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Integrating a Business Process with Design Controls


Client Issue: “We use design controls to develop our medical device products. However, we often have products that are not successful, we don’t have information that marketing needs for the product causing us to add more studies, the product can’t be reimbursed, or the launch is delayed while marketing gets ready.”

Solution: Successful medical device product development needs to include business elements, in addition to design controls. Design controls provide a technical framework to product development, but they miss the business elements needed for a successful product. Things like reimbursement or launch materials are business driven.

When we work with your organization, we use a cross-functional team to design the process that includes both business elements and design controls, but also makes sense based on the product complexity and your market needs. Common elements to include are the following.

  • Business case that examines how this product fits into the overall strategy and how this product fulfills that need, including reimbursement objectives and countries of launch
  • Forecasts
  • Contracts and intellectual property
  • Market launch requirements and preparation
  • New or modifications to a structured process, phased-and-gated, or our proprietary Exploratory PD

Post: Stop Using Medical Device Design Controls as Your Product Development Process

Post: Integrating Business and Design Controls in Medical Device Product Development

NPD-bytes: Medical Device Product Development: The Process is More than Design Controls

For more information, contact
Mary Drotar, Partner
Strategy 2 Market, Inc.
[email protected]
312-212-3144
or complete this contact form
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