Strategies to Influence a Quality and Compliance Culture

In drug, medical, and consumer products businesses, leaders should establish strategies that ensure production of quality products and drive profitability. Sales of defective or substandard products carry a potential risk of unintended effects on the consumer. The purpose of this single case study was to explore the strategies used by leaders to influence a culture of quality and compliance, leading to production of saleable products, and business profitability. The conceptual framework of the theory of constraints served to guide the scope and data analysis for this study. Participants included ten individuals with a minimum of 5 years of experience at the study company, based in the northeast region of the U.S., in director, manager, and technical leader roles who participated in individual, telephone-based interviews. Additional data sources for methodological triangulation included observations during a tour of the headquarters site, and analysis of policies, procedures, annual reports, and publicly available information. Data analysis included coding of the data and analysis to identify themes and patterns that identify the strategies leaders use to embed a culture of quality. The emergent themes in this study included: leadership, culture and habits, communications, and management systems and data analysis. The findings of this study may contribute to positive social change and improved business practice by providing tools and skills needed by business leaders to ensure product quality and business success. By consistently delivering quality products to the market, the organization builds a sustainable business where the community can benefit from a stable supply of jobs and the consumer from a reliable supply of products that safely meet customer needs

Challenges of translational research in cutting edge medical technology : a case of first-in-human (FIH) trials of medical applications of nanotechnology

The translation of discoveries in basic science into safe and effective clinical applications is essential for improving health care. Unfortunately, translational research is a long, arduous and resource intense process filled with high levels of uncertainty and renown for resulting in a series of failures before succeeding in its goal. This is particularly true when cutting-edge medical technologies are translated into improved diagnostic tests or better and safer therapeutic options. The aim of this doctoral research project was to describe the challenges involved in the translational research of medical applications of nanotechnology with a particular focus on first-in-human (FIH) trials. This exploratory research project was situated in a larger study and included in-depth qualitative interviews to gain insight into the perspectives of various stakeholders involved in planning, conducting or evaluating FIH trials in nanomedicine. Translational research is a multi-stakeholder enterprise and often requires the negotiation of various conflicting values and goals. FIH trials mark the moment in translational research when an experimental intervention is tested in human beings first time and poses the highest level of uncertainty with regard to the safety and efficacy. In-depth interviews conducted with expert stakeholders based in Europe and North America led to a greater understanding of the various challenges in translational nanomedicine and potential solutions. The key results of this research project indicate a number of challenges in the current practices of translational research. The results are mainly focused on insights obtained from stakeholder interviews and point to issues such as (1) diverse definitions of nanomedicine and its impact on the translational research, (2) financial, ethical and regulatory challenges in the translational research, (3) inconsistent disclosure practices with regard to the ‘nano’ nature of investigational products in patient information sheets and informed consent forms, (4) implications of the current practices of the researchers of including patients with end-stage cancer and no effective treatment options in FIH trials on the scientific value of the early phases of the translational research and (5) factors such as public health emergencies that can accelerate decision making and mobilize resources to initiate FIH trials with investigational products despite significant uncertainty related to their safety and efficacy. To understand all the complexities of translational research in nanomedicine, there is a need to further investigate the role of various regulatory guidelines and to define ‘meaningful’ public engagement in science and drug development. Both these aspects critically hinge upon scientific integrity and the public’s trust in science and regulatory mechanisms. Although these topics were not investigated in this research project, our results clearly indicate the need to explore them further. We conclude that while discussing the regulation of nanotechnology, careful attention must be paid to each application on a case-by-case basis. We argue for the critical examination of current procedures in regulatory assessments rather than creating new and special regulations for nanomedicine. Finally, we believe that the challenges in translational nanomedicine discussed in this project are also applicable to any cutting-edge medical technology.

The Largest Unethical Medical Experiment in Human History

This monograph describes the largest unethical medical experiment in human history: the implementation and operation of non-ionizing non-visible EMF radiation (hereafter called wireless radiation) infrastructure for communications, surveillance, weaponry, and other applications. It is unethical because it violates the key ethical medical experiment requirement for “informed consent” by the overwhelming majority of the participants. The monograph provides background on unethical medical research/experimentation, and frames the implementation of wireless radiation within that context. The monograph then identifies a wide spectrum of adverse effects of wireless radiation as reported in the premier biomedical literature for over seven decades. Even though many of these reported adverse effects are extremely severe, the true extent of their severity has been grossly underestimated. Most of the reported laboratory experiments that produced these effects are not reflective of the real-life environment in which wireless radiation operates. Many experiments do not include pulsing and modulation of the carrier signal, and most do not account for synergistic effects of other toxic stimuli acting in concert with the wireless radiation. These two additions greatly exacerbate the severity of the adverse effects from wireless radiation, and their neglect in current (and past) experimentation results in substantial under-estimation of the breadth and severity of adverse effects to be expected in a real-life situation. This lack of credible safety testing, combined with depriving the public of the opportunity to provide informed consent, contextualizes the wireless radiation infrastructure operation as an unethical medical experiment