Don Palme, PhD, has over 20 years of regulatory and preclinical testing experience. He specializes in designing and directing preclinical in vivo testing for devices and biologics to address safety, efficacy and biocompatibility endpoints. He also has experience in regulatory submissions and interactions with U.S. and international regulatory agencies.
Don has held previous roles at Wuxi Apptec, Boston Scientific, Acorn Cardiovascular and Guidant Corporation. He has authored numerous journal articles, technical presentations and book chapters on biocompatibility, medical device performance, immunology and pharmacokinetics.
- Prepared and defended product risk assessments for medical devices and materials for worldwide regulatory submissions
- Prepared and performed preclinical safety evaluations for medical devices, biological drugs and combination products for worldwide regulatory submissions
- Extensive experience with scientific evaluations of pathologic responses to medical device implants
- Expert in the area of preclinical model development and applications for medical devices, including urology, cardiovascular, dermal and tissue based devices and biologics
- Provided leadership and consulting to medical device companies covering study planning, efficiencies, research conduct and requirements needed to move devices forward to clinical evaluation
- Considered a U.S. expert in the application of ISO 10993 parts 1, 6, 9, 10 and 11 and U.S. FDA guidance for the testing of medical devices
- Author of numerous device and material risk assessments to support reduced testing in support of ISO 10993 part 2
- Participation in multiple Pre-IDE meetings with the FDA
- Supported review and data analysis for clinical trials involving an implanted cardiovascular product, dermal device and tissue-based device
- Consultant to multiple Sponsors regarding analysis and data interpretation collected from clinical studies
- Assisted with creating a new testing matrix in support of MDR compliance for a vascular and dialysis device, including testing and resubmission strategy for EU MDR and FDA to keep device in the market
- Overseeing antimicrobial device testing and data analysis—a new testing program developed to evaluate and test the effects of an existing catheter flush solution with claimed antimicrobial properties. Further testing evaluated and demonstrated efficacy using a real device model resulting in determination of biofilm reduction
- Managing a program for an emerging disease and impact on device approval—a microbiological assessment regarding the potential for new emerging diseases and the potential for autograft disease transmission. Analysis and written response was submitted for regulatory review; U.S. FDA and Notified Body accepted analysis and new tissue testing strategy