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...

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...

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...

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...

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...

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...

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...

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...

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...

Medical device firms operate at the frontiers of innovation. When functioning properly, innovative medical devices can prolong and improve lives; when malfunctioning, the same devices may harm patients and lead to product recalls. Product recalls create significant challenges for firms, but...

This paper addresses the impact of payment systems on the rate of technology adoption. We present a model where technological shift is driven by demand uncertainty, increased patients’ benefit, financial variables, and the reimbursement system to providers. Two payment systems are studied:...

We draw upon newly merged administrative data sets to study the relationship between payments from medical technology firms to physicians and medical device procurement by hospitals. These payments (and the interactions that accompany them) may facilitate the transfer of valuable information to...

The United States is the world’s largest supplier of medical technology (medtech). At the same time, growth in key emerging medtech markets - especially China, India, and Brazil - represent significant export opportunities for U.S. manufactures to further bolster their competitiveness. Yet,...

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...

The Covid-19 pandemic tragically emphasized severe failures of health systems. In particular, the saturation of hospital infrastructures and the lack of medical devices is crucial for respiratory ventilators. The medical and pharmaceutical sectors had to find urgently new ways to innovate...

WTO rules support efforts to address the threat of illicit trade in medical products by promoting transparency and predictability and setting the foundation for strengthened border and regulatory controls and enhanced cooperation. This publication explores WTO tools and activities that can help...

The COVID-19 (coronavirus) pandemic has exposed the upsides and downsides of international trade in medical goods and services. Open trade can increase access to medical services and goods—and the critical inputs needed to manufacture them—improve quality and variety, and reduce costs....

This report provides new data on trade in medical goods and services and medical value chains; surveys the evolving policy landscape before and during the pandemic; and proposes an action plan to improve trade policies and deepen international cooperation to deal with future pandemics

Die Publikation stellt die Ergebnisse eines vom BIBB durchgeführten Forschungsvorhabens vor, welches die Bedarfslage eines möglichen staatlich geregelten dualen Ausbildungsberufes in der Medizinprodukteaufbereitung untersucht. Hierfür werden die betrieblichen Strukturen,...

We examine the relationship between product liability litigation and innovation by systematically combining data on product liability lawsuits with data on new product introductions in a panel dataset of leading medical device firms. We first document a decline in the propensity to introduce new...

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...