Prototype to production medical device manufacturing

Posted on: July 29th, 2015, by: Bill Peatman
Prototype to production medical device manufacturing In the race to bring new products to market, more medical device makers are outsourcing the entire manufacturing process, from “prototype to production” to realize greater efficiencies, according to a new white paper. Knowing what to look for in a manufacturer can make all the difference in a product’s […]

Is your contract medical device manufacturer lean?

Posted on: July 24th, 2015, by: Bill Peatman
The term “lean manufacturing” became popular through Toyota, whose production efficiency is credited with driving the company’s growth from a small niche player to the largest automaker in the world. Since then, manufacturers in all sectors have sought to implement the lean model, including medical device manufacturers. The term, “lean manufacturing,” however, is a bit […]

Manufacturing equipment and medical device quality

Posted on: July 16th, 2015, by: Bill Peatman
In the medical device industry, speed and quality are two of the most important factors for manufacturers. In a highly competitive market, time to market is critical. In a highly regulated market, quality is also imperative. One important and often overlooked factor in medical device manufacturing is the quality and consistency of manufacturing equipment used […]

How to choose a “prototype to production” manufacturer

Posted on: July 9th, 2015, by: Bill Peatman
Medical device manufacturing can be roughly divided into three phases: prototype, pilot and production. A prototype is typically a working model of a design that demonstrates a device’s appearance and functionality. The pilot product is the version of the device used in clinical trials to prove a device’s safety and effectiveness, and to win clearance […]

Three things to look for in a manufacturer’s product lifecycle management

Posted on: July 2nd, 2015, by: Bill Peatman
Product Lifecycle Management (PLM) for medical device manufacturers has become increasingly complex for a number of reasons. First, of course, is regulation. Regulations for medical devices, especially complex implantable medical devices, are among the strictest in any industry, and they are not going to become less so. Policy changes and enforcement practices are difficult to […]

Why medical device manufacturing quality is hard

Posted on: June 24th, 2015, by: Bill Peatman
Implementing a comprehensive medical device manufacturing quality program is difficult. Compliance is relatively easy—tedious and time consuming, but straight forward. Regulatory agencies spell out exactly what needs to be documented, how documents need to be stored and updated, and what kind of information needs to be reported. Yet manufacturers that are compliant continue to face […]

New White Paper: What to look for in quality systems from med device manufacturers

Posted on: June 17th, 2015, by: Bill Peatman
It can be argued that there is nothing more important in medical device manufacturing than quality.  While the FDA’s qualification process stresses “safety and effectiveness,” a device is only safe and effective if it continues to work as designed for its expected lifetime. Poor quality can lead to device recalls and, in extreme cases, company […]

Glove box technology for hermetic welding

Posted on: June 10th, 2015, by: Bill Peatman
When you enter the word “hermetic” in Google, the following definition appears: “(of a seal or closure) complete and airtight. ‘a hermetic seal that ensures perfect waterproofing’” Clearly, this is not a scientific definition, as a seal that is airtight and a seal that is watertight are not necessarily the same thing. If you blow […]

Cirtec supports UT Dallas initiative to speed time to market for med devices

Posted on: June 3rd, 2015, by: Bill Peatman
CIRTEC Medical Systems, a leading provider of outsourced medical device manufacturing services for complex Class III implantable devices and minimally invasive devices, today announced plans to support a new UT Dallas-led initiative aimed at identifying potentially marketable biomedical technologies developed at University of Texas System institutions and moving them more efficiently from the laboratory bench […]

Communication key to medical device manufacturing efficiency

Posted on: May 26th, 2015, by: Bill Peatman
When thinking about ways to improve manufacturing performance and efficiency, one often-overlooked issue is communication. Communication between workers, between workers and managers, and between managers and customers can cause quality issues, disrupt the supply chain, erode morale and disappoint customers, to name of a few of the risks. While many believe that communication is a […]