14 August 2023

Should the FDA crack down on custom device promos?

Many people share their work on social media. Journalists share stories, musicians post their latest singles. Manufacturers might even tease their latest product if it hits the shelves.

The practice is also common in the American med-tech sector, with companies posting photos of prototypes of new devices set for mass-production.

But there is one type of product that’s a no-go for social: custom devices. 

The U.S. Food and Drug Administration (FDA) has clear guidance on what doctors and manufacturers can and can’t say about custom devices: you can’t promote a custom device online, particularly on social media. 

But this doesn’t stop some sales representatives of custom device manufacturers posting photos of them on platforms like LinkedIn and Instagram. 

MBK Search’s Managing Director of Med Tech Jan Triani says the practice of sharing photos of custom devices online deliberately flouts the letter of the law, as well as giving an unfair commercial advantage to those doing so.  

“The companies that are doing the right thing and following the rules lose business to the companies doing this,” she says. 

“The frustration is high because in essence you are watching others’ succeed while breaking the rules.”

“Surgeons see these custom devices and post-op x-rays and want to work with the manufacturers, not knowing that the company has violated  FDA regulations to advertise these devices.” 

Triani, who has 20 years of  experience leading quality and regulatory teams within med-tech, says she has seen examples of custom devices being shared going back as far as 2015. 

“I have worked for and with medical devices companies who followed the rules. We would find the appropriate regulatory pathway by working directly with FDA to provide patient specific and custom devices to patients in accordance with the regulations. My marketing and sales colleagues would often show me our competitors’ custom devices social media posts. The frustration is high because in essence you are watching others’ succeed while breaking the rules.” 

Under the regulations, manufacturers are only allowed to make five versions of a device per year for it to be defined as custom, and the device must be materially different from any commercially available device. 

The FDA rules are very clear. In its guidance document on custom devices, under the question ‘Can I market my custom device to the general public?’, the FDA states: “No. A custom device is made at a physician’s order on patients with a sufficiently rare condition or for a physician’s special needs […] a custom device is not made generally available in finished form through labeling or advertising.”

Posting images of custom devices is in direct violation of this guidance. “I think the FDA just doesn’t have the manpower to police this type of non-compliant behavior. It’s very unfair to  most medical device companies that are doing the right thing,” Triani said.

A Growing Problem 

It’s not just med-devices companies pushing the letter of the law, but practioners are also getting into the mix. 

A senior compliance officer at a med-tech company, who wishes to remain anonymous, says he has seen surgeons posting about custom devices used and crediting the manufacturer. 

“That’s also going against the regulations,” the officer said. “I’ve seen cases of surgeons and other third parties marketing these devices in posts and bringing them to public meetings to show people.”

In many cases, a custom device is a last resort for patients who are facing amputation as their only remaining course of treatment. “At the end of the day, we all just want to help people, but you need to do that within the rules and regulations that have been established,” said the senior compliance officer. 

“There are cases of custom devices being used by surgeons as a ‘Hail Mary’ before they would have to amputate a patient’s limb, so manufacturing these devices within the rules and regulations is really important.

“I think a lot of people are just unaware of what the regulations state. To me, they’re pretty clear on marketing devices but I think a lot of people don’t know what is and isn’t allowed. Sales representatives get trained to learn the regulations, but then either they go against them or they just forget, but neither is ok.”

As with most regulatory decisions, FDA warnings to companies are publicly available, which is part of the reason the mass production of custom devices decreased around 2014, alongside the publication of the FDA’s guidance document for custom devices. 

“When companies see that one company has received a warning from the FDA after they were audited, it has a knock-on effect across the industry because they don’t want to be found doing the same thing,” Triani said. “If one large medical device company receives a warning letter for promoting custom devices, I think that would go a long way.”

A spokesperson for the FDA told MBK that “The FDA continuously evaluates the medical device marketplace for violations of FDA regulations, and we are committed to taking action, when warranted, to protect the public health.” 

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