The impact of the COVID-19 pandemic on the medical device industry has been staggering and complex.
The shortage of certain types of equipment — PPE (personal protective equipment), ventilators, and testing kits — resulted in companies and governments around the globe scrambling to step up production. But, the increased focus and the frenetic pace required to manufacture adequate numbers of these devices means that resources have been pulled from the production of other, non-essential medical equipment. As a result, the impact of the pandemic has been incredibly uneven across the industry.
Additionally, lockdown protocols across different sectors affected how quickly and efficiently needed equipment could be produced. The lockdowns required the development and implementation of new workflow procedures, disrupted supply chains, and terminated many of the clinical trials that are a pivotal part of production.
As companies grappled with these shifting realities, many governments began to restrict the export of medical components and equipment. While this has led to a surge in domestic production around the globe, that surge has not always gone smoothly nor has it always been able to meet domestic demand. In late 2020, PPE shortages were still an issue in the USA.
These rapid shifts and complex challenges have meant that all sectors of the medtech industry have needed to become more creative and flexible in order to find solutions that both support human health and keep the industry viable. Let’s look at the key trends that have emerged.
Global Regulatory Changes
In order to meet the unprecedented need for certain types of medical devices (including PPE, ventilators, and diagnostic test kits), nations around the world have introduced regulatory changes that affect the medical device industry.
In the United States, the Food & Drug Administration (FDA) has issued “Emergency Use Authorizations” (EUA) for diagnostic testing kits and PPE. The implementation of EUAs means that the FDA can expedite the review process for these products, getting them approved, manufactured, and into the hands of health care providers more quickly.
In Europe, the European Union decided to postpone the implementation of its new Medical Device Regulation (MDR) from May 26, 2020 to May 26, 2021. The MDR is a set of regulations that medtech firms are required to follow. According to a piece at Medgadget, one stipulation of the MDR is that manufacturers, “conduct Post Market Clinical Follow-Up (PMCF) studies to demonstrate the continued safety and performance of their devices, as well as capture any emerging risks these may carry.”
However, the COVID-19 pandemic has disrupted clinical studies (which are required of medical device manufacturers around the world). Redeployment of medical professionals, lockdowns, travel bans, facility restrictions, and the need to social distance have made it difficult to carry out clinical trials. The postponement of the new MDR will expedite the production of much-needed medical equipment during this pandemic era.
Increasing Research Funding
Around the world, funding agencies are providing grants in order to fast-track research into medical devices and treatment options that would assist with the pandemic. While new research is of course encouraged, many agencies also offer funding to those who have existing projects underway, so that they can more easily shift their focus to COVID-19.
Surge in Domestic Production of PPE
The U.S Food & Drug Administration defines personal protective equipment (PPE) as:
protective clothing, helmets, gloves, face shields, goggles, facemasks and/or respirators or other equipment designed to protect the wearer from injury or the spread of infection or illness . . . When used properly, PPE acts as a barrier between infectious materials such as viral and bacterial contaminants and your skin, mouth, nose, or eyes (mucous membranes).
PPE is crucial in combating the spread of COVID-19. The virus primarily spreads through the respiratory droplets and aerosols expelled by an infected person as they talk, sneeze, or cough. It may also spread when one person touches an infected person and then touches their own mouth, nose, or eyes. While healthcare workers have always used PPE to minimize the spread of infection, the need for the devices exploded — both in the healthcare field and in the general public — in response to the high contagiousness and rapid spread of COVID-19
In order to ensure that their own healthcare workers had adequate supplies of PPE, many governments began restricting the export of PPE and its components. This resulted in supply chain disruptions, making it even more difficult for some countries to meet demand. It became clear that domestic production of PPE is a necessity.
In the USA, President-elect Joe Biden has prioritized domestic production of PPE. While the immediate goal is to overcome trade barriers and provide a reliable, sustainable, and high-quality supply of PPE for American healthcare workers, this decision may also engender exciting innovation. For example, as pointed out in an op-ed piece in The Hill, a shift to reusable PPE would not only make it easier for manufacturers to meet demand and lower costs for the healthcare field, but it could also reduce “energy consumption, greenhouse gas emissions, total water consumption, and solid waste generation.”
The shift to domestic production of PPE is still in its infancy. Even companies that have the equipment and capabilities to produce PPE might experience supply chain issues at this time and need to adhere to all national regulatory and certification policies. Still, there has been a very real shift towards domestic production of PPE that should continue to trend upwards.
Urgent Need For In Vitro Diagnostic Equipment
A key tool in the battle against COVID-19 is in vitro diagnostic (IVD) equipment – the testing kit. Identifying individuals infected with the coronavirus at an early date, so that they can self-isolate, is crucial to stopping community spread.
Early in the pandemic, several companies shifted to developing IVD products. Once their kits were approved by their national health agencies, these companies pushed forward with production, in order to meet the increasing demand. Other firms continue to come on board with the development of new IVD equipment, which will further ramp up production once their kits meet regulatory approval. Trends do show that there will continue to be substantial demand for IVD equipment well into the future.
Downscaling Production Of Aesthetic Medical Devices
It’s been estimated that 70-100% of elective surgeries in the USA have been delayed, postponed, or cancelled as the country grapples with an overwhelmed health care system. In particular, aesthetic procedures that involve injectables or implants, other types of cosmetic procedures, and bariatric surgery are being postponed since they don’t have a major impact on quality of life.
The demand for aesthetic medical devices will likely remain low for several months. In a piece at NS Medical Devices, Jamie Bell says that, “The recovery of procedures will start when new Covid-19 admissions have declined to low levels below 1.5 new cases per 100,000 of the population, and surgeries related to cancer or acute pain will be implemented first.”
Industry analysts are concerned that once these types of procedures become commonplace again, the resurgence of demand will be quite strong, which could make it difficult for manufacturers to meet demand at that time. And, in the interim, these manufacturers essentially have to sit in a holding pattern (unless they choose to innovate), which can strain business models and cause financial stress.
Shifting Needs For Aortic and Coronary Stent Grafts
Aortic and coronary stents are small tubes that are inserted into a person’s body to treat aneurysms and narrowed coronary arteries. Stent procedures are minimally invasive, since surgery is not required (the stents are inserted by means of a catheter device).
Before the pandemic hit, the market for both types of stents was expected to grow steadily over the next decade. However, in non-urgent cases, stent insertion procedures are being postponed. Manufacturers of these devices need to be innovative in order to wait out the pandemic. This may mean shifting business plans to weather the wait or developing new processes and products in order to continue production.
Increasing Use of Robotics
NS Medical Devices currently reports an increasing use of robotics and automation in India only, as a response to workforce shortages in the medical device industry. However, it’s logical to assume that other countries will follow suit as a way to expedite production while respecting lockdown procedures and personal safety concerns.
Getting automated processes in place is an astute long-term strategy for medical device companies. Robotics would allow manufacturers to ramp up production much more quickly should a similar health crisis occur in the future.
The world has undergone massive changes in 2020, which has caused turbulence in the medical device industry. Some manufacturers have seen their production levels fall precariously while others have ramped up production to try to meet ever-increasing demand. To stay viable, medical device companies may have to shift focus, change priorities, create new business models, work within new regulations, or embrace innovation. For many, the rapid changes have been difficult to handle. But, the medical device industry has a key role to play in the containment of COVID-19. Continued adaptation and innovation is necessary for human health.