New Jersey has seen a 14 percent increase in medical-device manufacturing jobs over the past couple of years—from around 18,000 to 20,500—“which is so promising because that means the industry is growing, even in tough economic times.”
So said U.S. Rep. Frank Pallone (D-N.J.) at a roundtable discussion he organized with industry representatives and FDA officials at Rutgers University in New Brunswick, N.J. on Nov. 21.
“I did not convene this discussion today to gripe,” Pallone told the participants. “What I hope to accomplish today is an open dialogue, a three-way street, if you will, between industry, the FDA and me. It is my hope that we can lay the foundation for a long-standing, stronger working relationship.”
Among the companies represented were Becton, Dickinson and Company, Cardinal Health, Colgate-Palmolive, C.R. Bard, the Healthcare Institute of New Jersey, Johnson & Johnson, Novo Nordisk, Philips, Roche Diagnostics, Siemens, Zimmer Holdings and Stryker, according to a statement from Pallone’s office.
Pallone pointed out that the U.S. accounts for 40 percent of the global medical technology market and said the industry indirectly creates two million American jobs.
“Maintaining American leadership in this field is essential for jobs and for patients,” he said. “Unless we make significant improvements to the predictability and transparency of the regulatory process, we will lose the industry, the jobs that go with it, and the innovation to transform our healthcare system.”
Pallone added that he has long been interested in the topic of regulation and has examined the current system to see where it works well and where it falls short. “I’ve heard from patients, from physicians, and from companies about problems with the 510(k) process,” he said. “Physicians and patients are concerned that products aren’t fully evaluated before they’re allowed on the market. And of course, I hear from companies who are frustrated at the lack of predictability and transparency in the process, as well as increased review times, inconsistent expectations, and poor communication from the FDA.”
Pallone closed by expressing his hopes for finding “common ground” so as to encourage innovation and, with it, continued growth of the medical device industry. “I believe that we can work together to change the rhetoric we’ve heard in the past to be more constructive,” he said. “And from what I’ve seen as of late, that is already taking shape.”