Engineering Expert Witness Blog

     Now imagine what would happen if a medical device company took this haphazard approach to designing new products.  Suppose the company’s engineers ignored the input of regulatory, marketing, procurement, quality control, and manufacturing staff?  What if they chose not to follow applicable industry standards for performance and safety?  And what if they failed to check design calculations or test prototypes for errors before putting the device into production and introducing it to the marketplace?  The result is likely to be unfavorable, just like your contractor forgetting that you wanted a black granite countertop, not a beige one.

     To help eliminate painful and costly scenarios such as these, the FDA requires that medical device manufacturers establish and maintain procedures to control the design of  Class II and III devices, and even some Class I.  This requirement for a system of design controls is part of the Quality System Regulation (QSR) under Title 21 of the Code of Federal Regulations.  In case you’re not too familiar with the Code of Federal Regulations, Title 21 gives the FDA legal authority to regulate food, drugs, and medical devices in the United States.

     So what falls under the premises of FDA design controls?  Well, the FDA requires that a medical device company develop procedures for:

• • Design and Development Planning
• • Design Input
• • Design Output
• • Design Review
• • Design Verification
• • Design Validation
• • Design Transfer, and
• • Design Changes

For now, let’s focus on Design and Development Planning and Design Input Procedures.

     In the Design and Development Planning Procedure companies must carefully plan who will be involved in each phase of product development, as well as how they will interact, all in an effort to ensure that information flows and design requirements are met.  The right pool of people would include design engineers, in addition to those employees responsible for making sure that regulations are complied with and those who are charged with securing intellectual property rights to the design.  Then there are those who must acquire the physical materials required to manufacture the device and those who will do the actual manufacturing of it.  Also, those responsible for quality control, marketing, sales, and product service should be involved.  Perhaps others should be involved as well.  Mind you, the Design and Development Planning Procedures are not set in stone.  They must be regularly reviewed and updated as the project evolves.

     Now let’s talk about Design Input, which is another term for a design requirement.  These inputs can come from inside or outside the company.  An example of a requirement coming from within is when Marketing stipulates that the maximum manufacturing cost of the device should not exceed $150 in order to maintain an acceptable margin of profit and be most competitive in the marketplace.  A design requirement coming from outside the company would include industry standards that make specific requirements, such as requiring that the device in question be designed to protect its electronics from radio frequency interference. 

     Next time we’ll continue our discussion on medical device design by exploring Design Output, Design Verification, and Design Review Procedures.

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