Biocompatibility and Performance of Medical Devices

Jean-Pierre (JP) Boutrand, DVM, MS is a Senior Vice President at Eurofins, Luxembourg.Dr. Boutrand is an executive leader, veterinarian, and recognized authority in nonclinical evaluation, biological safety, and testing strategies for medical devices and combination products. With over 25 years of global leadership—including senior executive roles at NAMSA (Vice President of Global Laboratory Services), Labcorp, Charles River Laboratories and Eurofins—Dr. Boutrand has guided the safety, compliance, and commercialization pathways for hundreds of complex medical devices worldwide. A former registered expert on the biological safety of medical devices for regulatory agencies including ANSM, Dr. Boutrand specialized in integrated risk management, ISO 10993 compliance, toxicology assessment strategies, and pharmacology models. He is the editor and author of the textbook Biocompatibility and Performance of Medical Devices (Woodhead Publishing / Elsevier), currently in its 3rd edition, and has authored over 120 scientific publications and global conference presentations on biomaterial safety, histopathology, and regulatory evaluation frameworks.

• Part One Introduction to biocompatibility in medical devices 0001 Strategies to accelerate medical market access and manage risks of biocompatibilityR. Eloy and S.J. Goldenberg2 Making use of a biological safety evaluation plan D. Parente3 Biomechanical and biochemical compatibility in innovative biomaterials J. Huang, X. Li, and Z.X. GuoPart Two Evaluation and characterization of biocompatibility in medical devices4 A practical approach to analytical chemistry of medical devicesD.E. Albert5 Tolerable intake values for leachables: Practical use of ISO 10993-17 standard R.P. Brown6 In vivo and in vitro testing for the biological safety evaluation of biomaterials and medical devices W.H. De Jong, J.W. Carraway, and R.E. Geertsma7 Practical approach to blood compatibility assessments: General considerations and standards M.F. Wolf and J.M. Anderson8 Quality strategies that fasten devices access to global markets J.A. Torfin and S. Gompertz9 Accelerating medical device biocompatibility evaluation: An industry perspective K.P. Coleman, W.V. Christian, and W. Zhang10 Overcoming negative test results during manufacture D. Parente11 Methods for the characterization and evaluation of drug-device combination productsA.L. LewisPart Three Testing and interpreting the performance of medical devices 12 Efficient evaluations of bone implants performances J.-P. Boutrand13 Methods and interpretation of performance studies for dental implantsM. Dard14 Optimizing the design of preclinical safety and performance studies—Examples in soft tissues and cardio-vascular implants E. Drevon-Gaillot, T. Blair, and G. Clermont15 Mechanical testing for soft and hard tissue implantsC. KaddickPart Four International regulation of medical devices16 Biological evaluation and regulation of medical devices in the European UnionT. Keene17 Biological evaluation and regulation of medical devices in JapanK. Kojima and K. Sakaguchi18 Medical device regulations in China C. Shan and M. LiuPart Five Histopathology principles for biocompatibility and performance studies19 Current considerations in medical device pathologyA. Alves, L. Wancket, A. Metz