Device Industry Examines Ways to Satisfy Need for Rapid Regulatory Response


By: Gabrielle Hirneise

November 18, 2020

Categories: AAMI News, Clinical, Early Career, Education & Academia, Executive , Health Technology Management, Individual Contributor, Information Technology, Manager or Director, Medical Device Manufacturers, Medical Device Manufacturing

In the modern age of technological advancement, it’s important to understand that critical situations similar to COVID-19—where rapid change will be needed from medical device regulators—will continue to emerge. Almost a year since COVID-19 swept the globe, the human population is still reeling. One aspect of healthcare that often gets overlooked—the standardization of medical device use—likely will never be the same in the wake of the pandemic.

New regulatory frameworks and the standardization of medical devices used in the diagnosis, monitoring, and treatment of COVID-19 paved a new path for the healthcare industry and the regulations that will need to adapt with it. The rapidity with which technology is evolving and the impact of COVID-19 on medical device regulations and standards were addressed at the BSI/AAMI International Medical Device Standards & Regulation Conference, which was held virtually Nov. 3–4.

“Our systems for regulating medical devices and the developing standards to support that regulation are under pressure from the nature and speed of new technology and increasing pace of change,” said Michael Kipping, innovation lead for Innovate UK. “This year, COVID-19 has been an added challenge, and we have seen innovative approaches taken by all stakeholders in enabling patients and healthcare professionals to safely utilize novel products in responding to the COVID-19 pandemic.”

The shortage of ventilators and personal protective equipment (PPE) in relation to the high number of COVID-19 cases is the perfect example of this.

“Thinking back to March, there was global demand for healthcare products, whether PPE, ventilators, diagnostics, whatever it was,” Kipping added. “You had this global competition for finite resources, and it was a really really worrying time.”

In fact, in the UK, an estimated 8,000 available operating ventilators were available for use, with a projected need of 18,000. This wide disparity resulted in a call to action.

On top of making sure all operational ventilators from both the private and public sector were being utilized or procured, the UK government initiated the Rapidly Manufactured Ventilator System Challenge, where two groups were tasked with ramping up the production of ventilators, either by inventing novel ventilators or by scaling up the production of preexisting ventilator systems.

For these novel products to hit the market in time for the projected ventilator shortage, they had to clear all preexisting regulatory frameworks in the matter of a week.

“Products usually take 18 months, but with the time constraints, that simply wasn’t possible,” Kipping said.

This shed light on the need for a more adaptable and incremental system for developing standards.

“We need to move toward more iterative forms of standards, and we are doing that with things like the BSI PAS [Publicly Available Specification], provisional standards for trial use that cannot last more than two years, and consensus reports, which are reports that lay out a snapshot of where consensus is right now and what we know right now,” said Joe Lewelling, vice president of standards development at AAMI.

“Those expedited deliverables help us to provide information to the industry and regulators quickly and promote safety and effectiveness before we can gain the formal consensus that is required for long-term standards. It’s an iterative process—you start with those and work toward the longer-term standards,” added Lewelling.

As a further way to acknowledge the open-ended nature of regulations surrounding COVID-19, in April, BSI drafted and posted a number of free standards collections on its website.

“These included standards in response to the ventilator challenge, but also in relation to PPE manufacturing and testing, hygiene, and standards related to business risk and continuity,” said Rob Turpin, head of sector (healthcare) at BSI Knowledge Solutions. “Over time, the collections grew through collaboration with government bodies. These collections are still available now and will be available for a short time on the BSI website.”

These rapid, short-term solutions were excellent ways to meet demand; however, long-term solutions are needed to combat similar situations in the future—not only for COVID-19–related technology but for other emerging technologies and their own unique complexities.

With medical devices, a mass-production mentality exists in which manufacturers and stakeholders want products to be produced in a way that makes them consistent and predictable. However, this overlooks postproduction changes, which can be dictated by changes in the software, the technology, or the way the healthcare providers are using the device.

That being said, taking a look at what downstream changes can occur in using medical devices comes with some unknowns.

“The big issue with cutting-edge technologies is just that they are cutting edge,” said Lewelling. “We may not know everything we know about other devices in terms of science and technology. When you combine that with the speed of change, it’s very hard for us to write standards and set requirements that are state of the art. The solutions here are, first of all, gaining more knowledge, as well as increasing postmarket monitoring of what’s going on.”

This is particularly evident in the implementation of artificial intelligence (AI) and machine learning. By nature, AI-enabled medical devices learn and change over time; therefore, the challenge is developing regulations to not only make them ready at the “loading dock” but also to ensure that they remain safe and efficacy over the long term.

To ameliorate this, Lewelling suggested that regulators and other stakeholders focus on when and how change can occur in these devices (such as how algorithms are structured and monitored), determine the competencies of the system with change in mind, and change the culture and mindset surrounding medical device regulation to include evolving technologies.

“As a former U.S. secretary of defense said, we have ‘unknown knowns and unknown unknowns,’” Lewelling added. “The risks that we can’t quantify and the risks that we don’t know exist are always there with technology like this.”