Yegor Piskarev

Medical Device Engineering & Development: I have hands-on experience in the complete lifecycle of medical device development, from concept to preclinical validation and regulatory compliance. I led the design and development of three cardiac ablation catheters, which are class III medical devices, meeting strict FDA and MDR/MDD requirements. Currently, I am overseeing the transition of an ENT medical device from proof-of-concept to a commercial product, including establishing a quality management system (QMS) compliant with ISO 13485 and ISO 14971.

Product Design & Preclinical Validation: My experience includes leading design iterations and conducting rigorous testing of prototypes, including thermomechanical testing, tensile and fatigue testing, and applied force characterization. I have overseen the fabrication of medical devices with precise control over material properties and have been deeply involved in the validation process, including preclinical trials in collaboration with clinicians.

Soft Robotics & Advanced Materials for Medical Devices: I have developed soft robotics technologies, such as versatile soft grippers and variable stiffness catheters, which are applicable in a wide range of medical procedures. My research in electroactive polymers and granular jamming has led to the development of novel soft actuators for medical applications, improving the capabilities and safety of medical devices.

Regulatory and Certification Expertise: I have extensive experience in navigating the regulatory landscape for medical devices, including FDA approval processes, and ensuring compliance with international standards. I led the preparation of two PCT patent applications related to medical device innovations and contributed to advancing soft robotics technologies for biomedical applications.

Leadership & Collaboration: I have managed cross-functional teams, supervised graduate students and interns, and initiated collaborations with leading academic institutions, such as North Carolina State University, ETH Zurich, and the University of Electro-Communications in Tokyo. These collaborations have enhanced my ability to lead projects with interdisciplinary expertise, particularly in the development of medical device technologies.

Simulation, Prototyping & Fabrication: I possess strong skills in computational modeling (SolidWorks, Abaqus, Ansys) and rapid prototyping techniques, such as 3D printing and laser micromachining, to develop and refine medical devices. My prototyping skills allow for the creation of accurate, functional models that are critical for both design validation and clinical trials.

Key words: Medical Device Development, Robotics, Soft Robotics, Variable Stiffness Technologies, Cardiac Ablation Catheters, ENT Medical Devices, Preclinical Validation, Regulatory Compliance (FDA, MDR/MDD), Quality Management System (QMS), ISO 13485, ISO 14971, Electrophysiology, Polymer Synthesis, Electromechanics, Biomedical Engineering, Actuation and Sensing, Electroactive Polymers, Granular Jamming, Electroadhesion, Rapid Fabrication, 3D Printing, FEA (Finite Element Analysis), Computational Modeling, Thermomechanical Testing, Medical Robotics, Medical Device Certification, Soft Actuators, Patent Applications, Preclinical Trials, Multidisciplinary Collaboration, Fundraising for Medical Devices.