So how do you publish an article from the client’s perspective, without breaking any non-disclosure agreements? Well you find yourself an ex-client which has been acquired for $1.5 billion, and have them tell you about [...]
The most critical factor for medical device packaging is product sterility, which must be maintained throughout distribution and storage, allowing for safe and effective use of the device. The primary standard governing medical device packaging and shelf life validation is ISO 11607-1
Most medical device companies have product returns which are biohazardous. Some of these returns are biohazardous because hospitals didn’t follow their internal procedures, some are products that would have been disposed off by the hospital, but due to an issue in surgery they must be returned to the manufacturer, and some products are intended for reuse but must go through
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
Packaging for medical devices, related products and materials is highly regulated and must meet very specific requirements. The most critical factor for medical device packaging is product sterility, which must be maintained throughout distribution and storage, allowing for safe and effective use of the device.
So let’s say that we validate to those parameters and it turns out that a specific hospital runs to one of the others, how hard is it for hospitals to change parameters?
A major issue when tasked with Cleaning and Steam Cycle validation parameters for reusable kit systems, is of course validating rugged processes at a reasonable cost. There are really two key drivers to sending validation costs into the stratosphere. The first is...
In the last 6 months the FDA has begun to focus more closely on ensuring that reusable instrument and implant kit systems have been properly validated and that the parameters listed in the kit systems’ Instructions for Use (IFUs) have a substantive validation to support them.
Distribution Simulation Testing assesses a medical package’s ability to protect and maintain sterility of the products within. This is accomplished by exposing the package to real-life hazardous conditions that it could face through the handling, [...]
Start-up companies are under constant pressure to use capital efficiently. A long-standing problem in the orthopedics industry is a company’s initial capital outlay for building the instrument sets necessary to implant their product and create revenue.