Living Innovation Blog
A blog about important topics for medical device and healthcare innovators.
Hospital Efficiency: Do All ER Patients Need Beds?
A recent article in The Wall Street Journal sparked spirited debate on care for emergency department (ED) patients. Reporter Laura Landro's story, titled "ERs Move to Speed Care; Not Everyone Needs a Bed," sheds light on a major challenge facing hospitals nationwide: improving hospital care and efficiency takes much more than cost cutting efforts.
The article covers lean principles and other efficiency models that hospitals are implementing to recover revenue and enhance the patient experience, including streamlining traditional triage methods, reserving beds for the sickest patients, publishing hospital wait times online, and testing other innovative solutions to provide timely patient care.
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Posted on Aug 25, 2011
FDA on Medical Devices Modifications; IOM on 510(k) Modification
The FDA recently issued guidance to clarify when modifications to a cleared device require a new application. The guidance, titled 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device, requires that device makers demonstrate how a modified device is similar to the one already on the market.
Medical device manufacturers must file a new 510(k) only when the changes significantly impact a device’s safety and effectiveness or if the revision constitutes a new intended use. Many medical device products undergo incremental changes even after they are introduced into the market, and most of those changes do not require a new 510(k) submission. This is good news for device manufacturers who are concerned about delays in speed to market while striving to improve the use and safety of their products.
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Posted on Aug 16, 2011
Optimizing Medical Devices' Regulatory Submissions
The FDA’s Center for Devices and Radiological Health recently published their “Analysis of Premarket Review Times under the 510(k) Program” in which they attribute the recent increase in total review time “primarily due to companies taking more time to respond to requests for additional information.” This analysis was prompted by recent industry-sponsored reports, which attribute problems with the 510(k) program to lack of predictability, disruptions, and delays due to staffing turnover and inconsistency in reviews.[ii]
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Posted on Aug 04, 2011