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Multidimensional typologies of faulty medical device events : analysis, risk characterisation, and stakeholder mapping

Goswami, Mohit; Chan, Felix T. S.; Ramkumar, M.; … - 2025

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015197669

Strategic enablers of sustainability in the Indian medical device supply chain : an ISM-DEMATEL approach

Srivastava, Deepak Kumar; Agrawal, Nishant Mukesh; … - 2026

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015614762

Building technological capabilities in India's medical devices industry

2026

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015675613

Key characteristics and role of lead users in medical device innovations : an exploratory study

Venesz, Béla; Dőry, Tibor - 2025

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...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015331669

Socio-economic Inequalities in access to Covid-19 tests in France in 2020 : evidence from the EPICOV socio-epidemiological cohort

Geoffard, Pierre-Yves; Jusot, Florence; Sireyjol, Antoine; … - 2025

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015176826

Medical device management : a comprehensive guide to markets, marketing, and regulations

2026

-- 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....

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015526349

Failure mode effect analysis use and limitations in medical device risk management

Nolan, Niamh; McDermott, Olivia - 2025

This study aims to investigate the application of risk analysis techniques in the medical device industry and the techniques most utilised to address compliance with ISO 14971:2019 with a view to assessing the challenges of risk management. Failure Mode Effect Analysis (FMEA) and its limitations...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015358509

Drivers of location advantages in the medical device industry : a qualitative study

Yun, Gawon; Hales, Douglas N. - 2026

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015675420

A review of the literature on the new European Medical Device Regulations requirements for increased clinical evaluation

McDermott, Olivia; Kearney, Breda - 2025

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015419422

Medical-device usability : human factors for medical device development

Juuso, Ilkka; Pöyhönen, Ilpo - 2026

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 --...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015616292

Recycling behavior in take-back programs : exploring driving factors and nudge-based interventions for end-user engagement : evidence From Novo Nordisk's take-back program Returpen™

Harden, Cecilie Wagner - 2025 - First edition

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015455331

Enhancing digital health innovation in the EU with effective industrial strategy policies : a focus on wearable medical devices

2025

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...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015428969

Factsheet for procurement ecosystem of medical devices and in vitro diagnostic medical device

2025

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...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015430964

Fact sheet for authorities in non-EU/EEA states on medical devices and in vitro diagnostic medical devices

2025

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,...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015431171

Competencies of medical device industry managers in an international context

Sitko-Lutek, Agnieszka; Jakubiak, Monika; … - 2025

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...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015526424

Cardiovascular medical device failure : using five-week moving averages to assess adverse event report data

Zhou, Elsa S.; Bhatia, Sujata K. - 2022

The COVID-19 pandemic had a variety of effects on the healthcare system, including the interruption of regular cardiology practices. We examined the pandemic's effects on cardiovascular medical device failure by investigating trends in the number of reports of adverse events of several...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10013393340

Getting the price right? : the impact of competitive bidding in the Medicare program

Ding, Hui; Duggan, Mark G.; Starc, Amanda - 2025

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015273107

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Getting the Price Right? : The Impact of Competitive Bidding in the Medicare Program

Ding, Hui; Duggan, Mark G.; Starc, Amanda - 2021

Book / Working Paper

Integrating self-powered medical devices with advanced energy harvesting : a review

Sohail, Anamta; Ali, Ahsan; Shaukat, Hamna; Bhatti, … - 2024

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...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10014583945

Short-term economic dynamism as a policy tool to address supply shortages during crises

Kalathil, Nikhil; Morgan, M. Granger; Fuchs, Erica R. H. - 2024

Persistent link: https://ebvufind01.dmz1.zbw.eu/10014634240

A maturity assessment methodology for ISO 13485 implementation in the medical devices industry

Linck, William; Tinoco, Maria Auxiliadora Cannarozzo; … - 2025

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015463153

Securing Medical Supply Chains in a Post-Pandemic World

2024

Secure medical supply chains are a cornerstone of resilient health systems. Medical supply chains are complex and internationalised, often involving many suppliers. The COVID-19 pandemic, which combined an unprecedented surge in demand with interruptions in supply and trade, exacerbated...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10014568036

Procuring medical devices : the price effect of mergers among orthopedic prostheses producers

Atella, Vincenzo; Ceschin, Nicola; Decarolis, Francesco - 2025

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015473989

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Procuring medical devices : the price effect of mergers among orthopedic prostheses producers

Atella, Vincenzo; Ceschin, Nicola; ecarolis, Francesco - 2024

Book / Working Paper

An exploratory study on the acceptance of new sustainable medical devices for biomedical and industrial applications

Evangelista, Ludovica; Leone, Daniele; Scaletti, Alessandro - 2025

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015438998

Product liability litigation and innovation : evidence from medical devices

Galasso, Alberto; Luo, Hong - 2024

Persistent link: https://ebvufind01.dmz1.zbw.eu/10014487268

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Product Liability Litigation and Innovation : Evidence from Medical Devices

Galasso, Alberto; Luo, Hong - 2024

Book / Working Paper

Product liability litigation and innovation : evidence from medical devices

Galasso, Alberto; Luo, Hong - 2024

Book / Working Paper

Medical professionals' adoption of AI-based medical devices : UTAUT model with trust mediation

Kim, Young Joon; Choi, Jin Hee; Ngayo Fotso, Guy Major - 2024

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...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10014518843

Tariffs on Medical Goods : Pass-through, Geography, and Aggregate Costs to the US Healthcare System

Kang, Manho; Meng, Xiangtao; Russ, Katheryn Niles; … - 2025

Have recent tariffs resulted in increased costs for the US healthcare system? We examine US trade data and compile a database of statutory tariff changes. Tariffs on medical goods narrowly defined resulted in $3.4 Billion in duties assessed between February and July 2025--more than 10 times the...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015560657

Healthcare entrepreneurship and management : a comprehensive guide for biomedical engineers and entrepreneurs

Chanda, Arnab; Gupta, Shubham - 2025

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015068723

Price Discrimination and Product Variety : The Case of Implantable Medical Devices

Goel, Kritika - 2023

Implantable medical device manufacturers are able to directly price discriminate by setting different prices for the same product in different hospitals. I analyze the welfare effects of this form of price discrimination in the case of Implantable Cardioverter Defibrillators (ICDs). I find that...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10014347484

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Price Discrimination and Product Variety : The Case of Implantable Medical Devices

Goel, Kritika - 2023

Book / Working Paper

Application of Design for Lean Six Sigma to strategic space management

Trubetskaya, Anna; McDermott, Olivia; Ryan, Anthony - 2023

Persistent link: https://ebvufind01.dmz1.zbw.eu/10014460355

Procuring medical devices : evidence from Italian public tenders

Atella, Vincenzo; Decarolis, Francesco - 2024

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015062783

Seizing the days of the COVID-19 pandemic : the catch-up of in vitro diagnostics companies in the Korean medical device industry

Kim, Dongwoo; Shin, Kwangsoo - 2023

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...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10014504881

Organizational citizenship behavior to the environment at medical device firms : the intersection of leadership characteristics, organizational factors and employee behaviors

Swearingen, Anne H.; Siats, Nathaniel; Nowakowski, … - 2024

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015077233

What motivates users to continually use wearable medical devices? : evidence from a developing nation

Jamwal, Mohit; Kanojia, Honey; Dhiman, Neeraj - 2024

Persistent link: https://ebvufind01.dmz1.zbw.eu/10014478312

New approaches to learning and regulation in medical devices and diagnostics : insights from Indian cancer care

Srinivas, Smita; Kale, Dinar - 2023

Persistent link: https://ebvufind01.dmz1.zbw.eu/10014330683

Global Supply Chain Effects on Medical Devices

Nze-Ekpebie, Ruby; Udealor, Luke - 2023

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...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10014344143

Innovation adoption by committee : evaluating decision-making in the FDA

Canen, Nathan; Iaryczower, Matiás - 2024

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015049943

Regional medical device security through safety standard harmonization

Panit Wattanakoon; Wanissa Suanin - 2023 - Revised

Persistent link: https://ebvufind01.dmz1.zbw.eu/10014441341

Patient Reported Outcomes als Qualitätsindikator in der Hüftendoprothetik

Übe, Renate - 2023

Persistent link: https://ebvufind01.dmz1.zbw.eu/10013554854

Role of prosthetic technology and design in improving quality of life of the amputees and challenges ahead

Kumar, Akshay; Yadav, Vinita; Kumar, Rajeev - 2023

Persistent link: https://ebvufind01.dmz1.zbw.eu/10013478661

User entrepreneurs for social innovation : the case of patients and caregivers as developers of tangible medical devices

Göldner, Moritz; Herstatt, Cornelius; Canhão, Helena; … - 2019

Prior research has shown that some patients and caregivers such as relatives are innovating in relation to their unmet medical needs. However, there is little evidence whether and how these ideas are later implemented into market-ready solutions and subsequently commercialized. We analyze cases...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10012104378

Cardiovascular medical device failure: Using five-week moving averages to assess adverse event report data

Zhou, Elsa S.; Bhatia, Sujata K. - 2022

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015466265

User needs in reverse logistics of electro medical equipment in a product-service system

Trevisan, Adriana Hofmann; Campese, Carina; Costa, … - 2023

Persistent link: https://ebvufind01.dmz1.zbw.eu/10014432494

Challenges and prospects in the medical device industry - heading toward a Leading Japanese Industry

Sugahara, Takuma - 2023

Persistent link: https://ebvufind01.dmz1.zbw.eu/10014330788

The top-down pattern of social innovation and social entrepreneurship : bricolage and agility in response to COVID-19 : cases from China

Crupi, Antonio; Liu, Sida; Liu, Wei - 2022

Persistent link: https://ebvufind01.dmz1.zbw.eu/10013163103

Trade competitiveness analysis of the Chinese medical device industry

Zhang, Weifan; Chatwin, Chris - 2023

Persistent link: https://ebvufind01.dmz1.zbw.eu/10014287212

Maker movement contribution to fighting COVID-19 pandemic : insights from Tunisian FabLabs

Abbassi, Wyssal; Harmel, Aida; Belkahla, Wafa; Ben … - 2022

Persistent link: https://ebvufind01.dmz1.zbw.eu/10013163124

Value-based pricing for advanced therapy medicinal products : emerging affordability solutions

Gonçalves, Elisabete - 2022

Persistent link: https://ebvufind01.dmz1.zbw.eu/10013173269

COVID-19 off-label uses of medicines : the role of civil liability and regulation

Parziale, Andrea - 2023

Persistent link: https://ebvufind01.dmz1.zbw.eu/10014326523

Chapter 13. The frugal design of a medical centrifuge: distributed production as a frugal technology to increase access to medical devices in low- and middle-income countries

Carel Diehl, Jan; Agbana, Temitope; Van, G-Young; … - 2023

A growing awareness of health as a human right, mainly in low- and middle-income countries, is promoting universal health access for increasing numbers of people. Universal access to health to a large extent depends on access to medical equipment and medical staff. In this chapter, we focus on...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015599319

How to Get Away with Merger : Stealth Consolidation and its Effects on Us Healthcare

Wollmann, Thomas - 2022

Only large mergers must be reported to the US government, so many anticompetitive deals may effectively avoid antitrust scrutiny. This paper uses data from the dialysis industry to show that premerger notifications are essential to antitrust enforcement and that ensuing enforcement actions...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10013309219

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