Nonpharmacological intervention therapies for dementia: potential break-even intervention price and savings for selected risk factors in the European healthcare system.

BACKGROUND: New effective treatments for dementia are lacking, and early prevention focusing on risk factors of dementia is important. Non-pharmacological intervention therapies aimed at these factors may provide a valuable tool for reducing the incidence of dementia. This study focused on the development of a mathematical model to predict the number of individuals with neurodegenerative diseases, specifically Alzheimer's disease, Parkinson's disease, vascular dementia, and amyotrophic lateral sclerosis. Scenarios for non-pharmacological intervention therapies based on risk factor reduction were also assessed. The estimated total costs and potential cost savings from societal were included. METHODS: Based on demographic and financial data from the EU, a mathematical model was developed to predict the prevalence and resulting care costs of neurodegenerative diseases in the population. Each disease (Alzheimer's disease, Parkinson's disease, vascular dementia, and amyotrophic lateral sclerosis) used parameters that included prevalence, incidence, and death risk ratio, and the simulation is related to the age of the cohort and the disease stage. RESULTS: A replicable simulation for predicting the prevalence and resulting cost of care for neurodegenerative diseases in the population exhibited an increase in treatment costs from 267 billion EUR in 2021 to 528 billion EUR by 2050 in the EU alone. Scenarios related to the reduction of the prevalence of dementia by up to 20% per decade led to total discounted treatment cost savings of up to 558 billion EUR. CONCLUSION: The model indicates the magnitude of the financial burden placed on EU healthcare systems due to the growth in the population prevalence of neurodegenerative diseases in the coming decades. Lifestyle interventions based on reducing the most common risk factors could serve as a prevention strategy to reduce the incidence of dementia with substantial cost-savings potential. These findings could support the implementation of public health approaches throughout life to ultimately prevent premature mortality and promote a healthier and more active lifestyle in older individuals.

Exploring business models for managing uncertainty in healthcare, medical devices, and biotechnology industries.

The medical devices, biotechnology, and healthcare industries are closely tied to innovation, with companies relying on research and development and new product introduction. However, innovation activities like research and development can be costly, and commercializing new products faces complexities. Having effective business models (BMs) aligned with such innovation activities is crucial. This study delves into the intricacies of BMs in these innovator companies, emphasizing the pivotal role of effective BMs in navigating uncertainties and fostering innovation. This study conducted a systematic literature review to synthesize knowledge on BMs in innovator health-tech companies and compare models on dimensions like infrastructure, offering, customers, and finances. The review of 34 recent papers revealed 9 key BMs - open innovation, sustainable, dynamic, dual, spin-off, frugal, high-tech entrepreneurial content marketing, back-end, and product-service systems BMs. The analysis found open innovation, sustainability, and dynamicity as foundational models that can serve as a basis when combined with others. The paper unveils a tailored Dynamic Sustainable Business Model (DSBM) for Health-Tech, designed to integrate adaptability and sustainability, providing a framework for companies to leverage emerging technologies effectively. Additionally, a conceptual framework outlining 28 groups of uncertainty factors in BMs was developed to aid risk management in health-tech. The findings offer crucial insights for companies in health-tech industries, aiding them in managing innovation and value creation amidst a rapidly evolving landscape.

Unveiling Seniors' Perception of Mobility: Urbanization, Region, and Physical Activity.

Background: Maintaining mobility is fundamental to active aging, allowing older adults to lead dynamic and independent lives. The perception of mobility among older adults significantly impacts their overall well-being and quality of life. Given the aging population, mobility has become an increasingly pressing issue. Aim: This study focused on the perception of urban neighborhoods, including considerations of urban tissue (crossings and sidewalk maintenance), urban scenes (benches and traffic), and safety (fears and street lighting quality). We investigated the differences in the perception of the surroundings of residences by urban and rural seniors concerning their demographic and social characteristics and environmental determinants. Methods: A quantitative study design utilizing a questionnaire survey was employed. Data were collected mainly through face-to-face interviews in the field (PAPI) and via an online questionnaire (CAWI). The final sample comprised 525 participants. Hypotheses regarding the influence of gender, age, social status, level of physical activity, degree of urbanization, and region on environmental perception were tested using ordinal regression. Results: The hypothesis regarding the dependence of the perception of the surroundings on the level of urbanization was confirmed; that regarding the dependence of the perception of the residence surroundings on seniors' age was not confirmed. The other hypotheses were partially confirmed. For the seven investigated environmental attributes, gender was significant in two cases, social status and physical activity in three cases, and region in four cases. Conclusion: While most studies have focused on urban settings, this study highlights the situation in rural municipalities. Substantially worse pedestrian conditions in availability of pedestrian crossings, benches, and lighting were recognized in rural municipalities versus cities. Understanding the complexity of mobility and the spatial locations relevant for older persons concerning potential barriers and facilitators for mobility aids in planning and adapting neighborhood environments to promote active and healthy aging in place.

Challenges and opportunity in mobility among older adults - key determinant identification.

BACKGROUND: Attention is focused on the health and physical fitness of older adults due to their increasing age. Maintaining physical abilities, including safe walking and movement, significantly contributes to the perception of health in old age. One of the early signs of declining fitness in older adults is limited mobility. Approximately one third of 70-year-olds and most 80-year-olds report restrictions on mobility in their apartments and immediate surroundings. Restriction or loss of mobility is a complex multifactorial process, which makes older adults prone to falls, injuries, and hospitalizations and worsens their quality of life while increasing overall mortality. OBJECTIVE: The objective of the study is to identify the factors that have had a significant impact on mobility in recent years and currently, and to identify gaps in our understanding of these factors. The study aims to highlight areas where further research is needed and where new and effective solutions are required. METHODS: The PRISMA methodology was used to conduct a scoping review in the Scopus and Web of Science databases. Papers published from 2007 to 2021 were searched in November 2021. Of these, 52 papers were selected from the initial 788 outputs for the final analysis. RESULTS: The final selected papers were analyzed, and the key determinants were found to be environmental, physical, cognitive, and psychosocial, which confirms the findings of previous studies. One new determinant is technological. New and effective solutions lie in understanding the interactions between different determinants of mobility, addressing environmental factors, and exploring opportunities in the context of emerging technologies, such as the integration of smart home technologies, design of accessible and age-friendly public spaces, development of policies and regulations, and exploration of innovative financing models to support the integration of assistive technologies into the lives of seniors. CONCLUSION: For an effective and comprehensive solution to support senior mobility, the determinants cannot be solved separately. Physical, cognitive, psychosocial, and technological determinants can often be perceived as the cause/motivation for mobility. Further research on these determinants can help to arrive at solutions for environmental determinants, which, in turn, will help improve mobility. Future studies should investigate financial aspects, especially since many technological solutions are expensive and not commonly available, which limits their use.

Impact of Regulatory Changes on Innovations in the Medical Device Industry Comment on "Clinical Decision Support and New Regulatory Frameworks for Medical Devices: Are We Ready for It? - A Viewpoint Paper".

Economic regulation is an instrument of the state or other institutions to correct market failures, rectify the business environment, or protect consumers. Regulation can be a major driver of innovation, and it has proven to be so in the past. On the other hand, there are also documented cases of ineffective regulation due to information delays or shortcomings in government decision-making. The complexity of the impact of regulatory changes on innovation can currently be observed in the medical device market in Europe. Regulation (EU) 2017/745 whose main idea is to ensure greater safety and health protection for consumers, is a challenge for originator, manufacturer, mostly small and medium-sized enterprises. The regulation is associated with an increase in the cost of developing and maintaining the product on the market. We can now gradually begin to analyze whether it can be ranked among those that have become drivers of innovation.

An SEM-ANN approach to evaluate public awareness about COVID, A pathway toward adaptation effective strategies for sustainable development.

This study was conducted to evaluate public awareness about COVID with aimed to check public strategies against COVID-19. A semi structured questionnaire was collected and the data was analyzed using some statistical tools (PLS-SEM) and artificial neural networks (ANN). We started by looking at the known causal linkages between the different variables to see if they matched up with the hypotheses that had been proposed. Next, for this reason, we ran a 5,000-sample bootstrapping test to assess how strongly our findings corroborated the null hypothesis. PLS-SEM direct path analysis revealed HRP -> PA-COVID, HI -> PA-COVID, MU -> PA-COVID, PM -> PA-COVID, SD -> PA-COVID. These findings provide credence to the acceptance of hypotheses H1, H3, and H5, but reject hypothesis H2. We have also examined control factors such as respondents' age, gender, and level of education. Age was found to have a positive correlation with PA-COVID, while mean gender and education level were found to not correlate at all with PA-COVID. However, age can be a useful control variable, as a more seasoned individual is likely to have a better understanding of COVID and its effects on independent variables. Study results revealed a small moderation effect in the relationships between understudy independent and dependent variables. Education significantly moderates the relationship of PA-COVID associated with MU, PH, SD, RP, PM, PA-COVID, depicts the moderation role of education on the relationship between MU*Education->PA-COVID, HI*Education->PA.COVID, SD*Education->PA.COVID, HRP*Education->PA.COVID, PM*Education -> PA.COVID. The artificial neural network (ANN) model we've developed for spreading information about COVID-19 (PA-COVID) follows in the footsteps of previous studies. The root means the square of the errors (RMSE). Validity measures how well a model can predict a certain result. With RMSE values of 0.424 for training and 0.394 for testing, we observed that our ANN model for public awareness of COVID-19 (PA-COVID) had a strong predictive ability. Based on the sensitivity analysis results, we determined that PA. COVID had the highest relative normalized relevance for our sample (100%). These factors were then followed by MU (54.6%), HI (11.1%), SD (100.0%), HRP (28.5%), and PM (64.6%) were likewise shown to be the least important factors for consumers in developing countries struggling with diseases caused by contaminated water. In addition, a specific approach was used to construct a goodness-of-fit coefficient to evaluate the performance of the ANN models. The study will aid in the implementation of effective monitoring and public policies to promote the health of local people.

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

INTRODUCTION: The 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. METHODS: The 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. RESULTS: The 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. DISCUSSION: As 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.

Predictors of COVID-19 Preventive Behavior Adoption Intention in Malaysia.

Preventive behavior adoption is the key to reduce the possibility of getting COVID-19 infection. This paper aims to examine the determinants of intention to adopt preventive behavior by incorporating perception of e-government information and services and perception of social media into the theory of reasoned action. A cross-sectional online survey was carried out among Malaysian residents. Four hundred four valid responses were obtained and used for data analysis. A partial least-square-based path analysis revealed direct effects of attitude and subjective norm in predicting intention to adopt preventive behavior. In addition, perception of e-government information and services and perception of social media were found to be significant predictors of attitude toward preventive behavior. The findings highlight the importance of digital platforms in improving people's attitudes toward preventive behavior and in turn contain the spread of the infectious disease.

Correction to: Cystic Fibrosis Revisited - A Review Study.

In the following article, the author reported an error in the abstract's result section [1]. The results section of the abstract has been changed as follows: Results: The main benefits (e.g., specialized centres for the treatment of CF exist or a new breakthrough in the gene therapy of CF has been made) and limitations (e.g., comorbidity of CF, lifelong and costly treatment, or adverse impact on patient's and caregiver's quality of life) in the treatment of CF are highlighted. The original results section of the abstract was published as: Results: The main benefits (e.g., specialized centres for the treatment of CF exist or a new breakthrough in the gene therapy of CF has been made) and limitations (e.g., comorbidity of CF, lifelong and costly treatment, or adverse impact on patient's and caregiver's quality of life) in the treatment of narcolepsy are highlighted. The original article can be found online at 10.2174/1573406412666160608113235.

Do Regulatory Changes Seriously Affect the Medical Devices Industry? Evidence From the Czech Republic.

Background: Within the EU, some of the challenges and perceived risks now facing medical device (MD) developers result from changes in the regulatory framework, emphasizing safety. Therefore, medical technology companies must adopt stricter quality assurance measures so that individual devices can be speedily tracked and retrieved in emergency situations. Objectives: We highlight the challenges and risks faced by the European medical devices industry, particularly those faced by SMEs in the Czech Republic. We address two important research questions: Q1. Do advantages from increased regulation outweigh the additional expenses? Q2. As many MD developers are SMEs, will the new regulatory regime result in some of those companies going out of business and therefore impede future innovation? Methods: The paper focuses on a single case study, with the situation and outcomes discussed in the context of the financial results of a further 50 medical device manufacturers marketing in the Czech Republic. Results: Our findings suggest that the new legislation will result in improved safety, facilitate product recalls, but the cost and administrative burden may be high. The evidence also indicates that some SMEs may be forced to diversify to "non-medical" products, with the inevitable loss of innovative MDs being made available to patients and healthcare providers.

Attitude Toward Protective Behavior Engagement During COVID-19 Pandemic in Malaysia: The Role of E-government and Social Media.

The coronavirus disease 2019 (COVID-19) pandemic is still evolving and affecting millions of lives. E-government and social media have been used widely during this unprecedented time to spread awareness and educate the public on preventive measures. However, the extent to which the 2 digital platforms bring to improve public health awareness and prevention during a health crisis is unknown. In this study, we examined the influence of e-government and social media on the public's attitude to adopt protective behavior. For this purpose, a Web survey was conducted among 404 Malaysian residents during the Recovery Movement Control Order (RMCO) period in the country. Descriptive and multiple regression analyses were conducted using IBM SPSS software. Social media was chosen by most of the respondents (n = 331 or 81.9%) as the source to get information related to COVID-19. Multiple regression analysis suggests the roles of e-government and social media to be significantly related to people's attitudes to engage in protective behavior. In conclusion, during the COVID-19 outbreak, public health decision makers may use e-government and social media platforms as effective tools to improve public engagement on protective behavior. This, in turn, will help the country to contain the transmission of the virus.

Does Employee Care Trigger Innovation Under a Healthy and Safe Working Environment? Evidence from the Pharmaceutical Industry in China.

Sustainability of the workforce becomes a crucial issue, of which responsible care for employees can increase job satisfaction and human capital that impact corporate ability to absorb and generate new knowledge. Firms are obligated to provide a healthy and safe working environment for their employees, but it may in turn hinder innovation due to rigid and structured institutional regulations. Drawing on data of 308 China's pharmaceutical firms from 2010 to 2017, we investigated whether employee care can trigger innovation under corporate adoption of the occupational health and safety management system (OHSMS). Our results suggest that both employee care and OHSMS adoption have a positive impact on innovation. Moreover, the positive relationship between employee care and innovation was more pronounced in firms that had adopted the OHSMS certification. These findings are valuable to policymakers and corporate managers in emerging economies through corroborating the important role of workforce sustainability in facilitating firm innovation.

Ethical Questions Linked to Rare Diseases and Orphan Drugs - A Systematic Review.

BACKGROUND: Rare or orphan diseases have become an important target of healthcare activities all over the world. The study aims to identify ethical questions linked to rare diseases and orphan drugs and ethical principles or approaches applied to solve them. METHODS: Relevant peer-reviewed articles were identified by means of a systematic review. The literature was searched from 20 May 2020 to 20 June 2020. The search included the databases PubMed, Scopus and Web of Science (2010 - April 2020). A total of 4,139 papers related to rare diseases were identified; with 1,205 papers obtained from Scopus; 2,476 papers from PubMed; and 458 from Web of Science with keyword search "ethics" AND "rare" AND "disease", "ethical" AND "orphan", "ethical" AND "orphan" AND "drug", and "ethical" AND "rare" AND "disease". Finally, XX studies were chosen for further analysis. RESULTS: The main findings reveal five main ethical issues. The most essential one shows that funding research and development in the field of orphan drugs poses an almost impossible dilemma. Other issues include the significance of non-economic values like compassion and beneficence in decision-making related to orphan drugs and rare diseases; the identification of limits to labelling diseases as rare; barriers to global, supranational and international cooperation; and last but not least, determining and establishing panels of decision-makers. CONCLUSIONS: A strictly global approach would be the most appropriate way to deal with rare diseases. Nonetheless, international, let alone global, cooperation seems to be completely beyond the reach of the current international community, although the EU, for instance, has a centralized procedure for labelling orphan drugs. This deficit in international cooperation can be partly explained by the fact that the current technologically globalized world still lacks globally accepted ethical values and rules. This is further aggravated by unresolved international and intercultural conflicts. In addition, the sub-interests of various parties as well as the lack of desire to deal with other people's problems need to be taken into account. The aforementioned problems are difficult to avoid. Nevertheless, let us be cautiously optimistic. At least, there are people who raise ethical questions about rare diseases and orphan drugs.

Anticipated Social and Healthcare Economic Burden of People with Alzheimer's Disease in Two Selected Regions of the Czech Republic.

Increasing life expectancy in modern society is undoubtedly due to improved healthcare, scientific advances in medicine, and the overall healthy lifestyle of the general population. However, this positive trend has led to an increase in the number of older people with a growing need for a sustainable system for the long-term care of this part of the population, which includes social and health services that are essential for a high quality of life. Longevity also brings challenges in the form of a polymorbid geriatric population that places financial pressure on healthcare systems. Regardless, one disease dominates the debate about financial sustainability due to the increasing numbers of people diagnosed, and that is Alzheimer's disease (AD). The presented paper aims to demonstrate the economic burden of social and healthcare services. Data from two regions in the Czech Republic were selected to demonstrate the potential scope of the problem. The future costs connected with AD are calculated by a prediction model, which is based on a population model for predicting the number of people with AD between 2020 and 2070. Based on the presented data from the two regions in the Czech Republic and the prediction model, several trends emerged. There appears to be a significant difference in the annual direct costs per person diagnosed with AD depending on the region in which they reside. This may lead to a significant inequality of the services a person can acquire followed by subsequent social issues that can manifest as a lower quality of life. Furthermore, given the prediction of the growing AD population, the costs expressed in constant prices based on the year 2020 will increase almost threefold during the period 2020-2070. The predicted threefold increase will place additional financial pressure on all stakeholders responsible for social and healthcare services, as the current situation is already challenging.

Activities of Daily Living and Associated Costs in the Most Widespread Neurodegenerative Diseases: A Systematic Review.

Nowadays, the population is rapidly ageing because of increasing life expectancy and decreasing birth rates. Thus, the purpose of this systematic review is to prepare a comprehensive overview which identifies the activities of daily living (ADLs) that are gradually reduced among patients with dementia, as well as explore the therapies applied in relation to dementia and how they effectively improve the quality of life (QoL) of patients and caregivers. Furthermore, we aim to summarise the ADL activities influenced by therapies and examine the treatment costs and care for patients so that recommendations for research and development (R&D) can be made to improve both the QoL of people with dementia and cost-saving measures. The research focuses on four selected neurodegenerative diseases: Alzheimer, Parkinson, vascular dementia, and amyotrophic lateral sclerosis. Therefore, the peer-reviewed English written articles from 2014 to 2019 were searched between September 1 and December 13, 2019. Twenty-seven papers were included in the analysis. The results show that essential assistance occurs in connection with activities: eating, drinking, dressing, bathing, personal hygiene, use of the toilet, and transport. By contrast, shopping or cleaning is not addressed as much. A lower ability to take care of oneself is connected with poor patient health and higher social care costs because the patient requires care from external sources, such as home aid or nurse visits. The challenge that remains is to shift new knowledge from scientific disciplines and connect it with the needs of patients to remove legitimate barriers and increase the acceptance of new solutions by popularisation. Additionally, regarding the burden on caregivers, it would be appropriate to promote this area of education and employment so that family members can use formal caregivers, ensuring them free time and much-needed rest.

Smart and Climate-Smart Agricultural Trends as Core Aspects of Smart Village Functions.

Attention has shifted to the development of villages in Europe and other parts of the world with the goal of combating rural-urban migration, and moving toward self-sufficiency in rural areas. This situation has birthed the smart village idea. Smart village initiatives such as those of the European Union is motivating global efforts aimed at improving the live and livelihood of rural dwellers. These initiatives are focused on improving agricultural productivity, among other things, since most of the food we eat are grown in rural areas around the world. Nevertheless, a major challenge faced by proponents of the smart village concept is how to provide a framework for the development of the term, so that this development is tailored towards sustainability. The current work examines the level of progress of climate smart agriculture, and tries to borrow from its ideals, to develop a framework for smart village development. Given the advances in technology, agricultural development that encompasses reduction of farming losses, optimization of agricultural processes for increased yield, as well as prevention, monitoring, and early detection of plant and animal diseases, has now embraced varieties of smart sensor technologies. The implication is that the studies and results generated around the concept of climate smart agriculture can be adopted in planning of villages, and transforming them into smart villages. Hence, we argue that for effective development of the smart village framework, smart agricultural techniques must be prioritized, viz-a-viz other developmental practicalities.

Aging at Work: A Review of Recent Trends and Future Directions.

Demographic data suggest a rapid aging trend in the active workforce. The concept of aging at work comes from the urgent requirement to help the aging workforce of the contemporary industries to maintain productivity while achieving a work and private life balance. While there is plenty of research focusing on the aging population, current research activities on policies covering the concept of aging at work are limited and conceptually different. This paper aims to review publications on aging at work, which could lead to the creation of a framework that targets governmental decision-makers, the non-governmental sector, the private sector, and all of those who are responsible for the formulation of policies on aging at work. In August 2019 we searched for peer-reviewed articles in English that were indexed in PubMed, IEEE Xplore, and Springer and published between 2008 and 2019. The keywords included the following phrases: "successful aging at work", "active aging at work", "healthy aging at work", "productive aging at work", and "older adults at work". A total of 47,330 publications were found through database searching, and 25,187 publications were screened. Afterwards, 7756 screened publications were excluded from the further analysis, and a total of 17,431 article abstracts were evaluated for inclusion. Finally, further qualitative analysis included 1375 articles, of which about 24 are discussed in this article. The most prominent works suggest policies that encourage life-long learning, and a workforce that comprises both younger and older workers, as well as gradual retirement.

Adopting Occupational Health and Safety Management Standards: The Impact on Financial Performance in Pharmaceutical Firms in China.

BACKGROUND AND PURPOSE: In recent years, the frequent occurrence of occupational accidents, illness, and injuries has become a major issue in China. This study aims to investigate the relationship between the adoption of Occupational Health and Safety Management System (OHSMS) standards and financial performance, with a particular focus on the pharmaceutical firms in China. METHODS: The study is based on a sample consisting of 125 pharmaceutical firms listed on the Shanghai and the Shenzhen stock exchanges in China for the period 2010-2018. Each sample firm was evaluated by whether and when it is certified by an OHSMS standard depending on secondary data collected from an independent certification database. Panel-based regression models were employed to explore whether adoption of an OHSMS standard has had an impact on financial performance. RESULTS: The regression results reveal that the adoption of an OHSMS standard positively affects contemporaneous financial performance measured by return on assets (ROA), return on equity (ROE), and earnings per share (EPS). Mixed results were found when financial performance indicators were extended by two years, suggesting that ROE will increase in the second year after a firm is certified with the standard, but EPS will decline in the third year. CONCLUSION: The study findings empirically show that adoption of an OHSMS standard contributes to better financial performance for pharmaceutical firms of China in the short term. However, executives of pharmaceutical firms need to be aware of the increased costs related to certification renewal and audit in the following periods and exercise their management discretion to achieve a win-win situation between OHSMS implementation and financial benefit.

Medical Device Development Process, and Associated Risks and Legislative Aspects-Systematic Review.

Objective: Medical device development, from the product's conception to release to market, is very complex and relies significantly on the application of exact processes. This paper aims to provide an analysis and summary of current research in the field of medical device development methodologies, discuss its phases, and evaluate the associated legislative and risk aspects. Methods: The literature search was conducted to detect peer-reviewed studies in Scopus, Web of Science, and Science Direct, on content published between 2007 and November 2019. Based on exclusion and inclusion criteria, 13 papers were included in the first session and 11 were included in the second session. Thus, a total of 24 papers were analyzed. Most of the publications originated in the United States (7 out of 24). Results: The medical device development process comprises one to seven stages. Six studies also contain a model of the medical device development process for all stages or for just some of the stages. These studies specifically describe the concept stage during which all uncertainties, such as the clinical need definition, customer requirements/needs, finances, reimbursement strategy, team selection, and legal aspects, must be considered. Conclusion: The crucial factor in healthcare safety is the stability of factors over a long production time. Good manufacturing practices cannot be tested on individual batches of products; they must be inherently built into the manufacturing process. The key issues that must be addressed in the future are the consistency in the classification of devices throughout the EU and globally, and the transparency of approval processes.

A Shortage in the Number of Nurses-A Case Study from a Selected Region in the Czech Republic and International Context.

A lack of nurses in the Czech Republic is an issue that has been under discussion for several years. The aim of this paper is to analyze the lack and need of general nurses and midwives in the Hradec Kralove region where the shortage is higher than the national average. The used methods are quantitative research and structured interviews, to determine the number of nurses in healthcare institutions. The study uses data obtained from publicly available sources, i.e., Czech Statistical Office (CSO) and the National Institute of Education (NIE). The shortage of nurses in the Hradec Kralove region can be expected by 2030 to be in the range between 647.6 and 667.1 nurses while maintaining the existing conditions, that is, five times more than at present. In addition to the commonly considered measures that appear in the country's strategies-such as improving the quality of conditions during studies and during employment, specifying or adjusting the role and competency of nurses and midwives in the healthcare system, or unifying employment standards- a focus on promoting the nursing profession can be recommended. Schools and ministries should be encouraged to focus on and invest in the promotion of this profession, so as to play a key role in recruiting new students for the nursing field of study at a time when the nursing profession is perceived positively, as an embodiment of solidarity and selflessness.