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Medical Device Product Development Using Lean and Agile Methods

Date: September 27 - 28, 2016

Location: Chicago, IL

Why Lean and Agile?

Lean and agile 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.

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.

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 




For more information and to register

About the Faculty

Therese GraffTherese Graff
Strategy 2 Market

Therese is an expert in product development processes, lean techniques, and Design Controls. She has over 25 years’ experience in medical device product development. Therese earned a BS from the University of Illinois, Urbana-Champaign, with concentrations in Chemistry and Biochemistry, and an MBA from The University of Chicago. Therese is certified as a Project Management Professional (PMP) by the Project Management Institute (PMI) and as a New Product Development Professional (NPDP) from the Product Development Management Association (PDMA).

What You Will Learn:

  • Minimum design control requirements versus over implementation
  • How to integrate the lean tools into a compliant medical device product development process, including hardware and software development
  • 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

For a more detailed agenda, please contact

Registration Information


The cost of the course is $1995 and includes all materials, breakfast, lunch and snacks. Use the code: MRT300 and receive a $300 discount on the fee.

Strategy 2 Market is not responsible for any airfare, hotel or other costs incurred by registrants. Registration closes five days before the first day of the session. Strategy 2 Market reserves the option to cancel or reschedule a course if the minimum number of participants is not met.

Cancellation Policy:

We understand that circumstances may arise requiring a participant to cancel or send a substitute. There is never a fee to send a substitute. Please let us know as soon as possible in advance. Written cancellations received at least 21 days prior to the start date of the event will receive a refund less a $250.00 administrative fee. No cancellations will be accepted, nor refunds issued within 21 days of the start date of the event. Strategy 2 Market is not responsible for any losses incurred by registrants.



For more information and to register


How to register

Register for this event:

Or register by phone:

Call 1-800-338-2223 or 781-891-8080 (9:00am - 5:30pm EDT)

In company training

This session can be brought directly to your site. Benefits include:

  • Lower cost per participant
  • Time savings
  • No travel required
  • Content tailored to your specific needs
  • Implementation is jump-started through team participation and instructor's hands-on guidance

Contact 781-891-8080 for more information and price quote.