To the Editor: I read the article “A different animal? Identifying the features of health technology assessment (HTA) for developers of medical technologies” by Bouttell et al. (Reference Bouttell, Briggs and Hawkins1) with great interest. The authors provide a useful framework for development-focused HTA (DF-HTA). In healthcare innovation, the definition of a common value across different stakeholders is often challenging, especially in the case of medical devices and digital health technologies (MedTech). Early engagement with HTA is, therefore, fundamental to successfully bridge the gap between research and policymaking and to guide the development of the value proposition and the evidence generation strategy (Reference Campbell, Campbell, Dobson, Higgins, Dillon and Marlow2). The new definition of HTA (Reference O'Rourke, Oortwijn and Schuller3) as a "multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its lifecycle" reflects the importance of HTA in determining a common value and highlights the importance of a DF-HTA framework.
Although the value a new health technology may bring to healthcare systems is defined at an early stage (Reference Lehoux, Miller, Daudelin and Denis4), reimbursement decisions come at a latter stage. The analytical stance adopted as part of a DF-HTA has to facilitate the link between the two. Bouttel et al. address the mindset (stance of analysis) of the analyst undertaking the DF-HTA assessment, advocating for a positive, rather than a normative, analytical stance. A positive analytical stance, they argue, is a fundamental feature of DF-HTA, as no value judgments are required and the analysis is focused on maximizing the return on developers’ investments. A positive analytical stance, however, often fails to capture the value proposition adequately, especially in MedTech, amplifying tensions among the different innovation stakeholders.
The source of this tension can be located in the current system of healthcare innovation. When the latter is situated within publicly funded national health service systems, it is often characterized by value misalignments and the disjointed relationship between research, regulatory approval, and policymaking (Reference Greenhalgh, Fahy and Shaw5). Entrepreneurs and investors (innovation suppliers) operate under different and often conflicting priorities than health policymakers, regulators, and procurement managers (Reference Lehoux, Miller, Daudelin and Denis4). This creates an unstable interdependent ecosystem where “value” varies among stakeholders. For innovation suppliers, whose main aim is to deliver a profitable business model, value is often speculative and influenced by a positive analytical stance. These misalignments distort the value of innovative health technologies so that entrepreneurs never see their innovation used in routine clinical practice and shareholders never see the return on an investment that never becomes viable (Reference Greenhalgh, Fahy and Shaw5). Indeed, a review by the National Institute for Health and Care Excellence (NICE) looking into the adoption of MedTech innovation reported that the benefit claims made by developers of innovative healthcare technologies often lacked sufficient merit and evidence to support their eventual adoption, noting a lack of consideration of the advantages they will bring not only to their business model but also to patients and the health service throughout the stages of conception, design, and prototype development (Reference Campbell, Campbell, Dobson, Higgins, Dillon and Marlow2).
Unavoidably, the authors miss a great opportunity with the proposed framework to bring synergy to the alignment of value proposition in the innovation ecosystem. Particularly in the UK, the upcoming MedTech Funding mandate and other initiatives developed by the Accelerated Access Collaborative offer new opportunities to test in practice and iterate the usefulness of DF-HTA frameworks such as the one proposed by Bouttell et al. (2020).
