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Medical Device Product Development Using Lean and Agile Methods

This 2-day class will provide a high level overview of design control requirements, a survey of key lean and agile techniques, and how they should be integrated into medical device product development.

Lean and agile[1],[2] have become frequently used techniques in product development. Medical device companies have struggled to incorporate these techniques effectively in their organizations. Some medical device companies don’t believe they can use lean or agile techniques for product development, outside of software development, because of design controls. However, the regulations don’t preclude the use of lean or agile techniques during product development. You just need to know how to integrate them effectively.

The benefits to your medical device company include: IMPROVING TIME TO MARKET through eliminating waste and incorporating dynamic development, while also delivering a successful product.

In addition to the techniques (e.g., lean and agile) used for product development, most companies use a product development process, such as phased and gated, to provide additional governance. We have found that these product development processes have evolved over time, creating roadblocks to effective utilization of lean and agile techniques.

The key to effective integration of lean and agile techniques is to

  1. Identify waste within the entire product development process including where agile is appropriate
  2. Select the best techniques for your organization
  3. Align the techniques within your design control procedures
  4. Implement changes

What your team will learn

  • How to integrate the lean tools into a compliant medical device product development process, including hardware and software development
  • Minimum design control requirements versus over implementation
  • How design controls should fit within your product development process
  • How to recognize waste in your product development process and opportunities for waste reduction throughout the product development process
  • Integrating flexibility and rapid learning versus a waterfall approach
  • How to realign activities within your process to get product to market faster
  • How to manage project risk (non-user hazard)
  • Alternate types of product development processes and how they differ from the traditional phased and gated approach

Medical Device Product Development Using Lean and Agile Methods Video
Watch an introductory video



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[1] Lean comes from lean manufacturing and is a systematic method for the elimination of waste.
Lean manufacturing. (2016, May 30). In Wikipedia, The Free Encyclopedia. Retrieved 12:46, June 2, 2016, from

[2] Agile comes from agile software development and is a set of principles in which requirements and solutions evolve through collaboration within cross-functional teams.
Agile software development. (2016, June 1). In Wikipedia, The Free Encyclopedia. Retrieved 12:49, June 2, 2016, from