic Basis of Drug Related Serious Adverse Events
Arthur Holden, Chairman and Chief Executive Officer, Serious Adverse Events Consortium; Former Chairman and Chief Executive Officer, Pharmaceutical Biomedical Research Consortium Ltd.; Former Chairman, The SNP Consortium

The Drug Safety Executive Council (DSEC) Efforts in Collaborative Drug Safety Evaluation
Ernie Bush, Ph.D., Vice President and Scientific Director, Preclinical Safety, Cambridge Healthtech Associates

Luncheon Presentation:
Health Commons: An e-Business Approach to Collaborative Therapy Development

Jay "Marty" Tennenbaum, Ph.D., Chairman and Chief Scientist, CollabRx, Inc.

CONSORTIA CASE STUDIES (Continued)
BIOMARKER CONSORTIA


HESI's Experience in Collaborative Approaches to Science
Syril D. Pettit, M.E.M., Associate Director, Scientific Outreach, ILSI Health and Environmental Sciences Institute (HESI)

The Predictive Safety Testing Consortium: Advancing Translational Toxicology through Inter-disciplinary and Inter-organizational Collaboration
Elizabeth Walker, Ph.D., Assistant Director, Toxicology, Predictive Safety Testing Consortium, The Critical Path Institute


The Future of Pre-Competitive Consortia - A Best Practices Panel Discussion
Discussion Leader:
William Mattes, Ph.D., Director, Toxicology, The Critical Path Institute
Panelists:
Jay "Marty" Tennenbaum, Ph.D., Chairman and Chief Scientist, CollabRx, Inc.
Arthur Holden, Chairman and Chief Executive Officer, Serious Adverse Events Consortium
Martin Leach, Ph.D., Executive Director, Basic Research & Biomarker IT, Merck & Co., Inc.
Jackie Hunter, Ph.D., Senior Vice President, Science Environment Development, GlaxoSmithKline


Be part of this leading-edge conference...
Register Early and Save up to $350!



Corporate Sponsor:
PTC Intellectual Property Law LLC


For information on sponsorships and exhibits, please contact:
Arnie Wolfson
Manager, Business Development
Phone: 781-972-5431
E-mail:
awolfson@healthtech.com


For detailed information on this event and to register, visit: http://www.healthtech.com/cbi


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