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8 Signs your Product Development System Needs Some Love

8 signs your product development system is broken and needs to be fixed.

Medical Device Companies: Ten Tips on Nailing Down Your Requirements Early

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 …
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How Many Design Reviews Do I Need for Medical Device Product Development

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…
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Balancing Medical Device Innovation and Clinical Trial Obligations

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,…
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Integrating Business and Design Controls in Medical Device Product Development

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…
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Look at Product Development Differently…Take a Systems Approach

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.

Stop Using Medical Device Design Controls as Your Product Development Process

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

There is no Silver Bullet to New Product Development

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…
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