Uptake of medical devices approved by NICE

Williams, Sarah; Hung, Isaac; Partridge, Gemma; Sanghvi, Sonali

doi:10.1136/bmjinnov-2018-000273

Cited by 4 publications

(4 citation statements)

References 6 publications

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“…According to the US Food and Drugs Administration (FDA), ~22,000 premarket submissions are made per year [18]. However, fewer than 7-9% of these products reach the marketa lengthy process that can take up to 17 years for innovations including devices [19][20][21][22][23][24]. Whilst the 'dominant design' of the existing healthcare practices certainly plays a role in the low proportion of innovations being implemented, it is likely that other factors are also responsible.…”

Section: Introductionmentioning

confidence: 99%

Barriers to the Diffusion of Medical Technologies Within Healthcare: A Systematic Review

et al. 2021

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Implementing medical devices into a clinical setting is a complex and lengthy process. Existing models, such as Rogers' Diffusion of Innovation, try to elucidate this process, however, need to be updated to the evolving healthcare context as fewer than 7% of devices achieve implementation. The aim of this systematic review was to describe the barriers to diffusion in relation to this model to understand why so few technologies are implemented and how to address these challenges to mitigate risk during the translation process. To do this, we searched PubMed, Medline, and Embase databases for studies published between 01/01/1999 -30/10/2019. Theoretical and application studies were included, and thematic analysis was employed using the Braun and Clarke framework to generate broad themes from the specific concepts described by included studies. A total of 33 articles were eligible for inclusion. Innovation processes constituting an obstacle to diffusion included: technology-specific challenges (8/33), clinical evidence/uncertainty (5/33), regulatory affairs (6/33), health technology assessment (7/33), reimbursement (15/33), and adoption (6/33). The factors that contributed to these themes were identified as being associated to the 11 tenets of Rogers' Diffusion of Innovation. This allowed the discussion of the identified barriers to medical device diffusion in relation with the Rogers' model. This analysis enabled the development and proposal of a framework that incorporates considerations within commercialization and translation strategies for these barriers to ultimately facilitate medical technology implementation.

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Section: Introductionmentioning

confidence: 99%

Barriers to the Diffusion of Medical Technologies Within Healthcare: A Systematic Review

et al. 2021

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“…97 – 99 Evidence shows that nationally managed schemes resulted in a more rapid and complete uptake compared with devices that were not part of a national programme. 100 In February 2019, NHSX was established as a government unit that is responsible for setting consistent national policy and developing best practice for technology, digital services and data throughout the NHS. 101 , 102 NHSX is actively looking at screening programmes for high-risk populations, but it is currently unclear whether or how this unit’s work would be relevant to this technology’s implementation.…”

Section: Barriers For Implementation Of Novel Osteoporosis Screening Technologies and Possible Solutionsmentioning

confidence: 99%

“…[97][98][99] Evidence shows that nationally managed schemes resulted in a more rapid and complete uptake compared with devices that were not part of a national programme. 100 In February 2019, NHSX was established as a government unit that is responsible for setting consistent national policy and developing best practice for technology, digital services and data throughout the NHS. A large proportion of routine CT attenders have specific co-morbidities, such as cancer, in comparison with the general population.…”

Section: Barriers For Implementation Of Novel Osteoporosis Screening ...mentioning

confidence: 99%

Opportunistic diagnosis of osteoporosis, fragile bone strength and vertebral fractures from routine CT scans; a review of approved technology systems and pathways to implementation

Aggarwal

Maslen²,

Abel

et al. 2021

Therapeutic Advances in Musculoskeletal

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Osteoporosis causes bones to become weak, porous and fracture more easily. While a vertebral fracture is the archetypal fracture of osteoporosis, it is also the most difficult to diagnose clinically. Patients often suffer further spine or other fractures, deformity, height loss and pain before diagnosis. There were an estimated 520,000 fragility fractures in the United Kingdom (UK) in 2017 (costing £4.5 billion), a figure set to increase 30% by 2030. One way to improve both vertebral fracture identification and the diagnosis of osteoporosis is to assess a patient’s spine or hips during routine computed tomography (CT) scans. Patients attend routine CT for diagnosis and monitoring of various medical conditions, but the skeleton can be overlooked as radiologists concentrate on the primary reason for scanning. More than half a million CT scans done each year in the National Health Service (NHS) could potentially be screened for osteoporosis (increasing 5% annually). If CT-based screening became embedded in practice, then the technique could have a positive clinical impact in the identification of fragility fracture and/or low bone density. Several companies have developed software methods to diagnose osteoporosis/fragile bone strength and/or identify vertebral fractures in CT datasets, using various methods that include image processing, computational modelling, artificial intelligence and biomechanical engineering concepts. Technology to evaluate Hounsfield units is used to calculate bone density, but not necessarily bone strength. In this rapid evidence review, we summarise the current literature underpinning approved technologies for opportunistic screening of routine CT images to identify fractures, bone density or strength information. We highlight how other new software technologies have become embedded in NHS clinical practice (having overcome barriers to implementation) and highlight how the novel osteoporosis technologies could follow suit. We define the key unanswered questions where further research is needed to enable the adoption of these technologies for maximal patient benefit.

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“…This is particularly true for non-pharmaceutical innovations where, unlike with drugs, commissioners are not required to fund NICE recommendations. Claims are continuing that the NHS is slow to adopt, although it is not clear how far NICE can be held responsible for the complex factors at play 5…”

Section: Controversymentioning

confidence: 99%