Clinical translation of the assets of biomedical engineering – a retrospective analysis with looks to the future

Abstract

Introduction: Biomedical-engineering (BME) plays a major role in modern medicine. Many BME-based assets have been brought to clinical translation in the twentieth century, but translation currently stagnates. Here, we compare the impact of past and present scientific, economic and societal climates on the translation of BME-based assets, in order to provide the BME-community with incentives to address current stagnation. Areas covered: In the twentieth century, W.J. Kolff brought kidney dialysis, the total artificial heart, artificial vision and limbs to clinical application. This success raises the question whether Kolff and other past giants of clinical translation had special mind-sets, or whether their problem selection, their training, or governmental and regulatory control played roles. Retrospective analysis divides the impact of BME-based assets to clinical application into three periods: 1900-1970: rapid translation from benchto-bedside, 1970-1990: new diseases and increased governmental control, and the current translational crisis from 1990 onward. Expert opinion: Academic and societal changes can be discerned that are concurrent with BME's translational success: mono-disciplinary versus multi-disciplinary training, academic reward systems based on individual achievements versus team achievements with strong leadership, increased governmental and regulatory control, and industrial involvement. From this, recommendations can be derived for accelerating clinical translation of BME-assets.

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“…The influence of regulatory oversight, henceforth described as 'regulatory affairs', appeared in 6 studies (18.2%) [8,41,53,[58][59][60]. Regulation in medical technology is vital to ensuring patient safety and the effectiveness and quality of devices that are applied clinically.…”

“…However, it has also been acknowledged that the processes, timelines, and requirements of regulating a medical device constitute significant barriers to clinical implementation [39]. In this review, it was identified that 'clinical evidence requirements' (n=3, 50%) [8,41,53] and 'jurisdictional requirements' (n=4, 66.7%) [41,[58][59][60] impeded diffusion.…”

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“…The multidisciplinary nature of this field (as in other areas of biomedical engineering [ 10 ] ) requires extensive collaboration and knowledge exchange to achieve the desired functions of hydrogels with high translation potential. In the chemical realm, this includes the rational design of the molecular building blocks, crosslinking mechanisms, and molecular architecture engineering at multiple size scales.…”

Toward Next-Generation Advanced Therapies: Extracellular Vesicles and Cell Therapy – Partners or Competitors?

“…Although in recent years some academic institutions have increased contact to commercial partners and created an infrastructure that supports scientists in interacting with these partners, this remains the exception [27,28]. This state of preparedness, often referred to as 'institutional readiness', depends primarily on technological infrastructure and use but is also related to the culture of the institution, including its strategy, political frameworks and understanding of learning analytics.…”