University of Nottingham, Faculty of Engineering, Tower Building, University Park, Nottingham, NG7 2RD, UK.
Health Res Policy Syst. 2012 Sep 3;10:29. doi: 10.1186/1478-4505-10-29.
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.
A 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.
The 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.
This 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.
随着政府对技术价值评估的兴趣日益浓厚,医疗器械制造商越来越需要熟悉经济评估方法,因此本研究旨在探讨中小企业(SME)内部健康经济学知识的水平,并概述他们采用的策略,以向购买者展示其产品的价值。
参与者在 2007 年至 2011 年期间在英格兰举办的五次医疗器械产品开发研讨会上完成了简短的问卷。从所有获得的答复中,有很大一部分参与者来自 SME(N=43),并对这些答复进行了分析。使用非参数检验对具有近似区间尺度的问题进行了统计分析。对参与者答复中的定性数据进行了分析,以揭示出现的主题。
问卷调查结果显示,60%的 SME 参与者(主要是公司董事或经理,包括产品或项目经理)在参加研讨会之前将自己评为对健康经济学的了解程度较低或没有,但其余的参与者则表示至少具有中等程度的了解。临床试验和成本分析或成本效益研究是 SME 旨在向购买者展示产品价值的最常用方法。购买者被认为最重视安全性、专家意见、成本效益和价格等因素。但是,许多公司并未利用正式的决策工具来对这些因素进行优先级排序。一般来说,使用决策工具的情况与健康经济学方法的知识水平没有显著的依赖关系。SME 并未在决定是否开发产品时表示对潜在价值的任何特定方面有偏好。大多数 SME 表示他们将使用健康经济学工具。研究与开发团队或营销和销售部门最有可能使用该工具。
本研究表明,需要进一步研究中小企业在健康技术评估(HTA)领域的教育需求,还需要调查中小企业如何根据 NICE 等评估人员的要求参与现有的 HTA 流程。