Innovation in cardiovascular disease in Europe with focus on arrhythmias: current status, opportunities, roadblocks, and the role of multiple stakeholders

Abstract

The European Heart Rhythm Association (EHRA) held an Innovation Forum in February 2016, to consider issues around innovation. The objective of the forum was to extend the innovation debate outside of the narrow world of arrhythmia specialists and cardiology in general, and seek input from all stakeholders including regulators, strategists, technologists, industry, academia, health providers, medical societies, payers, and patients. Innovation is indispensable for a continuing improvement in health care, preferably at higher efficacy and lower costs. It requires people who have been trained in a good scientific environment, high-quality research for achieving ground breaking inventions and the certainty of return on innovation investments. In the context of cardiovascular disease, innovation can imply better risk assessment and stratification, device technology, drug development, and process design. Several areas of promising developments were identified as well as several roadblocks to innovation. To drive innovation forward all stakeholders need to play a significant role. In a globalized and extremely competitive world, the leading role of Europe in medical innovation can only be achieved through a combined and well-coordinated effort from all involved parties.

Barriers to the Diffusion of Medical Technologies Within Healthcare: A Systematic Review

“…21.2% (n=7) of studies identified 'HTA' as a barrier to medical device diffusion [5,6,9,42,44,45,48].…”

“…The subtheme of 'process' (n=3, 42.3%) [42,44,45] related to limitations in HTA processes that delay access to a technology due to several issues including the complex submission requirements and overall lack of transparency/clarity for timelines and evaluation processes. Additionally, 'decision-maker characteristics' (n=3, 42.3%) [5,9,44] can be associated with the HTA process, as biases, a lack of appropriate expertise, or the general backgrounds and training of members in the assessing committees can influence the final decision.…”

“…As a theme, a considerable number of studies (n=15, 45.5%) identified 'reimbursement', or the fiscal compensation associated with providing care, as a key area that influences the diffusion of medical technologies [7, 8, 30, 40, 43, 45-50, 52, 56, 57, 60]. When considering the subthemes, the presence and appropriateness of 'coding' (presence of billing codes which healthcare providers use to claim payment from 3 rd party payers) appeared in 5 studies (33.3%) [43,45,46,49,60], whilst factors relating to the 'coverage and payment' (agreement of and extent to which a 3 rd party payer will pay for a medical service) and reimbursement 'policies' were discussed in 6 (40%) [7,8,30,43,50,57] and 3 (20%) [47,56,57] of studies, respectively. Often considered a facilitator of diffusion, reimbursement is essential for the commercial success of a medical technology as it represents a means of generating revenue for providing a service.…”

“…In the case of coding, a lack of fixed and accepted procedural codes can result in a technology not being used and face significant delays due to the long and complex processes associated with the creation and acceptance of new, relevant codes [43,45]. This holds especially true for disruptive devices, eg.…”

Computational models in cardiology

“…As a result, models linking cellular electrophysiology, myocardial tissue mechanics, and system haemodynamics have become promising platforms for virtual-patient simulations and for in silico evaluation of novel diagnostic and therapeutic strategies 188 . These biophysically detailed models of the heart are having an increasingly important role in the road to personalized medicine in cardiology clinics 189,190 . In this time of growing regulatory and administrative burdens that restrict the ability to develop new drugs, medical devices and diagnostic technologies, simulations of virtual patients and therapy provide the means for the pharmaceutical and biomedical device industries to reduce the developmental costs of innovation and the time to market 189 .…”