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Annual survey from Emergo Group finds growing international reports:
A new survey by medical device regulatory consultancy Emergo Group has found that medical device manufacturers' international sales growth rates continued to outpace their domestic business in 2011, demonstrating the increasingly global nature of the industry.
The survey of more than 2,600 medical device industry participants showed that more than 53% of respondents reported increased international sales in 2011, compared to nearly 42% of respondents reporting growth in domestic sales.
US versus EU: Preferences Emerge
Another key finding in the survey examines claims that a more cumbersome FDA registration process has led more and more manufacturers to commercialize their devices first in Europe. Although nearly 22% of participants indicated that the European CE Marking process for medical devices became more difficult in 2011 due partly to stricter clinical data requirements, more than half of participants have found the US FDA registration process to be more difficult since 2010.
While most North American participants still prefer to launch products in the US first-and most European firms prefer to launch in Europe first-nearly 40% of North American participants stated they'd choose Europe as their first path to market. Only 17% of European firms would consider launching products in the US first.
"These results seem to validate industry perceptions that the US regulatory process has grown more complicated since 2010, and that European registration is in comparison more transparent and predictable for manufacturers," says Stewart Eisenhart, Regulatory Editor for Emergo Group.
Read more from SFGate
Read the full results of Emergo Group's 2012 Medical Device Industry Survey
From WSJ - FEBRUARY 2, 2012
Medical-device companies have reached a tentative deal to pay the Food and Drug Administration $595 million over five years to increase the number of federal workers who approve devices and get new devices on the market faster.
The deal is more than double the $287 million the industry currently pays the agency in "user fees"—money paid by companies seeking to get a new device approved. For the first time, the agency will have hard-and-fast goals for how long it can take to approve devices on average before they go to market.
The agreement will beef up the number of full-time employees in the FDA's Center for Devices and Radiological Health considering applications for medical-device approval. It is expected to increase review staffing at the center by about 200 employees, from the current 1,001, over the course of the agreement. One goal is to bolster safety of medical devices, a hot topic given the relatively high failure and recall rates of devices like heart defibrillator wires and metal hip joints.
Diana Zuckerman, president of the National Research Center for Women & Families, said the new user fees still won't be enough when devices fail. In the case of metal hips, she said, "FDA had to calculate the adverse reactions, review the data on the high revision rate, work with the company regarding the recall of that device, and respond to congressional and media questions about that defective device."
Stephen J. Ubl, chief executive of the industry trade group AdvaMed, said, "The establishment of total time goals for device approval is a big deal." He said the new deadlines will mean that "the agency has an interest in ensuring that its requests for information are reasonable."
The agreement comes after what people familiar with the talks said were particularly acrimonious negotiations. The talks stretched over more than a year, and the FDA failed to meet a mid-January deadline for when it was supposed to get a deal to Congress.
The FDA's medical-device division has been under pressure both from industry and from safety advocates. Last year, a panel from theinfluential Institute of Medicine recommended the FDA's device division should give more intense, and lengthy, scrutiny to thousands of devices that currently get only an abbreviated review.
But at the same time, companies have complained about the unpredictable time it takes to get devices approved, with some approvals taking years. One prominent device inventor, Robert Fischell, testified last summer before Congress that the FDA's device center "is the worst that I have experienced in my 42-year career involving medical technologies."
The director of the FDA's medical-device center, Jeffrey Shuren, testifying last summer at a congressional hearing, said "We do have a challenge attracting the best people." He said his division has a "very high turnover rate" and can't pay salaries competitive with the industry. He said that approvals took too long partly because "sometimes we asked for things we shouldn't" in requests to applicants for approvals.
The new agreement is designed to take steps to alleviate these problems. While the FDA device center does currently have goals it seeks to meet for the timing of approvals, they are flexible, and the clock can be stopped when the agency asks a company for information. The new agreement would set goals to complete the most complex approvals in 385 days on average and abbreviated ones in 124 days on average.
Write to Thomas M. Burton at tom.burton@wsj.com
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The job search continues to evolve. From the company bulletin board and classified ads to job search websites and social networks, job seekers must keep up with the trends. So what does today's job search look like? Well, it might go something like this:
"I found a medical device sales job posting on MedReps.com and used LinkedIn to research the job poster. We had a mutual connection that I leveraged to get an interview – which was conducted on Skype. I accepted the job offer offer via text message."
The above scenario is not unlike many of the stories shared in the recent MedReps.com Social Networking Job Search Survey. One in four survey respondents said their activity on a social network had either directly or indirectly led to a career opportunity. So how are they doing it? The MedReps.com Social Networking Job Search Survey Report reveals how medical sales job seekers are using social networks in the job search.
We’ve yet to reach the day when everyone has a Facebook or LinkedIn account, but the majority certainly do. In our survey of more than 350 medical sales professionals, 94% said they belonged to at least one social network, a slight increase from the 89% who professed social network membership in the 2009 survey. When asked how often they login to social networks, 43% of respondents reported that they login multiple times a day. Another 21% said they login daily, meaning a total of 64% of respondents login to a social network at least once a day (up from 47% in 2009).
While Facebook may have more members globally, medical sales professionals prefer LinkedIn. In a sharp increase from the 2009 data, 87% of respondents now have a LinkedIn profile (up from 56% in 2009). Facebook held steady with 76% of respondents professing membership (slightly up from 74% in 2009). Twitter held a distant third place with 16% of respondents claiming to use the site. Newbie Google+ beat out the seemingly forgotten MySpace with 12% of respondents reporting a Google+ membership and just 2% saying they are still on MySpace.
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Read more: http://www.miamiherald.com/2011/12/05/2530943/can-rick-scotts-jobs-czar-bring.html
]]>Bob Collins
bob@thebobcollins.com
www.linkedin.com/in/thebobcollins
Chances are you are already familiar with social networks as tools for keeping in touch with friends, or to broadcast your thoughts. But if their value as a way of connecting with potential employers has passed you by, it’s time to wise up fast. Arecent US survey showed that nearly 90% of employers either use, or plan to use, social media for recruiting.
In the rapidly changing world of social recruitment, barely a week goes by without the appearance of some new website or gizmo purporting to change the face of job-hunting forever. Last month, for example, saw the launch of the “Apply with LinkedIn” button, enabling jobseekers to send their public profile data from the business professional network directly to an employer. Reports of the death of the traditional paper CV may be premature, but clearly it is becoming an increasingly less influential part of the jobseeker’s armoury.
LinkedIn, with 100 million members, is still the site of choice for companies hiring directly, but Facebook (750 million) and Twitter (200 million) are catching up, with many believing a tipping point has been reached in the ways employers seek to hire staff.
But what does it all mean for jobseekers? Understanding the rules of social recruitment is key. At first glance, employers may seem to hold all the cards, but understanding their tactics can considerably improve your odds of getting noticed.
“It’s about the whole degree of proactivity now,” says Matthew Jeffery, head of talent acquisition at software house Autodesk. “It’s not enough to simply push your CV up on the web and hope a company is going to come to you; the onus is on you to get out there and persuade.”
If you are one of the 10% of LinkedIn members actively seeking work, the bad news is that the site’s Corporate Recruiter tool, which it sells to employers, allows them access to the “passive” 90% of members in jobs.
“From the corporate perspective, the talent pool is shrinking,” says Jeffery, co-author of an essay entitled Recruitment 3.0: A Vision for the Future of Recruitment. “Competitors are getting better at recruiting people from rivals, and graduate talent is becoming of a more mixed quality. We have to be much more aggressive at getting out into the passive pool.”
However, Jared Goralnick, founder of email management service AwayFind, believes social media can empower jobseekers.
“If employers are filtering for people who have jobs when they’re recruiting, maybe you can’t get into that pool. But it’s still only one of the pools,” he says. How people present themselves online, he says, is “a huge opportunity to put yourself in a position of authority”.
Goralnick says LinkedIn “has predictive algorithms that can tell when someone is looking to move on, when someone starts updating their profile in a certain way” – one reason why it pays to keep your profile up to date.
To make yourself more visible, think about how you present and express skills and experience on a LinkedIn profile just as carefully as you would with a paper CV. Keep your summary and experience concise and to the point, incorporating key search terms.
And widen your appeal by linking out to blogposts or articles of professional relevance – even to your other social media profiles if you are confident they portray you in a good light (see point five). LinkedIn has more tips here.
But making too much noise without substance can be risky. Employers can be suspicious of people who seem to be trying too hard to get noticed, so think carefully about paid-for services that claim to flag up your visibility, such as LinkedIn’s Job Seeker Premium.
“Who are you a ‘featured’ candidate for? All this tells me is that you opted to pay so you can get moved to the top of the search list. It does NOTHING to prove you are a top-notch candidate,” writes entrepreneur and employer Adrienne Graham on her Forbes blog, Work in Progress. “If you didn’t get attention before, what makes you think paying a few extra dollars will make you all of a sudden desirable?”
Many firms now put significant resources into Facebook pages with the end goal of identifying future employees. “Companies are building their own communities of people interested in their products or services, or what they’ve got to say,” Jeffery says. “They then start mapping out competitors and talent within other areas, then try to attract them in – be it through employment branding, social media, whatever they can use.”
Participating in these professional communities – or “talent networks”, as HR professionals call them – is key, says Lucian Tarnowski, chief executive of social recruitment consultancy Brave New Talent.
“Everybody is now in the jobs market for their career, and people should keep themselves open,” he says. “Talent networks are a way to do that. They’re saying, one day you might be interested in working for IBM or whoever. Or if, for example, you work for Google, you might one day be interested in working for Facebook, so you can follow Facebook.”
Employers also take a keen interest in broader professional networks, perhaps based around chartered institutes or other industry-specific websites. Joining these not only lets you connect with others in your trade but also puts you in sight of many smaller employers who cannot afford to recruit through LinkedIn or maintain a serious Facebook presence. “Most jobs are in smaller businesses – and they’re not using that level of recruiting,” Goralnick points out.
At first glance, Facebook, with all its potential for indiscretion, might seem like a terrible place from which to tout yourself to potential employers. But, says Tarnowski, it illustrates another truth of the new social recruitment landscape: different networks have markedly different limitations.
“If an employer is looking to fill a specific role, they can find someone suitable [onLinkedIn],” he says. “But it’s not so good for an employer who will need a certain number of, say, marketing professionals next year. That’s where the power of the community can come in.”
Twitter is not yet widely incorporated into many companies’ recruitment strategies, but is extremely popular within certain industries, especially media, technology, advertising and PR. Like texting, messages are limited to 140 characters or less, but Twitter gives you the ultimate flexibility to bypass official channels and communicate directly to employees in a company you want to work for.
It’s easy and effective to link out to your other online profiles. And, crucially, the brevity of the medium encourages creativity, like the jobseekers who opened several separate accounts so the letters “HIRE US” appeared on the Twitter pages of the people they wanted to work for (watch the video to get a better idea of how it worked).
A recent article in the New York Times told the story of Social Intelligence, a company used by some US firms to scour the web for information about potential recruits.
Much of Social Intelligence’s data reportedly comes from non-social internet use – an individual’s comments on blogs or eBay activity records, for example. For many, it is a disturbing vision, and Robert Hohman, chief executive of Glassdoor.com, a website that lets employees anonymously review their employers (see below), foresees a backlash against such data mining that will lead to government regulation.
“When we get down to personal information, there’s two types,” he says. “There’s that which you have willingly shared with the world on social networks, and I think that’s completely fair game. Then there’s information which you had no intention of sharing which, by some mechanism, is being made available … morally it runs foul of what we think of as privacy.”
Tarnowski points out that the Facebook data of real interest to employers may lie beyond drunken holiday snaps and in your primary and secondary connections which, collectively, paint a far more accurate picture.
“The list of people I choose to be friends with says a lot about the kind of person I am,” Tarnowski says. “Past job titles say a lot about what I’m likely to do in the future. The courses I’ve done say a lot about what might be suitable jobs. All these snippets, if you amass them, could be incredibly valuable.”
For now, there remains an understandable risk for Facebook users regarding the kind of information employers might be party to. The network’s data privacy rules remain notoriously slack, and it is hard to delete permanently a Facebook profile. Google+, a new attempt to rival Facebook, attempts to bridge these problems by allowing users to group their contacts into “circles” – of family, friends and work – and share different updates with each, as well as deploying much stronger data privacy rules.
Perhaps, thankfully for jobseekers, there is a silver lining in that transparency can work both ways. Jeffrey likens the situation for those checking out employers to that of researching a hotel on Tripadvisor: “I don’t trust the spin in the brochures, I see what other people have written and trust them to help me make my holiday decisions. You can see the same in recruitment.”
For many larger employers, such openness has taken a bit of getting used to. “Companies building social media communities are no longer in charge of the message, which is a bit scary,” says Jeffery. “In the old days, you could put a message out there in print or broadcast, and there was no way to respond to it. In the social media age, everyone is talking out there. So whatever companies say about themselves has to be realistic, or else we’re going to get shot down.”
Four years ago, Robert Hohman was working for the travel website Expedia and wondering about his own next career move when he had the idea for GlassDoor.com. Seeing how easy it was for employers to research potential recruits, why, he wondered, was it so difficult for jobseekers to see the other way through the mirror?
“There’s a tremendous information assymetry between the jobseeker and the employer,” Hohman says. “You’re asking people to make some of the most important decisions of their entire life … and asking them to do it with almost no information. But it’s not because it doesn’t exist.”
At GlassDoor workers can anonymously rate their employers on a range of criteria such as management structure, career prospects, salary and staff morale. Collectively the data – 1.75m entries covering 120,000 companies so far – builds up an intriguing and, at times, brutally honest picture of corporate working life.
Hohman says the aim was to build a “constructive, balanced and fair community where we could collect information in a responsible way”. All content is reviewed by GlassDoor employees before it goes live, and there are strict guidelines about what can go up. “For example, you have to give us some good things and some things that could be improved. We don’t want a puff piece, or a rant piece.”
Originally a US concept, GlassDoor is now taking off globally, with the UK being the site’s next highest source of traffic. But what do employers under the microscope think of such warts-and-all exposure of their pay and practices? Hohman says much of the initial suspicion has faded away as companies see the wisdom in being honest and open online.
“You can view employer sentiment changing as the years have gone by,” he says. “I wanted to build a community that was safe for employers. If they didn’t feel that, we had failed. I think we’ve largely succeeded.”
via PSFK: http://www.psfk.com/2011/08/why-jumping-onto-the-social-network-is-a-good-career-move.html#ixzz1VpiOC4Qy