“We have a new driver in the front seat. She’s got more budget, more resources, and she’s not kidding,” noted Nikki Willett, vice president of marketing and regulatory affairs for Pilgrim Software, a Tampa, Fla.-based software solutions provider. Willett was one of about a half-dozen analysts and industry experts who addressed an audience of contract manufacturers and suppliers on the first day of the fourth annual Orthopedic Design & Technology Conference in Fort Wayne, Ind.
“What does Dr. [Margaret] Hamburg expect from you? In her own words, she expects ‘a commitment to compliance backed by a strong compliance program.’ If you haven’t looked at your supplier programs now, you’d better do it. The wiggle room you had before is no longer going to be there.”
And Hamburg is serious. According to Willett, the new FDA commissioner no longer intends to issue multiple warning letters to companies with quality control violations. She expects the offending company to take immediate steps to correct the problem even before a warning letter is issued. Post inspection deadlines will be whittled down to 15 days (at the most), and companies also will be expected to develop a formal warning letter “close out” process, Willett said.
The number of warning letters is not expected to decline, either. Last year, the FDA issued 98 warning letters to medical device firms for deficiencies in their quality systems and good manufacturing practices, data from Pilgrim Software showed. Eighty of those letters, or 82 percent, contained citations for production and process control subsystem deficiencies, the data indicated. The FDA expects to issue the same number of warning letters this year to device firms for supplier-related issues, Willett said.
Besides swift action on warning letters and development of a warning letter “close out” process, Hamburg expects global and domestic device firms to secure their increasingly complex and growing supply chains. “Suppliers have to have the quality and purchasing controls in place as much as the OEMs they work with,” Willett explained. “One of the key differentiators that many companies petition to their clients is the fact that they can provide products faster, cheaper and better. But that’s not going to be a differentiator any longer. Service and quality are going to be key.”
In addition to greater scrutiny from the FDA, Tier I and possibly sub-tier suppliers can expect to be subjected to more inspections from the federal government under Hamburg’s reign. Willett said the FDA is going to look at both internal and external suppliers with a more critical eye.
As if greater scrutiny by the FDA wasn’t enough, suppliers and their outsourcing partners also can expect some changes in quality regulations. The design input for the next incantation of ISO 9001 has already begun; since this regulation is the basis for ISO 13485:2003, suppliers and OEMs can expect changes to be made to this quality regulation as well.
And, next March 21 (2010), medical device companies must apply EU Directive 2007/47/EC (or M5), which modifies the Medical Devices and Active Implantable Medical Devices directives. The updated regulation will result in a greater emphasis on outsourcing and suppliers, including the selection and activities of notified bodies, Willett said.