Product Development Lifecycle Expertise:● Advising entrepreneurs and startups in the medical and healthcare industries on strategic product development initiatives.● Designing customized roadmaps aligning business goals with effective product development execution strategies.● Leading innovative medical product development from concept generation to proof of concept (POC), prototyping, minimum viable product (MVP), and successful market launch.● Seamlessly integrating multi-disciplinary aspects crucial for product development success: R&D, IP, Regulatory Affairs, Pre-Clinical, Clinical, Manufacturing, Supply, and Quality.Comprehensive Project Planning and Management:● Designing and executing comprehensive project plans for product development execution.● Support in project management and control across all lifecycle phases.● Support in optimizing project time, resources, and performance, and leveraging outcomes for generating strategic value.Mentorship and Training:● Mentoring and training entrepreneurs and professional teams in medical product development and project management foundations.

Supporting early-stage medical ventures and entrepreneurs in:● Designing product development roadmaps and comprehensive execution plans.● Optimizing strategic and product development plans to align with business goals and needs. ● Leveraging product development outcomes for financial collaborations, opportunities, and growth.● Training on medical product development and project management foundations.

Supporting early-stage medical ventures and entrepreneurs in:● Designing product development roadmaps and comprehensive execution plans.● Optimizing strategic and product development plans to align with business goals and needs. ● Leveraging product development outcomes for financial collaborations, opportunities, and growth.● Training on medical product development and project management foundations.

● Establishing product development roadmaps aligned with the company's business needs and strategic goals.● Planning and leading the programs and projects supporting the company's multiple-product pipeline, from the concept phase to product registration, including R&D, pre-clinical, clinical phases 1-3, product registration and commercialization.● Ownership of all stakeholder management, cross-disciplinary integration and project communication throughout the products' life cycle, encompassing management, business, technology, operations, quality, and regulatory affairs.● Implementing Project Management methodologies and establishing a Project Management Office (PMO) governance system to ensure effective project management, control, performance optimization, value delivery assurance, risk management, and project quality assurance.● Supporting the company's business alliances by managing project interfaces, integrating requirements, and providing regular project status and performance reports.● Designing, implementing and controlling the organizational Business Continuity Management System according to ISO 22301:2019.● Organizational education and training of Business Continuity Management, strategic risk management and disruption recovery preparedness.

● Managing the design and development projects for the company’s medical device-drug combination products towards pivotal clinical activities and market registration.● Leading the Design Control life-cycle of device-drug combination products.● Establishing and maintaining product Design History File (DHF).● Planning and controlling the execution of products Verification & Validation activities. ● Leadership role in planning towards Notified Body CE mark audit and ISO 13485 certification.

● Managing the company's Chemistry, Manufacturing and Control units● Design, tech-transfer and operation of aseptic manufacturing processes at CMOs● Design of product specification, development and qualification of quality control methdos● Product supply chain for global clinical studies ● Direct management and supervisions of employees