Since early 2020, our lives have been turned upside down. Unfortunately, we now live in very challenging times.
Cases of COVID-19 are still increasing in many parts of the world, and many families must deal with the loss of loved ones as deaths associated with this pandemic continue. Even for those of us who have not experienced this loss, the pandemic has changed every aspect of our lives, including how we perform our daily tasks and operate in our work environments.
This is no different for those of us in the medtech space. Our response to COVID-19 has pushed us to rethink our processes. And throughout the pandemic, the industry has stepped up and asked what they needed to do and to deliver. More importantly, the industry has delivered in an innovative, agile and safe manner. Whether it was PPE, ventilators, or other ICU or airway management equipment, the consensus is that the industry responded in an open, effective and patient-focused manner.
This coordinated effort didn’t simply happen by accident; my own feeling is that the industry recognized the global nature of our business and the need to respond safely, with speed, while leveraging the way our interconnected industry works. Quite simply, I believe that without the willingness of the industry to work globally and to stay focused on what patients and hospitals needed most, this incredible response would not have happened.
Cook Medical, I am proud to say, responded in a very positive way. We changed how we did things and responded to where the need was greatest. Our operations and supply chain groups focused on where we could help. From the beginning, we were willing to change how we did things so that we could safely supply additional much-needed devices. We never compromised on safety nor did we ever question the need to operate in a very agile manner during this period. We, like many other companies, continue to experience the ripple effects of COVID-19 in regards to having the workforce and raw materials to ensure we are manufacturing devices in the quantities needed to keep up with demand. However, we are taking what we have learned throughout the pandemic and applying it to how we do business to become more efficient. The lessons we’ve learned will make lasting changes.
In my experience, the global regulatory agencies also responded positively. Their willingness to engage with the industry was evident and the use of such things of Emergency Use Authorizations helped ease the roadblocks in getting much-needed devices to patients.
It must be also said, however, that the pandemic exposed some of the weaknesses of the various global regulatory agencies. It laid bare the fact that the various regulators aren’t as well aligned globally as they probably should be. The pandemic highlighted the need for more agility, speed, change management and urgency—while never compromising on safety—in our current regulatory agencies.
The pandemic also highlighted that the pace at which the various regulators are driving harmonization, though organizations such as the International Medical Device Regulators Forum (IMDRF), is simply not speedy enough. The pandemic coincided with the 10-year anniversary of the IMDRF, and the delivery of harmonization projects has fallen behind what the global patient population requires.
Many examples highlight this lack of harmonization progress, but for this article, let’s focus on remote audits. As the reader may know, a remote audit is an audit performed off-site using information and communication technology. It mirrors all activities that are carried out during an on-site inspection. In simple terms, it is a robust alternative to a physical audit. Cook Medical’s experience with remote audits has demonstrated an adequate level of safety with no compromise to the overall reliability of assessments.
There are many benefits to optimizing regulatory and conformity assessment bodies and industry human and financial resources. Some of those benefits include minimizing the environmental footprint, increasing the speed of use, and quickening the execution of required inspections.
During COVID-19, the need for remote audits became even greater. Travel restrictions were implemented globally, and the various global lockdowns for public health meant that it was extremely difficult, if not impossible, to schedule on-site inspections. This all came at a time when our industry was tasked with ramping up production to meet the needs of the global patient population during a pandemic.
The overall response from global regulators was fragmented, so when steps were taken by regulators, the lack of a global approach meant that remote audits were not implemented in an effective manner.
The FDA was positive and has adopted various measures in this space that include the recent launch of a pilot program. The EU responded in January of 2021 with a system that pushed the authorization and approval of a remote inspection down to the member state level. This has only led to the fragmentation of the approach; in Europe, we now have to deal with 27 different competent authority interpretations.
Globally others responded, but the simple concept of remote audits highlighted the fact that even between the major regulatory bodies, there was not a cohesive and global approach.
This, of course, led to delays and confusion for the industry and, ultimately, made it more difficult to deliver a timely ramp-up in production and authorizations with the ongoing headache of arranging onsite inspections.
The bigger message here, however, is not just about remote audits. The COVID-19 pandemic has taught us to behave and manage our businesses in new ways. It has shown the need and the necessity to work together to solve problems and to find speedy and safe solutions in the world in which we live.
This pandemic knows no borders, doesn’t differentiate between countries, and certainly does not take account of different regulatory systems. In many ways, and unfortunately for us, COVID-19 has adapted and continues to adapt to our world. It operates globally, and when it hits a problem, it mutates at a very quick speed.
There is so much that we can learn and will learn from this pandemic. For the medtech industry and its regulators, it has shone a light on the lack of speed in our regulatory systems and the pace of change that is needed for the global way that we all operate. The concept of a remote audit is a good one, but the challenge for all of us is to ensure that we push ahead with the global implementation of a common approach across the global regulators.
The Medical Device Single Audit Program (MDSAP) was and is an excellent example of a good regulatory tool; however, we need to work on systems such as the single product review program and the global label requirements, to name two, as well as the recognition of key elements of each other’s regulatory systems.
By working together, both the medtech industry and the global regulators can ensure that we can design and build the global regulatory system that patients will need as we hopefully exit this pandemic.