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Strategic Management, Regulatory Challenges, and Global Governance of MedTech

Strategic Management, Regulatory Challenges, and Global Governance of MedTech
Author(s)/Editor(s): Ricardo Marcão (ISLA Santarem, Polytechnic University, Portugal & NECE, University of Beira Interior, Portugal ), Vasco Ribeiro Santos (Instituto Politécnico de Tomar, Portugal)and Stéphanie Monteiro (Institute for Systems and Robotics, Portugal)
Copyright: ©2025
DOI: 10.4018/979-8-3373-1205-7
ISBN13: 9798337312057
EISBN13: 9798337312071

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Description

Innovations in the development of medical technology (MedTech) have been instrumental for improving healthcare and patient outcomes. MedTech is also significant in the fields of economics, management, administration, strategy, and international relations, bridging a gap between these traditionally distinct fields. Exploration of the application of MedTech is crucial for introducing actionable insights and tools that can drive policy-making and organizational change, fostering a new generation of leaders in MedTech and global healthcare.

Strategic Management, Regulatory Challenges, and Global Governance of MedTech It provides a cohesive framework for understanding and implementing strategic initiatives that drive advancements in MedTech and healthcare. It equips leaders, researchers, and practitioners with the skills needed to navigate and influence evolving fields, including healthcare, economics, and international strategy. Covering topics such as emergency services, risk management, and competition law, this book is an excellent resource for healthcare managers, business administrators, policymakers, government officials, professionals, researchers, academicians, and more.



Author's/Editor's Biography

Ricardo Marcão (Ed.)
Ricardo Marcão , PhD, MBA, PMP, is a global expert in Project Management, Strategy, Finance, and Healthcare Innovation, with experience in Pharma, MedTech, IT, and Professional Services. He is Chairman of ICoE Portugal at SCIP, Senior PM at Feedzai, and Professor at ISLA Santarém - Polytechnic University. His work spans Grand Strategy, Democracy, and International Relations, focusing on how geopolitics and competitive intelligence shape global business. He has led major transformations, implemented gamification for engagement and sales, and introduced a risk control model that improved project margins by 20%. From 2022–2023, he led global CRM projects for top pharma firms. Currently combating fraud, Ricardo is also an academic, editor, and speaker, with several books on strategy and innovation. As coordinator of MBA and graduate programs at ISLA Santarém, he develops future leaders at the intersection of business and technology.

Stéphanie Monteiro (Ed.)
Stéphanie Monteiro is a senior quality and regulatory affairs professional with extensive experience across the pharmaceutical, medical device, and medical technology sectors. Her professional background encompasses quality management systems, regulatory compliance, risk management, and product lifecycle governance in highly regulated healthcare environments, including pharma, MedTech, and medical device innovation contexts. She has built her career at the intersection of quality, innovation, and operational excellence, contributing to the development, validation, and continuous improvement of products and processes in accordance with international regulatory frameworks and standards. Her expertise includes quality assurance, compliance strategy, process optimization, and cross-functional collaboration with R&D, clinical, regulatory, and executive leadership teams. Stéphanie is actively involved in academic and applied research initiatives related to medical technology, healthcare innovation, and organizational performance, and has contributed to several academic publications and edited volumes in these domains. Her professional and academic interests focus on how quality systems, human capital, and leadership practices enable sustainable innovation and performance in regulated industries.

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