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面向科学家和研究人员的诊断或生命科学产品的开发与商业化。

Product Development and Commercialization of Diagnostic or Life Science Products for Scientists and Researchers.

作者信息

Alonso Meghan M

机构信息

IMUA Services, Medical Invention and Device Development Consulting, 1630 Faraday Ave. Ste. 102, Carlsbad, CA, 92008, USA.

出版信息

Methods Mol Biol. 2017;1606:399-407. doi: 10.1007/978-1-4939-6990-6_26.

Abstract

Commercializing a diagnostic or life science product often encompasses different goals than that of research and grant funding. There are several necessary steps, and a strategy needs to be well defined in order to be successful. Product development requires input from and between various groups within a company and, for academia, outside entities. The product development stakeholder groups/entities are research, marketing, development, regulatory, manufacturing, clinical, safety/efficacy, and quality. After initial research and development, much of the work in product development can be outsourced or jointly created using public-private partnerships. This chapter serves as an overview of the product development process and provides a guide to best define a product strategy.

摘要

将诊断或生命科学产品商业化,其目标往往与研究及拨款资助有所不同。要取得成功,有几个必要步骤,且需要精心制定策略。产品开发需要公司内部各部门之间以及(对于学术界而言)外部实体的投入。产品开发的利益相关者群体/实体包括研究、营销、开发、监管、制造、临床、安全/功效和质量。在初步研发之后,产品开发中的许多工作可以外包,或者通过公私合作共同开展。本章概述了产品开发过程,并提供了最佳定义产品策略的指南。

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