02189nas a2200241   4500008004100000022001400041245007500055210006800130260001300198300001200211490000700223520146400230100002301694700002501717700001701742700002101759700002401780700001801804700002501822700002301847700001701870856006001887       2012                        ENG d  a1533-029X00aThe Value of Clinical Needs Assessments for Point-of-Care Diagnostics.0 aValue of Clinical Needs Assessments for PointofCare Diagnostics  c2012 Jun  a108-1130 v113 a<p>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.</p>1 aWeigl, Bernhard, H1 aGaydos, Charlotte, A1 aKost, Gerald1 aBeyette, Fred, R1 aSabourin, Stephanie1 aRompalo, Anne1 aSantos, Tala, de Los1 aMcMullan, Jason, T1 aHaller, John  uhttps://www.microfluidicsciences.com/drupal/?q=node/206