Feel the Need for Speed? These Product Development Tips are Key

During a conference session at BIOMEDevice Boston, Bill Betten, president of Betten Systems Solutions, and Tom Waddell, CEO of the Waddell Group, shared their collective insights for getting new technologies to market fast. These were the key takeaways: 1. A corporate culture that rewards calculated risks "The larger the company, the less likely it goes that way," Waddell said. "Small companies are much more excited about getting their product to some kind of proof of concept or in-human clinical trial and then they hope it gets sold or they can leap from there, so they have different reward levels." Strong support from the top is key, Betten added. 2. Quality management system design  Companies have to employ a strategy of "do what's required," not what is easy and less risky, according to Waddell. Production readiness is responsible for about 60% of the required documents for a class III medical device, he said. Waddell said a quality management system (QMS) design is the strongest indicator of how fast a company is going to be able to develop a product.  3. A carefully chosen team Just as it takes a village to raise a child, it takes a team to develop a new medical device. From a solid project manager to a good design team and competent regulatory affairs expert, Waddell said each person on the team has to be able to work well together. While it might seem obvious, this is the part that a lot of large companies, and some small companies, have the most trouble with. "In...
Source: MDDI - Category: Medical Devices Authors: Tags: BIOMEDevice Boston R & Source Type: news