Preference Testing in Medical Devices: Current Framework and Regulatory Gaps.

Preference testing is a valuable source of information that can be provided by both healthcare professionals (HCPs) and patients (users). It can be used to improve the design and development of medical devices by feeding into device usability and, ultimately, risk management. Furthermore, it can aid with selecting the most appropriate clinical endpoints to be used in the clinical evaluation of a device and increase patient engagement by incorporating patient-relevant outcomes.

Companion Diagnostics: State of the Art and New Regulations.

Companion diagnostics (CDx) hail promise of improving the drug development process and precision medicine. However, there are various challenges involved in the clinical development and regulation of CDx, which are considered high-risk in vitro diagnostic medical devices given the role they play in therapeutic decision-making and the complications they may introduce with respect to their sensitivity and specificity. The European Union (E.

Impact of Design on Medical Device Safety.

The growing number of emerging medical technologies and sophistication of modern medical devices (MDs) that improve both survival and quality of life indexes are often challenged by alarming cases of vigilance data cover-up and lack of sufficient pre- and post-authorization controls. Combining Quality with Risk Management processes and implementing them as early as possible in the design of MDs has proven to be an effective strategy to minimize residual risk. This article aims to discuss how the design of MDs interacts with their safety profile and how this dipole of intended performance and safety may be supported by Human Factors Engineering (HFE) throughout the Total Product Life-Cycle (TPLC) of an MD in order to capitalize on medical technologies without exposing users and patients to unnecessary risks.

Continuous subcutaneous insulin infusion (CSII) pumps.

Optimal blood glucose control and the restoration of the physiological insulin secretion is a current medical challenge andwill account for an overall cardiovascular morbidity and mortality related to diabetes mellitus complications. Continuous Subcutaneous Insulin Infusion (CSII) is the first step to the development of the so-called "artificial pancreas" and is intended to restore blood glucose levels and the frequency of hypoglycemic episodes. CSII using an external pump, offers both a better glycemic profile compared to multiple daily insulin injections (MDI) and a broader flexibility in everyday activities.

[The impasses of unconditional poverty: the experience of Collective Ombudsman in the Leopoldina region, Rio de Janeiro (RJ, Brazil)].

The experience of Collective Ombudsman developed in the Leopoldina region, city of Rio de Janeiro, enlarges the traditional vision of health vigilance and consists in organizing a system of qualitative evaluation of the sanitary vigilance able to identify the health problems of the population and the methods utilized in the attempt to overcome these problems. Health professionals, religious and community leaders congregated in monthly forums to present and discuss living conditions perceived in the communities in which they carry on their activities. From the point of view of the social dimensions involved in the health-illness processes, this work aims to discuss the way that poverty compromises the popular classes' health, especially for the mental health and the "diffuse suffering".