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September 13, 2010
By: Christopher Delporte
Editorial Director, Medical Devices
As a journalist, one of the challenges of covering a “beat” is finding the best way to stay in front of newsmakers and to cultivate sources. This takes on an even more unusual slant in the trade media, because your sources most often also are your primary audience. Finding face time with leaders in the medical device space can be tough—extra time on both sides is at a minimum these days. I have been fortunate, however, in the past few months to meet with a number of representatives from major manufacturers located in the largest device hubs in the United States. Recent travel has taken me to Boston, Mass., Warsaw, Ind., Minneapolis, Minn., and Memphis, Tenn.—world-class orthopedic technology and barbecue and blues. How could you go wrong? Given recent economic conditions, I wasn’t sure what overall mood I could expect from manufacturers—OEMs and outsourcing partners alike. I was pleased to discover that all the firms reported that business is good—in some cases great. Despite the upbeat message, however, there’s an underlying feeling of cautious optimism. There are a number of issues swirling that keep manufacturers up at night. For one, OEMs are bracing for the medical device tax. Though it’s not slated to start until 2013, there’s certainly a chilling effect taking place. Some industry representatives say it will impact research and development and new product launches. Others claim it will hurt U.S. jobs. A few glass-is-half-full souls said a lot could happen between now and then. “Taxes can be repealed. This industry has overcome obstacles before. We will again,” said one OEM. Another medtech insider said: “Reimbursements should be more of a concern.” Yet another concern is the U.S. Food and Drug Administration (FDA). While there’s always been a love-hate relationship with the watchdog group, OEMs are reporting a slower, less predictable agency, though the FDA is attempting to make certain processes easier, recently releasing the results of its much-anticipated internal review of the 510(k) program. A study of the device clearance process by the Institutes of Medicine is expected next year. “It still pays to be in medical technology,” said one OEM, with a caveat. “But every time something new comes out of Washington, we hold our breath.” The FDA may be slower in its review of new devices, but according to OEMs and suppliers, the agency increasingly is vigilant about quality and supply chains. And that pressure certainly trickles down.“Our customers are in here a lot more than they used to be,” noted a supplier. “Our audits are up because theirs are up. If your quality system is where it should be, it’s not a problem.” In the near term, a positive sign that things are still strong and perhaps improving from a year ago are employment levels. While unemployment continues to dog the economy as a whole, a recent report from ZRG Partners, a recruiting and consulting firm based in Westborough, Mass., claims that the medical device space is doing much better than others. According to the report, in the second quarter of 2010, the medical device and supply sectors showed the greatest number of global job opportunities. The firm’s findings revealed that the outsourcing and service sectors had 500 percent more current hiring opportunities than life sciences and pharmaceuticals and 250 percent more than medical device and supply sectors (numbers are based on employee pool size). The report showed that medical device and supply had the greatest number of global healthcare opportunities (46 percent). Life-sciences and pharmaceutical sectors placed second with a 37 percent job opportunity, while outsourcing and services were smallest, with 17 percent of the total healthcare opportunities. Medical device and supply firms are seeking sales and marketing talent as the top need, the report noted. A total of 63 percent of the opportunities in the regulatory, quality and clinical segments come from the outsourcing and services sectors. Clinical roles had the highest hiring demands, with 27.2 percent of all hiring opportunities. Information technology, finance and general executive and administrative positions came in second at 26.9 percent of all the global healthcare opportunities. “On a size of revenue and employee basis, the outsourcing and services segment is showing strong hiring demand in terms of current organizational size to new requests, showing the biggest projected growth,” according to the report. The results were based on more than 12,000 global life-sciences employment opportunities. Often, it’s the little triumphs that give you the strength to tackle the larger battles. Employment news like this demonstrates that we remain a strong and vibrant industry. The news may not be on par with the repeal of the device tax—but it certainly puts me among those in the glass-half-full column.
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