There has been an increase in the number of start-up med device companies joining, or being founded in conjunction with, Incubators. Medical Device Incubators have traditionally catered more to the business plan development or product research/design aspects of the business. And in most cases these incubators require an equity stake in the company in return for their services
Although there are many advantages to manufacturing offshore, there are several factors to be considered before making the decision to manufacture offshore.
Implementing a CAPA system is required by the FDA for Medical Device Manufacturing companies selling equipment within the US.
Clinical / Project Builds: What factors decide whether to internally manufacture or outsource the builds to a Medical Device Contract Manufacturer.
Startup and small medical device companies have utilized the contract manufacturing model for a number of years. These outsourcing organizations have proven to be...
MD&M West 2012, held at the Anaheim Convention Center, was LSO’s 14th time at the annual convention. The diversity of exhibitors and the quality of meetings makes this one of the best tradeshows in the industry. [...]
Investment in Medical Device Industry R&D has been negatively impacted in the last few years. Although President Obama views the health care sector as an industry primed for substantial job growth, the AMA projects dramatic [...]
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 [...]
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 [...]
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.