8 signs your product development system is broken and needs to be fixed.
Medical device product development teams often think they need to have all the customer requirements and design inputs defined when they enter design controls. In this posting, I’ll explain to you why it isn’t necessary to have them completely defined upfront and ways to add more detail over time. In our experience, we find teams […]
Question: How many design reviews are required during medical device product development? Answer: There are many factors that go into determining the number of design reviews needed. 21 CFR Part 820 and ISO 13485 both require design reviews (Additional information is also found in FDA Design Control Guidance for Medical Device Manufacturers and in ISO/TR […]
Product development is about delivering products to the customer, which contain the features and quality that they are willing to pay for. Truly new products, which are innovative and provide a product that is substantially different from other products, are important for companies especially if they want to be the market innovator. To deliver successful products, […]
Product development is a necessary function to grow your company. However, medical device product development often focuses solely on following design controls. The business needs of the project are done by ‘someone else’ in marketing. The lack of closely aligned processes and information for a project affect the final product. It becomes easy to develop […]
Virtually every department in an organization is touched by product development, meaning that multiple people, functions, processes, and infrastructures must be coordinated. As a result, product development is complex and needs to be managed as a system.
Some companies use medical device design controls as their product development process. In this article, we discuss why design controls should be a subset of the product development process and how to integrate design control
Many of the organizations we work with are pursuing some kind of ‘silver bullet’ solution for their various new product development challenges. The truth is that there is no single solution. Instead, a well-run new product development organization is a complex and demanding endeavor. This is probably why so many organizations struggle with organic growth […]
It’s fairly easy to reduce cycle time on clearly defined activities such as in development phases. How do you reduce cycle time in the Fuzzy Front End?
