The presented article concerns managerial competencies in the medical device industry. The research aimed to identify and assess certain managerial competencies and diagnose the gap between the declared and desired competencies of the interviewed managers. We asked the following question: How...

Realignments of global value chains (GVCs) are occurring at a time when the technological dynamics in manufacturing industries, including in healthcare-related industries like medical electronics, is undergoing significant changes due to the wave of new digitalisation. This study examines...

The report analyses trends, opportunities, challenges and barriers affecting digital health, and specifically, the innovation, deployment and use of wearable medical devices in the EU. The use of digital health solutions along the patient pathway could drive the integration of clinical services...

This factsheet is aimed at people within hospitals, clinics (or associations of clinics), ministries and competent bodies responsible for the procurement of medical devices and in vitro diagnostic medical devices. For a general overview of the impact of the Regulations, please refer to the...

This report documents the process and findings of a horizon scanning exercise, part of a series under the FUTURINNOV (FUTURe-oriented detection and assessment of emerging technologies and break-through INNOVation) project, a collaboration between the European Innovation Council (EIC) and the...

In April 2017, the European Parliament and the Council adopted the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). These two Regulations aim to create a robust, transparent and sustainable regulatory framework,...

Background: In a world increasingly shaped by technological innovation, the healthcare sector plays an important role in society's sustainable advancement. This study explores the use of IoT and RFID technologies to improve hospital operations and modernize healthcare services. Methods: We...

The objective of this study is to investigate whether Mergers and Acquisitions (hereafter, M&A) can promote Business Model Innovation (hereafter, BMI) in the medical device industry by examining 101 M&A cases in the U.S. from 2018 to 2024. Medical device firms have strived to achieve accelerated...

This paper presents a novel methodological approach for the dynamic evaluation of innovative medical devices under consideration of external stochastic risks. We develop a model based on the Hamilton-Jacobi formalism with stochastic extensions that integrates both deterministic aspects of...

Künstliche Intelligenz gehört zu den wesentlichen technologischen Treibern im Markt für Medizinrobotik. Sie bietet in vielfältiger Weise Potential für Neu- und Weiterentwicklungen in den Anwendungsfeldern Diagnostik, Chirurgie, Labor und Reha/Therapie. Die verschiedenen Marktsegmente sind...

Developing medical device innovations is a lengthy and costly endeavor, so engaging the right participants early in the process is crucial. While much of the existing literature focuses on procedural aspects of innovation, the human factors that influence success are often overlooked. The Lead...

The purpose of this study is to identify the factors impacting medical professionals' adoption intention of AI-based innovative medical devices focused on the mediating role of trust. Drawing on the UTAUT model, we examined the mediating effect of trust in the relationships between these factors...

This paper reviews self-powered medical devices integrated with advanced energy harvesting technologies. This article aims to explain the advantages of integrating self-powered medical devices with advanced energy harvesting technologies, outlining the transformation in healthcare system and...

This study introduces a new adoption model for assessing the quality of experience (QoE) of radiologists using AI-based medical imaging technology. While AI has increasingly been used by radiologists for screening, diagnosis, and classification of medical images, previous investigations have...

Background: The integration of drone technology into healthcare logistics presents a significant opportunity to enhance the speed, reliability, and efficiency of medical sample transportation. Methods: This paper provides a narrative review of current advancements in drone technology, focusing...

Precision medicine (PM) is an approach to healthcare that customizes treatment and prevention strategies based on individual characteristics such as genetics, environment, and lifestyle. By utilizing detailed data from diverse populations, precision medicine aims to provide accurate and...

Health Technology Assessment (HTA) is essential for evidence-based healthcare decision-making, yet its integration into Iran's healthcare system faces political and logistical challenges. Despite HTA's potential to improve resource allocation, limited awareness, data gaps, and competing...

The European Union stepped up its action in the area of health - a shared competence between the EU and its Member States - in response to the COVID-19 pandemic. Yet, the EU lacks a joint health policy that recognises health as a public good. This study investigates three areas where there is...

Cover -- Half Title -- Title Page -- Copyright Page -- Dedication -- Table of Contents -- Preface -- About the Editors -- List of Contributors -- Acknowledgments -- Part 1 Transforming the Continuum of Care -- Chapter 1 Towards AI and Human Collaboration -- Chapter 2 AI in Healthcare and...

-- PART I – Medical Devices: an overview. -- 1. Introduction: Medical Devices in a VUCA world. -- 2. Relevance of Medical Devices to humans and their impact in different geographical areas. -- 3. Why is there a need for control and regulation?. -- 4. Market environment: stakeholder analysis....

Efforts to move care out of hospitals and into the community face a hard constraint: while most medications can be delivered anywhere, diagnosis is still mostly trapped inside the formal health system--clinics, hospitals, and the people and machines inside them. This is especially binding in...

What to know before getting started -- Usability engineering -- Usability toolbox -- Medical-device documentation -- Clinical environment -- Benefit management -- Practical transparency -- Listening to the user -- Integration with quality management -- The metro map -- Seeing into the future --...

Governments rely on private firms to provide public goods and services. Although competition among these firms reduces prices and the costs of procurement, it has an ambiguous effect on fraud: competition can both dissipate the rents that attracted fraudulent firms to the market while at the...

HTA or Health Technology Assessment is the procedure for assessing the added value, effectiveness, costs and broader impact of health care interventions including medicines, medical devices and procedures. This factsheets explains the respective EU regulation.

The development and distribution of medical devices, which are necessary for identifying, treating, and keeping track of a variety of health issues, is heavily dependent on the global supply chain. However, the availability, quality, and price of medical devices can be significantly impacted by...

Despite an increasing recognition of the importance of health for economic growth, there is still a lack of understanding of the role of medical innovation in this process. Specifically, what are the causal effects of medical innovation on economic growth and which non-linearities matter in this...

This paper explores the economic incentives for medical procedure innovation. Using a proprietary dataset on billing code applications for emerging medical procedures, we highlight two mechanisms that could hinder innovation. First, the administrative hurdle of securing permanent, reimbursable...

Health technology assessment (HTA) is a comprehensive and structured evaluation that aims to analyze the potential impacts of health technologies, including medical devices, diagnostic tools, pharmaceuticals, and public health interventions. Its purpose is to provide policymakers with...

The aim of this study is examining Korean In Vitro Diagnostics (hereafter, IVD) companies' catch-up with established medical device companies by analyzing the process of sensing, seizing, and reconfiguration during the Corona Virus Disease 2019 (hereafter, COVID-19) pandemic. The potential...