According to the CDC, in American hospitals alone, hospital-acquired infections (H.A.I.) account for an estimated 1.7 million infections and 99,000 associated deaths each year (source). A recent study in Emerging Infectious Diseases found that hospital-acquired [...]
Theoretically, even though the tax will have a major negative initial impact on Medical Device companies, it will end up generating more business, due to the increased patient population having access to healthcare, and having procedures which require the use of medical devices. However, that is not likely to happen.
5 Project Management Rules for the Success of your Medical Device LaunchFulfillment & Distribution Services, LSO Blog, LSO Incubator Services, Medical Device Manufacturing, Medical Package Testing, Offshore Manufacturing, Sterilization Validation Services
At LSO, we typically manage 50-55 new product launches a year. This doesn’t include helping existing customers with product revisions and follow on work. This is a launch rate that far surpasses that of many [...]
We are happy to announce that LSO is in the final phases of installation of two 8 cubic foot EtO sterilizers. We expect them to be certified and ready for production by the end of [...]
Most medical device companies have product returns which are biohazardous. Some of these returns are biohazardous because hospitals didn’t follow their internal procedures, some are products that would have been disposed off by the hospital, but due to an issue in surgery they must be returned to the manufacturer, and some products are intended for reuse but must go through
So let’s say that we validate to those parameters and it turns out that a specific hospital runs to one of the others, how hard is it for hospitals to change parameters?
A major issue when tasked with Cleaning and Steam Cycle validation parameters for reusable kit systems, is of course validating rugged processes at a reasonable cost. There are really two key drivers to sending validation costs into the stratosphere. The first is...
In the last 6 months the FDA has begun to focus more closely on ensuring that reusable instrument and implant kit systems have been properly validated and that the parameters listed in the kit systems’ Instructions for Use (IFUs) have a substantive validation to support them.
Start-up companies are under constant pressure to use capital efficiently. A long-standing problem in the orthopedics industry is a company’s initial capital outlay for building the instrument sets necessary to implant their product and create revenue.
Reprocessing of reuseable medical devices continues to make news. Both the Today Show and MSNBC recently aired segments based on an investigation documented in Filthy surgical instruments...