Stop Using Medical Device Design Controls as Your Product Development Process

Stop Using Medical Device Design Controls as Your Product Development Process

Topics: Medical Devices


Product development is a complex process, which requires integration of business and technology to deliver a successful product.  Medical devices must also follow the requirements of design controls, which are based on engineering best practices for product development.  We often see companies using the required elements of design controls as their product development process, at the risk of ignoring the business elements needed for a successful product.  This lack of integrating business elements risks delivering products which are technically sound, but are unsuccessful, since they do not meet the market needs or market entry is significantly delayed to redesign the product.

Why Design Controls Are Not Enough

Companies make money through the sale of products designed by product development.  While most companies have a product development process which covers how they develop new products, the actual process varies widely.

The best companies use cross-functional teams [1]which includes the business and technical aspects of product development.  Companies that ignore the business portion of product development or integrate business elements poorly are at the greatest risk of delivering unsuccessful products.

The business elements include market understanding, how this product fits the overall strategy, user understanding (how the products are used, including what doesn’t work today), forecasts, market introduction, etc.

The technical elements of product development include product requirements, designing the product and collecting feedback, testing the product to show that it meets the requirements, and successfully transferring the product to production.  This sounds a lot like design controls!

Many of the companies we work with have segregated the business and technical processes, so that they are independent from each other.  In these situations, marketing says here’s what we want, then ‘throws it over the wall’ to engineering/R&D, who now has to figure it out.  When the product is designed, then Marketing gets ready to launch and finds the product isn’t what they wanted.  Design controls become the default product development process because it contains the technical requirements for the regulatory agencies. The regulatory bodies are not concerned with the business requirements needed to ensure the product is successful.

The result of this separation of business and design controls often yields products that are unsuccessful because they do not meet the business need.  Examples can include low sales, cost structure that is too high, a product which is over-designed for the market, product which is no longer relevant, etc.

Integrate Design Controls and Product Development Processes

To integrate design controls into the product development process, you can use the following key steps.

  • Identify the elements of your product development process.
    • If the business elements are not visible, you should ask when they are done, by whom, and why they aren’t included in product development.
    • Then determine which elements fall under design controls and those that do not.
  • Document your process for product development and store in your controlled document location. Clearly indicate how design controls fit within the product development process.
    • You can keep design controls separate from the product development process by focusing on activities in the procedure, rather than design control deliverables.
  • Update your design control procedure (which you should already have) with any references to the product development process, as needed.

Closing Remarks

As you can see, design controls are one element of product development, but they are entirely technical.  We recommend that you develop a product development process to ensure that you incorporate important business elements in order to deliver a successful product to market.  In essence, weave a picture of product development which allows you to keep design controls distinct, yet a part of the whole process.

[1] Markham, S.K., and Lee, H. 2013. Product Development and Management Association’s, 2012 Comparative Performance Assessment Study. Journal of Product Innovation Management, Vol. 30, No.3.

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