We continue our Question & Answer blog post series, focusing on medical device product development.
I just started working for a medical device company. They use a sequential or waterfall approach to product development. At my previous company, we used more of an agile approach and we iterated our product design throughout the product development process. Can I use agile processes with medical device product development? I’m a little concerned with all the regulations.
Agile is a broad term covering multiple elements. Your question focuses on design iterations and work that is done in multiple, short time frames including user input. Each iteration allows you to learn and further refine, as needed, and may be executed on the entire product or a component of the product. The final output is a product that solves a customer’s problem.
However, the process still needs to fit within your company’s design controls. The FDA recognizes that product development is iterative (Design Control Guidance for Medical Device Manufacturers). The challenge is managing the information and testing between development prior to design verification & validation.
Below are some things to consider when using lean and agile in medical device product development.
Agile product development methods may be included in medical device product development. You need to ensure it fits within design controls by planning and documenting the results of the iterations.
If you have any questions regarding medical devices and product development, please feel free to ask, and we will answer your question in one of our future blog postings.
Strategy 2 Market helps companies increase growth and decrease product development complexity. www.strategy2market.com
For more information or to speak with one of our consultants, please contact Mary Drotar at 312-212-3144 or [email protected]
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