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Integrating Business and Design Controls in Medical Device Product Development

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Product development is a necessary function to grow your company.  However, medical device product development often focuses solely on following design controls.  The business needs of the project are done by ‘someone else’ in marketing.  The lack of closely aligned processes and information for a project affect the final product.  It becomes easy to develop a product that is safe and effective, but is a failure for the business.

So what are some of the business elements that need to be considered as part of product development and why are they important?

  • Target market and segment, which helps define critical product features for that customer and the sales channels
  • Countries of launch, which define registration requirements, labeling requirements and may influence design requirements
  • Forecasts, which enables production to prepare so the product can be manufactured for distribution
  • Reimbursement, which may define needed features or additional testing requirements
  • Product cost targets and margins, which are needed for business viability
  • Market timing requirements, which ensure the product is delivered to meet the window of opportunity
  • Financial analysis, which helps management determine whether the project and product should be undertaken

These elements provide context to make your product successful.  Without them, the project is at significant risk of failure.  Therefore, the medical device product development process needs to integrate the business elements.

We recommend your product development process capture both design controls and business elements in a single process.  See the image below for how business and design controls fit into a typical phased and gated product development process.

Generic phased and gated process with business and design controls timing

Figure 1: Generic phased and gated process with business and design controls timing

Business and market information are captured early in the project and is updated throughout development.  At launch, the product is transferred to sales or downstream marketing.  Design controls start when the product requirements are defined, but last until the product is removed from the market.  A single process ensures business and product development are working together on the project.  An additional benefit of this coordination is that the original product context can be more easily reviewed for future product updates or changes.

Although there is a single process, you should still maintain separation of the design control information from the business information.  The overall process document should describe how business and design controls each fit into the process and when the deliverables are due.  Then use your design control documents to prescribe the specific procedures, forms, deliverables, and their storage.  The business elements should also be described in their respective areas and collected for the relevant reviews.

While the integration of business and design controls is typically well understood with phased and gated processes, it can also be integrated with Lean Launchpad, agile, Exploratory PD,  and other product development processes.  Just document how you want to integrate the elements.  Be very clear when design controls start.

Product development is more than just the technical elements.  It must include the business elements to ensure successful products.  By integrating design controls and business elements into your product development process, you ultimately build more successful products.

 

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