Testing Company Expands Capacity to Reduce Lead Times
Testing company DDL has acquired 5000 sq ft of space in Orange, CA. The additional facility for medical testing will help the company meet customer needs to reduce lead times, a request that is becoming more common as the device industry struggles to cut costs, says Corey Hensel, General Manager at DDL.
The new facility is close to one of DDL’s existing buildings in Orange. It will house environmental test chambers that can be used for shelf-life studies such as accelerated aging and real-time aging, and also will have the capabilities for environmental conditioning testing.
Hensel says that the new facility will expand the testing capabilities DDL already provides, but will enable the company to complete these projects quicker.
“One of the things we have noticed is a shift in the medical device industry,” says Hensel. “They want stuff done in a tighter timeline than they wanted in the past. This additional capacity and the additional resources that we will purchase to put in this additional space will allow us to meet our customer demands.”
Hensel says that the device industry’s push for shorter timelines is a direct result of a more challenging financial climate.
“With the R&D budgets being affected over the last two years, because of the economy, the MDMs are forced to make decisions on how they are going to spend their dollars. The ability to get some of their newer stuff to the market quicker is going to free up some cash for them to allow them to expand their product offering in the future.”
Besides financial pressure, the medtech industry also is facing regulatory demands from FDA as the agency places more emphasis on oversight.
“Increased oversight from FDA is causing MDMs to lean on their vendors a bit more from a technical standpoint to help them get their project through the FDA submission process quicker,” says Hensel. “That is requiring DDL to stay in the know on new standards and knowing all the ins and outs of the existing standards to help our customers get their products to market quicker.”
The testing industry is a stable industry that doesn’t change much, and there are few other challenges for DDL to tackle, says Hensel. Even an upcoming revision of ISO 11607, the main standard for terminally sterilized medical device packaging, is not expected to create many new hurdles.
“We don’t expect any significant additions or changes in regards to the testing. Most of those changes are going to be in the form of editorial or improvements to make the standard more clear and easy to follow….The biggest challenge we have now is to have enough capacity to meet the increased demands for getting testing done quicker.”
By Camilla Andersson