Medical Device Industry Research Articles

Corporate lobbying and product recalls: an investigation in the U.S. medical device industry

While corporate political activity is increasing, its effects on firms’ marketing-relevant outcomes have been largely overlooked in the literature. We propose that corporate lobbying will decrease a firm’s emphasis on product safety and, in turn, increase its product recalls. We further propose that the positive indirect effect of corporate lobbying on a firm’s product recalls via lower emphasis on product safety will be moderated by the firm’s (a) CEO’s functional background and (b) focus on radical (vs. incremental) innovation. We provide empirical support for the proposed model using data on 86 U.S. medical device firms from 2005–2018. The findings extend the literature on the effects of non-market forces on firms’ marketing-relevant outcomes. They also extend the literature on the antecedents of product recalls, which has, hitherto, overlooked the role of non-market forces. The findings on the moderating roles of the firm’s marketing CEO and focus on radical (vs. incremental) innovation generate actionable managerial implications.

SCAI Position Statement on Best Practices for Clinical Proctoring of New Technologies and Techniques.

The field of interventional cardiology continues to evolve with the introduction of new techniques and technologies. From the first angioplasty to transcatheter aortic valve replacement (TAVR), dissemination of new treatments has generally required a training program of didactics and observation, culminating in a hands-on experience with a patient. Trainees and facilities starting new programs often require support from outside experts, traditionally known as “medical proctors,” whose costs are typically borne by the medical device industry.

Seven Pillars of Inclusive Ecosystem -Transforming Healthcare Special reference to MSME & SME sectors

Purpose: The present paper analyzes the inclusive approach of the MSMEs (Micro, Small and Medium Enterprises) and the Seven pillars that play a significant role in promoting Indian health care to achieve Sustainable Development goals. The MSMEs & SME focuses on designing and manufacturing a wide range of medical products or devices, innovative drugs, COVID-19 related products act as a catalyst to bring a social-economic transformation of rural and urban by delivering a new wave ecosystem and also by the new generation entrepreneurship. MSME contributes one-third to India’s GDP and is the crater of opportunities, employment and contributes to women empowerment. Digital India promotes ICT-Artificial Intelligence, Internet of Things, Blockchain technology, Make in India in manufacturing indigenization health care innovation to withstand global competition in healthcare products to meet requirements of the society and global demand through the Government Schemes and policies with Partnership and Collaboration Model with support of Unicorn startup to bring the private sector and NGO in providing affordable healthcare infrastructure facilities under National Health Policy, Ayushman Bharat PM-JAY, Budget and Niti Aayog has proved more funds and promoting the health care. The medical device industry contributes very significantly to the top 20 markets for medical devices. MSME contributes 6.11% of the manufacturing GDP, 24.63% of the GDP service activity, and 45% of overall export. The medical technology through Digital India is projected to reach US $50 billion by 2025 band ranked 10th in the Medical Tourism Index (MIT) for 2020-21. Out of 46 destinations, the healthcare market in India is expected to reach US $ 372billion by 2022 and India is among the top 12 destinations for biotechnology and 100% FDI allowed under the automatic route and the largest provider of generic drugs. Design/methodology/approaches: The study is based on secondary data gathered from diverse sources such as articles published in Journals, government and other web site, newspapers, etc. Findings and results: Indian economy will contribute to the GDP of the country. Public health is the major factor that we need to take care of then only there will be a possibility of progress in the country. Originality/value: This study analyzes the seven pillars of healthcare that can be transferred to the healthcare industry and society. The seven pillars are “Economic Growth, Innovation, Digital Technology, Government Scheme and Budget, SME & Unicorn Entrepreneur, healthcare infrastructure and Partnerships and collaboration” are they provide strength to healthcare. The public health care infrastructure in both rural and urban areas is not up to the mark expect private health care. We suggest that more focus on providing primary healthcare with more staff for the large population and more tax rebates on health expenditure and health care schemes to be provided to all sections of the society. Type of Paper: Research Analysis.

Non-competes and innovation: Evidence from medical devices

Despite two decades of research on non-competes, whether non-competes promote or inhibit innovation remains an open question. The lack of consensus rests on not only the theoretical ambiguity but also the empirical limitations. Marshalling data on introductions of new medical devices as the direct measure of innovations in the medical devices industry and decomposing innovations according to their exploitative or exploratory natures, this work shows that an increase in the enforceability of noncompetes is associated with a higher rate of exploitative innovations and a lower rate of exploratory innovations. Further analysis shows that through such a shift of attention in the innovation process, an increase in the enforceability of non-competes results in a higher rate of total innovations. The implications and caveats of the enforcement of non-competes for stimulating innovation are discussed.

NIR-Based Intelligent Sensing of Product Yield Stress for High-Value Bioresorbable Polymer Processing.

PLA (polylactide) is a bioresorbable polymer used in implantable medical and drug delivery devices. Like other bioresorbable polymers, PLA needs to be processed carefully to avoid degradation. In this work we combine in-process temperature, pressure, and NIR spectroscopy measurements with multivariate regression methods for prediction of the mechanical strength of an extruded PLA product. The potential to use such a method as an intelligent sensor for real-time quality analysis is evaluated based on regulatory guidelines for the medical device industry. It is shown that for the predictions to be robust to processing at different times and to slight changes in the processing conditions, the fusion of both NIR and conventional process sensor data is required. Partial least squares (PLS), which is the established ’soft sensing’ method in the industry, performs the best of the linear methods but demonstrates poor reliability over the full range of processing conditions. Conversely, both random forest (RF) and support vector regression (SVR) show excellent performance for all criteria when used with a prior principal component (PC) dimension reduction step. While linear methods currently dominate for soft sensing of mixture concentrations in highly conservative, regulated industries such as the medical device industry, this work indicates that nonlinear methods may outperform them in the prediction of mechanical properties from complex physicochemical sensor data. The nonlinear methods show the potential to meet industrial standards for robustness, despite the relatively small amount of training data typically available in high-value material processing.

A global-responsive supply chain considering sustainability and resiliency: Application in the medical devices industry

Given the requirements of international businesses, this research addresses the supply chain network design problem in the real-world situation by considering four critical features: sustainability, resiliency, responsiveness, and globalization. For this purpose, a multi-objective mathematical model is proposed that minimizes the environmental impacts and the total costs and maximizes the social impacts while considering the resilience and responsiveness of the global supply chain. Then, the modified fuzzy robust stochastic method is employed to tackle the uncertainty. This study selects one of the most important medical devices during the pandemic (COVID-19) namely the blood bank refrigerator as a case study. Afterwards, the proposed multi-objective model is solved by developing a novel method named as augmented lexicographic weighted Tchebycheff method. Based on the obtained results, an increase in the responsiveness level of the supply chain can lead to increasing the sustainability dimensions, including job opportunities, safety, carbon emission, and economic aspects. Moreover, an increase in demands harms the economic, environmental, and responsiveness targets. The demand has a pivotal role in selecting resilience strategy, as well.

Pharmaceutical and Medical Devices Industry Regulation in Indonesia: Human Rights Perspective

AbstractA deficiency in supply of medicines and medical devices, especially in remote areas, has become a national problem since the mid-2000s until now. This problem is certainly made worse by the presence of COVID-19. The main causes of this supply shortages are, among others, economic factors, ineffective regulations that result in problems related to business and supply chains. Indonesia, a country where 90% of raw materials for medicines are imported from abroad, of course is deeply affected by the export ban of countries that supply raw materials. Do not forget that Indonesia's geographical condition is so vast that it creates huge obstacles for the distribution of drugs and medical devices, and it is understandable if the private sector does not want to open hospitals, pharmacies or clinics in remote areas due to economic factors. As a result, human health, something which should be a human right feels like a luxury during this pandemic. Therefore several policies have been implemented, ranging from increasing production capacity, enacting regulations regarding limits on the number of drugs that can be prescribed to patients or purchased by the public to prevent hoarding, simplifying the industrial licensing process to increasing hospital beds.Keywords: Medical Devices; Medicine; COVID-19. AbstrakKurangnya pasokan obat dan alat kesehatan khususnya di daerah terpencil telah menjadi masalah nasional sejak pertengahan tahun 2000-an hingga saat ini. Masalah ini tentunya diperburuk oleh adanya COVID-19. Penyebab utama kekurangan pasokan ini diantara lain karena faktor ekonomi, regulasi yang kurang efektif yang mengakibatkan masalah terkait bisnis dan juga rantai pasok. Indonesia sebuah negara dimana 90% bahan baku obat obatan didatangkan dari luar negeri tentu sangat terpengaruh oleh larangan ekspor negara negara pemasok bahan baku. Tidak lupa kondisi geografis Indonesia yang begitu luas menghasilkan kendala yang begitu besar untuk distribusi obat dan alat medis, dan dapat dipahami jika pihak swasta tidak ingin membuka rumah sakit, apotek ataupun klinik di daerah terpencil karena faktor ekonomis. Lantas kesehatan yang seharusnya adalah Hak Asasi Manusia terasa seperti kemewahan di pandemi ini. Oleh sebab itu beberapa kebijakan yang dilakukan yaitu mulai dari meningkatkan kapasitas produksi, memberlakukan peraturan mengenai batasan jumlah obat yang dapat diresepkan untuk pasien atau dibeli oleh masyarakat untuk mencegah penimbunan, simplifikasi proses perizinan industri hingga memperbanyak tempat tidur rumah sakit.Kata Kunci: Alat kesehatan; Farmasi; COVID-19.

Stakeholders, Prototypes, and Settings of Front-End Medical Device Design Activities

Abstract Successful medical device design entails an understanding of stakeholder-driven requirements early in the process to assure device safety and usability and support successful and positive patient experiences. Prototypes can be used during stakeholder engagement in the design front end to gather information to inform design decisions. However, an understanding of medical device industry practices of front-end stakeholder engagement with prototypes is lacking. Through interviews with medical device design practitioners, this study explored the variety of stakeholder groups engaged by design practitioners, prototype types used during stakeholder engagements, and settings in which engagements took place during front-end design activities. This study describes the 14 types of stakeholders, 14 types of prototypes, and six types of settings described by practitioners as well as patterns across engagement strategies, stakeholders, prototypes, and/or settings in front-end activities. These outcomes can contribute to broadening designers' stakeholder engagement planning and practices.

Ethical and regulatory implications of the COVID-19 pandemic for the medical devices industry and its representatives

The development and deployment of medical devices, along with most areas of healthcare, has been significantly impacted by the COVID-19 pandemic. This has had variable ethical implications, two of which we will focus on here. First, medical device regulations have been rapidly amended to expedite approvals of devices ranging from face masks to ventilators. Although some regulators have issued cessation dates, there is inadequate discussion of triggers for exiting these crisis standards, and evidence that this may not be feasible. Given the relatively low evidence standards currently required for regulatory approval of devices, this further indefinite reduction in standards raises serious ethical issues. Second, the pandemic has disrupted the usual operations of device representatives in hospitals, providing an opportunity to examine and refine this potentially ethically problematic practice. In this paper we explain and critically analyse the ethical implications of these two pandemic-related impacts on medical devices and propose suggestions for their management. These include an endpoint for pandemic-related adjustments to device regulation or a mechanism for continued refinement over time, together with a review of device research conducted under crisis conditions, support for the removal and replacement of emergency approved devices, and a review of device representative credentialling.

Robust design of a green-responsive closed-loop supply chain network for the ventilator device.

This study aims to investigate the closed-loop supply chain network design problem considering the environmental and responsiveness features. For this purpose, a multi-objective mathematical model is suggested that minimizes the carbon emissions and the total costs and maximizes the responsiveness of the system. Due to the dynamic space of the business environment, uncertainty is an integral part of the supply chain problem. Therefore, this research applies the robust possibilistic programming method to cope with uncertainty. Afterwards, since the research problem has a high level of the complexity, a hybrid solution approach based on a heuristic method and the meta-goal programming method is developed to solve the research problem in a reasonable time. Then, due to the importance of the ventilator device during the recent pandemic (COVID-19), this study considers this product as a case study. The main contribution of the current study is to design a green-responsive closed-loop supply chain network under uncertainty using a multi-objective robust possibilistic programming model, for the first time in the literature, especially in the medical devices industry. On the other side, the other contribution of this study is to develop an efficient hybrid solution method. The achieved results demonstrate the efficiency of the offered model and the developed hybrid method. Eventually, by carrying out sensitivity analysis, the impact of some of the critical parameters on the model is investigated. Based on the obtained results, an increase in the demand sizes leads to increasing the environmental damages and the total costs while reducing the responsiveness level. On the other side, an increase in the rate of return leads to an increase in all of the objective functions. Also, the achieved results show that when the capacity parameter is increased, the total costs are decreased, but the responsiveness and environmental impacts are increased.Supplementary InformationThe online version contains supplementary material available at 10.1007/s11356-022-19105-1.

Deep Learning Methods in the Medical Device Industry: An Overview

Deep Learning Methods in the Medical Device Industry: An Overview

Knowledge, Attitude and Awareness towards the Usage of Halal Medical Devices in Shah Alam, Selangor

The halal industry nowadays not only covers the food industry, but has expanded to logistics, consumer goods, cosmetics, and pharmaceutical industries. Halal medical device industry players started to request the certification for medical devices in 2013 to make the products accepted in Muslim countries, thus expanding the marketability of the product worldwide. With the addition of medical devices as one of the latest schemes that can be applied for the halal certificate, this study aims to investigate the knowledge, attitude and awareness among Muslim society towards the usage of halal medical devices in Shah Alam, Selangor. This study adopted a quantitative method to collect the data. The data collected were analysed for Descriptive Statistics and Correlation Analysis by using the SPSS. All the items in the questionnaire were analysed with Reliability Testing (Cronbach Alpha) to test for their reliability. The findings of this research showed that all the independent variables in this study, which were knowledge attitude and the awareness level have a significant relationship with the dependent variable, which was the usage of halal medical devices. Besides, the correlation analysis showed that knowledge, attitude, and awareness are positively correlated with the usage of halal medical devices. However, the awareness level has the lowest positive correlation relationship with the usage of halal medical devices, indicating that Muslim’s consumer awareness is still low. Therefore, this study recommended that both stakeholders, whether the government or the halal authority may increase the awareness level on a halal medical device for Muslim consumers by campaign promotion as the demands are increasing with the growth of the industry.

Review on people's trust on home use medical devices during Covid-19 pandemic in India.

With the rapid development of the medical device against COVID-19 is an excellent achievement. There are numerous obstacles effectively facing the worldwide population, from manufacture to distribution, deployment and, acceptance. Many manufacturers have entered the market rivalry as people's knowledge and demand for home-use medical equipment has increased. India represents a compelling market opportunity for global medical device manufacturers. Substantial growth for the Indian medical device industry is expected to be driven by the current low per-person spending rate for medical devices. The growth of the medical devices industry in India raises competition law issues (anti-trust) and therefore maintaining public trust in home-use medical devices during COVID-19 will be as essential. The review article aims to create awareness among people about commonly used medical devices during the COVID-19 pandemic and to survey people’s trust in home usable medical devices in India. In a worldwide pandemic, manufacturers of medical devices face insufficient storage and the impossibility of meeting the requirements of the health centre. The sale of some of the most significant medical devices has increased, making it more difficult for the medical device industry to satisfy demand with high-quality goods since the quality of COVID-19 items plays a vital part in the present scenario. Despite the difficulty in providing enough medical equipment during a pandemic, they are striving to adapt to the circumstance. After recognizing the need to promote awareness and grasp the selling, and production, handling of medical instruments during COVID-19 at home was conducted. In addition, medical equipment manufacturers and distributors look at this scenario as an opportunity to profit more. This review article would enable researchers during COVID-19 to build more knowledge and widespread trust in medical technologies respectively.

A Review of Lean Adoption in the Irish MedTech Industry

There have been many literature reviews carried out on Lean implementation in larger organisations with specific focus on the automobile industry. Lean implementation in the medical device industry has not been extensively investigated. Thus, this research endeavored to analyse the benefits of Lean, tools utilised and challenges and results of Lean implementation in Medtech companies. This article aims to bridge a gap in the literature by reviewing the literature that discusses Lean implementation in MedTech companies in Ireland with a perspective of identifying the benefits and challenges faced. The quantitative methodology allows us to review the comprehensive numbers and data which were collected from 20 Enterprise Ireland MedTech case studies. There are very few published case studies in the literature on Lean due to the highly regulated nature of MedTech sector and the vast array of medical devices, which are often under privacy and confidentiality constraints. The results showed that integration of Lean has brought benefits to companies by increasing productivity and product quality, optimised cost, and time. An inclusive discussion of Lean tools for Lean implementation within MedTech was established and suggestions for future research orientations are thus provided.

Overview of the Drivers of Low-Value Care Comment on "Key Factors that Promote Low-Value Care: Views of Experts From the United States, Canada, and the Netherlands".

Verkerk and colleagues explored the key drivers of low-value care from the perspective of 18 policy-makers and researchers who had led and evaluated at least one initiative to reduce low-value care or had been responsible for reducing low-value care in an organisation. They identified several drivers of low-value care presented in the 2017 Lancet Right Care Series (eg, fee for service payment systems, the pharmaceutical and medical device industry, fear of malpractice litigation, issues with research conduct and reporting, a culture of 'more is better' and 'new technology is better') but did not discuss some other important ones. In this commentary, we aim to extend the work of Verkerk and colleagues and provide some additional perspectives on the drivers of low-value care within the following categories: Economic incentives; Money, finance, and organisation; Knowledge beliefs, assumptions, bias and uncertainty; and Power and human relationships.

Exposure, access and interaction: A global analysis of sponsorship of nursing professional associations.

To analyse the nature and extent of sponsorship of nursing professional associations and their major scientific conferences. Cross-sectional content analysis. Data were extracted from the websites and conference documents of 156 national and international professional nursing associations in 2019 to identify sponsors. Sponsorship prospectuses were analysed to estimate the value and describe the nature of sponsorship arrangements. We analysed sponsorship patterns using social network analysis. Most associations (84/156, 54%) did not report any sponsors. Sponsorship was concentrated among specialty nursing associations in high-income countries. Half of identified sponsors promoted products used in clinical care (50%; 981/1969); the majority represented the medical device industry (69%; 681/981). Top sponsors generally favoured opportunities that promoted interaction with conference attendees. Globally, commercial sponsorship of nursing associations is a common, but not the dominant source of support for these activities. Half of sponsors were commercial entities that manufactured or distributed products used during clinical care, which presents a risk of commercial influence over education and ultimately, clinical practice. Sponsors favoured opportunities to interact directly with nurses, determine educational content, or foster continued interaction.

Trends in the Approval and Quality Management of Artificial Intelligence Medical Devices in the Republic of Korea.

Artificial intelligence (AI) is being implemented in many areas of medicine, such as patient-customized diagnosis. Growth in the artificial intelligence medical device (AIMD) field is expected in the coming years. Major countries are currently establishing systems and policies to gain a leading position in the medical artificial intelligence market. The Republic of Korea has initiated the Act on Nurturing the Medical Devices Industry and Supporting Innovative Medical Devices for the development of AIMDs and is implementing it preemptively. As a result, the country has achieved an effective strategy for coping with the COVID-19 pandemic, an increase in the number of AIMD approvals (85 approved as of September 2021), and the creation of a document pertaining to internationally harmonized guidelines on AIMD-related terms and definitions. However, in order to develop and activate more AIMD products, it is necessary to improve post-market management such as product change and quality control in addition to approval. Here, we review the current regulatory status of AIMD in the Republic of Korea and what needs to be improved for AIMD to be more developed and activated.

Critical Factors and Economic Methods for Regulatory Impact Assessment in the Medical Device Industry.

IntroductionThe regulatory area is one that restricts human behaviour and opportunities, but it also allows the prevention of loss of property, health, or even life in various fields. Regulations provide the market with public confidence, which is extremely important in the field of innovative medical devices. The aim of this article is to analyse critical factors and economic methods for regulatory impact assessment in the medical device industry, to focus on the finances, processes, or innovation activity of organisations operating in the medical device sector.MethodsThe paper consists of a scoping review according to the PRISMA methodology of the available literature in Web of Science and Scopus database, whereby combing the keywords “regulation” AND “innovation” AND “medical device” AND “economic impact,” we obtained a set of 156 results in the form of English-written articles. The output was then limited to the period between 2011 and 2020. Finally, 23 papers were used based on the exclusion and inclusion criteria.ResultsThe resulting challenges of the identified problems in particular are the amount of high-quality data available at an appropriate cost and the availability of a flexible notified body. There are also challenges specific to the situation, such as demands on the safety of medical devices for children. From a public expectations point of view, there is a continuing need to maintain the urgency of the balance between available innovation and safety.DiscussionAs for the methods of economic assessment in general, or methods for assessing the economic impact of regulations in particular, cost-effectiveness analysis is the most commonly used method for research and development, while internal rate of return is frequently used for the producers, and budget impact analysis is typically used for healthcare service providers. A non-financial indicator that is often discussed is the time demands associated with meeting compliance requirements. The time-to-market indicator is also often mentioned. Economic and financial topics are not discussed in depth, as the reviewed articles simply mention the generally high costs attendant on complying with regulations and obtaining certificates.

Development of Duration-Based Non-Mutagenic Thresholds of Toxicological Concern (TTCs) Relevant to Parenteral Extractables and Leachables (E&Ls).

The threshold of toxicological concern (TTC), i.e., the dose of a compound lacking sufficient experimental toxicity data that is unlikely to result in an adverse health effect in humans, is important for evaluating extractables and leachables (E&Ls) as it guides analytical testing and minimizes the use of animal studies. The Extractables and Leachables Safety Information Exchange (ELSIE) consortium, which consists of member companies that span biotechnology, pharmaceutical, and medical device industries, brought together subject matter expert toxicologists to derive TTC values for organic, non-mutagenic E&L substances when administered parenterally. A total of 488 E&L compounds from the ELSIE database were analyzed and parenteral point of departure (PPOD) estimates were derived for 252 compounds. The PPOD estimates were adjusted to extrapolate to subacute, subchronic, and chronic durations of nonclinical exposure and the lower fifth percentiles were calculated. An additional 100-fold adjustment factor to account for nonclinical species and human variability was subsequently applied to derive the parenteral TTC values for E&Ls. The resulting parenteral TTC values are 35, 110, and 180 μg/day for human exposures of >10 years to lifetime, >1-10 years, and ≤1 year, respectively. These parenteral TTCs are expected to be conservative for E&Ls that are considered non-mutagenic per ICH M7(R1) guidelines.

Role of qualification and validation in medical device industry: a study

The need for orthopedic implants is increasing due to the rise in the number of accidents. As people begin to age, they begin to experience pain in their joints, bones, and wrists. If it is not managed with medication, an orthopedic implant may be deemed as the best solution. As per the Bureau of Indian Standard Research, the global market for orthopedic products in 2016 in US dollars was 4.20 billion. Industries seem to have an annual growth rate of 6.1 percent when compared with the previous year, which means the market is expected to reach 61.02 billion dollars by 2023. Therefore, the demand for orthopedic devices is significant and the quality of implants manufactured should be strictly controlled and checked for human health safety worldwide. Nowadays, the regulatory agencies also focus on every medical device manufacturing industry with highly stringent needs. Therefore, the knowledge of standards, validation, and differences between Good Manufacturing Practice (GMP) and Current Good Manufacturing Practice (CGMP) is highly important. Therefore, this paper focuses on the importance of validation in detail for the safety of patients.