Smit Paul H, Lymberis Andreas
Agathellon, Esbeek, The Netherlands.
European Commission, Directorate General for Communications Networks, Content and Technology (DG Connect), Components, Brussels, Belgium.
Stud Health Technol Inform. 2015;211:3-17.
Our Healthcare systems worldwide are facing grand challenges that can be addressed by intelligent, miniaturized and interconnected devices. Many of today's pharmaceutical drugs create bigger problems than solutions, as drugs help only 40% of the patients and kill, in the USA alone, over 100,000 people per year. The widespread use of antibiotics has led to new strands of bacteria that defy all known antibiotics and kill well over 100,000 people yearly in the world. Outbreaks of infections by new viruses and anti-resistant bacteria are expected with even more grave consequences. The quality of food around the world is steadily deteriorating, as the soils are becoming depleted of essential nutrients and contain increasing amounts of pesticides, herbicides and fungicides. Our environment is burdened with 2.5 billion tonnes of chemicals per year that accumulate in the soil, groundwater, rivers and seas, and eventually end up in our food and our drinking water. As a consequence, there is a strong increase in the incidence of diseases hardly known fifty years ago. In parallel, an increasing number of people are taking the responsibility for their health and well-being in their own hands and are looking for mobile and in-obtrusive ways to objectively monitor their health status. The development of intelligent, miniaturized systems, by the heterogeneous integration of technologies such as micro- and nano-electronics, photonics, biotechnology, materials and information & communication, addresses these issues and has received intensive public support in the EU over the past two decades in the FP6 and FP7 programs. Proven concepts and functional prototypes exist with the potential to create new opportunities to improve our healthcare systems, in particular personalized or precision medicine. These device concepts offer unique abilities to sense, detect, analyze, communicate, respond, and monitor phenomena from the macro (e.g. body, tissues) to the nano scale (e.g. molecules, genes) on the spot, with short response times. For the majority of the projects, the planning for the next phase of prototype validation, through product design, supply chain setup, user targeting, clinical validation and commercial roll-out is now taking full attention. However, significant hurdles exist in the successful translation of the new technology to new products. As these technologies are new-to-the-world the resulting products carry a high risk, often necessitating the creation of new companies. Therefore the EU has developed the Horizon 2020 program as a framework for technology development and new business creation. Horizon 2020 is focusing on support for technology transfer, and on building ecosystems and value chains to ensure shorter times-to-market, thus enabling a higher impact of knowledge-based technologies. This paper will argue the necessity of developing these new class of devices, discuss its state-of-the-art, and the challenges for the implementation of Horizon 2020 and the new opportunities in intelligent miniaturized systems for pHealth.
全球范围内的医疗保健系统正面临着巨大挑战,而智能、小型化和互联设备能够应对这些挑战。当今许多药物带来的问题比解决的问题更多,因为药物仅对40%的患者有效,仅在美国每年就有超过10万人因药物致死。抗生素的广泛使用导致了新的细菌菌株出现,这些菌株对所有已知抗生素都具有抗性,在全球每年导致超过10万人死亡。预计新病毒和耐药细菌引发的感染疫情将带来更严重的后果。世界各地的食物质量在稳步下降,因为土壤中 essential nutrients(此处原文有误,可能是“必需营养素”之意)逐渐枯竭,且含有越来越多的杀虫剂、除草剂和杀菌剂。我们的环境每年承载着25亿吨化学物质,这些化学物质积聚在土壤、地下水、河流和海洋中,最终进入我们的食物和饮用水中。因此,五十年前几乎不为人知的疾病发病率大幅上升。与此同时,越来越多的人开始自主承担起自身健康和幸福的责任,并在寻找便捷且不引人注意的方式来客观监测自己的健康状况。通过微纳电子、光子学、生物技术、材料以及信息与通信等技术的异构集成来开发智能、小型化系统,能够解决这些问题,并且在过去二十年里,欧盟的第六框架计划(FP6)和第七框架计划(FP7)中得到了公众的大力支持。已证实的概念和功能原型已经存在,它们有潜力创造新的机会来改善我们的医疗保健系统,特别是个性化或精准医疗。这些设备概念具备独特能力,能够即时感知、检测、分析、通信、响应并监测从宏观(如身体、组织)到纳米尺度(如分子、基因)的各种现象,响应时间短。对于大多数项目而言,目前正全力关注通过产品设计、供应链搭建、用户定位、临床验证和商业推广等环节,对下一阶段的原型验证进行规划。然而,将这项新技术成功转化为新产品存在重大障碍。由于这些技术是全新的,由此产生的产品风险很高,通常需要创立新公司。因此,欧盟制定了“地平线2020”计划,作为技术开发和新企业创建的框架。“地平线2020”计划专注于支持技术转移,并致力于构建生态系统和价值链,以确保缩短产品上市时间,从而使基于知识的技术产生更大影响。本文将论证开发这类新型设备的必要性,讨论其当前的发展水平,以及“地平线2020”计划实施过程中面临的挑战和个性化健康领域智能小型化系统的新机遇。