Understanding the Intent of FDA’s Design Control Regulation

Every manufacturer must meet a set of design control regulations given by the FDA for each medical device they produce. An important part of the product manufacturing process, each of these design control requirements must be relevant to all devices, no matter how complicated or simple they are. Nevertheless, many manufacturers put too much emphasis on simply following the FDA’s regulations and not enough on actually understanding them – resulting in much longer product approval timeframes.

For a more effective product approval process it is important to recognize the intent behind FDA’s Design Control Regulation while also working to fulfill the strict requirements. Let’s dig in.

Calculating Risk Management

Part of the FDA’s design control regulation requires that companies provide a risk management plan. A risk management plan attempts to foresee risks, estimate impacts, and define an organization’s responses to issues should they arise. This is similar to a risk analysis but helps to provide a greater level of product safety. A risk management plan allows organizations to analyze and minimize risk early in the development of a product, preventing the unwarranted expenditure of considerable time and money for a product that will never be safe enough to reach the market.

Of course, merely calculating the risk of a particular product in order to comply with FDA requirements is not the true intent behind this regulation. The idea is to keep risky products out of the market and to have safeguards in place to deal with the issue should something go awry. Thus, it is important to spend as much time and effort on your risk management plan during the design control phase of FDA approval as you would for an audit. This can both ensure FDA approval while helping to avoid needless expense and prepare for problems, should they arise.

Effective and Objective Design Reviews

The FDA requires that manufacturers perform periodic design reviews on their products. This is meant to help your company find blind spots in the design process or identify issues that can be fixed much more easily early in the design process rather than closer to the product’s release date. Unfortunately, many companies do not see the reason behind the FDA’s design reviews and miss the point altogether.

As a result, many design reviews are conducted by someone inside the company planning to manufacture the product. This person is typically paid for his or her opinion. Unfortunately, that means he or she may not be as forthcoming with observations, since this could cut into that person’s long term career prospects (particularly if the person notes flaws that might be impossible to correct). On the other hand, someone outside the company who will be paid no matter what the outcome is in a far better position to offer an unbiased opinion.

Manufacturers must realize that the reason for these design reviews is to have an unbiased opinion on the product in question in order to instill confidence regarding its safety and efficacy. Using reviewers that are biased, while possibly making it easier to meet FDA design control regulations, is a short sighted course of action. This will ultimately expose the company to much greater liability should the product fail in ways that would have been predicted by an outside, unbiased reviewer as intended by the regulation.

Developers and Manufacturers Working Together

Design control regulations allow manufacturers to assess a product’s effectiveness and safety at an early stage. While individuals working in research and development may understand how to create the product and make it work, they may not be the most knowledgeable individuals when it comes to determining how to manufacture it in bulk. Unfortunately, history has proven that translating an item from small quantities produced in a lab to bulk manufacturing can introduce serious and unintended variations. These variations can affect the safety and efficacy of a product. Therefore, the FDA requires a dialogue between R&D and the manufacturing department as part of their design control regulations.

Mass producing and then distributing products can be just as tricky as designing them in the first place. A product that does not allow for mass production and distribution will likely be unable to reach either FDA approval or commercial success. Thus, the FDA requirement for inter-departmental development serves the interests of both the public and the manufacturer by keeping a product from transforming from something useful when produced for immediate use in a lab to something useless when mass produced and distributed for eventual consumption by the end user.

Verification and Validation

Verification and validation requirements merely give a manufacturer one final opportunity to ask the truly important questions about their product. In truth, you, as a manufacturer, are not asking “Is the device designed correctly?” and “Did we design the correct device?” You are also asking, “Does the product solve the correct problem?” These questions force manufacturers to consider whether or not a product is well designed but also if it is necessary. The FDA expects a confident answer to this question, as it is important to remember that unnecessary or ineffective products should not continue into the manufacturing stage.

Indeed, it is at this point that many manufacturers have opted to take their product in a new and different direction. Several pharmaceutical products, for example, were originally found to be effective for treating one condition, but much more useful for something else. Sildenafil (better known by its trade name of Viagra), for example, was originally developed to deal with high blood pressure. However, its use for treating erectile dysfunction proved much more meaningful. Thus, during the verification and validation process, the makers changed directions and sought approval for the drug as a treatment for ED rather than hypertension.

FDA Design Control Regulations Protect Both the Public and the Manufacturer

Following the strict letter of the FDA’s regulations is all well and good, but it is not enough to ensure you have a well-designed product. Understanding the FDA’s intent when attempting to meet design control regulation ensures that you will produce a product that is safe, effective, and commercially viable. This will protect both the maker and the public from useless or dangerous products and help to encourage the commercial success of any product that achieves FDA approval. While not a guarantee of success, understanding the intent behind these regulations and attempting to comply with those goals can greatly boost a product’s approval rate and merchantability.