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Outsourcing and CMO Selection Criteria
In February, LSO participated, for the 17th consecutive year in the MD&M West show at the Anaheim Convention center. This year, Barry Kazemi, LSO’s CEO & President, had been invited to be one of the [...]
Designing Medical Devices to prevent Hospital Acquired Infections
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 [...]
Dye Penetration Testing – Recent ASTM Enhancements
Dye penetration testing is a common method of checking for seal leaks in medical packaging such as pouches, trays, and blisters. The intent of this article is to review and clarify the recent developments in [...]
3 Key tools to mitigate ISO 11607 Package Design failure
As a project leader for medical device manufacturing, there is one area in particular that I feel can really derail projects. When a project reaches me, often times the packaging has already been created and [...]
Medical Device Tax – Something’s Got to Give
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 Launch
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 [...]
Almost there… EtO Sterilization for Medical Devices
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 [...]
Exit this Way
In today’s economic environment, with nationwide unemployment at an all time high, companies are holding on to their cash and investors are holding on to their wallets. Multinational, as well as, medium and small device companies alike are under “revenue attack”
Medical Device Manufacturing: Quality Cheat sheet
Over the years LSO has worked with numerous start-ups – visionaries with innovative products and good business sense, but lacking knowledge on the intense amount of regulatory policies and procedures involved in manufacturing and getting [...]