Responsible for development of polymeric, bioresorbable, and metallic materials for permanently implanted devices based on biocompatibility, mechanical and chemical properties. Areas of focus are controlled drug delivery from intravascular devices, drug coated balloons, intravascular stent coatings, coating processes, and intravascular stent materials. Experienced in biocompatibility testing and analysis of medical devices and regulatory processes, both domestic and foreign, for device approval. • Engaged in customer visits with physicians in most countries of Asia and some in Europe on XIENCE DES design, fluoropolymer coating biocompatibility, preclinical and clinical data.• Lead author for Absorb BVS PMA regulatory pre-submission and submission modules on biocompatibility.• Responsible for defining principles of operation and value proposition for use of bioresorbable vascular scaffolds in treating infrapopliteal arterial disease.

• Co-wrote manufacturing process development sections for the XIENCE V IDE filing. Managed assay development and in vivo degradation studies on drug eluting stents coated with bioabsorbable polymers in several animal models. Objectives were to evaluate vascular biocompatibility, determine polymer degradation rate and change in physico-chemical properties, and to generate supporting data for regulatory filings.• Designed studies, wrote protocols, and performed the in vitro degradation experiments for drug eluting stents coated with bioabsorbable polymers.• Wrote with regulatory, the bioabsorbable stent coating test plan for the pre-IDE meeting with FDA• Through study of available biomedical alloys, research into biocompatibility, mechanical properties, and history of use, proposed and performed early work on a new, more radiopaque, cobalt chromium stent alloy. Fabricated first stent of this cobalt chromium alloy. An outcome was the launch of the VISIONTM intracoronary stent system now approved in Europe and the US.• Researched drug eluting stent coating polymers based on biocompatibility, drug permeation properties, polymer mechanical properties, polymer processability and history of use in permanent implants. Selected the polymer, developed a coating process, and performed the first porcine in vivo biocompatibility studies on the drug reservoir polymer. This polymer coating system is now in the XIENCE Sierra DES system currently approved globally.