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Global Standards in Medical Device, Technology Development

By Dr. Bill Gluck, Vice-President, Clinical Knowledge Recently, the European Forum for GCP (EFGCP) and MedTech Europe established a Medical Technology Working Party to promote the collaboration of defining and establishing standards within the medical device sector of the much larger clinical development industry. As noted by Dr. Klingmann, the Chair of EFGCP, the focus within the industry has been to create a more standard environment for the pharmaceutical and biotechnology sectors. The collaboration and discussion to be held by the working party will be critical as it is nearly impossible to simply over-lay the current pharmaceutical standard and apply them to the medical device/technology world. The establishment of the Medical Technology Working Groups provides an avenue to review the benefits of standardization within our industry as a whole. Standards must be global in reach and based on both good clinical practice and manufacturing guidelines, especially in the case of medical devices and technology. The work defined by the group will likely consider standards, based upon expert opinion and fit for purpose; consensus, based upon best practices; and guidelines and regulations. They should also demonstrate independence. Done correctly, standards should encourage innovation and have distinct links to the healthcare world. Standardization can be implemented through eClinical solutions, which CDISC has done a good job of addressing. As the industry experiences success with eClinical solutions, new pain points are being addressed, with each solution offering its interpretation of efficiency. The best solutions are flexible and can accommodate both the needs of the trial and the standardization to maximize efficiency, without requiring additional complexity of data integration. While there are clearly no right or wrong standards, their implementation can save significant time and cost especially when considered as part of a study and not applied retrospectively. There needs to be an a priori culture to develop and implement standards in the early stages of trials. The application of standards does not ensure quality; in fact retrospective application of standards has the potential to adversely affect data quality and analysis. Unfortunately information is also sometimes lost if data are collected using different methods and later mapped into a common standard – trying to force a square peg into a round-hole syndrome. Standardization done correctly and involving experts like that of the initial organization of the combined working group of the EUGCR and MedTech Europe has a great chance to succeed and is positioned to help enhance future device and medical technology innovation through the use of standards, which can only benefit us all…the first steps have been taken and we will all be better served in helping this important working group achieve its objectives.