Software development and risk management in the safety critical medical device domain

The healthcare sector is one of the fastest growing economic sectors of today. The medical device domain is one part of that sector. An increasing part of functionality in medical devices and systems is implemented in software and many features should not be possible to implement without software. The use of medical software is an inherent risk to the patient and the outcome of a failure can vary from death to almost no effect at all. Risks and risk management is closely connected to medical device domain and it is crucial to all medical device companies to have a good risk management process. It is also stated in law that the companies developing medical devices must have a risk management process. One part of the research in this thesis focuses on the current state of practice in the medical device domain. As a result of this research, the need for high quality software in this domain has been identified and also the needs for new techniques, methods and processes to further improve software quality in the medical device domain. The results have been used to derive a set of requirements on new processes, methods and techniques in the area, to be used by researchers as a guide in the development of more adapted processes, methods and techniques for software development in the medical devices domain. The other part of the research in this thesis focuses on risk and is based on two experiments. A number of decisions regarding risks are taken during software project risk management and it is the people involved that make the decisions. Different people’s opinions about the importance of identified risks are investigated in an experiment and it is concluded that different participants have different opinions about how serious risks are concerning faults remaining after testing are. Probably it is possible to generalise this and conclude that in the software engineering process different people are more or less risk seeking. From the second experiment it could be concluded that multiple roles and thereby different experiences will affect the risk identification process. Involving multiple roles will result in a more complete set of identified risks than if only one role is included

The Blurred Line Between Failure and Success in Student–Industry Projects

Student–industry activities are often heralded as win–win–win activities in which students gain knowledge of their future professional fields, companies access student knowledge, and universities both offer students stimulating learning opportunities and strengthen ties with industry. Student–industry projects can be defined as an active learning methodology characterized by pedagogical values such as improving student understanding of the concepts, motivation, interest in the subject, and work efficiency (Barak, 2009). Biggs and Tang (2009) find that a stimulating learning environment relies on three main components: 1. an open environment, 2. worthwhile tasks, and 3. demands that students can realistically hope to meet. In the same vein, Perkins (1991) stresses the importance of learners’ attitudes towards the learning situation and of students’ “buying in” to the instruction agenda, factors that are much more easily stimulated when students are confronted with real problems by stakeholders than when presented with constructed problems in simulated situations. Leenders and Maufette-Leenders (2010) argue that a fictitious scenario will not appear credible and not engage students the way an authentic situation does. Authentic learning “focuses on real-world, complex problems and their solutions” (Lombardi, 2007, p. 2), and introduction into a professional environment helps students become “enculturated” into the discipline, a crucial concept according to Lave and Wenger, as “a training program that consists of instructional settings separated from actual performance would tend to split the learner’s ability to manage the learning situation apart from his ability to perform the skill” (1991). University representatives generally agree that student–industry activities make students more employable after graduation (Dawson et al., 1997). Seen in this light, one may wonder why so many student–industry activities are established, only to survive a few iterations. Student–industry activities are by no means homogenous, and include a wide variety of collaboration models ranging from short undemanding meetings between students and industry representatives to long complex relationships demanding considerable effort from universities, companies, and students alike. We have no reason to believe that the success factors for these widely divergent collaboration models are identical. In approaching the concept of “success”, we find it desirable to distinguish between various student–industry activities in a defined framework. In the project management field, critical success factors are often discussed and identified (Pinto and Prescott, 1988; Westerveld, 2003); to better the odds of survival of student–industry activities, the same needs to be done in the field of university–industry collaboration to create more stable student–industry activities

Student–industry collaboration models: challenges and risks

Many student–industry activities have emerged in recent years, and universities have invested considerable time and energy in designing and implementing such collaboration models. However, as models differ significantly, student–industry activities should not all be bundled together. This paper examines student–industry activities conducted as integral parts of engineering study programmes. These activities allow students and industry representatives to meet. The results are based on four major components: an interview study, a case study of the Meet with industry guest lecture series, a case study of the Industry link project course, and a risk analysis of two student–industry collaboration models. Two very well-known, but markedly different, types of collaboration models have been chosen, one collaboration model, delivering real results to industry (e.g., project) and one collaboration model, not delivering real results to industry (e.g., guest lectures). Both collaboration models have been subjected to risk analysis, leading to the identification of strategic areas specific to the particular collaboration model. Based on the findings we suggest that, before choosing a specific model of student–industry collaboration, a risk analysis should be conducted focusing on the three key areas, i.e., Resources, Framework, and Pedagogic considerations, perhaps not primarily to identify specific risks, but to identify the typical risk areas for the activities to be offere

Different conceptions in software project risk assessment

During software project risk management, a number of decisions are taken based on discussions and subjective opinions about the importance of identified risks. In this paper, different people's opinions about the importance of identified risks are investigated in a controlled experiment through the use of utility functions. Engineering students participated as subjects in the experiment. Differences have been found with respect to the perceived importance, although the experiment could not explain the differences based on undertaken role in a development course

Love and affectionate touch toward romantic partners all over the world

Touch is the primary way people communicate intimacy in romantic relationships, and affectionate touch behaviors such as stroking, hugging and kissing are universally observed in partnerships all over the world. Here, we explored the association of love and affectionate touch behaviors in romantic partnerships in two studies comprising 7880 participants. In the first study, we used a cross-cultural survey conducted in 37 countries to test whether love was universally associated with affectionate touch behaviors. In the second study, using a more fine-tuned touch behavior scale, we tested whether the frequency of affectionate touch behaviors was related to love in romantic partnerships. As hypothesized, love was significantly and positively associated with affectionate touch behaviors in both studies and this result was replicated regardless of the inclusion of potentially relevant factors as controls. Altogether, our data strongly suggest that affectionate touch is a relatively stable characteristic of human romantic relationships that is robustly and reliably related to the degree of reported love between partners.info:eu-repo/semantics/publishedVersio

Reasons for facebook usage: Data from 46 countries

Seventy-nine percent of internet users use Facebook, and on average they access Facebook eight times a day (Greenwood et al., 2016). To put these numbers into perspective, according to Clement (2019), around 30% of the world\u2019s population uses this Online Social Network (OSN) site. Despite the constantly growing body of academic research on Facebook (Chou et al., 2009; Back et al., 2010; Kaplan and Haenlein, 2010; McAndrew and Jeong, 2012; Wilson et al., 2012; Krasnova et al., 2017), there remains limited research regarding the motivation behind Facebook use across different cultures. Our main goal was to collect data from a large cross-cultural sample of Facebook users to examine the roles of sex, age, and, most importantly, cultural differences underlying Facebook use

Affective interpersonal touch in close relationships: a cross-cultural perspective

Interpersonal touch behavior differs across cultures, yet no study to date has systematically tested for cultural variation in affective touch, nor examined the factors that might account for this variability. Here, over 14,000 individuals from 45 countries were asked whether they embraced, stroked, kissed, or hugged their partner, friends, and youngest child during the week preceding the study. We then examined a range of hypothesized individual-level factors (sex, age, parasitic history, conservatism, religiosity, and preferred interpersonal distance) and cultural-level factors (regional temperature, parasite stress, regional conservatism, collectivism, and religiosity) in predicting these affective-touching behaviors. Our results indicate that affective touch was most prevalent in relationships with partners and children, and its diversity was relatively higher in warmer, less conservative, and religious countries, and among younger, female, and liberal people. This research allows for a broad and integrated view of the bases of cross-cultural variability in affective touch

Sex differences in mate preferences across 45 countries: A large-scale replication

Considerable research has examined human mate preferences across cultures, finding universal sex differences in preferences for attractiveness and resources as well as sources of systematic cultural variation. Two competing perspectives—an evolutionary psychological perspective and a biosocial role perspective—offer alternative explanations for these findings. However, the original data on which each perspective relies are decades old, and the literature is fraught with conflicting methods, analyses, results, and conclusions. Using a new 45-country sample (N = 14,399), we attempted to replicate classic studies and test both the evolutionary and biosocial role perspectives. Support for universal sex differences in preferences remains robust: Men, more than women, prefer attractive, young mates, and women, more than men, prefer older mates with financial prospects. Cross-culturally, both sexes have mates closer to their own ages as gender equality increases. Beyond age of partner, neither pathogen prevalence nor gender equality robustly predicted sex differences or preferences across countries

Involving user perspective in a software risk management process

More and more user groups are using medical devices. Heart starters are, for example, available in public places and used by non-professionals. Different mobile medical applications, designed to help people manage their own health, are now being added to the medical device spectra. Users handling medical devices make errors, but by involving users in the risk management process, it is possible to lower the risk of these errors. This paper presents an evaluation of the value of complementing a traditional risk management process with an emphasised user perspective. A medical device software risk management framework is being designed, and the risk management process should be regarded as the first part of the framework. The main goal of the evaluated risk management process is to integrate users and user perspective into the risk management process. The results indicate that the use of use cases as input at risk meetings makes the discussions more focused, saving effort and time. When users attend the risk meetings, user perspective and domain knowledge are brought into the process, affecting risk identification and risk assessment. The results also show that the use of usability testing gives valuable input to the risk management process