Northeastern University School of Law, Boston, MA 02115, USA.
Nanomedicine. 2013 Aug;9(6):729-31. doi: 10.1016/j.nano.2013.04.006. Epub 2013 Apr 29.
The nano tattoo represents a nascent technology designed to be implanted in the skin to provide continuous and reliable glucose detection for diabetics. Its potential benefits are compelling not only for its ability to prevent diabetic complications and decrease related social costs, but also for its ease of use and relative patient-user comfort. This Note aims to articulate a checklist of fundamental intellectual property, bioethical and system design issues that are appropriately considered in the pre-clinical, pre-commercialization phase of nano tattoo development. Early and regular consideration of these factors can increase the odds of a societally beneficial dissemination of this device by engaging relevant researcher, medical, patient-user and patient-advocate communities concerned with its appropriate application, as well as policymaking communities focused on effectively managing diabetes-related healthcare costs. The checklist of factors includes fundamental issues and is generally applicable to nanomedical inventions.
This paper presents a comprehensive list of fundamental intellectual property, bioethical, and system design issues to be considered in the pre-commercialization phase of nanomedicine development, through the specific example of nano tattoo development. Nano tattoo is designed to be implanted in the skin to provide reliable glucose monitoring for diabetics, enabling enhanced prevention of complications and decreased socioeconomic costs.
纳米纹身代表了一种新兴技术，旨在植入皮肤，为糖尿病患者提供持续可靠的葡萄糖检测。它不仅因其预防糖尿病并发症和降低相关社会成本的能力，而且因其易用性和相对的患者舒适度而具有吸引力。本说明旨在阐明一套基本知识产权、生物伦理和系统设计问题的清单，这些问题在纳米纹身开发的临床前和商业化前阶段应适当考虑。早期和定期考虑这些因素可以通过让相关研究人员、医疗保健人员、患者用户和关注其适当应用的患者权益倡导者社区，以及关注有效管理糖尿病相关医疗保健成本的政策制定者社区参与进来，增加该设备在社会上有益传播的机会。该清单包括基本问题，通常适用于纳米医学发明。
本文通过纳米纹身开发的具体示例，提出了在纳米医学开发的商业化前阶段应考虑的一套全面的基本知识产权、生物伦理和系统设计问题清单。纳米纹身旨在植入皮肤，为糖尿病患者提供可靠的葡萄糖监测，从而增强预防并发症和降低社会经济成本的能力。
