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 infections are the sixth leading cause of death nationally, costing the health care industry $6 billion annually. Most H.A.I’s are […]
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.
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 multi-billion dollar medical device companies. Our volume is driven by our focus on the start-up market and our willingness to […]
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 August, if not sooner. We are really excited about the opportunities these small batch sterilizers provide to our customers, and […]
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
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.