Literature DB >> 31657961

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

Yijin Ren1, Paul H Fagette1,2, Connie L Hall3, Herman Broers4, David W Grainger5, Henny C Van Der Mei2, Henk J Busscher2.   

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 bench-to-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.

Entities:  

Keywords:  Translational medicine; biomedical engineering; clinical impact; innovation; medical technology; translational stagnation; valorization

Year:  2019        PMID: 31657961     DOI: 10.1080/17434440.2019.1685869

Source DB:  PubMed          Journal:  Expert Rev Med Devices        ISSN: 1743-4440            Impact factor:   3.166


  1 in total

Review 1.  Navigating the Regulatory Pathway for Medical Devices-a Conversation with the FDA, Clinicians, Researchers, and Industry Experts.

Authors:  Aaron E Lottes; Kenneth J Cavanaugh; Yvonne Yu-Feng Chan; Vincent J Devlin; Craig J Goergen; Ronald Jean; Jacqueline C Linnes; Misti Malone; Raquel Peat; David G Reuter; Kay Taylor; George R Wodicka
Journal:  J Cardiovasc Transl Res       Date:  2022-03-14       Impact factor: 3.216

  1 in total

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