Challenges in the Assessment of Medical Devices: The MedtecHTA Project

Abstract

Assessing medical devices (MDs) raises challenges which require us to reflect on whether current methods are adequate. Major features of devices are: (i) device-operator interaction can generate learning curve effects; (ii) incremental nature of innovation needs to be addressed by careful identification of the alternatives for comparative and incremental costeffectiveness analysis; and (iii) broader organizational impact in terms of training and infrastructure, coupled with dynamic pricing, requires a more flexible approach to costing.The objective of the MedtecHTA project was to investigate improvements in HTA methods to allow for more comprehensive evaluation of MDs. It consisted of several work packages concerning (i) the available evidence on the currently adopted approaches for regulation and HTA of medical devices; (ii) the geographical variation in access to MDs; (iii) the development of methodological frameworks for conducting comparative effectiveness research and economic evaluation of MDs; and (iv) the organizational impact of MDs.This introductory paper summarizes the main results of the project and draws out the main overarching themes. This supplement represents a comprehensive report of all the main findings of the MedtecHTA project, and it is intended to be the main source for researchers and policy makers wanting information on the project.

Physicians’ Decision Making on Adoption of New Technologies and Role of Coverage with Evidence Development: A Qualitative Study

“…High service availability might improve device-operator interactions, as it generates learning curve effects by increasing operators' experience in the utilization of technologies. Learning curve effects might affect the technologies' effectiveness [41], as shown by Varabyova et al [42] for endovascular aneurysm repair (EVAR), a minimally invasive treatment method for abdominal aortic aneurysms. This emphasizes the need for training in the use of medical devices.…”

Evaluation of the New Lateral Flow Card MDmulticard® Basic Extended Phenotype in Routine Clinical Practice

“…Moreover, the MDmulticard system could not only be adequate for blood typing in emergency situations [4,8,9,10] and extreme environment conditions [22], but could also be more cost-effective, as it limits the number of genotyping investigations necessary (and therefore the costs) to provide antigen-matched blood, especially for patients with autoantibodies or sickle cell disease. However, this should be confirmed by studies specifically aimed to cost and time analyses [23]. …”

Obstacles to Prosthetic Care—Legal and Ethical Aspects of Access to Upper and Lower Limb Prosthetics in Germany and the Improvement of Prosthetic Care from a Social Perspective

“…One reason for the scarcity of clinical studies and HTAs is the legal framework for medical devices in Germany and the EU. Medical products of low risk (class I and IIa), there is no obligation for manufacturers to make a benefit evaluation at all [10,73]. The sole requirement to gain market access is the CE mark which is basically a certificate for compliancy with safety standards [10] (p. 58).…”

“…The third issue is that there are methodological difficulties with the evaluation of medical devices in general, as they are characterised by complexity, incremental innovation and dependency of effectiveness on the care provider (as discussed in depth in [73]). Medical device manufacturer associations in Germany are calling for the development of scientific guidelines for a transparent benefit evaluation of new medical products [64].…”