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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 [...]

By | 2014-08-05T17:23:22+00:00 August 5th, 2014|LSO Blog, Sterilization Validation Services|

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 [...]

By | 2014-05-16T07:00:17+00:00 May 16th, 2014|LSO Blog, Medical Package Testing|

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 [...]

By | 2014-03-17T15:53:44+00:00 March 17th, 2014|LSO Blog, Medical Device Manufacturing, Medical Package Testing|

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 [...]

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 [...]

By | 2013-06-06T21:59:27+00:00 June 6th, 2013|LSO Blog, Medical Device Manufacturing|

Offshoring vs Outsourcing: A world of Difference

There has always been much confusion when using the terms Offshoring and Outsourcing. Are they the same thing or different? How are they different? Which term applies in which instance?

By | 2013-05-17T17:28:33+00:00 May 17th, 2013|LSO Blog, Medical Device Manufacturing, Offshore Manufacturing|