Medical Device Industry Research Articles

Dilemmas Encountered by Small and Medium-sized Orthopedic Medical Device Manufacturing Companies in Healthcare Reform Based on a Supply Chain Perspective: Taking a Manufacturer in Jiangsu Province as an Example

As China’s healthcare reform progresses, the medical device industry is receiving significant attention as an essential part of the healthcare delivery system. Current research on the supply and management of medical devices in the context of healthcare reform mainly focuses on the downstream of the supply chain to innovate the management model of orthopedic consumables in hospitals and realize competent healthcare. However, only a few studies have focused on medical device manufacturers upstream of the supply chain and proposed measures to improve supply chain performance. This paper takes a medium-sized customer medical device manufacturer in China as a case study. This study analyzes the problems revealed in its supply chain operation through literature research, case study analysis, and fieldwork. It proposes countermeasures for the continuous improvement of the industry against the background of healthcare reform. The study found that small and medium-sized medical device manufacturers were not using management information systems adequately and were suffering from the impact of healthcare reform by sticking to their old distribution models. For long-term growth, these small and medium-sized medical companies should focus on research and development, cater to market needs, integrate downstream distributors, and work with hospitals to establish a more transparent and efficient healthcare supply chain.

Threat Assessment and Risk Analysis (TARA) for Interoperable Medical Devices in the Operating Room Inspired by the Automotive Industry.

Prevailing trends in the automotive and medical device industry, such as life cycle overarching configurability, connectivity, and automation, require an adaption of development processes, especially regarding the security and safety thereof. The changing requirements imply that interfaces are more exposed to the outside world, making them more vulnerable to cyberattacks or data leaks. Consequently, not only do development processes need to be revised but also cybersecurity countermeasures and a focus on safety, as well as privacy, have become vital. While vehicles are especially exposed to cybersecurity and safety risks, the medical devices industry faces similar issues. In the automotive industry, proposals and draft regulations exist for security-related risk assessment processes. The medical device industry, which has less experience in these topics and is more heterogeneous, may benefit from drawing inspiration from these efforts. We examined and compared current standards, processes, and methods in both the automotive and medical industries. Based on the requirements regarding safety and security for risk analysis in the medical device industry, we propose the adoption of methods already established in the automotive industry. Furthermore, we present an example based on an interoperable Operating Room table (OR table).

An Overview of the Importance of Fogging Disinfection Method in the Healthcare Setups

The medical device industry is a critical sector that plays a vital role in healthcare delivery. Due to the nature of the work, medical device facilities are at risk of contamination from harmful microorganisms. Fogging is an essential method of disinfection that is used to eradicate pathogens and prevent the spread of infectious diseases in medical device facilities. This paper presents an overview of the importance of fogging in the medical device industry, highlighting the benefits of fogging as a disinfection method. The paper discusses the different disinfectants that can be used for fogging, and the equipment that is required for the process. The methods of preparation of disinfectants and the different machines that are used for fogging are also described. The paper highlights the importance of monitoring the environment after fogging to ensure the effectiveness of the disinfection process. Overall, the paper emphasizes the critical role of fogging in preventing the spread of infectious diseases in the medical device industry, ensuring the safety of both patients and healthcare professionals.

Designing an IoT-enabled supply chain network considering the perspective of the Fifth Industrial Revolution: Application in the medical devices industry

The rapid growth of technology, environmental concerns, and disruptions caused by the COVID-19 pandemic have led researchers to pay more attention to an emerging concept called the fifth industrial revolution (I5.0). Despite the high importance of the I5.0, the literature shows that no study investigated the supply chain network design problem based on the I5.0 pillars. Hence, this research develops a multi-stage decision-making framework to configure a closed-loop supply chain based on I5.0 dimensions to cover this gap. In the first stage, the score of technologies that utilized in the supply chain is calculated using the analytic hierarchy process method. Afterwards, in the second stage, a mathematical model is proposed to configure the supply chain. Then, Furthermore, an efficient solution method, named the fuzzy lexicographic multi-choice Chebyshev goal programming method, is developed to obtain the optimal solution. In general, the main contributions of the current study can be divided into two major parts as follows: (i) the current study is the first research that incorporates the dimensions of the I5.0 into the supply chain network design problem, and (ii) this work develops a novel and efficient solution method. In this regard, the major problems and challenges that existed include the limitation of available resources in relation to Industry 5, especially in the field of the supply chain, as well as quantifying the elements of Industry 5.0 in the form of a mathematical programming model.

Evolution of China regulatory guidance on the clinical evaluation of medical devices and its implication on pre-market and post-approval clinical evaluation strategies

ABSTRACT Introduction The rapid growth of the medical device industry has driven the evolution of regulatory guidance on medical device clinical evaluation (MDCE) of the China National Medical Products Administration (NMPA), which consequently influences pre–market and post–approval clinical evaluation (CE) strategies. Areas covered We aimed to investigate the 3–stage evolution of NMPA regulatory guidance on MDCE (1. The era before specific CE guidance, 2. 2015 CE Guidance, and 3. 2021 CE Guidance Series), analyze the gaps between each stage, and assess the evolution’s impact on pre–market and post–approval CE strategies. Expert opinion The fundamental principles of the NMPA 2021 CE Guidance Series were transformed from the 2019 International Medical Device Regulatory Forum documents. Compared with the 2015 guidance, the 2021 CE Guidance Series further clarifies the CE definition by emphasizing the ongoing activity of CE through an entire product lifecycle and the use of scientifically sound methods for CE and narrows the pre–market CE pathways into the equivalent device and clinical trial pathways. The 2021 CE Guidance Series simplifies the process for selecting the pre–market CE strategy but does not specify post–approval CE update cadency and general requirements for post-market clinical follow–up.

Building a Business Ecosystem in the Medical Device and Medical Material Manufacturing Industry:

近年，医療に携わる製造業が手術用途に合わせた医療材料のキット化やそれに伴う競合他社との協業関係の構築，手術室の物流および情報管理など，自社をプラットフォームとして生産体制と供給体制をシームレスに繋げようとする動きが活発である。本研究では，医療に携わる製造業がビジネス・エコシステムを構築し，「製造業のサービス化」による新たな価値創出の可能性について検討した。医療機器および医療材料企業84社を対象に価値創出の状況を確認した結果，伝統的なバリューチェーンモデルに基づき，顧客に対し「製品価値」を中心とした価値提供を行っていることが示された。さらに，製品とサービスの一体化の状況を検討すべく，サービタイゼーション誘因モデルによる検証を行い，「サービタイゼーション」につながる「カスタマイズソリューション」および「ビジネスプロセスの統合」に企業が対応できていない構造的空隙があることを確認した。最後に，ビジネス・エコシステムを構築するためには，顧客との情報流を活性化させ，サービタイゼーションを促進する構造的空隙を架橋する戦略を提案した。

Marketing Strategy to Increase Sales during a New Normal Era on PT. Promedika Mitra Utama (Distributor in the Medical Device Sector)

COVID-19 has affected all economies. increases demand in Southeast Asia, particularly Indonesia, notably in the health and pharmaceutical industries, which grow significantly. Some entities like micro-retailers hope to make a profit. Micro retailers dominate Indonesian based on product sales. Micro retailers sales and revenue rise significantly. Promedika Mitra Utama (PMU) sells and marketing their product using B2C business model. as micro retailer categorizes in micro in medical device industry, PMU has also been affected positively and negatively by the pandemic. In 2023, market condition of medical devices had started to fall, this caused corona cases to have gone down, people don’t really need medical devices. PMU as a micro retailer experienced a decline in sales as well, Learn from this dynamic condition. PMU wants to maintain the stability of sales performance at least will be stable to for a next a few years as a player on health and pharmaceutical industries. Marketing activities are one of those that can aid in this regard and directly relate to sales. In general, PMU has carried out marketing activities, but that kind of marketing activities PMU running are poor on measurement and monitoring, this led to his marketing activities often ineffective in Budgeting, scheduling, utilization. Entering 2023, PMU wants to make a marketing plan approach to efficiently budget campaigns, promotions, and other marketing activities according to the company’s goals and objective. Good marketing plan approach will be anticipated volatility of the market by enhancing sustainable competitive advantage. and evaluating ongoing marketing activities. Using the AFI analysis framework based on internal, external, and SWOT formulation, will result in some proposed marketing planning strategy. Marketing plan will be used for 2023 and for 2024 input evaluation, where the results are in the form of a formulation of 7Ps of marketing mix, TOWS, and Porter Generic analysis. Finding of this research, it was found that PMU will plan and applied some strategy and policies offline and online-based marketing activities in 2 semesters during 2023. Which is the goal of the first semester to build awareness and discount incentives to boost sales and Finding of this research, it was found that PMU will plan offline and online-based marketing activities in 2 semesters during 2023. Which is the goal of the first semester to build awareness and discount incentives to boost sales.

ANALISA DAN RANCANG BANGUN TEMPAT TIDUR BAYI ( BABY COT )

The success of the national health insurance program (JKN) requires certainty of the availability of drugsupplies and medical devices from local industries. The limitation of the local medical device industry is anobstacle to the success of the program, and then released national program to accelerate the development ofthe independence of the national medical device industry. This research is intended to find an alternativeway to accelerate the development of the medical device industry by developing upstream technology,namely product design and development. With this technology, an effective way of developing medical deviceproducts for small industries will be obtained, the product reaches the market immediately, and meetsregulatory requirements. The product used in this case is a baby cot. The product development model used isto follow the regulatory requirements for good medical devices manufacturing practices (CPAKB), SNI ISO13485 and a systematic approach to design a product that is safe, and effective as intended use. Informationon product requirements and test methods is taken from EN 1130 Part 1 and Part 2. Using a systematicapproach the requirements and functions for the product can be analyzed. Furthermore, the embodimentdesign and detailed design are developed. The correctness of the design is proven by making functionalprototypes and verified by the stipulated design requirements. From this research, it was found a way todevelop medical device products for baby box products that are safe, and effective as intended use meetregulatory requirements.

Minimizing the Main Strains and Thickness Reduction in the Single Point Incremental Forming Process of Polyamide and High-Density Polyethylene Sheets

Polymeric materials are increasingly used in the automotive industry, aeronautics, medical device industry, etc. due to their advantage of providing good mechanical strength at low weight. The incremental forming process for polymeric materials is gaining increasing importance because of the advantages it offers: relatively complex parts can be produced at minimum cost without the need for complex and expensive dies. Knowing the main strains and especially the thickness reduction is particularly important as it directly contributes to the mechanical strength of the processed parts, including in operation. For the design of experiments, the Taguchi method was chosen, with an L18 orthogonal array obtained by varying the material on two levels (polyamide and polyethylene) and the other three parameters on three levels: punch diameter (6 mm, 8 mm and 10 mm), wall angle (50°, 55° and 60°) and step down (0.5 mm, 0.75 mm and 1 mm). The output parameters were strain in the x direction, strain in the y direction, major strain, minor strain, shear angle and thickness reduction. Two analyses were conducted: signal-to-noise ratio analysis with the smaller-is-better condition and analysis of variance. The optimum values for which the thickness was reduced were the following: wall angle of 50°, punch diameter of 10 mm and step down of 0.75 mm.

Operations Management, and Quality Control in the U.S. Medical Device Industry

This abstract discusses various aspects of the medical device industry, including the need for efficient supply chain management, the importance of partnerships between suppliers and manufacturers, and the critical role of specific parts and electronic boards in the design of medical devices. The paper also addresses the concept of outsourcing in the medical device electronics industry, highlighting the hesitation of industry leaders to trust outside firms with the production of proprietary products. It emphasizes that trust is at the core of outsourcing decisions and that companies in the medical device business have the opportunity to create a business model that deserves trust. The research paper highlights the need for development firms to have confidence that quality and delivery needs are being met, and that regulatory procedures with agencies such as the Food and Drug Administration are efficiently managed.

Operations Management, and Quality Control in the U.S. Medical Device Industry

This abstract discusses various aspects of the medical device industry, including the need for efficient supply chain management, the importance of partnerships between suppliers and manufacturers, and the critical role of specific parts and electronic boards in the design of medical devices. The paper also addresses the concept of outsourcing in the medical device electronics industry, highlighting the hesitation of industry leaders to trust outside firms with the production of proprietary products. It emphasizes that trust is at the core of outsourcing decisions and that companies in the medical device business have the opportunity to create a business model that deserves trust. The research paper highlights the need for development firms to have confidence that quality and delivery needs are being met, and that regulatory procedures with agencies such as the Food and Drug Administration are efficiently managed.

Understanding Regulatory Requirements and Registration Practices for Medical Devices in Germany: Perspectives of Industrial Experts

The medical device industry in Germany is advanced and innovative. Moreover, it stands at the third position in the world in terms of volume and quality of medical device production in a year, as well as annual revenue generation from the industry. However, there is a lack of understanding regarding the regulatory requirements and registration practices that can be used by new entrants in the market for medical devices in Germany. Therefore, the current study aimed to analyze these processes from the perspective of industrial experts. The researcher conducted semi-structured interviews with five biotechnologists and five legislative managers working within the biotech industry in Germany. The findings include a discussion regarding regulatory requirements, the importance of regulatory practices, innovation in the medical device industry, and the registration practices for medical devices in Germany. In the future, there is a need to conduct any empirical and statistical analysis regarding the impact of regulatory requirements and practices, innovation, funding, and research and development on the success of the medical device industry in Germany.

How to improve IFRS for intangible assets? A milestone approach

This study focuses on the decreasing relevance of financial information associated with current financial reporting standards for intangible assets. We summarize and compare three approaches to improving financial reporting standards for internally generated intangibles—the recognition approach, the fair value approach and the disclosure approach, among which we focus on the recognition approach. We investigate the impact of current International Accounting Standard 38 on the R&D capitalization policies of the high-tech industry, particularly among medical device firms in China. We conclude that the current recognition criteria are so stringent that they disincentivize firms from capitalizing their R&D investments. A large variation exists in capitalization timing within the medical device industry. Accordingly, we propose the milestone approach to revising financial reporting standards for intangible assets. We suggest that determining the capitalization criteria for intangibles based on the R&D cycle and capitalization timing should be moved forward.

Improving the competencies of managers in the medical devices industry from an international perspective

Purpose: The subject of the presented study concerns the improvement of the competencies of managers in the medical devices industry. The presented research aimed to identify and evaluate the improvement process and forms of improvement used in the analyzed enterprises. Design/methodology/approach: Empirical research was conducted using the diagnostic survey method and survey technique in 2018-2020. The research covered 130 managers representing various medical device industry companies from four selected European countries, i.e., Germany, Great Britain, France, and Poland. Findings: The analysis of the research results showed that 71% of organizations care about improving the competencies of their management staff. The most popular forms of manager development were learning by practice, short training, and mentoring. Most of the surveyed managers felt the need for development. Research limitations/implications: The research was limited to four selected European countries, which does not allow the generalization of the results to the entire population. In the future, more in-depth and extensive research on competency development among managers in the innovative medical device industry will be worthwhile. Practical implications: The analysis of the results of the conducted research makes it possible to develop recommendations for the management and owners of enterprises in the medical device industry regarding the pragmatics of improving managerial competencies. Originality/value: The research findings provide insights into specific trends related to improving the competencies of managers in the medical device industry. Keywords: competence development, improvement methods, managers, medical devices industry. Category of the paper: Research paper.

Investigating factors that impact employee turnover in the medical device industry in the United Arab Emirates

The United Arab Emirates (UAE) has established itself as the medical device industry's preferred regional center. Major multinational corporations either have a regional subsidiary or are planning to open up a principal office in the UAE to expand their business. Employees in the industry are in high demand as new opportunities open up frequently and that causes challenges to companies, namely employee turnover. This research helps bridge the gap found in the literature by investigating the factors that impact employee turnover in the medical device industry in the UAE. These factors were tested with their subsequent sub-factors. Using a quantitative approach, the study surveyed 230 participants from 47 medical device companies in the UAE. The result of one-way ANOVA demonstrated a significant relationship between employee salary and employee turnover. The linear regression analysis revealed that employee turnover had a statistically significant relationship with perceived external prestige, location, flextime, organizational justice, job satisfaction, organizational commitment, extrinsic rewards, career advancement, lack of alternatives, and constituent attachments. These findings indicate the need for a strategy utilizing these factors for existing and new medical device companies in the UAE to prevent high employee turnover or limit it at least.

Medical device industry in Iran: key driving forces of domestic production up to 2040

The medical device industry (MDI) has excellent potential for development in Iran due to the current Domestic Production (DP) potential and the increasing global demand for medical products. The present study aimed to identify the driving forces of the DP in the MDI in Iran. This explorative study was conducted by a three-round Fuzzy Delphi method. The fuzzy weighted means of each factor paved the way for the final ranking. A total of 19 key driving forces of the DP in MDI were obtained. The most important factors were: 1) access to medical-grade raw materials, energy, and physical infrastructure; 2) medical device demand; 3) research and development; 4) complying with international regulations; 5) economic stability; 6) human resources expertise; and 7) emergence and integration of technologies. The findings offer practical implications for policy-making, developing futures scenarios, and road mapping. Additionally, they provide components of production strategy development.

A Z-score-based early warning study of financial risk in the medical device industry

It has become urgent to find a solution for the problem of how to use the financial risk early warning system to effectively evaluate the financial risk of enterprises and determine whether the risk threshold is standard across different industries (Lei, Menghao, & N, 2021). This paper applies the Z-Score model and focuses on the medical device industry. Using a total of 48 listed companies on the Science and Technology Innovation Board as observation samples, empirical analysis of the companies’ financial risks is conducted in addition to establishing a more reliable and practical financial risk early warning model suitable for the medical device industry. APT Medical and Endovastec were selected as observation samples, followed by an empirical analysis using traditional indicators and the Z-Score model. The results show that the applicability of the Z-Score model to a certain company in financial risk early warning is low. Furthermore, the threshold of the financial risk early warning model should be dynamically adjusted according to various industries to assist enterprises in realizing the financial risk crisis in time to take adequate measures. (Lu & Zhan, 2018)

Scaling AI-based industry 4.0 projects in the medical device industry: An exploratory analysis

As technological advancements in artificial intelligence (AI) accelerate, the effect it has on the adoption of Industry 4.0 is significant. The adoption of AI-based Industry 4.0 projects creates a significant opportunity to generate new revenue streams and high-value customer-centric products. However, medical device manufacturing organisations are strictly scrutinised by regulatory authorities due to the critical nature of these devices and their impact on humans. This presents a challenging environment for medical device manufacturers to experiment with and implement new technologies. However, the significance and impact of AI-based projects are acknowledged by regulatory authorities such as the FDA and EMA and PMDA, allowing the incorporation of AI-based devices. This change in regulations, although limited, opens up immense opportunities for medical device manufacturers. Although extensive studies on the barriers, challenges, and failure factors of AI projects are available, very few studies explore these from a medical device manufacturing perspective. This is essential due to the significant limitations posed by the regulations governing medical device development. This study analyses the challenges and factors affecting the scaling of AI-based Industry 4.0 projects in medical device manufacturing organisations. The study found three major factors influencing the scaling of AI-based Insutry 4.0 projects. They comprise infrastructural costs, security risks and a change management migration plan. However, investing in these factors with a view to scaling may create additional revenue sources and also help in reaching a faster return on investment. Such investments can also improve the overall productivity of the industry, allowing the creation of high-value customer-centric products. The perceived security risks in the industry were found to be higher than the risks analysed in previous literature, suggesting a need to create an informed workforce. The study also found that for effective implementation of scalable AI-based industry 4.0 projects a skilled workforce with a shared long-term vision is required.

Medical device industry in Iran: key driving forces of domestic production up to 2040

Medical device industry in Iran: key driving forces of domestic production up to 2040

Is There a Difference in Innovation Performance Depending on the Investment in Each Stage of Development Process? Evidence From Medical Device Industry

Is There a Difference in Innovation Performance Depending on the Investment in Each Stage of Development Process? Evidence From Medical Device Industry