By Shawn M. Schmitt
Communications Specialist, Enzyme
Those who play in the MedTech industry have undoubtedly heard the term Cost of Poor Quality, which, in the simplest of explanations, affixes a price for when a manufacturer makes subpar products and/or operates a problematic quality system. A quick Google search for “Cost of Poor Quality” returns a mountain of in-depth thought pieces, expert white papers, YouTube videos, charts, graphs, and more from a variety of stakeholders.
But what isn’t discussed as much, it appears, is the Cost of Poor Regulatory. That is, how much a MedTech company could pay not only in lost sales, but also in employee time and reputation, if decisions made by its regulatory affairs (RA) department prove problematic. There is so little online about Cost of Poor Regulatory that it’s essentially “crickets” when the term is the topic of a Google search.
“I think the reason it’s difficult for people to see the Cost of Poor Regulatory, and the reason a person might have trouble finding much about it online, is because it’s an invisible expense,” said Theresa Poole, Director of Regulatory Affairs for 4DMedical, a maker of lung and heart imaging devices. “If a company has a failure with a product, then there are going to be all these different reasons for why you failed. It’s not going to just be regulatory. It’s going to be, ‘Well, you know, engineering didn’t do this,’ or ‘You know, quality didn’t do that.’”
Because every manufacturer’s situation is unique, it’s difficult for Poole to say whether the Cost of Poor Quality surpasses the Cost of Poor Regulatory in a typical company.
“The Cost of Poor Quality can, say, affect a company’s ability to register, because the manufacturer can’t become certified if it can’t get its paperwork done or approved – those kinds of things. That’s quality,” she said. “But if regulatory is not doing its job, a company can design a product and have it ready to be in a market, and the firm can invest millions of dollars and then find out that the medical device can’t be shipped because it wasn’t designed properly, because someone in RA didn’t explain what the regulatory requirements were.
“So it’s a different kind of cost.”
My, How Times Have Changed for RA
The ever-expanding role of the RA professional is one of the more common ways that costly regulatory mistakes can unwittingly be made. And with a general lack of global regulatory harmonization, the constant addition of new international standards on a variety of topics, and a stream of industry guidances and guidelines from regulators, it’s no wonder that problems crop up.
And that’s just naming a few of the pressures felt by the modern RA professional.
“It’s just the sheer complexity of the job nowadays,” said Jared Seehafer, CEO of Enzyme, a maker of quality management system (QMS) software. “In the EU, the delta between the old Medical Devices Directive [MDD] and the new Medical Device Regulation [MDR] is immense. There’s no other way to put that. And so, if you’re someone who is active in OUS [outside the US] or EU regulatory affairs, that has made everything much more difficult. And in the US, you have an FDA [Food and Drug Administration] that seems to be firing on all cylinders but is leaving a lot of things up in the air.”
For example, he said, the FDA’s coming switch from its 1990s-era Quality System Regulation (QSR) – the agency’s bedrock rule for ensuring that only safe and effective medical devices come to market – to the new Quality Management System Regulation (QMSR) has some manufacturers scratching their collective head. In the works for several years, the QMSR aims to harmonize the QSR with international quality systems standard ISO 13485:2016 from the International Organization for Standardization (ISO). The QMSR will come into force in February 2026.
“Today’s regulatory professional has to know not only the current QSR requirements, but the upcoming new QMSR requirements, too. And on top of that, the FDA will be changing regulations but it’s still not clear how the agency is going to evaluate a facility inspection,” Seehafer said. “And that’s just one example of things becoming more difficult and complicated from a regulatory policy and a regulatory design perspective. Meanwhile, the level of regulatory oversight has become more complex, as well.”
MedTech manufacturers have been inspected by the FDA since 1999 under its (publicly available) Quality System Inspection Technique, or QSIT. In its QMSR preamble, the FDA makes clear that it will eventually update QSIT to align with requirements found in the new harmonized rule.
Longtime industry expert Elisabeth George agrees with Seehafer that RA’s role has become much more complex. “The things that you have to know as a regulatory professional makes it much more difficult to be in that role now than in the past,” said George, who is President of her own Florida-based consulting firm.
“The significant change in what a regulatory professional is expected to do today versus what they were expected to do 30 years ago – when I started in regulatory – is significantly more,” she said. “When I first started, regulatory was very much focused on making sure that their quality systems complied. The other big part of the job was putting together an FDA 510(k), and that was usually linked to a very simple 510(k) guidance and other tangential guidance documents that the FDA had – so it was somewhat basic.”
Adding to the seemingly never-ending stream of documents from MedTech regulators and standards orgs are items related to cybersecurity, artificial intelligence (AI), and software, among others.
“The RA job is much more technical now. Cybersecurity has been added. AI has been added. There are many more directives on software, many more directives on wireless,” George said. “Materials management has been added. Sustainability – all of the ‘ilities’ that used to not be seen, like usability. …All of those things are now far more burdensome.”
She went on: “Now, that doesn’t mean the regulatory professional owns all of those because there may be subject matter experts behind them. There may be a usability engineer or there may be a cybersecurity engineer, but nevertheless, an RA professional needs to be knowledgeable and familiar with all of those things.”
Tips to Stay One Step Ahead
While staying on top of all relevant aspects of the job can be daunting, there are different tacks an RA professional can take to make sure they’re not overwhelmed and can perform the role well, 4DMedical’s Poole said.
“For the regulatory professional, you must give up the false idea that you’ll be an expert in everything – you can’t be. You have to specialize,” she said. “And if you need to be an expert in everything, then you need to have people that support you who are the experts and can feed you the data you need. And having a good team is imperative, because nobody can do it alone.”
Poole also recommends that RA professionals become involved with lobbying groups and standards organizations to make sure they’re aware of any regulatory changes that are coming down the pike.
“Pick a specialty and pick some countries that you really want to know well,” she advised. “If you know those well and they match what your company needs, then you’re 80 percent there. And if you can, get into the lobbying groups, find out what mechanisms your country uses to create laws, and leverage that so you can understand the ‘whys’ – knowing why a change is happening in regulatory is an immense help.”
Using digital solutions like QMS software to enhance quality systems is another invaluable tool for RA professionals to stay up to date and make sure their company is in line with various regulator expectations, Enzyme’s Seehafer said.
Such software, Seehafer said, is a “huge, huge weight off of your shoulders when it’s time to prep a regulatory submission for your product and all of your source documentation is clean, consistent, and easy to follow. Because if that’s the case, the RA professional can then focus on making sure the communication and narrative are clear, and that all regulatory requirements are properly addressed, instead of worrying about ‘gotchas’ in their source docs that may show up during submission review.”
