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Agile Methods in Medical Device Product Development

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We continue our Question & Answer blog post series, focusing on medical device product development.

Question:  Can I use agile processes with 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.

Answer:

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.

Now to answer your question:

Yes, you can use agile methods with medical devices product development.

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.

  • Ensure your written procedures for product development don’t preclude agile product development methods.
  • Include development strategies, such as agile, in your Design and Development Plan.
  • Collect and document customer feedback early and often. This feedback doesn’t have to be a clinical study. A discussion with users, especially early in the project, may be sufficient to gain the necessary input. Make sure you also check with different user types who may interact with the product (e.g., surgeon, nurse, and cleaning group).
  • Document what went into each iteration and the results. In essence, the iterative loops are mini-development cycles. Auditors will be looking for the progression of how you developed the product. As the developer, you want to collect the information so you can learn and determine what may need to be retested based on future product changes.
  • Freeze the product design, meaning the design inputs and product design are defined and documented. Document and justify any subsequent changes to the requirements and product design.
  • Complete design verification & validation testing.

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.

 

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