New-wave diagnostics

Chapter 15 - Biopesticides in South America: Regulation and commercialization

Understanding which elements are important when perceiving the goodness of a ship is crucial. Traditional driving factors, such as cost and value for money, have been augmented by additional ones, such as environmental issues and increasing risks associated with a rapidly changing commercial and regulatory environment. In this paper, we propose ways for these new elements to be incorporated in the perception of a value robust ship. We use complex systems engineering theory to classify these elements in five aspects: structural, behavioural, contextual, temporal and perceptual. Emphasis is given to the last aspect, linking the perception of a value robust design with rational decision-making, and incorporating the uncertainty and inherent lack of perfect information and agreement in the process. An extended definition of mission concept is combined with epoch-era analysis as proposal to incorporate and quantify the perception of value robustness in the early stages of maritime design.

Franchisor Failure: An Assessment of the Adequacy of Regulatory Response

Ultrasound energy offers unique capabilities to treat a wide range of medical conditions, through numerous distinct physical interactions with tissue. Unlike diagnostic ultrasound, where safety and efficacy are easily demonstrated and the underlying technology has been available for decades, therapeutic ultrasound applications have explored new regimes and therefore required novel technologies and approaches. This presentation will describe the journey from discovery to clinic, based on examples from the author’s personal experience as a consultant and entrepreneur. Developing therapeutic ultrasound products involves several specific and sometimes unique steps. It generally starts with the observation of a therapeutic effect, or a realization that an existing approach could be applied to a different clinical situation. Moving from “N = 1” to a repeatable treatment paradigm can be both exciting and discouraging. The next key steps, which are the hardest, involve translating the initial idea/data/concept into a commercial design, or at least a plan for one. The regulatory, financial, commercial, and clinical environments can be as challenging as the purely technical hurdles, and all factor into the development process. While creating new clinical ultrasound treatments and devices can be difficult and time consuming, it can also be immensely rewarding and satisfying.