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.

A comparison of 0°-0° and 45°-45° bridge-seeded, YBCO single grains

A variety of multiseeding techniques have been investigated over the past 20 yr in an attempt to enlarge bulk (RE)BCO superconducting samples fabricated by the top-seeded melt growth (TSMG) process for practical applications. Unfortunately, these studies have failed to establish whether technically useful values of trapped field can be achieved in multiseeded bulk samples. In this work specially designed, 0°-0° and 45°-45° bridge seeds of different lengths have been employed to produce improved alignment of the seeds during the TSMG process. The ability of these bridge-seeded samples to trap magnetic field, which is the key superconducting property for practical applications of bulk (RE)BCO, is compared for the samples seeded using 0°-0° and 45°-45° bridge seeds of different lengths. The grain boundaries produced by these bridge seeds are analyzed in detail, and the similarities and differences between the two bridge-seeding processes are discussed. © 2013 The American Ceramic Society.