Andy Wyen is a Board Certified Senior Toxicologist at NAMSA. With over 16 years’ medical device industry experience, his previous positions include R&D Technician, Chemist and Biocompatibility Study Director. Andy’s expertise includes In Vitro methods, analytical chemistry, chemical characterization, study direction, biocompatibility and toxicology. He obtained his Bachelor and Master Degrees in Pharmacology/Toxicology from the University of Toledo (Ohio, U.S.). 

CORE COMPETENCIES

• Prepares risk assessments, evaluation plans and reports in compliance with ISO 10993-1, ISO 10993-17 and ISO 14971 for FDA submissions and other regulatory agencies
• Working knowledge of FDA, EU MDR and other global medical device regulations, as well as biologic regulations, the ISO 10993 series and 14971
• Develops of biological evaluation plans and biological risk assessments for the evaluation of the biological safety of medical devices. Plans and assessments take into account the safety of the materials of construction, clinical use, type and duration of patient contact, biocompatibility/ chemical testing performed, clinical history, patient population, regulatory guidance and safety thresholds of extractable chemicals
• Plans toxicological risk assessments of extractable chemicals observed during analytical analysis through toxicological literature searches, calculated tolerable intake/exposure of chemicals and subsequent margin of safety determinations as they relates to patient exposure
• Prepares gap analysis documents to ensure previously performed biocompatibility studies are in compliance with most the recent regulatory requirements and provides biological significance of differences that may be observed
• Advises Clients on technical issues related to biocompatibility and material characterization, in addition to determining biological relevance of unexpected results
• Responsible for all aspects of GLP compliance of preclinical biocompatibility studies (ISO-10993 series, MHLW, USP, EP) and provides interpretation of results, observations and impact of unexpected circumstances
• Develops and coordinates special toxicology/efficacy studies, as well as routine biocompatibility studies according to GLP and Non-GLP regulations for various models. Studies include: cytotoxicity, local tissue implantation, irritation, hemocompatibility, sensitization, systemic toxicity, pyrogenicity, ocular toxicity, genotoxicity, bone regeneration, dura repair, hemostasis, and wound healing
• Serves as primary analyst of semi-volatile compounds using Gas Chromatography Mass Spectroscopy (GC-MS), trace metal quantification using Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES), and Differential Scanning Calorimetry (DSC)
• Performs routine and complex United States, British, European, and Japanese Pharmacopoeia testing utilizing wet chemical techniques
• Assists in various other analytical techniques such as osmolality, Fourier Transform Infrared Spectroscopy (FTIR), Gas Chromatography Flame Ionization Detector (GC-FID), and Liquids Chromatography Ultra-Violet (LC-UV)
• Optimizes and develops chemical indicating inks and printed ink products for sterilization processes (steam, radiation, ethylene oxide, dry heat, hydrogen peroxide, and formaldehyde)

RECENT PROJECTS

• Two (2) year MDR remediation project for an orthopedic company that included the biological and chemical evaluations of thousands of devices
• Toxicological evaluation of eight (8) separate packaging and cleaning components in contact with contact lens solution