Christopher Delporte08.31.10
This takes an even more unusual slant in the trade media, because your sources often 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, to have sat down in the past few months with a number of representatives from manufacturers—many of them orthopedic—located in the largest U.S. device hubs. Given recent economic conditions, I wasn’t sure what overall mood to 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, even great. Despite the upbeat message, however, there’s an underlying feeling of cautious optimism.
A number of issues are keeping 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 “Taxes can be repealed.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. Said another industry expert: “Reimbursements should be more of a concern.”Yet another topic 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. The FDA is attempting to make certain processes easier, recently releasing the results of its much-anticipated internal review of the 510(k) process (see Industry News on page 72).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 improving from a year ago are employment levels. While unemployment continues to dog the overall economy, a recent report from ZRG Partners, a recruiting and consulting firm based in Westborough, Mass., claims that medical device firms are hiring. According to the report, in the second quarter, the medical device and supply sectors had 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 science and pharmaceuticals and 250 percent more than the medical device and supply sectors (numbers are based on employee pool size).
The report also showed that medical device and supply had strong global healthcare opportunities (46 percent). Life-science and pharmaceuticals placed second with a 37 percent job opportunity, while outsourcing and services were smallest with 17 percent of total healthcare opportunities. Medical device and supply firms are looking for sales and marketing talent most, 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-science employment opportunities.
Often, it’s the little triumphs that give you the strength to tackle the larger battles. News like this demonstrates that we remain a vibrant industry. It 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.
Christopher Delporte
Group Editor