Newsletter & Events - September wk 40/2025
Springer Gabler / Springer Nature Series in Healthcare Management and Innovation (available in November 2025)
Editors: Andreas Krämer · Cosimo Franco · Fabiola Hartung-Linz · Ellen Thom
🚀USP:
✅This book is open access, which means that you have free and unlimited access.
✅Examines market and management trends in the medical device industry
✅Provides current market developments as well as differences across regional medical device markets
✅Examines different stakeholders in the medical device market (e.g., regulation, product management, finance)
SNEAK PREVIEW - STAY TUNED for the next upcoming news🚀
📘 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 – 𝗖𝗵𝗮𝗽𝘁𝗲𝗿 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 #𝟲, #𝟳 & #𝟴
🔹 Chapter 6: 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗮𝘁𝗲𝗴𝗼𝗿𝗶𝗲𝘀, 𝗖𝗵𝗮𝗿𝗮𝗰𝘁𝗲𝗿𝗶𝘀𝘁𝗶𝗰𝘀 & 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁𝘀
Authors: Armando Romaniello and Giulia Magri
Abstract: Medical devices are a very large family of instruments, machines, systems, reagents and much more, all characterized by having a specific medical purpose. Their definition varies across countries; this chapter mainly refers to European legislation, with references to the U.S. and China. It outlines the main categories and characteristics of devices and introduces classification rules defined by the European MDR and IVDR regulations, including examples of devices and associated risk classes. The chapter concludes with an overview of the typical development process of a medical device, from conception to market launch.
🔹 Chapter 7 : 𝗥𝗼𝗹𝗲 𝗼𝗳 𝘁𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝘆 𝗶𝗻 𝘁𝗵𝗲 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 𝗯𝘂𝘀𝗶𝗻𝗲𝘀𝘀
Author: Gerry Chillè
Abstract: This chapter traces the evolution of medical device technology from prehistoric stone tools to modern digital systems. It examines how the industry has adapted technologies to address persistent healthcare challenges, with particular focus on artificial intelligence, data analytics, and consumer technology integration. The text highlights regulatory challenges created by accelerated innovation cycles, including cybersecurity concerns in connected devices. Key emerging technologies discussed include digital twins, advanced biosensors, 3D bioprinting, and cross-industry convergence. The chapter explores how human-machine interfaces and interoperability standards are transforming healthcare delivery, concluding with an examination of an eventual shift toward ambient, preventive healthcare. Throughout, the fundamental tension between technological advancement and regulatory oversight is analyzed, with approaches suggested for balancing innovation with necessary safeguards.
💡 Chapter 8: 𝙄𝙣 𝙫𝙞𝙩𝙧𝙤 𝗗𝗶𝗮𝗴𝗻𝗼𝘀𝘁𝗶𝗰 (𝗜𝗩𝗗) 𝗗𝗲𝘃𝗶𝗰𝗲𝘀: 𝗰𝗿𝘂𝗰𝗶𝗮𝗹 𝗶𝗻 𝗗𝗶𝗮𝗴𝗻𝗼𝘀𝗶𝗻𝗴 𝗮𝗻𝗱 𝗠𝗼𝗻𝗶𝘁𝗼𝗿𝗶𝗻𝗴
Authors: @ Peter Hartung and Kirsten Theiling
📌 Key insights: A must-read for everyone navigating the evolving IVD landscape!
🔹The role of IVDs in modern healthcare 🔹Regulatory differentiation between IVDR and MDR 🔹Classification & conformity asessement procedure 🔹Performance Evaluation vs. Clinical Evaluation 🔹IVD software: Not every diagnostic algorithm is an IVD 🔹Practical implications for manufacturers and regulatory teams 🔹Trends like AI, digital biomarkers, and global regulatory divergence
𝗘𝗩𝗘𝗡𝗧 - 𝗦𝗔𝗩𝗘 𝗧𝗛𝗘 𝗗𝗔𝗧𝗘:
📍 Official launch at MEDICA - Leading International Trade Fair / COMPAMED 2025 - 17–20 November, Düsseldorf
👉 Meet the editors & authors in person at CQY Booth hall 10, booth E31
📍Book presentation will be on 18th November 2025, from 3 pm to 5 pm, Room #18, CCD (Convention Center Düsseldorf)
📖 Secure your copy and visit us at Medica/Compamed – Open Access via Springer Gabler / Springer Nature