Weigl Bernhard H, Gaydos Charlotte A, Kost Gerald, Beyette Fred R, Sabourin Stephanie, Rompalo Anne, de Los Santos Tala, McMullan Jason T, Haller John
Technology Solutions, Program for Appropriate Technology in Health, Seattle, WA.
Point Care. 2012 Jun;11(2):108-113. doi: 10.1097/POC.0b013e31825a241e.
Most entrepreneurial ventures fail long before the core technology can be brought to the marketplace because of disconnects in performance and usability measures such as accuracy, cost, complexity, assay stability, and time requirements between technology developers' specifications and needs of the end-users. By going through a clinical needs assessment (CNA) process, developers will gain vital information and a clear focus that will help minimize the risks associated with the development of new technologies available for use within the health care system. This article summarizes best practices of the principal investigators of the National Institute of Biomedical Imaging and Bioengineering point-of-care (POC) centers within the National Institute of Biomedical Imaging and Bioengineering POC Technologies Research Network. Clinical needs assessments are particularly important for product development areas that do not sufficiently benefit from traditional market research, such as grant-funded research and development, new product lines using cutting-edge technologies developed in start-up companies, and products developed through product development partnerships for low-resource settings. The objectives of this article were to (1) highlight the importance of CNAs for development of POC devices, (2) discuss methods applied by POC Technologies Research Network for assessing clinical needs, and (3) provide a road map for future CNAs.
由于技术开发者的规格与终端用户需求之间在性能和可用性指标（如准确性、成本、复杂性、检测稳定性和时间要求）方面存在脱节，大多数创业企业早在核心技术推向市场之前就失败了。通过开展临床需求评估（CNA）流程，开发者将获得重要信息并明确重点，这将有助于降低与医疗保健系统中可用新技术开发相关的风险。本文总结了美国国立生物医学成像和生物工程研究所即时检测（POC）技术研究网络中各POC中心主要研究者的最佳实践。临床需求评估对于那些无法从传统市场研究中充分受益的产品开发领域尤为重要，例如资助型研发、使用初创公司开发的前沿技术的新产品线，以及通过产品开发合作关系为资源匮乏地区开发的产品。本文的目的是：（1）强调CNA对POC设备开发的重要性；（2）讨论POC技术研究网络用于评估临床需求的方法；（3）提供未来CNA的路线图。
