Latest News & Articles from LSO

Will the FDA eliminate the 510k process?

Will The Medical Device Industry finally get a break or just encounter another roadblock?  It is clear to all involved in this industry, that the regulatory approval process has become longer and more arduous over the past couple of years. The proof of that statement is that better than half of the 510k with clinicals

5 things that OEM’s should look for in a Full-Contract Medical Device Manufacturer

A medical device company taking off on the success of a new product must consider the pros and cons of performing manufacturing in-house versus outsourcing the process to contract manufacturers.  For the OEM there are many marked advantages to partnering with a ‘Full-Contract’ Medical Device Manufacturer.  For starters, the company wouldn’t spend resources on identifying

Issues facing the Medical Device Contract Manufacturing Industry

There are a multitude of complex issues facing the medical device contract manufacturing industry today. Consistent with all businesses in our country, there has been some level of “impact” from the decline of the economy since 2008.

Creative Approaches for Start-up Companies May Change Conventional Venture Funding

Creative new concepts that launch medical device companies from concept to market have addressed the paradigm shifts in medical device funding; such as short and quick utilization of venture money and the use of a certified manufacturing facility on a rental basis. Conventional venture capital investments in medical device start-ups may no longer be filling

Cinco de Mayo at LSO

At LSO, we decided to join in on the celebration with our Annual “Cinco de Mayo Lunch”, where all employees enjoy Tacos, Aguas Frescas, costume contests and taking potshots at the piñata.