Reliability assessment of autonomous vehicles based on the safety control structure

The recent social trends and accelerated technological progress culminated in the development of autonomous vehicles (AVs). Reliability assessment for AV systems is in high demand before its market launch. In safety-critical systems (SCSs) such as AV systems, the reliability concept should be broadened to consider more safety-related issues. In this paper, reliability is defined as the probability that the system performs satisfactorily for a given period of time under stated conditions. This paper proposes a reliability assessment framework of AV, consisting of three main stages: (i) modeling the safety control structure through the Systems-Theoretic Accident Model and Processes (STAMP); (ii) mapping the control structure and functional relationships to a directed acyclic graph (DAG); and (iii) construct a Bayesian network (BN) on DAG to assess the system reliability. The fully automated (level 5) vehicle system is shown as a numeric example to illustrate how this suggested framework works. A brief discussion on involving human factors in systems to analyze lower levels of automated vehicles is also included, demonstrating the need for further research on real case studies.

Consumer Acceptance and Market Potential of Iodine-Biofortified Fruit and Vegetables in Germany

Biofortification of food crops with iodine is a novel approach to preventing iodine deficiency in humans. The present study analyses the consumer target groups and the market potential of iodine-biofortified fruit and vegetables in Germany. For this purpose, an online survey of 1016 German fruit and vegetable consumers was conducted to investigate the acceptance of different product categories as well as relevant criteria for the market launch. The results show that iodine-biofortified fruit and vegetables are particularly attractive to consumers who purchase at farmers’ markets, organic food shops, and farm stores. Out of this group, 39% of consumers rate such iodine-rich foods as very appealing. They attach importance to food that naturally contains iodine and prefer produce from integrated domestic cultivation. With their focus on sustainability and naturalness, this group of consumers clearly differs from typical users of dietary supplements, who are primarily concerned with health benefits. However, overall about 85% of respondents would prefer biofortified fruits and vegetables to supplements to improve their iodine supply. The greatest market potential for iodine-biofortified fruit and vegetables is to be expected in supermarkets, as this is the preferred food shopping location for most consumers. A total of 28% of those who buy here rate the biofortified foods presented as very appealing. Nevertheless, a successful market launch requires that the benefits of the new products are communicated according to the potential consumer group needs.

Safety and efficacy of RNA vaccines: State of the art

This review describes principles of action and the method of delivery of mRNA molecules into cells, as well as some of developed RNA vaccines and the results obtained in their study, though they have not been authorized for use yet. In addition, the review discusses efficacy and safety proved for RNA vaccines registered for COVID-19 prevention at the time of writing. The development, clinical trials and market launch of RNA vaccines for mass immunization in a few months can be considered one of the major breakthroughs in pharmacology over the past year. Despite of all seemingly indisputable advantages, none of RNA vaccines had reached Phase III of clinical trials since the moment of its discovery in 1993 until last year. The first experience of the successful use of mRNA vaccines was back in the 90s of the last century, when vaccination of mice with liposomes encoding an antigen-encoding mRNA was found to initiate specific immune response in mice. However, in these years, the method did not find application, due to the toxicity of lipids used. Subsequently, a large number of attempts have been made to develop vaccines against other viral infections, including Zika virus, Dengue virus, Ebola virus, cytomegalovirus, influenza virus and others. Despite the importance for preventing the spread of these diseases, the development of a vaccine preparation is a rather lengthy process, and final success is not guaranteed. However, the COVID-19 pandemic has become speeded the development of mRNA vaccines up.At the time of writing the review, two mRNA-based vaccines have been registered only in the world, both, BNT162b2 and mRNA-1273, were against COVID-19. Their effectiveness and safety are still actively studied. Moreover, it took less than a year for new strains of SARS-CoV-2 to appear, and the efficiency of vaccines against them was found to be lower than against the reference pathogen variant. Considering that the three new strains of SARS-CoV-2, “British”, “African” and “Brazilian”, are rapidly spreading in the world, the first results of efficiency evaluation of vaccines against them have already been published. One may expect that, considering mutations in these strains, the BNT162b2 and mRNA-1273 vaccines will remain effective against the “British” strain, but their protective properties are greatly weakened against the “African” variant.

The Promise of the Dual Prevention Pill: A Framework for Development and Introduction

Women of reproductive age need multipurpose prevention technology (MPT) products to address two overlapping health risks: unintended pregnancy and HIV. Currently, condoms are the only available MPT, however male condoms are not within the control of a woman, and the use of female condoms has been limited by low acceptability and cost. Oral pre-exposure prophylaxis (PrEP) is highly effective for HIV prevention, yet uptake and adherence among women have been low to date. Women globally need more options for HIV and pregnancy prevention. Several MPTs for simultaneous HIV and pregnancy prevention are in various stages of development and clinical testing, although most are many years away from market launch. A dual prevention pill (DPP), a daily oral pill combining oral contraceptives and PrEP, both of which are licensed, approved products in many low- and middle-income countries (LMIC), is likely to be the fastest route to getting an MPT product into the hands of women. The DPP is one option that could enhance method choice, particularly for women who are already using oral contraceptives. By leveraging the oral contraceptive market and reaching women currently using condoms or with an unmet need for contraception, the DPP has the potential to increase the uptake of PrEP. The successful rollout of the DPP will require careful consideration of user-, provider-, and product-centered factors during product development and introduction. Early attention to these interrelated factors can help ensure that the DPP has the ideal characteristics for maximum product acceptability, that effective and quality services are designed and implemented, and that users can make informed choices, demand the product, and use it effectively. The proposed framework outlines key considerations for the effective development and introduction of the DPP, which could also facilitate integration models for future MPTs.

Customer Knowledge Enabled Innovation: Analyzing Pricing-Promotion Coordination Mechanism

Pricing and promotion are two important decisions during the market launch of new consumer electronics products. Nowadays, the pricing and promotion of consumer electronic products are often not made separately but at the same time. This study focuses on the pricing-promotion coordination mechanism of a secondary supply chain of new consumer electronics products (which consists of a manufacturer and a seller). Price and the degree of promotion together affect the demand for products. Manufacturers give sellers a sales target. Manufacturers and sellers set prices and promotions separately, introduce repurchase penalty joint contracts, and establish supply chain profit models to compare and analyze optimal pricing, promotion efforts, and maximum profit of supply chains under different decision-making situations. We prove that the repurchase penalty joint contract can coordinate the supply chain under the assumptions of a single-period game and a multiperiod repeated game. The results show that under the repurchase penalty joint contract, when manufacturers and sellers choose high prices and high promotions at the same time, the supply chain of new consumer electronics products has the largest profit. Finally, numerical experiments are conducted to study the influence of parameters on optimal decision-making and supply chain profits.

Pneuma: entrepreneurial science in the fight against the COVID-19 pandemic - a tale of industrialisation and international cooperation

When the COVID-19 pandemic hits Portugal in early March 2020, medical doctors, engineers and researchers, with the encouragement of the Northern Region Health Administration, teamed up to develop and build, locally and in a short time, a ventilator that might eventually be used in extreme emergency situations in the hospitals of northern Portugal. This letter tells you the story of Pneuma, a low-cost emergency ventilator designed and built under harsh isolation constraints, that gave birth to derivative designs in Brazil and Morocco, has been industrialized with 200 units being produced and is now looking forward to the certification as a medical device that will possibly support a go-to-market launch. Open intellectual property (IP), multidisciplinarity teamwork, fast prototyping and product engineering have shortened to a few months an otherwise quite longer idea-to-product route, clearly demonstrating that when scientific and engineering knowledge hold hands great challenges can be successfully faced.

505(b) (2) - A smart pathway to differentiate from competitive, low margin environment of generics

Purpose 505(b) (2) application is one of the advantageous ways of regulatory submission. This submission approach can lead to fast-track approval for wide-ranging products, exclusively for those that exemplify a limited change from formerly approved drug. Safety and efficacy evidence in terms of non-clinical and clinical portion of the Reference Listed Drug (RLD), are trusted upon. Additionally, supplementary data essentially required to establish comparability with the RLD, are presented in the dossier. Methods This retrospective analysis is to understand the FDA's expectations and avoid errors in terms of data support approval for a new product submitted under the 505 (b) (2) route. The current script is an analysis on how to architect 505(b) (2) regulatory strategy by developing a different set of documents/information. Results The ultimate goal of this review is to allow drug developers to easily navigate through various 505 (b) (2) submissions and defense strategies for registration processes available to the new drug manufacturers and to understand an effective, safer filing route by facilitating early market launch with a prospect of lower cost. Conclusion Before considering option 505 (b) (2), general companies should have a good understanding of product’s potential productivity, scalability, patent infringement, expensive clinical studies and/or non-clinical studies to appropriately strategize scientific and commercial opportunities. This leverage will potentially quicken the development program and will definitely lower the clinical and regulatory risk of new product entrants.

Diffusion Model of Various Modifications of an Innovative Product

Digitalization entails the application of digital technologies to a wide range of existing tasks and enables solution of new tasks. This article is based on data sets on current sales volumes of innovative products to forecast their future sales. The first stage is applying the innovation diffusion in the F. Bass model to calculate the diffusion coefficients of different modifications of Sony’s PlayStation. To estimate factors which influence innovation and related results within firms, the company IMPRINTA producing 3D printers was surveyed. It is shown that taking into account technical parameters, a cascade diffusion model of product innovation is the best for describing the process of product realization. The information obtained from the diffusion analysis of two 3D printer models can be used to improve the efficiency of key business processes, including production, procurement, marketing and advertising. The use of the diffusion model made it possible to generate three different scenarios for the release and promotion of a new modification of one of the 3D printer models depending on the selected niche, the time of market launch and the intensity of the marketing and advertising campaign. Each scenario enables adjusting the cost and technical parameters of the future modification.

Co-constructing an Opportunity with a Community of Inquiry

Entrepreneurs can learn about potential opportunitiesthrough social interactions with communities of inquiry. However, how do entrepreneurs build such communities, and how do they engage community members over time to develop their potential opportunities? Building on a recent study of eight new ventures and their communities of inquiry over nine months (Shepherd et al. in Journal of Business Venturing, 106033), this chapter presents a social model of opportunity development. The chapter explains how entrepreneurial teams that progress well toward market launch consist of varied specialists who openly engage their communities of inquiry. This open engagement leads such teams to gather diverse information, generate multiple alternatives (technology and market), and test conjectures about their potential opportunities through disconfirmation. In contrast, unsuccessful entrepreneurial teams rely on focused engagement with their communities of inquiry. This focused engagement leads these teams to gather specific information, generate a few related alternatives, and seek to confirm their opportunity conjectures. This chapter highlights new insights into entrepreneurial teams’ engagement with communities of inquiry to explain opportunity development and, ultimately, new venture progress.