Abstract
BackgroundWith increased governmental interest in value assessment of technologies and where medical device manufacturers are finding it increasingly necessary to become more familiar with economic evaluation methods, the study sought to explore the levels of health economics knowledge within small and medium-sized enterprises (SMEs) and to scope strategies they employ to demonstrate the value of their products to purchasers.MethodsA short questionnaire was completed by participants attending one of five workshops on product development in the medical device sector that took place in England between 2007 and 2011. From all responses obtained, a large proportion of participants were based in SMEs (N = 43), and these responses were used for the analysis. Statistical analysis using non-parametric tests was performed on questions with approximately interval scales. Qualitative data from participant responses were analysed to reveal emerging themes.ResultsThe questionnaire results revealed that 60% of SME participants (mostly company directors or managers, including product or project managers) rated themselves as having low or no knowledge of health economics prior to the workshops but the rest professed at least medium knowledge. Clinical trials and cost analyses or cost-effectiveness studies were the most highly cited means by which SMEs aim to demonstrate value of products to purchasers. Purchasers were perceived to place most importance on factors of safety, expert opinion, cost-effectiveness and price. However many companies did not utilise formal decision-making tools to prioritise these factors. There was no significant dependence of the use of decision-making tools in general with respect to professed knowledge of health economics methods. SMEs did not state a preference for any particular aspect of potential value when deciding whether to develop a product. A majority of SMEs stated they would use a health economics tool. Research and development teams or marketing and sales departments would most likely use one.ConclusionThis study points to the need for further research into the education requirements of SMEs in the area of Health Technology Assessment (HTA) and also for investigation into how SMEs engage with existing HTA processes as required by assessors such as NICE.
Highlights
With increased governmental interest in value assessment of technologies and where medical device manufacturers are finding it increasingly necessary to become more familiar with economic evaluation methods, the study sought to explore the levels of health economics knowledge within small and medium-sized enterprises (SMEs) and to scope strategies they employ to demonstrate the value of their products to purchasers
For the medical device sector, this focus has permeated through an increasing reliance on Health Technology Assessment (HTA) to ensure that the introduction of a new drug, medical device, or procedure is cost effective in line with static or shrinking health budgets in Europe and elsewhere [2]
Projections using a range of possible return rates), basic health economics (HE) models and use of Quality-adjusted Life Years (QALY) were highlighted
Summary
With increased governmental interest in value assessment of technologies and where medical device manufacturers are finding it increasingly necessary to become more familiar with economic evaluation methods, the study sought to explore the levels of health economics knowledge within small and medium-sized enterprises (SMEs) and to scope strategies they employ to demonstrate the value of their products to purchasers. The potential value of economic evaluation to public health policy decisions, at the early stages of development, includes supplementation of monitoring and assessment of innovations in horizon scanning and HTA activities, the control of technology diffusion by informing coverage and reimbursement decisions, and the direct public promotion of healthcare technologies, leading to increased efficiency [4] In line with this subscription to HTA methodology, there has been an increase in demand for economic evidence and its evaluation from purchasers and regulators. More recently the Medical Technologies Evaluation Programme (MTEP) of the National Institute of Health and Clinical Excellence (NICE) has taken over the remit of CEP with the aim of helping the National Health Service (NHS) in England and Wales adopt efficient and cost-effective medical devices and diagnostics more rapidly and consistently [6] This technology evaluation programme demands that manufacturers provide their own evidence of economic value from existing literature or from de novo economic models in addition to the usual clinical evidence. It has meant changes for the evaluation organisations involved, several of which have provided services throughout the transition from DES to NICE
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