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Many experienced engineers outside the medical device industry will inherently recognize the principles of design controls previously described. Many of the design control concepts have historically been part of robust design and development procedures for decades. Design controls are simply a proven way that the FDA has formalized the widely accepted practice of development. So some may ask, “if these design and development principles are so common, why do some medical device companies have such trouble following them?” Companies that have a problem following the regulation typically have one or more of the following issues:

  1. They don’t fully understand the regulation and how to apply its principles
  2. The procedures that they have established to apply the design control regulation are inefficient and greatly hinder product development.
  3. Management does not provide sufficient resources (people, money, equipment) to support aggressive target development timelines.

No matter what the role or position that is held in the medical device industry, design control regulations should be respected and effectively implemented to ensure no harm occurs to patients or users of the medical device. Remembering this charge given to the medical device industry can often be forgotten when companies are under intense pressure to launch new products within budget and under aggressive timelines. Medical device manufacturers may often get lost in the technical development of the device and may lose sight of individuals that may benefit, or in some cases potentially be harmed from the device. It is important to remember that this is not just another commercial product that is targeted to be launched as soon as possible to meet quarterly sales targets. On the contrary, these devices improve, sustain, support or in many cases save lives. Every reasonable effort should be made to make these devices safe and effective.

Unfortunately, in some medical device companies design controls are basically a paper work exercise simply to have the appearance of being compliant to FDA inspectors. There is no doubt that this strategy may work for a time, but sooner or later either the FDA will catch on and issue significant fines or the defective devices can lead to lawsuits against the medical device manufacturer. During the investigation, evidence of following design controls will be scrutinized. Manufacturers are significantly vulnerable to a negligence verdict if compliance to design control regulation cannot be proven. Regardless of the business risk, the ultimate worst case scenario is if ineffective design control implementation leads to patient harm.


Kevin Ong has this to say about why design controls are important in attempts to avoid product liability claims,

“Having effective design controls in place can go a long way in preventing and bolstering the defense against products-liability claims alleging a design defect—one of three bases for products liability. The basic allegation behind a design-defect claim is that a safer design exists for the product in question, but that the manufacturer failed to use the safer design. Robust design controls help to ensure that the safest, technologically feasible, design for the product is being used. Further, in the event of litigation, design controls can be used by the manufacturer to demonstrate that the risks associated with alternative designs were weighed and considered.

In addition to creating product liability risks for design flaws, failure to institute sufficient design controls is likely to result in regulatory actions. Design controls constitute about a quarter of what the FDA evaluates during a site inspection. This emphasis appears to be appropriate, as the FDA found that approximately 44 percent of the quality problems that led to voluntary recall actions during a six-year period in the 1990’s may have been prevented by adequate design controls. As a significant part of the FDA’s focus in inspections, it is not surprising that 55 percent of Warning Letters issued in 2010 cited design controls as a deficiency.” (Ong, 2012)


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