Challenges and Regulations in Medical Manufacturing

Pivot International  |   April 18, 2017

In any form of manufacturing, there’s little room for error. It’s simply a fact of life. Regulations and restrictions are part of the deal, and though they may tighten or loosen over the years, they’ll always be in the picture if you’re a product designer or manufacturer.

So imagine being a medical manufacturer. When your products involve people’s health, in whatever respect, the restrictions and requirements for compliance are even more stringent. Of course, that’s how it should be – after all, in cases like this, people’s lives are often in the balance.

But it still makes the field of medical manufacturing more challenging than others. Here are just a few examples of how medical products are regulated, and what medical product designers must to make sure their products are in compliance.

Medical manufacturing is overseen by the FDA

While there are many government-based regulations that many manufacturers must comply with, they are not necessarily under the aegis of one specific agency.

But medical manufacturers are. The U.S. Food & Drug Administration oversees any devices or products that are used in treatment, diagnosis, cure, or prevention of medical conditions.

The agency is also in charge of any products that affect body function or structure.

Medical products are broken down into classes

Medical manufacturing creates products that fall into three different classes under FDA regulation. Each class has progressively stricter regulations.

For example, products that fall under Class I include simpler items like bandages, patient-monitoring systems, prosthetics, and hearing aids. These products are held to high safety standards already under general FDA regulations.

But Class II products fall under much stricter controls that are specific to each device under the Class II heading.

That’s right; every product that falls into the Class II category has individual controls that apply only to that product.

Class III products, which are defined as products that contribute to the sustenance or support of human life, even have regulations about how they’re marketed. The marketing campaign must meet FDA approval, a process which can take up to six months.

And if there’s any alteration in the product to improve it, the approval process begins all over again. Imagine preparing a marketing campaign for your new product and having to submit it to a government agency for an approval process that could take six months!

This is because the devices that fall under the Class III heading have a much greater potential for causing illness, injury, or death if used improperly.

It’s also worth noting that the most new regulations the FDA creates for medical products are for Class III devices. Often the products are so new that no previous regulations exist.

Additive manufacturing

One of the most challenging areas of medical manufacturing comes in the area of additives. These are products that largely function inside the body. As you can imagine, this opens up a whole host of potential issues that a medical manufacturer has to safeguard their product against.

The biggest of these issues is called biocompatibility, or the behavior of biologic materials in different contexts. The body’s response to impurities in an additive can be extremely unpredictable and dangerous, so an incredibly strict process of filtering out those impurities is required.

Even the smallest impurity can cause a severe reaction inside the human body. The list of side-effects you often hear in those ads for medications are largely caused by impurities.

Various primary cleaners and solvents must be applied to the additives to deal with these impurities, and the process of applying those solutions to the products can sometimes take months.

Creating medical devices and products can be an exciting field to work in, but it’s important to remember how challenging developing these devices can be. Perhaps the best way to deal with these regulations is to simply remember that they’re designed to keep the end user – the patient – safe.