Industry perceptions of barriers to commercialization of regenerative medicine products in the UK.

AIMS: Regenerative medicine is an emerging field with the potential to provide widespread improvement in healthcare and patient wellbeing via the delivery of therapies that can restore, regenerate or repair damaged tissue. As an industry, it could significantly contribute to economic growth if products are successfully commercialized. However, to date, relatively few products have reached the market owing to a variety of barriers, including a lack of funding and regulatory hurdles. The present study analyzes industry perceptions of the barriers to commercialization that currently impede the success of the regenerative medicine industry in the UK. MATERIALS & METHODS: The analysis is based on 20 interviews with leading industrialists in the field. RESULTS: The study revealed that scientific research in regenerative medicine is thriving in the UK. Unfortunately, lack of access to capital, regulatory hurdles, lack of clinical evidence leading to problems with reimbursement, as well as the culture of the NHS do not provide a good environment for the commercialization of regenerative medicine products. CONCLUSION: Policy interventions, including increased translational government funding, a change in NHS and NICE organization and policies, and regulatory clarity, would likely improve the general outcomes for the regenerative medicine industry in the UK.

Innovation processes within the healthcare industry: Determining critical success factors aligned to product strategies

The impact of differing product strategies on product innovation processes pursued by healthcare firms is discussed. The critical success factors aligned to product strategies are presented. A definite split between pioneering product strategies and late entrant product strategies is also recognised.

The fracture energy of metal fibre reinforced ceramic composites (MFCs)

A model is presented for prediction of the fracture energy of ceramic-matrix composites containing dispersed metallic fibres. It is assumed that the work of fracture comes entirely from pull-out and/or plastic deformation of fibres bridging the crack plane. Comparisons are presented between these predictions and experimental measurements made on a commercially-available composite material of this type, containing stainless steel (304) fibres in a matrix predominantly comprising alumina and alumino-silicate phases. Good agreement is observed, and it's noted that there is scope for the fracture energy levels to be high (~20kJm-2). Higher toughness levels are both predicted and observed for coarser fibres, up to a practical limit for the fibre diameter of the order of 0.5mm. Other deductions are also made concerning strategies for optimisation of the toughness of this type of material. © 2010 Elsevier Ltd.

Damage development in an armor ceramic under quasi-static indentation

The objective of the present study is to assess the capabilities of a recently developed mechanism-based model for inelastic deformation and damage in structural ceramics. In addition to conventional lattice plasticity, the model accounts for microcrack growth and coalescence as well as granular flow following comminution. The assessment is made through a coupled experimental/computational study of the indentation response of a commercial armor ceramic. The experiments include examinations of subsurface damage zones along with measurements of residual surface profiles and residual near-surface stresses. Extensive finite element computations are conducted in parallel. Comparisons between experiment and simulation indicate that the most discriminating metric in the assessment is the spatial extent of subsurface damage following indentation. Residual stresses provide additional validation. In contrast, surface profiles of indents are dictated largely by lattice plasticity and thus provide minimal additional insight into the inelastic deformation resulting from microcracking or granular flow. A satisfactory level of correlation is obtained using property values that are either measured directly or estimated from physically based arguments, without undue reliance on adjustable (nonphysical) parameters. © 2011 The American Ceramic Society.