The results are extremely useful for healthcare planning and for the prioritization of health policy interventions in groups with most needs.

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IntroductionTreatment-resistant schizophrenia (TRS) is a severe form of schizophrenia. In the European Union, approximately 40% of people with schizophrenia have TRS. Factors such as the persistence of positive symptoms or higher risk of comorbidities leave clinicians with a complex scenario when treating these patients. Intervention strategies based on mHealth have demonstrated their ability to support and promote self-management-based strategies. Mobile therapeutic attention for treatment-resistant schizophrenia (m-RESIST), an innovative mHealth solution based on novel technology and offering high modular and flexible functioning, has been developed specifically for patients with TRS and their caregivers. As intervention in TRS is a challenge, it is necessary to perform a feasibility study before the cost-effectiveness testing stage.Methods and analysisThis manuscript describes the protocol for a prospective multicentre feasibility study in 45 patients with TRS and their caregivers who will be attended in the public health system of three localities: Hospital Santa Creu Sant Pau (Spain), Semmelweis University (Hungary) and Gertner Institute & Sheba Medical Center (Israel). The primary aim is to investigate the feasibility and acceptability of the m-RESIST solution, configured by three mHealth tools: an app, wearable and a web-based platform. The solution collects data about acceptability, usability and satisfaction, together with preliminary data on perceived quality of life, symptoms and economic variables. The secondary aim is to collect preliminary data on perceived quality of life, symptoms and economic variables.Ethics and disseminationThis study protocol, funded by the Horizon 2020 Programme of the European Union, has the approval of the ethics committees of the participating institutions. Participants will be fully informed of the purpose and procedures of the study, and signed inform consents will be obtained. The results will be published in peer-reviewed journals and presented in scientific conferences to ensure widespread dissemination.Trial registration numberNCT03064776; Pre-results.

The purpose of this work is to review and synthesise prior research concerning the product life cycle concept in the specific context of medical technology innovation. Based on a review of both general and context specific literature in this field, it finds that medical technology innovation is strongly influenced by life cycle effects, particularly with respect to price erosion. It also finds that our general understanding of product life cycle indicates that individual curves are strongly influenced by supply side constraints, such as patent protection and barriers to entry, and demand side factors, such as market heterogeneity and diffusion mechanisms. Importantly, these two complementary domains have not been previously synthesised. This has important social and economic implications for access to improved therapies, healthcare spending and investment in innovation. This article represents a first attempt to bring together valuable work in strategic management and health economics and, by developing some postulates from the literature, attempts to inform future research in this area.

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