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Business Model
Published in Gennadi Saiko, Bringing a Medical Device to the Market A Scientist's Perspective, 2022
The US is not unique here in any way. To get the product use reimbursed in other jurisdictions, it is typically required to perform some sort of “Technology Assessment” For example, it is called a Health Technology Assessment or HTA in Canada. HTA is a method of evidence synthesis that considers evidence regarding clinical effectiveness, safety, cost-effectiveness and, when broadly applied, includes social, ethical, and legal aspects of the use of health technologies. The primary focus of HTA is on cost-effectiveness/cost-utility. HTA processes in Canada are highly decentralized. HTAs are conducted at national, provincial, and hospital levels. A major use of HTAs is in informing reimbursement and coverage decisions. Decisions to participate or adhere to recommendations from province-wide review by hospitals and administrators may still be voluntary depending on the province.
Managing variety in healthcare through personalized medication
Published in Sergio Barile, Raul Espejo, Igor Perko, Marialuisa Saviano, Francesco Caputo, Cybernetics and Systems, 2018
Rita Patrizia Aquino, Sergio Barile, Antonio Grasso, Marialuisa Saviano
It clearly appears a relevant variety to manage in the personalization of healthcare. Managing this variety, however, is expected to imply an increase in costs (Puschmann & Alt, 2001; Holmes et al., 2009; Swan, 2009). Yet, using technology to manage this variety may help to avoid this increase in costs, i.e. to harmonize the efficiency and effectiveness of healthcare. In fact, health technology assessment can be approached on the basis of cost-effectiveness evaluations: focus is both on increasing effectiveness and reducing costs (Ash et al., 2004; Chaudhry et al., 2006).
The Lean and Agile Multi-dimensional Process (LAMP) – a new framework for rapid and iterative evidence generation to support health-care technology design and development
Published in Expert Review of Medical Devices, 2020
Melody Ni, Simone Borsci, Simon Walne, Anna P. Mclister, Peter Buckle, James G. Barlow, George B. Hanna
Health technology assessments (HTAs) are traditionally used to inform health policy, resource allocation, and decision-making [1]. Of the three fundamental questions of test evaluation, namely can it work (efficacy), does it work (effectiveness), and is it worth it (value), the focus of HTAs has been on generating and synthesizing clinical and health economic evidence in order to establish the effectiveness and value of a technology [2]. Used with Multi-Criteria Decision Analysis (MCDA), HTAs also play a key role in hospital-based implementation studies [3–5]. This enables the selection of technologies (medicine, devices, or procedures) that are most compatible with the perspectives and values of the local decision-makers [3], and with the local contexts [6]. However, and especially as digital platforms and interventions gain wider penetration, it has increasingly been recognized that far-reaching consequences on patients, clinicians, and health-care providers are ideally captured early on so that risks can be mitigated and value can be co-created [7,8]. This requires the development of new approaches to HTAs.
Towards a regulation of HTA in Europe: the proposal from the European Commission
Published in Expert Review of Medical Devices, 2019
Health Technology Assessment (HTA), defined as the systematic evaluation of the properties and effects of a health technology, addressing the direct and intended effects of this technology, as well as its indirect and unintended consequences, and aimed mainly at informing decision making regarding health technologies [1], is nowadays well-known across many regions of the world [2,3] due to its capacity of providing valuable elements for decision-making at different levels. At European level, the investment into the development of shared methodological frameworks for HTA and the transfer of its outputs to local contexts has been of great magnitude, from the many projects funded by the European Union Framework Programme 7 (FP7) [4] to the extensive EUnetHTA collaboration, started in 2006 and being currently ongoing with its third Joint Action (JA3), which is supposed to end in 2020 [5].
Designing medical technology for resilience: integrating health economics and human factors approaches
Published in Expert Review of Medical Devices, 2018
Simone Borsci, Ijeoma Uchegbu, Peter Buckle, Zhifang Ni, Simon Walne, George B. Hanna
The WHO describes HTA as the ‘systematic evaluation of properties, effects, and/or impacts of health technology’ [65]. Current HTAs entail the assessment of clinical effectiveness by clinical trials or review of the literature as well as the economic evaluation of this effect. This assumes a uniform impact across environments. This is readily understood with dosing and formulation of pharmaceuticals but not MT. MT interacts with its context to achieve different outcomes. Human factors methodology entails the understanding of the device context including interactions with users and environmental processes. This knowledge can be utilized by health economists to better understand potential improvements that a new device may bring to a context based on current processes and devices. This enables an acknowledgement of differences between clinical contexts in achieving the potential improvements of a new device. In keeping with this, the base case created by health economic modelers may be enriched at early stages to incorporate difference within clinical contexts.