Technology confidence in early stage development of medical devices

Innovation is a critical factor in ensuring commercial success within the area of medical technology. Biotechnology and Healthcare developments require huge financial and resource investment, in-depth research and clinical trials. Consequently, these developments involve a complex multidisciplinary structure, which is inherently full of risks and uncertainty. In this context, early technology assessment and 'proof of concept' is often sporadic and unstructured. Existing methodologies for managing the feasibility stage of medical device development are predominantly suited to the later phases of development and favour detail in optimisation, validation and regulatory approval. During these early phases, feasibility studies are normally conducted to establish whether technology is potentially viable. However, it is not clear how this technology viability is currently measured. This paper aims to redress this gap through the development of a technology confidence scale, as appropriate explicitly to the feasibility phase of medical device design. These guidelines were developed from analysis of three recent innovation studies within the medical device industry.

Physicians in leadership: the association between medical director involvement and staff-to-patient ratios

In a hospital environment that demands a careful balance between commercial and clinical interests, the extent to which physicians are involved in hospital leadership varies greatly. This paper assesses the influence of the extent of this involvement on staff-to-patient ratios. Using data gathered from 604 hospitals across Germany, this study evidences the positive relationship between a full-time medical director (MD) or heavily involved part-time MD and a higher staff-to-patient ratio. The data allows us to control for a range of confounding variables, such as size, rural/urban location, ownership structure, and case-mix. The results contribute to the sparse body of empirical research on the effect of clinical leadership on organizational outcomes.

Multi-objective optimization for multiphase orbital rendezvous missions

A multi-objective optimization approach was proposed for multiphase orbital rendezvous missions and validated by application to a representative numerical problem. By comparing the Pareto fronts obtained using the proposed method, the relationships between the three objectives considered are revealed, and the influences of other mission parameters, such as the sensors' field of view, can also be analyzed effectively. For multiphase orbital rendezvous missions, the tradeoff relationships between the total velocity increment and the trajectory robustness index as well as between the total velocity increment and the time of flight are obvious and clear. However, the tradeoff relationship between the time of flight and the trajectory robustness index is weak, especially for the four- and five-phase missions examined. The proposed approach could be used to reorganize a stable rendezvous profile for an engineering rendezvous mission, when there is a failure that prevents the completion of the nominal mission.