An MD&DI April 1999 Column
When Lillian Yin, PhD, formed the team that would ultimately win the Hammer Award in January 1999 for creating FDA's Product Development Protocol (PDP) process, she contacted a number of people in the industry whom she believed could contribute valuable insight and experience to the reengineering project. Pamela Weagraff, currently vice president of regulatory and quality for MediSpectra Inc. (Lexington, MA), was one of those people.
At the time, Weagraff was chairperson of the ultrasound section for the National Electronic Manufacturers Association, and Yin was the director of FDA's Office of Device Evaluation, Division of Reproductive, Abdominal, ENT, and Radiological Devices. Of all the reengineering teams established by FDA, Yin's team was the only one that included participants from industrya somewhat unusual case. As part of vice president Al Gore's National Partnership for Reinventing Government, the Hammer Award is designated to recognize federal employees who have made a significant contribution in support of efficient, cost-effective government operations. As a nongovernment employee receiving the award, Weagraff was thankful that Yin and other FDA team members were receptive to industry participation and gave thoughtful consideration to her views.
Weagraff suggests frequent interactions with FDA to improve communications.
"The team members' role was to develop a guidance document that could be used by FDA and industry alike in developing product development protocols to bring medical devices to market in a more timely, efficient manner," Weagraff explains. "In addition, we held a one-day public meeting to share our efforts and answer FDA's questions, because the agency was responsible for making the final determination in regard to how the PDPs would be implemented. This input was then used to make adjustments to the follow-on documents."
In retrospect, Weagraff describes the process as an excellent learning experience for industry and FDA alike. "I think the industry participants were able to demonstrate their ability to thoughtfully consider FDA's concerns and gain an understanding of why the agency needs to do things a certain way," she says. "Similarly, FDA was able to appreciate why some of the agency's approaches were problematic for industry." Part of the challenge for Weagraff was trying to figure out how FDA and industry could work together as a team. "FDA and industry are two different cultures," she says. "FDA is chartered with protecting public health while industryalthough also concerned about public healthis interested in developing products and bringing them to market in a timely fashion." To strike a balance between these two different yet related objectives, Weagraff suggests that device companies find a common ground with FDA so that there is a cross-fertilization of ideas and a true collaborative effort. She also emphasizes interacting with the agency early in the product approval process and frequently thereafter. "Too few companies avail themselves of this opportunity," she relates, "but the more they communicate with FDA, the better. That way, FDA has a better understanding of what companies are trying to achieve."
Weagraff recommends that device firms participate in trade associations to increase their knowledge of regulatory and quality issues. Many trade associations offer training programs and networking opportunities, which she believes are excellent means of gaining experience. "I think trade-association participation gives people an opportunity to learn from others in industry and then apply that to their own companies," Weagraff says. She also advises regulatory professionals to be open to cross-functional interactions. "We need to be tuned in to what's happening in R&D, marketing, and manufacturing. All of these functional activities can impact the regulatory strategy." Weagraff notes that her background in marketing has proven invaluable in terms of interacting with FDA.
Weagraff was hired by MediSpectra as vice president of regulatory and quality in October 1998. The company specializes in optical biopsy technologya noncontact, non-invasive system used for real-time, in vivo detection and diagnosis of cervical cancer and other human tissue abnormalities. At present, MediSpectra is poised to enter the development phase with its product. According to Weagraff, the optical biopsy system will not use the PDP process, since MediSpectra is an early-stage startup, and the PDP process is best suited for technologies that are well established and familiar to FDA and the medical community at large.
For those companies that have used the PDP process, the feedback has been positive. "As with any new process, there are some teething pains, but generally people are pleased," Weagraff says. "The PDP process appears to offer a good alternative to the more-traditional PMAs, and that was the purpose of developing it in the first place."
Kassandra S. Kania is assistant editor of MD&DI.