Medical Device Market Research Articles

User Entrepreneurs for Social Innovation: The Case of Patients and Caregivers as Developers of Tangible Medical Devices

Prior research has shown that some patients and caregivers such as relatives are innovating in relation to their unmet medical needs. However, there is little evidence whether and how these ideas are later implemented into market-ready solutions and subsequently commercialized. We analyze cases of patients and their caregivers becoming user entrepreneurs – persons who develop and market medical devices according to their own and/or their relatives’ needs. We apply the framework of opportunity recognition and exploitation and conduct 14 case studies with medical device developers who have successfully brought their product to market. Our findings show that these innovation opportunities were mostly recognized during time-consuming and exhausting daily routines when no suitable medical device or other solutions were present. In 12 cases, the inventor founded a company to commercialize a product; in the remaining two cases, the idea was licensed after IP was secured. In all cases, the innovation had significant impacts on the quality of lives of the patients and, in case of caregivers, on both the patients and relatives. Since technical knowledge was not present in most cases, knowledgable friends and relatives were consulted and often integrated into the product development. The most prevalent motivation for further development and diffusion turned out to be the aspiration to validate the product idea and to deliver the benefits to others with the same ailment. This finding on innovation’s social component complements current research on lead-users, as the solution of one’s own problem was previously regarded as the key motivation. One major constraint to diffusing a medical device are regulations in the healthcare sector. Ten of 14 products in our sample were approved medical devices, with five classified as a higher-risk products and five as lower-risk products. We observe that patients and caregivers who recognize and exploit their ideas in the medical devices market did so despite particularly high market entry barriers in this sector. Few patients and caregivers were capable to bring even higher-risk medical devices to the market. This is unsurprising, because neither patients nor cargivers are experienced or trained to go through these time-consuming, demanding, and sometimes costly procedures. Healthcare companies should establish measures to support innovative patients and to systematically integrate them into their innovation processes.

Current state and development trends of domestic medical device market for in vitro diagnostics in the segment of diagnostic reagents and their kits.

The problem of import substitution in the Russian medical device market for in vitro diagnostics (MDivd) has not been solved, despite a number of measures taken by the government of the Russian Federation since 2011. The reasons hampering this process are the lack of modern analytical equipment of domestic production and deficiencies of the current regulatory system for MDivd circulation in the market. It is proposed the transition from licensing system of MDivd registration to notification system as a radical measure to solve the problem of import substitution.

Medical devices: Regulatory environment forecasts

The regulatory landscape of medical devices is currently undergoing tremendous changes in the EU – changes that will directly affect Switzerland. Following numerous serious incidents resulting from medical devices (most notably, hip prostheses and defective silicone breast implants), a searchlight has been cast on the manufacturing, marketing, and surveillance of medical devices, as they stand in the EU. The systems in place contained many loopholes and shortcuts, which allowed some poor-quality and risk-compromising devices to be authorised. Consequently, the EU decided to tighten the regulatory procedures and two new EU regulations entered into force in 2017. They will apply, starting in 2020 and 2022, respectively. These changes set out in the regulations seek to improve medical device safety and performance and will carry consequences in terms of clinical evaluations and investigations on the devices, and how they are conducted. Switzerland is currently adapting its legislation on medical devices, to ensure that Swiss-based patients will also benefit from the improvements made. At the same time, only by aligning its own legislation to EU developments, will Switzerland be able to maintain its position as an equal partner in the EU internal market for medical devices. Nevertheless, some issues still need to be solved urgently for a smooth transition to take place.

The Exploration of Extrapolation of Data from Adults to Pediatric Population

Pediatric medical devices cannot meet the existing medical needs now. In consideration of the difficulty that clinical trials conducted in pediatric population, reasonable extrapolation of adult device data to pediatric population can maximize the use of existing data, as well as reduce unnecessary clinical trials in pediatric populations. It can also help accelerate the development and marketing of pediatric medical devices and ensure the clinical demand of pediatric devices. We analyzed the related guiding principles in America, and explored the extrapolation of medical device data to pediatric population in China from the perspective of medical device technology evaluation, hoping to provide reference in promoting China's data extrapolation.

Is it Possible to Build a Profitable Maintenance Business in the Market of Heavy Medical Equipment in the B2G Segment?

The relevance of the study is defined by the dramatic situation associated with the new high-margin medical device market in Russian Federation. The study shows the industry practice of heavy medical equipment maintenance2 and challenges in shaping the business model in conditions of legislative and regulatory gaps, an objective deficit of qualified technical experts and the poor quality of maintenance at public healthcare. The relevance of the article is formed by the absence of formal and informal rules of market performance. There is no consentience neither in the legislative, executive and judicial authorities, nor among the healthcare managers, suppliers (including Company’s subsidiary in Russia) and consumers (healthcare sites) of complex medical equipment. The problem is also dramatized by the black-market spare parts supply in Russia and the trend to its validation by the authorities. It’s difficult to embrace the phenomenon, to define values and goals, and specify ethical and practical results. Low development of theoretical economy rules at the new market cause the uncertainty of business compliance in the Russian Federation. The purpose of the study is to identify the basic theoretical foundations at the emerging market of heavy medical equipment that have an impact on the development of this innovative sector of the economy. The research item is presented as a KeyKis and defined as follows: Is it possible to build a profitable maintenance business at the market of heavy medical equipment (HME) in the B2G segment and guarantee its high-quality in the situation of legislative loophole? The answers could serve as a basis for development the legislative provision and maintenance guidelines, as well for forming managerial and marketing strategies for the company. The research methods consist in examining this phenomenon in a particular challenging situation in time, space and interrelation of key participants of the emerging industry market, including public and private stakeholders, domestic and foreign businesses, responsible and irresponsible characters. The case study (KeyKis) is based on authoring tools of academic economy that are applied in practice: the product matrix, the market carotid (3-D economy model), the amplified marketing strategy matrix. The research results show the mutual influence of stakeholders on the new market branch of medical technologies and business development opportunities at the heavy medical equipment maintenance market in Russian Federation. The practical importance of the paper is to facilitate the definition of difficult economic situation, provide guidelines for strategic processing and apply these tools to practical management.

Advantages and perspectives of using medicines in the form of auto injectors and prefilled syringes

Today, there is a need to introduce medical devices into everyday medical practice with the goal to self-administer injectional drugs. The speed and safety of auto-injectors / pre-filled syringe pens use (AI/PFS) is the introduction of an injectional form drug in a special medical device, which allows patients to enter a pre-designated therapeutic dose due to the characteristics of the structure of the product, automatic dosing, data of the interactive display on some devices, comfortable design, etc. Considering that AI/PFS were developed to improve the quality of life of patients with various pathological conditions, therefore the creation of affordable medical devices for low-income groups of the population is relevant today. Also an actual issue is the provision of high-quality first-aid kits for soldiers, which is a vital component for medical care in the context of active combat conditions and the lack of the required number of field hospitals.The speed of administration, the onset of effect and ease of use provides significant advantages for AI / PFS. Therefore, the issue of affordability for the low-income groups of the population and the army with the necessary drugs should be sufficiently supported by state regulation.Purpose of study – study of the international experience in the implementation and use of drugs (drugs) in the form of affordable, safe and effective modern dosage forms in the form of autoinjectors.Materials and methods – foreign and domestic literature on the use of AI/PFS in complex and monotherapy treatment of various diseases. State registries of medicines of Ukraine, the USA and some EU countries. The study used systematic, statistical and comparative analyzes, as well as the generalization of information. The data used is freely available among various medical scientific and metric bases, the Internet and international scientific conferences.The analysis of the use of AI/PFS indicates that today the world market of medicines and medical devices contains a large number of drugs under different trade names. However, many patients in the world refrain from using these dosage forms due to the significant cost of medical devices, which makes impossible the required regular use of such drugs for the low-income population groups. This is a significant disadvantage, since AI / PFS is implemented to correct not only chronic diseases such as rheumatoid arthritis, multiple sclerosis, but also to provide emergency careinurgent conditions (anaphylactic reactions, intense pain, etc.).In the global market for drugs and medical devices, injectable medicines in the form of AI/PFS are widely represented. The effectiveness of the use of such devices indicates the advantages and prospects for the use of existing AI/PFS on the global market for patients and medical personnel. Today, the most commonly used drugs in AI/PFSare for the treatment of diabetes, emergency conditions in civil and military medicine, chronic diseases of various etiologies, pediatric practice. The use of AI /PFS significantly improves patient compliance for the treatment of chronic diseases due to ease of use and reduction of adverse reactions at the site of administration. Most of the analyzed sources indicate a low level of economic affordability of drugs in the form of AI/PFS for the population and the government sector of drug supply due to the high cost of the medical devices, compared to traditional syringes. But the results of the study indicate a high level of advantages and prospects in the use of drugs in AI/PFS in medical practice for both medical personnel and patients.

Price discrimination in the Italian medical device industry: an empirical analysis

In this paper we ascertain that the Italian market for medical devices is characterized by significant price dispersion. We have, therefore, carried out an econometric analysis, as well as a Bayesian network analysis to verify if price dispersion is due to price discrimination. We have found that ASLs (Aziende Sanitarie Locali) incur higher procurement costs than AOs (Aziende Ospedaliere), which purchase larger quantities as Centralized purchasing agencies do. Consequently, second-degree price discrimination may be one of the causes of price differences. Price levels are also inversely related to product age because of intense innovative activity, making product differentiation more likely than price discrimination. Public procurement agents located in Southern Italy pay higher prices than those located in Northern or Central Italy. This is due to the higher probability for Southern procurement agents to purchase from independent wholesalers, rather than from producers, implying a double marginalization effect which raises final prices. It is also more likely that obsolete medical devices are sold to Southern health care providers.

Trends and Prospect of the Market for Veterinary Medical Devices in Korea

This study reviewed the trends and prospect of the market for veterinary medical devices in Korea. The registration of veterinary medical devices has sharply increased since 2013, and a total of 2,133 products from 348 companies were registered by 2018. Of these products, the proportion of the instrument, in vitro diagnostic (IVD) reagents, medical only used for animal and supplies were 51.6%, 35.7%, 7.6% and 5.1%, respectively. The sales amount of veterinary medical devices is approximately 95.8 billion won in 2017. The sales of domestic consumption and imports were 53.9 and 41.9 billion won, respectively. They are increasing 14.9% (CAGR) in the domestic consumption, and 44.0% (CAGR) in the export from 2011 to 2017, respectively. The proportion of IVD reagents, instrument, medical only used for animal and supplies were 54.2%, 41.0%, 3.8%, and 1.0%, respectively. The top 10 items with high sales were IVD reagents for clinical immunochemistry, visceral function testing instrument, hematological testing apparatus, syringes, IVD reagents for molecular genetics, etc. They are widely used from 3,926 animal hospitals in 2017. This study suggested that registration and sales of veterinary medical devices have gradually increased since 2013 as the demand of health care services for various animals. Therefore, the veterinary medical devices industry is expected to grow in the future.

Consolidation and maturation of the orthopaedic medical device market between 1999 and 2015.

Orthopaedic surgeons often require highly specialized medical devices, implants, and equipment, which are usually offered by several vendors/companies. This study assesses long-term market trends for orthopaedic medical device companies and examines various implications for healthcare cost. Using S&P Capital IQ, a Wall Street database, financial data were gathered on orthopaedic device companies, ranked by worldwide sales, from 1999 to 2015. Annual sales were aggregated to calculate market share and compounded annual growth rates (CAGRs). Overall, the global orthopaedic device market grew at 12.0% CAGR from 1999 to 2008, before slowing to 2.8% from 2009 to 2015. Between 1999 and 2015, the top 5 companies increased total market share from 52.8 to 62.2%. The orthopaedic device market is not only consolidating under a few dominant players, but also growing at a decreasing rate, both of which signal a maturing industry. These trends are likely to shape patient care and healthcare costs in orthopaedic surgery in years to come.

Marketing Approval for Medical Devices in European Union

The demand of medical devices has risen globally, especially in Europe. The devices regulated in Europe must ensure the safety and effectiveness of these products. There are various principles to approve the medical devices in the European market. The biggest companies are in Germany (27%), UK (11%), Italy, Switzerland, Spain and France (16%). The Europe has very good gobal impact in medical device marketing. The classification is based upon risk management, the medium and high risk requires the conformity assessment (CE marking) done by Notified bodies. There are four levels of classification of devices. Various EU directives that has impact on medical devices. International medical device regulatory forum (IMDRF), is followed by regulatory department of countries like Austrila, Brazil, Canada, China, EU, Japan, the United States, and WHO. The approved medical devices in European market must ensure the best protection of patient health. The development timelines for Noval drug and chemical entity take much longer time compared to medical devices. There are about 500, 000 life supporting machines in which 20, 000 are of generic group. Various rules on clinical evaluation and clinical investigation help in strengthening the regulatory system in Europe. To explore in marketing level premarket testing and postmarked vigilance is required.

Ежеквартальный обзор рынка медизделий: текущее состояние и перспективы развития российского рынка хирургических шовных нитей

Ежеквартальный обзор рынка медизделий: текущее состояние и перспективы развития российского рынка хирургических шовных нитей

Ежеквартальный обзор рынка медизделий: текущее состояние и перспективы развития российского рынка нетканых изделий и комплектов – шприцы и иглы

Ежеквартальный обзор рынка медизделий: текущее состояние и перспективы развития российского рынка нетканых изделий и комплектов – шприцы и иглы

Halal certification of medical device in Malaysia: A shariah analysis into the compliance process and legal requirements

The manufacture, marketing and use of medical instrumentations and devices (‘medical device’) is a big business on a global scale-in Malaysia and elsewhere in Asia-Pacific region. Medical manufacturers of these devices in Muslim majority countries are required to address both not only ethical issue but also Halal certification of such devices. Growing consumer trends among Muslim consumers for Halal certification of food and products now appears to have expanded into medical device due to increased Halal awareness among Muslim consumers. The business need for Halal certification as part of global business strategy for manufacturers, importers and exporters has now become an integral part of business strategic decision process. The main objective of this research is to explore the needs of laws and regulation and syariah compliance process in a journey of Halal certification in various categories, such as the use of medical devices and providing halal supports for business rationality in the making of Halal medical to be part of Halal Economy in 21st Century.

Pharmaceutical marketing: educative campaigns as strategy of environmental education for the Colombian population

The program of technology in pharmacy regencia of the UNAB (Universidad Autónoma de Bucaramanga) in the curricular development of the academic space of marketing and sell of medicines and medical devices, develops the strategy related with a suitable management of the medicines waste, this in homes located on the 26 departments of Colombia. Remote regions like Amaga, Belen de Bajira, Cumaribo, San Vicente del Caguán, El Doncello, Paujil, Toribio, Argelia, Sibundoy, Samaniego, Tuquerres among others municipalities have felt the positive impact of the educative model implemented in this module, having as principal objective the application of marketing strategies, developing the creativity, in planning and implementation of educational campaigns in the area of pharmaceutic marketing. The methodology used for the strategy development is through of the teleclases, also of the existing tools in the virtual platform. the campaign deployment will be performed with 132 students in different municipalities of Colombia, through different advertising tools and the usage of digital tools. With this strategy has been possible to create a Colombian population awareness in the municipalities where the UNAB is present in its educative offer and in this way start from the exercise of an effective management as a medium so that the present generations and the future ones have a good human environment ecologically balanced.

Filling the Gap With Sand: When CMOS Reaches THz

This article presents some of our efforts from the electronic side. Instead of using expensive materials, we rely on silicon CMOS, a technology that is probably the most viable but often ignored, due to its speed and power-handling capability. CMOS is expected to drastically reduce the cost and size of current THz systems. Meanwhile, THz components can be built with other analog/digital signal processing circuitry on the same die, which enables unprecedented levels of integration and flexibility. This can trigger tremendous opportunities for the portable medical device market, such as detecting tooth cavities in vivo [3] and analyzing breath to diagnose disease [7]. In the following sections, we first discuss the challenges in THz CMOS and then show how we fill the THz gap with silicon chips that originate from sand.

In-depth review on ‘innovation and regulatory challenges of the drug delivering medical devices’

The medical device market is generally seen as an area with high growth potential and provides greater profit margins including significant positive benefits to the patients. As the medical device regulations and the guidance document are becoming stringent in the US, manufacturers of these types of products are now facing these conundrums along with a need for clarification on matters related to various drug and device provisions. The European Union is making major changes to the Medical Device Directive which is its regulatory scheme for devices. Some parts are focused on the medical devices. The new changes in the regulations represent an important step forward in the growing philosophy of medical devices in Europe. Along with the regulatory challenges, there are various challenges faced during the innovation of such products. There are many factors that affect innovation including the patent aspects. In general, the key thing is that small firm face lots of difficulty compared to larger firm in bringing medical device in market. Thus, the proposed manuscript focuses on understanding the regulatory issues in various countries for ease of innovation and marketing authorization of medical devices.

New European medical device regulation: How the French ecosystem should seize the opportunity of the EUDAMED and the UDI system, while overcoming the constraints thereof

The European regulation governing the placing on the market of medical devices (MD) provides for the gradual and mandatory phasing-in, within the European Union, of a unique device identification (UDI) system and a European database (EUDAMED) aimed at improving traceability and transparency of the market. The deployment of these tools will have a significant impact on the stakeholders of the medical device world (companies, health institutions, healthcare professionals, competent authorities, etc.). A strengths/weaknesses/opportunities/threats (SWOT) analysis conducted among the think tank participants shows real support for the objectives but also distinguishes a great deal of issues relating to the implementation of these tools. An inventory of the current traceability tools and databases used in France was then carried out to measure the gaps between the requirements of the European regulation and the current situation revealing that EUDAMED and the UDI system will ultimately have to slot into a complex and poorly interoperable ecosystem. An essential first step to facilitate this integration will be to increase the number of educational, awareness-raising and information initiatives for the stakeholders concerned. Several other recommendations were put forward to support the implementation of EUDAMED and the UDI system in France and thus enable their promises to crystallise in the future.

Impact of regulations on innovation in the field of medical devices

Abstract Introduction The regulatory framework and standardized assay methods for classical biomaterials and implantable devices are harmonized at the international level, based on the risk assessment. However, innovative products need the development of more appropriate assay methods and streamline regulatory and scientific evaluation to encourage innovation and ensure more expedite delivery of novel, safe and effective innovative medical devices to patients. The aim of this work is to review the latest focus on the conflicting issues that are involved in the evaluation of recently developed biomaterials and medical devices. Methods This paper is based on a review of the relevant academic literature regarding the field of medical devices over the last ten years (2008-2017). A systematic search was conducted in Medline data base for articles using “medical devices” + “regulations” + “innovation” in the title or abstract. Discussion There is the widespread perception that research and marketing of innovative medical devices are moving swifter, even more so than the issues concerning evaluation methods and regulations. Collaboration among all the stakeholders could contribute to overcome the existing problems in medical device innovation.

Assessing risk by analogy: a case study of us medical device risk management policy

Medical devices occupy an increasingly important place in global medical care, and yet the risk management systems that govern them are largely overlooked in academic literatures. In the US, home to the largest medical devices market, Food and Drug Administration (FDA) regulation allows most medical devices to enter the market based on analogy, or substantial equivalence, with previously marketed devices. Thus, risk assessment is administered without premarket clinical trials for safety and efficacy. This system represents a permissive regulatory regime based in neoliberal tenets, where risk, in the form of adverse events, is inherently tolerated within governance structures, evidencing risk colonisation. This paper employs a case study approach, examining market clearances of vaginal mesh surgical devices, which have been the subject of US multi-district litigation. We identified 266 devices cleared before 31 December 2017 and analysed the complicated web of device ‘ancestry’ whereby devices as disparate as cardiac patches and hernia mesh allowed clearance of surgical devices for urogynecology. Perhaps of greatest concern, 10 recalled or withdrawn devices influenced new device clearances for up to 17 years after their market-removal. While the FDA must balance its dual mandate to safeguard patients and promote innovation, we find that medical device regulation structurally favours innovation over safety. ‘Light touch’ risk assessment is not counterbalanced with postmarket mechanisms to safeguard against residual and developmental risks that are associated with medical devices, particularly permanent implants. The proportionality principle associated with a precautionary approach should inform medical device risk management.

REGULATIONS OF REGISTRATION AND IMPORT OF MEDICAL DEVICE IN INDIA

India is a huge market for medical devices and is increasing constantly for the last few years. The registration certificate and import license is mandatory for a manufacturer of India who wishes to import any medical device in India. If a company which wants to imports its medical devices in India does not have a registered office in India it needs Indian agent authorized by CDSCO, to do so. Duly filled form-10 is required to be submitted for import license, while form-44 duly filled is required to be submitted for marketing authorization of a new medical device or its re-registration. The review focuses on regulation concerned to the registration procedures import of a new medical device in India with latest amendments in the regulation concerned.