Innovation for Safe and Effective Medical Devices: Contributions From Postmarket Surveillance

Zippel, Claus; Bohnet-Joschko, Sabine

doi:10.1177/2168479016674040

Cited by 6 publications

(7 citation statements)

References 30 publications

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“…At an organizational level, physician adaptation of innovation is discouraged, and although it may be given lip service, attempts to introduce technologies are stifled by red tape and the hurdles that physicians must jump through. [13][14][15][16] New market leaders have been transforming their tactics from focusing on the return of investment to return on failure. This 360-degree vision allows reverse engineering of challenges and optimizing of failures in an attempt to save millions.…”

Section: Challengesmentioning

confidence: 99%

Section: Challengesmentioning

confidence: 99%

“…The majority of physicians are willing to accept an improvement on current technology; however, their skepticism overrides their adoption of innovative techniques. [10][11][12][13][14][15][16][17] Furthermore, physicians are becoming increasingly aware of cost-effectiveness. This strategy discourages innovation, as innovation might not be viable economically at its early phase.…”

Section: Challengesmentioning

confidence: 99%

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Why Are Medical Device Multinationals Choking Disruptive Technology and Killing Innovation? Challenges to Innovation in Medical Device Technology

et al. 2021

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Medical device innovation has maintained momentum, irrespective of changing socioeconomic trends, as medical device companies recognize the need to innovate. However, the translation of device innovation into clinical practice continues to be a daunting, and often a complex and protracted process.The clinical community is diverse. On one end of the spectrum are the "innovators and early adopters" (interventional cardiologists, endovascular key opinion leaders, and neuroradiologists), who are enthusiastic about adopting new ideas (Figure 1). [1][2][3] The most prominent example is the late professor Edward B. Diethrich, who was one of the early vascular surgeons to introduce and adapt endovascular grafts in the history of vascular surgery. Then the "early majority" (vascular and endovascular specialists), mostly from the United States, continental Europe, Ireland, and New Zealand, who are keen to use something new but only after they feel it is safe to do so. Then, the "late majority," mostly from the United Kingdom, Japan, Australia, Brazil, and Argentina, who follow everyone else's lead. Finally, the other end of the spectrum constitutes the rest-the laggards, who will never accept any solution, no matter how many others use it or how promising it has been. Although there is a natural tendency to lag and avoid the burden of rapid development, there is no excuse for not being open to the adoption of newer technologies as we move forward.The three individual innate traits that mandate our future goals and act as our natural differentiators are expertise, creative thinking, and intrinsic motivation (Figure 2). 4 Innovators tend to have outstanding educational credentials and often a state-of-the-art facility, but without motivation, there is no hope for accomplishment. Therefore, we believe that "excellence is not competitive."Our autonomy and freedom fosters creativity and heightens our intrinsic motivation and sense of ownership. Freedom allows us to approach problems through our expertise and creative thinking. Intrinsic motivation and interest in solving a problem are key driving factors, which are independent of material gain. The intrinsic motivation of relishing a challenge, and our drive to crack a challenging situation that no 989356J ETXXX10.

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Section: Challengesmentioning

confidence: 99%

Section: Challengesmentioning

confidence: 99%

Section: Challengesmentioning

confidence: 99%

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Why Are Medical Device Multinationals Choking Disruptive Technology and Killing Innovation? Challenges to Innovation in Medical Device Technology

et al. 2021

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“…Vigilance aids in identifying new or escalating risks with a device, as well as possible improvements to the useability or functionality of the device. 2 The reporting of device failures to manufacturers or regulators helps identify risks at the earliest possible timepoint. The hazard may be novel or due to regional factors, such as environmental conditions or clinical practice, which were unknown or not initially considered by the manufacturer.…”

Section: Introductionmentioning

confidence: 99%

The Need for Greater Reporting of Medical Device Incidents

2019

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Post-market monitoring of medical devices by manufacturers and regulatory agencies aids the identification of novel hazards or increasing trends in the risks associated with devices. This narrative review estimates the rates of under-reporting of medical device adverse events and explores the reasons and possible solutions. Incident reports may be presented to the manufacturer or the regulatory agency spontaneously by consumers, patients, clinicians, or distributors of medical devices. However, it is evident that reporting does not occur to a great extent, with the rate of reporting estimated to be as low as 0.5% of all occurrences. The programmes and processes to increase and support the reporting of adverse events need to be reviewed, with consideration given to the cost-benefit of increased reporting in relation to the regulator, regulated entities, healthcare facilities, and professionals, as well as the public.

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“…The clinical trials for medical devices are conducted under strictly controlled conditions, so it is difficult to say that the safety of medical devices is completely evaluated in these trials. Therefore, to supplement the limitations of pre-market evaluations of medical device safety, the post-market surveillance system continues to manage medical device adverse events even after the device is licensed [3,4].…”

mentioning

confidence: 99%

Inadvertent free flow of remifentanil caused by a damaged syringe installed in syringe pump

Kim

Cho

Moon

et al. 2021

Korean J Anesthesiol

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Innovation for Safe and Effective Medical Devices: Contributions From Postmarket Surveillance

Abstract: The transfer of this postmarket-related device knowledge can have a positive impact on the improvement or development of (especially incremental) medical device innovations, thus contributing to a company's success and strengthening device-related patient safety at the same time.

Cited by 6 publications

References 30 publications

Why Are Medical Device Multinationals Choking Disruptive Technology and Killing Innovation? Challenges to Innovation in Medical Device Technology

Why Are Medical Device Multinationals Choking Disruptive Technology and Killing Innovation? Challenges to Innovation in Medical Device Technology

The Need for Greater Reporting of Medical Device Incidents

Inadvertent free flow of remifentanil caused by a damaged syringe installed in syringe pump

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