7 Steps to Integrate Medical Device and Lean Product Development

Here are some steps to get started implementing lean product development in your organization. The goal is to identify and remove waste, so work (including product development) can flow through the organization,

Medical Devices Undergo Extensive Safety Testing; Is This Really Necessary?

As part of ongoing efforts to encourage more physical activity among children, McDonald’s added the “Step it” fitness tracker to Happy Meals.  After only a few days, following reports of skin irritation caused by the wrist worn fitness tracker, McDonald’s decided to remove the fitness tracker from Happy Meals. In July, 2016, the FDA released […]

Regulatory Requirements Do Not Prevent Integration of Lean and Agile Methods into Medical Device Product Development

Lean and agile are frequently used terms in product development.  The advantages of these techniques to improve time to market are well known.  Some medical device companies feel that lean and agile techniques cannot be used because of design controls.  However, the regulations don’t prevent the use of those techniques during product development. In the […]

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  […]

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 […]

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, […]

Human Factors – Changes You Should Know and Why You Should Care

The FDA issued a new guidance, Applying Human Factors and Usability Engineering to Medical Devices in early Feb 2016.  On April 3, 2016, it will replace Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management issued in 2000.  This lengthy document (49 pages) contains some very specific language on how human factors should be […]

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 […]

What Can We Learn from the Theranos Experience?

Theranos, a blood testing laboratory, has been the subject of media scrutiny after a number of articles were published in the Wall Street Journal. Since clinical testing laboratories are not usually regulated by the FDA, this article will provide a short history of what has happened and some lessons learned to consider for the future. […]

Design Controls: Just Good Design Practices

In the world of medical device product development, we often hear complaints about the burden of design controls.  However, when you examine the elements of design controls, you see they actually represent good design and engineering practices.  The goal of these practices is to show that you can manufacture products of the required quality as […]

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