REGULATORY APPROVAL OF NEW MEDICAL DEVICES: A CROSS SECTIONAL STUDY

Objective To investigate the regulatory approval of new medical devices. Design Cross sectional study of new medical devices reported in the biomedical literature. Data sources PubMed was searched between 1 January 2000 and 31 December 2004 to identify clinical studies of new medical devices. The search was carried out during this period to allow time for regulatory approval. Eligibility criteria for study selection Articles were included if they reported a clinical study of a new medical device and there was no evidence of a previous clinical study in the literature. We defined a medical device according to the US Food and Drug Administration as an “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article.” Main outcome measures Type of device, target specialty, and involvement of academia or of industry for each clinical study. The FDA medical databases were then searched for clearance or approval relevant to the device. Results 5574 titles and abstracts were screened, 493 full text articles assessed for eligibility, and 218 clinical studies of new medical devices included. In all, 99/218 (45%) of the devices described in clinical studies ultimately received regulatory clearance or approval. These included 510(k) clearance for devices determined to be “substantially equivalent” to another legally marketed device (78/99; 79%), premarket approval for high risk devices (17/99; 17%), and others (4/99; 4%). Of these, 43 devices (43/99; 43%) were actually cleared or approved before a clinical study was published. Conclusions We identified a multitude of new medical devices in clinical studies, almost half of which received regulatory clearance or approval. The 510(k) pathway was most commonly used, and clearance often preceded the first published clinical study

Making the leap: the translation of innovative surgical devices from the laboratory to the operating room

MINI-ABSTRACT: A decade from publication, approximately one in ten surgical devices described in the literature made the leap from the laboratory to a first-in-human study. Clinical involvement was a significant predictor of translation; devices developed with clinical collaboration were over six times more likely to be translated than those without. STRUCTURED ABSTRACT: OBJECTIVE: To determine the rate and extent of translation of innovative surgical devices from the laboratory to first-in-human studies, and to evaluate the factors influencing such translation. SUMMARY BACKGROUND DATA: Innovative surgical devices have preceded many of the major advances in surgical practice. However, the process by which devices arising from academia find their way to translation remains poorly understood. METHODS: All biomedical engineering journals, and the five basic science journals with the highest impact factor, were searched between January 1993 and January 2000 using the Boolean search term “surgery OR surgeon OR surgical”. Articles were included if they described the development of a new device and a surgical application was described. A recursive search of all citations to the article was performed using the Web of Science (Thompson-Reuters, New York, USA) to identify any associated first-in-human studies published by January 2015. Kaplan-Meier curves were constructed for the time first-in-human studies. Factors influencing translation were evaluated using Log Rank and Cox proportional hazards models. RESULTS: 8,297 articles were screened, and 205 publications describing unique devices identified. The probability of a first-in-human at 10 years was 9.8%. Clinical involvement was a significant predictor of a first-in-human study (p = 0.02); devices developed with early clinical collaboration were over six times more likely to be translated than those without (RR 6.5 [95% CI 0.9 - 48]). CONCLUSIONS: These findings support initiatives to increase clinical translation through improved interactions between basic, translational, and clinical researchers

Regulatory approval of new medical devices: cross sectional study

OBJECTIVE:  To investigate the regulatory approval of new medical devices. DESIGN:  Cross sectional study of new medical devices reported in the biomedical literature. DATA SOURCES:  PubMed was searched between 1 January 2000 and 31 December 2004 to identify clinical studies of new medical devices. The search was carried out during this period to allow time for regulatory approval. ELIGIBILITY CRITERIA FOR STUDY SELECTION:  Articles were included if they reported a clinical study of a new medical device and there was no evidence of a previous clinical study in the literature. We defined a medical device according to the US Food and Drug Administration as an "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article." MAIN OUTCOME MEASURES:  Type of device, target specialty, and involvement of academia or of industry for each clinical study. The FDA medical databases were then searched for clearance or approval relevant to the device. RESULTS:  5574 titles and abstracts were screened, 493 full text articles assessed for eligibility, and 218 clinical studies of new medical devices included. In all, 99/218 (45%) of the devices described in clinical studies ultimately received regulatory clearance or approval. These included 510(k) clearance for devices determined to be "substantially equivalent" to another legally marketed device (78/99; 79%), premarket approval for high risk devices (17/99; 17%), and others (4/99; 4%). Of these, 43 devices (43/99; 43%) were actually cleared or approved before a clinical study was published. CONCLUSIONS:  We identified a multitude of new medical devices in clinical studies, almost half of which received regulatory clearance or approval. The 510(k) pathway was most commonly used, and clearance often preceded the first published clinical study

Making the Leap: the Translation of Innovative Surgical Devices From the Laboratory to the Operating Room

OBJECTIVE: To determine the rate and extent of translation of innovative surgical devices from the laboratory to first-in-human studies, and to evaluate the factors influencing such translation. SUMMARY BACKGROUND DATA: Innovative surgical devices have preceded many of the major advances in surgical practice. However, the process by which devices arising from academia find their way to translation remains poorly understood. METHODS: All biomedical engineering journals, and the 5 basic science journals with the highest impact factor, were searched between January 1993 and January 2000 using the Boolean search term "surgery OR surgeon OR surgical". Articles were included if they described the development of a new device and a surgical application was described. A recursive search of all citations to the article was performed using the Web of Science (Thompson-Reuters, New York, NY) to identify any associated first-in-human studies published by January 2015. Kaplan-Meier curves were constructed for the time to first-in-human studies. Factors influencing translation were evaluated using log-rank and Cox proportional hazards models. RESULTS: A total of 8297 articles were screened, and 205 publications describing unique devices were identified. The probability of a first-in-human at 10 years was 9.8%. Clinical involvement was a significant predictor of a first-in-human study (P = 0.02); devices developed with early clinical collaboration were over 6 times more likely to be translated than those without [RR 6.5 (95% confidence interval 0.9-48)]. CONCLUSIONS: These findings support initiatives to increase clinical translation through improved interactions between basic, translational, and clinical researchers

What cost components are relevant for economic evaluations of palliative care, and what approaches are used to measure these costs? A systematic review

BACKGROUND: It is important to understand the costs of palliative and end-of-life care in order to inform decisions regarding cost allocation. However, economic research in palliative care is very limited and little is known about the range and extent of the costs that are involved in palliative care provision. AIM: To undertake a systematic review of the health and social care literature to determine the range of financial costs related to a palliative care approach and explore approaches used to measure these costs. DESIGN: A systematic review of empirical literature with thematic synthesis. Study quality was evaluated using the Weight of Evidence Framework. DATA SOURCES: The databases CINAHL, Cochrane, PsycINFO and Medline were searched from 1995 to November 2015 for empirical studies which presented data on the financial costs associated with palliative care. RESULTS: A total of 38 papers met our inclusion criteria. Components of palliative care costs were incurred within four broad domains: hospital care, community or home-based care, hospice care and informal care. These costs could be considered from the economic viewpoint of three providers: state or government, insurers/third-party/not-for-profit organisations and patient and family and/or society. A wide variety of costing approaches were used to derive costs. CONCLUSION: The evidence base regarding the economics of palliative care is sparse, particularly relating to the full economic costs of palliative care. Our review provides a framework for considering these costs from a variety of economic viewpoints; however, further research is required to develop and refine methodologies

Topological and conventional nanophotonic waveguides for directional integrated quantum optics

Directionality in integrated quantum photonics has emerged as a promising route towards achieving scalable quantum technologies with nonlinearities at the single-photon level. Topological photonic waveguides have been proposed as a novel approach to harnessing such directional light-matter interactions on-chip. However, uncertainties remain regarding the strength of the directional coupling of embedded quantum emitters to topological waveguides in comparison to conventional line defect waveguides. In this work we present an investigation of directional coupling in a range of waveguides using a combination of experimental, theoretical, and numerical analyses. We quantitatively characterize the position dependence of the light-matter coupling on several topological photonic waveguides and benchmark their directional coupling performance against conventional line defect waveguides. We conclude that topological waveguides underperform in comparison to conventional line defect waveguides, casting their directional optics credentials into doubt. To demonstrate this is not a question of the maturity of the field; we show that state-of-the-art inverse design methods, while capable of improving the directional emission of these topological waveguides, still place them significantly behind the operation of a conventional (glide-plane) photonic crystal waveguide. Our results and conclusions pave the way towards improving the implementation of quantitatively predicted quantum nonlinear effects on-chip

Can strong consumer and producer effects be reconciled to better forecast 'catastrophic' phase-shifts in marine ecosystems?

The indirect effects of climate on species interactions were initially surprising, but ecological models that account for ecosystem decline have long underestimated their ubiquity and strength. Indirect effects not only yield "unexpected results", but also some of the strongest ecological effects (i.e. phase-shifts) that have been regarded as "catastrophes" on coral reefs, "collapses" of kelp forests and "crises" in seagrass meadows. Such effects went unanticipated because the impact of one species on another required knowledge of a third element that was inadequately understood. Subsequent debate over the causes of habitat loss has often been polarised by two extreme points of view, i.e. consumer versus producer effects. It is our perspective that these debates will persist unless we clarify the context-dependency of two kinds of indirect effect; those driven by strong consumer effects and those driven by strong producer effects. On human-dominated coasts, loss of coral, kelp and seagrass can occur as a function of change in trophic cascades (i.e. consumer effects) as well as change to competitive hierarchies (i.e. producer competition for resources). Because production and consumption are under strong physiological control by climate (providing predictable responses), there is merit in recognising the type and context of indirect effects to reduce errors associated with model-based forecasting. Indeed, forecasts of how global (e.g. elevated temperature and CO2) and local drivers (e.g. fishing and pollution) combine to drive ecological change will often depend on the relative strength of different kinds of indirect effects (i.e. consumer effects vs producer effects). By recognising the context-dependency of the indirect effects under investigation, the information content of forecasts may not only increase, but also provide an improved understanding of indirect effects and community ecology in general. © 2011 Elsevier B.V.Sean D. Connell, Bayden D. Russell, Andrew D. Irvin

Autism as a disorder of neural information processing: directions for research and targets for therapy

The broad variation in phenotypes and severities within autism spectrum disorders suggests the involvement of multiple predisposing factors, interacting in complex ways with normal developmental courses and gradients. Identification of these factors, and the common developmental path into which theyfeed, is hampered bythe large degrees of convergence from causal factors to altered brain development, and divergence from abnormal brain development into altered cognition and behaviour. Genetic, neurochemical, neuroimaging and behavioural findings on autism, as well as studies of normal development and of genetic syndromes that share symptoms with autism, offer hypotheses as to the nature of causal factors and their possible effects on the structure and dynamics of neural systems. Such alterations in neural properties may in turn perturb activity-dependent development, giving rise to a complex behavioural syndrome many steps removed from the root causes. Animal models based on genetic, neurochemical, neurophysiological, and behavioural manipulations offer the possibility of exploring these developmental processes in detail, as do human studies addressing endophenotypes beyond the diagnosis itself

Towards mentoring as feminist praxis in early childhood education and care in England

Following our contribution to a study of mentoring in seven European countries, we explored epistemological and ontological inconsistencies within mainstream mentoring systems and their regulated practice in England. We considered how feminist mentoring praxis can unsettle conceptualisations of mentoring relationships and challenge inequity in the early education systems and the practice of teaching young children. Predominantly female, early childhood educators suffer from low status in England, and their working lives may be controlled and policed through inequitable systems. On entering the workforce, trainees encounter a reductionist policy milieu where mentoring structures and normative assessment arrangements contribute to inequity. Mentors play pivotal roles in inducting trainees into their worlds of work with young children. Mentoring relationships can determine whether trainees accept the status quo. Principles derived from feminist praxis enable mentors to practise an ‘engaged pedagogy’, co-constructing knowledge, subverting hierarchies and contesting taken-for-granted aspects of policy and practice

A Thermodynamically-Based Mesh Objective Work Potential Theory for Predicting Intralaminar Progressive Damage and Failure in Fiber-Reinforced Laminates

A thermodynamically-based work potential theory for modeling progressive damage and failure in fiber-reinforced laminates is presented. The current, multiple-internal state variable (ISV) formulation, enhanced Schapery theory (EST), utilizes separate ISVs for modeling the effects of damage and failure. Damage is considered to be the effect of any structural changes in a material that manifest as pre-peak non-linearity in the stress versus strain response. Conversely, failure is taken to be the effect of the evolution of any mechanisms that results in post-peak strain softening. It is assumed that matrix microdamage is the dominant damage mechanism in continuous fiber-reinforced polymer matrix laminates, and its evolution is controlled with a single ISV. Three additional ISVs are introduced to account for failure due to mode I transverse cracking, mode II transverse cracking, and mode I axial failure. Typically, failure evolution (i.e., post-peak strain softening) results in pathologically mesh dependent solutions within a finite element method (FEM) setting. Therefore, consistent character element lengths are introduced into the formulation of the evolution of the three failure ISVs. Using the stationarity of the total work potential with respect to each ISV, a set of thermodynamically consistent evolution equations for the ISVs is derived. The theory is implemented into commercial FEM software. Objectivity of total energy dissipated during the failure process, with regards to refinements in the FEM mesh, is demonstrated. The model is also verified against experimental results from two laminated, T800/3900-2 panels containing a central notch and different fiber-orientation stacking sequences. Global load versus displacement, global load versus local strain gage data, and macroscopic failure paths obtained from the models are compared to the experiments