Medical Device Industry Research Articles

Digital Marketing Challenge in Medical Device Industry under the Regulation

Digital Marketing Challenge in Medical Device Industry under the Regulation

Application of Big Data Information Platform in Medical Equipment

The application of big data in the medical device industry mainly refers to the analysis and processing of various medical devices, so as to provide patients with better treatment and rehabilitation services. At present, our country already has a relatively mature and reliable large database system. This article studies the application of medical equipment in the big data information platform. The main methods used in this article are survey method, case analysis method, and interview method. The big data information platform and medical devices are studied from different aspects. The survey results show that 41% of people completely agree with the role of big data information platforms in medical devices.

Physician centricity in the deployment of digital solutions for neurological conditions.

The widespread deployment of telemedical approaches to managed care during the CoV2 pandemic has provided an opportunity for clinicians to engage in the development and refinement of this mode of delivery. This also represents a pivotal moment to help effect a paradigm shift in how new and more sophisticated digital health services are designed and delivered with the caregiver playing a guiding role. Building on momentum this way can allow the fuller potential of digital health to be realized by focusing on “end user pull” which balances the omnipresent “technology push” of the consumer product and medical device industries. Perhaps nowhere is this more critical than in the care of neurological illnesses where patient–provider interactions must be managed frequently and rely on a complex battery of data measures. The emergent role of the physician-entrepreneur can be envisioned, complimenting established physician-scientist career paths and represents a timely and opportune moment to refine medical education curricula.

Trade competitiveness analysis of the Chinese medical device industry

Trade competitiveness analysis of the Chinese medical device industry

Enriching in vivo clinical trials with in silico models for orthopedic implants

Clinical trials are used by the medical device industry to confirm products safety, performance, and clinical benefits. Traditional clinical studies typically follow a limited number of volunteers, which prevents capturing the full breath of patient demographics and implant use. New tools are required to overcome the limitations of traditional trials while fulfilling increasingly demanding regulatory requirements. Computer simulations have the potential to enrich traditional clinical trials with so called in silico clinical trials (ISCT) by providing data on a much broader spectrum of patients, clinical conditions and implant configurations. The historical use of simulation in the orthopedic device industry is described here to explain how it is now technically possible to model virtual populations. We also discuss the multiple benefits of such a translational research approach for the patients, healthcare systems, and manufacturers, but also the challenges to overcome. A more detailed version is available in English [1].

Integrated Multilayer Architecture with Multi Interface Entity Model for Risk Management in Modular Product Design

The purpose of this paper is to propose a framework where risk management is a living, decision-driving process in a Product Lifecycle Management (PLM) supported product development environment. This is especially relevant in the realm of the medical devices industry where products have a direct impact in customer’s health. The challenge is finding a methodology where risk management is a living, concomitant process throughout the lifecycle, which is cumulative, so the risk assessments refine with the product’s definition while adhering to a tightly regulated environment for medical devices. This process needs be fully embedded in the PLM processes so it is able to accompany the product at any change throughout its life. To achieve this goal we narrow the definition of risk to fit our purposes. We introduce the Multi Interfaces Entity Model (MIEM) as method to do a scalable and summative product decomposition. The results of the MIEM will be translated in a multilayered architecture that recognizes the functional, the modular, the generative and the physical view. In the next step, we evaluate the possible solutions to these modules creating a bridge the configurable products in PLM. From the decomposition throughout the design until the configuration, different risk assessment will be performed with the goal to accumulate them at the point of configuration to choose the best product based the lowest possible risk. The results lay the ground for a recursive methodology that supported with a PLM integrated risk management, which can be automated to make sure the risk assessment is complete, re-usable and configurable as an additional PLM function. This allows the creation of a configured design structure, applying recursively the same cumulative properties of the risk assessment. Further investigation is needed on how to implement this framework in an open source environment that is still compatible with proprietary PLM systems.

The GARD™skin assay: Investigation of the applicability domain for metals.

New approach methodologies (NAMs) for hazard identification of skin sensitizing chemicals were adopted as test guidelines by the OECD during the last decade. These alternatives to animal models align to individual key events (KE) in the adverse outcome pathway (AOP) for skin sensitization for which the molecular initiating event (MIE) is covalent binding to proteins. As it currently stands, the AOP does not include mechanistic events of sensitization by metals, and limited information is available on whether NAMs accurately predict the sensitization potential of such molecules, which have been proposed to act via alternative mechanisms to organic chemicals. Methods for assessing the sensitization potential of metals would be valuable tools to support risk management within, e.g., occupational settings during production of new metal salts or within the medical device industry to evaluate leachables from metal alloys. This paper describes a systematic evaluation of the applicability domain of the GARD™skin assay for the assessment of metals. Hazard classifications were supplemented with an extended analysis of gene expression profiles induced by metal sensitizers to compare the induction of toxicity pathways between metals and organic sensitizers. Based on the results of this study, the accuracy, sensitivity, and specificity of GAR­D™skin for the prediction of skin sensitizing hazard were 92% (12/13), 100% (7/7), and 83% (5/6), respectively. Thus, the performance of GARD™skin for the assessment of metals was found to be similar to that observed for conventional organic substances, providing support for inclusion of metals within the applicability domain of the test method.

Domestic component level analysis for multipurpose autonomous robot

Multipurpose autonomous robot technology has been developed to assist transportation sectors or the current emergency as the Covid-19 pandemic. A practical issue in the robotic industry concerns the domestic content in commodities, services, and a combination of goods and services commonly determined as domestic component level (DCL). To be considered a standardized national product, a product's DCL must surpass a certain level of local content composition. This research aims to investigate the DCL of a developed multipurpose autonomous robot in Indonesia called ROM20. The research was initiated by interviewing specialists in DCL calculation and robotics research to perform DCL analysis on ROM20. The next step was breaking down the ROM20 components into a second layer component, in which the amount of domestic component and overseas components can be derived. Finally, the ROM20 DCL value was calculated by dividing the cost of domestic components by the total cost of domestic and overseas components. As a digital product, the ROM20 DCL calculation result showed that the manufacturing aspect is 70 %, and the development aspect is 30 %. The overall ROM20 DCL value has been calculated as 52.23 %, which surpasses the national standard threshold at 40 % DCL value. Therefore, ROM20 can be considered a high-value standardized national product, impacting the competitiveness of local products and the fast-growing medical device industry in Indonesia.

Impact of Total Quality Management Practices on Customer Satisfaction: Perspectives of Medical Device Company

Customer satisfaction is an asset that should be protected and retained just like any other asset in an organization. The management needs practices that promote customer satisfaction in an organization's service provision. The study objective was to determine the effect of Total Quality Management (TQM) practices in medical device companies in Malaysia on customer satisfaction. This research aimed to establish quality management practices among Malaysia's medical device manufacturing industries and determine their influence on customer satisfaction. The study involved a descriptive overview that undertook a cross-sectional survey design to establish the TQM practices and customer satisfaction in several medical device companies in Malaysia. The study population was employees from various divisions and positions in the medical device industry. Qualitative research methodology has been applied due to the large number of respondents who participated. Data was captured through the interview process and research questionnaire to evaluate the respondents focusing on quality control activities and customer satisfaction in the medical device industry. This qualitative analysis was employed to help this study which seeks to identify cause and effect relationships. Further studies may embark on a larger scale of respondents to better overview the current practices in medical device companies.

Gender differences in the medical industries’ payments to physicians: a systematic review

PurposeThis paper aims to explore gender differences in payments made to physicians by the pharmaceutical and medical device industries via the performance of a systematic review of articles based on the Open Payments Database (OPD).Design/methodology/approachThree databases (Scopus, Web of Science and PubMed) were searched for articles published from September 30, 2014 to May 10, 2019, using two search terms: “Sunshine Act” and “Open Payments.” The systematic review is reported according to preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines.FindingsThe search identified 359 abstracts. Thirty-nine articles were selected for full review, and 17 of these met the inclusion criteria. Although the articles considered are based on the same database, they adopt diverse approaches and analyses are conducted in different ways. A substantial proportion of the studies show total payments from the two industries to be higher for male physicians than for female physicians. However, a few exceptions exist, higher female mean or median values occurring for payments involving research, ownership, honoraria, grants, royalties/licenses and travel/lodgings. Also, in the case of obstetric–gynecological specializations, a higher proportion of women than men are shown to cooperate with the industries.Originality/valueThere is gender inequality in terms of industries’ funding for doctors. While analyses of secondary OPD data show that a gender inequality exists, they do not provide an understanding of why this occurs. However, from the exceptions identified, it can be speculated that this phenomenon is connected with greater adherence to ethical standards on the part of female physicians and/or the likelihood that fewer opportunities for industrial cooperation are extended to them.

Tools for improvement of the ecological environment for innovative entrepreneurship of the medical device industry

The article discusses the main problems of the development of the domestic market for medical equipment and medical devices. The main reasons for the insufficiently high share of the presence of domestic manufacturers and developers are analyzed. The purpose of the study is to identify factors and participants in the ecological environment that affect the development of the Russian market of medical equipment and determine their contribution to ensuring the development of the industry. The research is carried out on the basis of empirical methods based on the study of various sources of information. The theoretical methods used were analysis, synthesis, deduction and induction. The research was carried out using statistical methods. Building a modern and effective eco-environment for innovative technological entrepreneurship is the most important task that needs to be solved for the development of the domestic market for medical equipment. To this end, it is necessary to introduce a number of analysis tools, the use of which will allow, depending on the stage of maturity of the company and the stage of development of a new medical device, to determine how target requests for services, services and opportunities provided by the ecosystem are changing, as well as to obtain information on the status of technology and possible risks for all participants in the process. The authors came to the conclusion that, based on the presence of an extensive network of various members of the innovative ecological environment and the low activity of technological entrepreneurs in the industry, there is no effective management system that ensures the constant application of the competencies of the members of the ecological environment at the necessary time. Amanagement analysis tool was proposed, the use of which allows to provide consistent support for the complete innovation cycle of technology, consisting of the stages of knowledge generation, transformation of knowledge into experimental development and technology commercialization.

When Medical Devices Have a Mind of Their Own: The Challenges of Regulating Artificial Intelligence.

How can an agency like the U.S. Food & Drug Administration ("FDA") effectively regulate software that is constantly learning and adapting to real-world data? Continuously learning algorithms pose significant public health risks if a medical device can change overtime to fundamentally alter the nature of a device post-market. This Article evaluates the FDA's proposed regulatory framework for artificially intelligent medical devices against the backdrop of the current technology, as well as industry professionals' desired trajectory, to determine whether the proposed regulatory framework can ensure safe and reliable medical devices without stifling innovation. Ultimately, the FDA succeeds in placing effective limits on continuously learning algorithms while giving manufacturers freedom to allow their devices to adapt to real-world data. The framework, however, does not give adequate attention to protecting patient data, monitoring cybersecurity, and ensuring safety and efficacy. The FDA, medical device industry, and relevant policymakers should increase oversight of these areas to protect patients and providers relying on this new technology.

Internationalization of China’s medical device industry: a case study in Brazil

Purpose The singularity of being the first Chinese manufacturer of drug-eluting stents to arrive in Brazil and the country being selected as the company's first experience outside its home country motivated the interest in the study of this case, vis-à-vis with the characteristic of internationalization medical device companies according to the Uppsala model. Considering this context, the following research question was outlined: “How did Microport internationalize before the distribution of its stents product in Brazil?” The aim of the study is to investigate Microport's internationalization process for the distribution of its drug-eluting stents in Brazil. Design/methodology/approach Exploratory research under the qualitative method was adopted. It chose the single case study as a procedure for data collection, as it is a revealing, exemplary subject that offers opportunities for access to unusual research. The company MicroPort was chosen because in the period when Chinese medical device companies were focused on gaining market share in China, MicroPort began its international expansion, choosing Brazil as the first country to have its own subsidiary. It consists in the case of the internationalization of a high-tech EMNE in an emerging country that has institutional and cultural differences. Findings Taking advantage of new technology in highly internationalized environments favors its insertion; the internationalization of medical technology can expand according to the Uppsala Model, which does not explain internationalization, but rather its evolution. Cultural and behavioral issues reinforce that the development of the market for medical devices depends on local perspectives and values. The formation of an ecosystem in the local market for internationalization is observed. One implication of the study is that MicroPort's experience and the application of the Uppsala model for international expansion can serve as an important learning experience for Brazilian multinational companies. Research limitations/implications Empirical analysis carried out in the context of a single company. Although the results can be used as lessons learned from the application of the Uppsala model for international expansion of EMNE in an emerging market, caution should be exercised when generalizing its findings. Future studies could carry out comparative cases considering other emerging multinational companies, from the same sector or even from different industries, investing in other emerging markets. There is a limitation of the fact that the case studied does not explore the concepts of the later stages of the Uppsala model. Practical implications High-tech EMNEs internationalizing in other markets need to adopt aggressive strategies. The need to adopt different strategies for supply chain operations according to the specificities of the markets in which they operate. Important contributions to the Uppsala model, with regard to the process of passing stages, learning and networking. The findings of this study have similarities to the process described as a sequence of distinct phases of activities. Social implications A local top management team is essential to deal with institutional issues of government agencies when EMNE is internationalized in a culturally distant market. When there are major institutional differences between the country of origin and the host country, the autonomy in the management of the foreign subsidiary positively influences the acceleration of the internationalization process of companies in the high-tech sector. When there are major institutional differences between the country of origin and the country of destination, the use of local social networks positively influences the acceleration of the internationalization process of companies in the high-technology sector. Originality/value Regardless of these limitations, the study provided an exciting case of internationalization of a Chinese company in Brazil operating in a high-tech medical sector. The challenges for the internationalization of EMNEs continue, which makes it opportune for future studies to include more research in this area. The propositions suggested in the study may be the first step.

Finding a happy medium: meeting the rising demand for bioproduction media

<div class="authors authors-lg"><div class="author"><div class="author-img"><img src="https://cdn.insights.bio/uploads/ee3f65cf17f740c5bee1343ad4d70da5.jpg" data-image="1"></div><div class="author-det"> <b>Marlin Frechette</b> has over 30 years of experience in the medical device industry, servicing pharmaceutical and biopharmaceutical customers. As Chief Quality and Compliance Officer at FUJIFILM Irvine Scientific, she holds global responsibility for all FUJIFILM Irvine Scientific sites and affiliates for Compliance, Quality Systems, Global Regulatory, and EHS. She holds a Bachelor’s of Science with a major in Business Administration and Personnel Management. </div></div></div>

What Are the Success Factors for a Partnership with Global Medical Device Companies? Evidence from Korea

The medical device industry is uniquely characterized by both resourceful global companies and innovative catching-up companies. The studies by Chatterji have analyzed how large and established medical device companies could better utilize the ideas from innovative groups such as physicians. While the existing literature on the topic of open innovation is enriched, there are few studies on the partnership between larger global medical device companies and smaller catching-up medical device companies. This study focuses on a structured partnership with global medical device companies. To understand how such a deal could be better arranged, this study adopted the Analytic Hierarchy Process (hereafter, AHP) analysis to derive the success factors of such partnership with a focus on the case of the Korean medical device industry. This survey interviewed 30 experienced professionals who currently work for global medical device companies. The study results found that global medical device companies prefer a licensing deal along with broader territories. In terms of the preferred requirements for a partnership deal, the study revealed that there is strong emphasis on factors such as Quality and Intellectual Property (hereafter, IP) protection. This study has practical managerial implications for catching-up medical device companies which drive an open innovation practice with a view to accelerating their growth trajectory in the global market.

The Status of Industry and Supervision of Medical Devices for Human Assisted Reproductive Technology in China

This study summarizes the status of domestic industries of medical devices for assisted reproductive technology, product category, the status of product classification management, the status of technical review, the progress of quality evaluation technology, and the progress of standardization. The domestic industry of medical devices for assisted reproductive technology in my country has begun to take shape, and a solid foundation has been laid for standardization and supervision technology. These will become an important driving force and guarantee for the subsequent development of medical devices for assisted reproductive technology. Under the guidance of the new development concept and the trend of accelerating the construction of the main body of the domestic cycle, my country's independent and controllable assisted reproductive medical device industry is gaining momentum.

Can Regulatory Efforts Motivate Innovation? The Case of Ventilator Innovations During COVID

In 2020, the United States Food and Drug Administration enacted the Emergency Use Authorization (EUA) to help respond to the COVID-19 pandemic. This regulatory pathway allowed for alternative uses of the existing medical devices and temporary authorization of new medical device designs, including ventilators. Given that regulation is often seen as a barrier to innovation, looking at ventilator innovation under the EUA is a good case study to explore if reducing regulatory barriers leads to increased or different forms of innovation. In this article, publicly available data are used to track the nature of innovation across all forms of ventilators submitted under the EUA pathway. We found that the EUA encouraged innovation in the ventilator industry, as indicated by new entrants to the medical device industry, a shift in the types of ventilators submitted for approval, and a wide variety of innovations. It also promoted new management practices to facilitate innovation, such as frugal design, a broader range of collaboration, and the use of open-source designs; these practices can be more widely used by industry to reduce costs, increase innovation, and serve traditionally underserved markets.

Orthopaedic Trauma Surgeons' Financial Relationships With Industry: An Analysis of the Sunshine Act Reporting of Physician Open Payments From 2014 to 2019.

Introduction:Orthopaedic trauma surgeons have an intricate relationship with the medical device industry. In the past decade, legislation has created transparency of monetary exchanges between physicians and industry. In 2013, the Physician Payments Sunshine Act was passed and ultimately led to the creation of the Open Payments Database. The purpose of this study was to evaluate trends in industry payments to orthopaedic trauma surgeons.Methods:A retrospective review of the Centers for Medicare & Medicaid Services' Open Payments Database was conducted for general industry payments to orthopaedic trauma surgeons from 2014 to 2019. Total payments and subtype payments were analyzed for yearly trends. All payments were converted to 2019 US dollars to adjust for inflation. Descriptive statistics included analysis of payments, number of surgeons, types of payments, top contributing companies, and regional comparisons. Trends were assessed through the Jonckheere-Terpstra test. Statistical significance was defined at P < 0.05.Results:From 2014 to 2019, 45,312 individual payments were given to orthopaedic trauma surgeons (N = 3208) accounting for a total of $41,376,397.85 (USD), with a mean of $919.54 per payment. Increased trends were noted for median annual payments, number of payments, and number of surgeons receiving payments. Compared with 2014 ($460.91), median payments were increased by 90.9% in 2016 ($879.85), 102.6% in 2018 ($933.81), and 178.6% in 2019 ($1284.06). Payment subtypes that demonstrated increasing median payments included consulting fees (P = 0.028); education (P < 0.001); entertainment, food, and beverage (P < 0.001); and travel (P = 0.019). Decreases in median payments were seen in royalties (P = 0.044) and grant funding (P < 0.001). Regional comparisons demonstrated increasing trends in median payments in the midwest (P = 0.011), south (P < 0.001), and west (P = 0.003), but not in the northeast (P = 0.081).Discussion:In our study, we found that industry payments to orthopaedic trauma surgeons were increasing markedly between 2014 and 2019, particularly among consulting fees, education, entertainment, food and beverage, and travel.

THE FUTURE: 3D MANUFACTURING OF MEDICAL DEVICES

-Three-dimensional (3D) printing is the future in the manufacturing world; its applications are widely applicable from the construction industry, engine components, replacement parts, oil and fuel tanks, welding, and manufacturing medical devices. It allows transforming designs in the digital environment into physical objects using layers manufacturing methods. Specifically, in the medical segment, 3D manufacturing is spreading faster since it will enable the unique customization to meet the patient's needs, such as heart valve design, and for physicians such as a unique ergonomic surgical tool to increase useability, thus positively impacting patient outcome. Various 3D manufacturing technologies depending upon the material have made it possible to achieve a variety of applications and provide a competitive cost advantage. However, like any other new technology, 3D printing is no different in facing the challenges in its adoption. It is imperative to take a deeper dive to discuss 3D manufacturing in the medical device industry, current 3D printer technology, its applications in the medical industry, and finally, the manufacturing and product design challenges

Creation and Analysis of Technological Intelligence Reports as Educative Tool in Biomedical Engineering.

Identifying and analyzing quality information sources of technical information is a fundamental skill to create and maintain a technological intelligence system. In the present work, we propose the intentional training of undergraduate biomedical engineering students to create a simple technological intelligence report by analyzing scientific publications and patents. Computerized Maintenance Management Systems (CMMS) focused on the medical devices industry is proposed as the central topic, results suggest that the creation of technological intelligence report generates value to the undergraduate biomedical engineering students given them a tool to identify the impact of new technology in healthcare and medical devices.