Development concepts of a Smart Cyber Operating Theater (SCOT) using ORiN technology

2018 ◽  
Vol 63 (1) ◽  
pp. 31-37 ◽  
Author(s):  
Jun Okamoto ◽  
Ken Masamune ◽  
Hiroshi Iseki ◽  
Yoshihiro Muragaki

AbstractCurrently, networking has not progressed in the treatment room. Almost every medical device in the treatment room operates as a stand-alone device. In this project, we aim to develop a networked operating room called “Smart Cyber Operating Theater (SCOT)”. Medical devices are connected using Open Resource interface for the Network (ORiN) technology. In this paper, we describe the concept of the SCOT project. SCOT is integrated using the communication interface ORiN, which was originally developed for industry. One feature of ORiN is that the system can be constructed flexibly. ORiN creates abstracts of the same type of devices and increases the robustness of the system for device exchange. By using ORiN technology, we are developing new applications, such as decision-making navigation or a precision guided treatment system.

2017 ◽  
Vol 23 (2) ◽  
Author(s):  
Katarzyna Markiewicz ◽  
Janine Van Til ◽  
Maarten IJzerman

To improve successful development and clinical use of medical technologies, it is suggested that manufacturers should start collecting evidence on devices effectiveness and efficiency early in their development. The aim of this study was to explore whether and how Dutch manufacturers perform an early assessment of medical devices through semi-structured interviews with key-informants from medical device companies. The primary focus was to identify why, how and to what degree these informants were engaged in early assessment activities to analyse the clinical context, the market, potential stakeholders, and the financial and health economic impact of their medical device. 37 interviews were performed with key-informants of 36 companies. The majority (N=19) of the companies are using internal resources and external consultants to perform early assessment activities. Typically, the assessment activities starts at the idea generation stage, and lasts until the post-marketing surveillance. The least developed areas of the assessment are health economic evaluation from the society perspective and formal stakeholders’ analysis. Many methods seem to be in use to assess medical devices, however, there is no clear understanding of how they should be used, what evidence manufacturers could gather with their use, and how they influence the decision-making process within the companies.


2015 ◽  
Vol 31 (1-2) ◽  
pp. 12-18 ◽  
Author(s):  
Nicolas Martelli ◽  
Mathilde Billaux ◽  
Isabelle Borget ◽  
Judith Pineau ◽  
Patrice Prognon ◽  
...  

Objectives: Local health technology assessment (HTA) to determine whether new health technologies should be adopted is now a common practice in many healthcare organizations worldwide. However, little is known about hospital-based HTA activities in France. The objective of this study was to explore hospital-based HTA activities in French university hospitals and to provide a picture of organizational approaches to the assessment of new and innovative medical devices.Methods: Eighteen semi-structured interviews with hospital pharmacists were conducted from October 2012 to April 2013. Six topics were discussed in depth: (i) the nature of the institution concerned; (ii) activities relating to innovative medical devices; (iii) the technology assessment and decision-making process; (iv) the methodology for technology assessment; (v) factors likely to influence decisions and (vi) suggestions for improving the current process. The interview data were coded, collated and analyzed statistically.Results: Three major types of hospital-based HTA processes were identified: medical device committees, innovation committees, and “pharmacy & management” processes. HTA units had been set up to support medical device and innovation committees for technology assessment. Slow decision making was the main limitation to both these committee-based approaches. As an alternative, “pharmacy & management” processes emerged as a means of rapidly obtaining a formal assessment.Conclusions: This study provides an overview of hospital-based HTA initiatives in France. We hope that it will help to promote hospital-based HTA activities in France and discussions about ways to improve and harmonize practices, through the development of national guidelines and/or a French mini-HTA tool, for example.


2020 ◽  
Vol 6 (3) ◽  
pp. 85-86
Author(s):  
Niels Grabow ◽  
Volkmar Senz ◽  
Klaus-Peter Schmitz

AbstractThe consortium RESPONSE is a cooperation of partners from science and industry within the BMBFProgram “Twenty20 - Partnership for Innovation”, 2014- 2021. Current efforts are being made towards the transfer of new products, technologies and processes in the field of medical devices. Here, RESPONSE is focusing on novel concepts of implantable medical devices for cardiovascular, ophthalmologic and otolaryngologic application. Platform technology approaches, such as drug delivery systems for responsive functionalized implants or smart implant technologies, are being used to enable new applications.


Author(s):  
Chi-Yo Huang ◽  
Hong-Ling Hsieh ◽  
Hueiling Chen

In an era of global aging, spinal and other joint degeneration issues have become a major problem for many elders. Bone-related operations have become the largest percentage of surgeries, accounting for 40% of the top 10 operations in the United States. Further, these spine-related operations are now ranked second among all bone-related operations. Due to this enormous and daily increasing market demand, more and more firms have started to pay closer attention to related medical devices and products. The global venture capitalists (VCs) have also started to follow the mega trend and will continue to invest heavily in this industry. Although most VCs recognize that investing in firms that produce innovative spinal products or devices is a must, very few practical managers or research scholars have defined the appropriate evaluation methods for these firms to use. The traditional net present value (NPV) method, which does not consider operation flexibility and changes in strategy, is far from the reality. The real option method can reveal the vagueness and flexibilities of the values being embedded in the investment projects at spinal medical device firms. However, the real option method is strictly quantitative. Usually, the evaluation aspects contain qualitative factors or local criteria which are hard to quantify in monetary terms. Thus, the adoption of multiple criteria decision making (MCDM) methods that can manipulate both quantitative and qualitative factors will be very helpful in evaluating and selecting investment cases like the spinal medical device firms, where both quantitative and qualitative factors should be considered. An analytical framework that consists of hybrid MCDM methods and the real option method will thus be very useful to evaluate the newly established firms producing spinal medical devices. Therefore, the authors propose a real option valuation as well as the Decision-Making Trial and Evaluation Laboratory (DEMATEL) based analytic network process (DANP) and the modified VIšekriterijumsko KOmpromisno Rangiranje (VIKOR) method (DANP-mV) based MCDM framework for evaluating the investment projects offered by these firms of spinal medical devices. An empirical study based on three newly established spinal medical device companies specializing in vertebral compression fracture (VCF) surgical devices was used to demonstrate the feasibility of the proposed analytical framework. Sensitivity analysis is performed to determine the influence of modeling parameters on ranking results of alternatives. This analytical framework can thus serve as a tool for VCs to use to determine the value of a potential candidate for investment. The proposed method can also serve as an effective and efficient tool for investment projects in other fields.


2020 ◽  
Vol 63 (4) ◽  
pp. 49-59 ◽  
Author(s):  
Noé Pérez Carrillo ◽  
Carlos Emiliano García Córdova ◽  
Ana Paula Ruiz Funes Molina ◽  
Alberto Manuel Ángeles Castellanos ◽  
Mayra Estrada Serrano ◽  
...  

The current landscape represents an unprecedented challenge in managing surgical patients, decision-making and the use of resources such as protective equipment in the context of the COVID-19 pandemic. Therefore, the objective of this article is to provide guidelines for good conduct in the operating room, the use of personal protective equipment, suggestions for surgeries and the best approach in the context of this situation. The main objective of these recommendations is to mitigate the risk of contagion and to educate medical-surgical health personnel in how to deal with this pandemic. Key words: COVID-19; coronavirus: protective equipment; surgery; operating room; training; emergency


Author(s):  
Patricia J. Zettler ◽  
Erika Lietzan

This chapter assesses the regulation of medical devices in the United States. The goal of the US regulatory framework governing medical devices is the same as the goal of the framework governing medicines. US law aims to ensure that medical devices are safe and effective for their intended uses; that they become available for patients promptly; and that manufacturers provide truthful, non-misleading, and complete information about the products. US medical device law is different from US medicines law in many ways, however, perhaps most notably because most marketed devices do not require pre-market approval. The chapter explores how the US Food and Drug Administration (FDA) seeks to accomplish its mission with respect to medical devicecough its implementation of its medical device authorities. It starts by explaining what constitutes a medical device and how the FDA classifies medical devices by risk level. The chapter then discusses how medical devices reach the market, the FDA's risk management tools, and the rules and incentives for innovation and competition. It concludes by exploring case studies of innovative medical technologies that challenge the traditional US regulatory scheme to consider the future of medical device regulation.


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