Invibio Biomaterial Solutions’ PEEK-OPTIMA family of biomaterials has achieved considerable regional regulatory milestones says Invibio’s director of Regulatory Affairs, Craig Valentine. As of February 2013, the number of implantable medical devices manufactured from PEEK-OPTIMA and cleared for market in the U.S. reached 500, with more than 80 approved for market in China.
“The regulatory environment globally is more challenging than ever. Support of data and knowledge through the process can help device companies overcome regulatory barriers. We are committed to continuing our investments in resources to support medical device companies’ regulatory submissions across global markets. Invibio maintains a Drug & Device Master file data at the U.S. Food and Drug Administration (FDA) and has specific test data required for both China and Japan available to customers on file. This data is utilized by the regulatory authorities and provides the verification of PEEK-OPTIMA’s biocompatibility and biostability, which is supported by a dedicated global regulatory team, ” said Valentine in a March 14, 2013 news release.
“As demonstrated by these global regulatory milestones, PEEK-OPTIMA continues to set an industry standard for biomaterials biocompatibility and quality. Invibio’s commitment to advancing medical device design innovation does not stop at our biomaterial capabilities. Our strong strategic alliances within the research and surgical community and across the global medical device industry, combined with our depth and breadth of biomaterials, and manufacturing capabilities enable Invibio to partner with our customers to access and accelerate their time to market in a challenging environment, ” said Valentine.
Asked where they go from here, Valentine told OTW, “PEEK-OPTIMA is already a truly global product, so that we are now supporting our clients with registrations in all of the BRIC emerging markets in addition to the established markets of North America, Europe and Japan.”
Regarding their global regulatory team, Valentine commented to OTW, “In order to deliver regulatory support in all the key regions its necessary to put a team in place that is highly skilled, with a wealth of experience of the local regulatory requirements, and a proven track record of managing the regulatory challenges. This team is also supported by a network of local regulatory consultants who can supplement our internal knowledge when required. The major challenge remains the diversity of process, and the continual evolution of regulations that ensures we must work constantly to ensure our customers have sufficient support to progress with device registrations, particularly in the emerging markets. This, coupled with the increasing focus on the materials from a quality, regulatory and risk perspective resulting from the highly publicized PIP issue, will mean that the regulatory landscape for medical device manufacturers will continue to evolve. The Invibio regulatory team will continue to work with regulatory authorities in all the key markets to ensure we clearly understand new requirements from a material perspective, which will keep the pathway to market open for our customers irrespective of the strengthening of regulations.”
