How to address the COVID-19 challenges of the medical devices industry

The COVID-19 pandemic has significantly altered conditions for the medical devices industry. The drivers of demand have shifted: ICU ventilators and CPAP machines have been priorities, while there has been a decline, albeit temporary, in devices for elective surgery. More than ever, medical device manufacturers need ways to improve their responsiveness to rapid and unpredictable market changes, the supply chain visibility, and their ability to leverage the resources at their disposal, internally and externally.

Medical device manufacturing is one of the most critical industries in times of pandemics. Ironically, it is also one of those that are the most affected. The COVID-19 pandemic has brought opportunity but has also left medical device manufacturers scrambling to cope with supply chain disruptions, new political agendas, and evolving health regulations.

What are the challenges in meeting ICU devices demand?

COVID-19 causes respiratory problems that can be life-threatening. This has meant an unprecedented surge in the demand for intensive care unit (ICU) ventilators and continuous positive airway pressure (CPAP) machines. However, the pandemic has also affected the workforces of manufacturers making these devices. Infection and sickness have kept staff away from work. With many manufacturing facilities based in China, the epicenter of the COVID-19 outbreak, the suspension of industrial activities there has affected enterprises relying on Chinese facilities for components and products. Reorganization of manufacturing operations to minimize the transmission of the virus on premises has also impacted productivity.

Manufacturers face additional challenges in shipping and servicing the medical devices that they offer. National economy lockdowns and travel restrictions are hampering the flow of devices and services across borders. Post-sales activities including installation and maintenance have become difficult to carry out. In many cases, there is pressure to start using devices wherever and as soon as possible. Manufacturers may have little or no idea of where their products have ended up, making predictive maintenance and timely intervention difficult or impossible.

Device development and certification to meet new market needs and regulatory requirements are also hurting. The intense focus on COVID-19 treatment in healthcare organizations has left them no time to collaborate with manufacturers for clinical trials and data collection essential for regulatory approvals.

How can medical device manufacturers move forward?

In this time of COVID-19, the status quo is not an option. As a medical device manufacturer, you need to adapt rapidly and find the best way forward. If you do not supply ICU devices now, patients will suffer, healthcare customers might defect, and the future of your business could be at risk.

On the bright side however, there is real opportunity for medical device manufacturing, even with the challenges described above. While countries attempt to ease shortages by importing equipment, domestic manufacturing of many devices has increased during the crisis. The pandemic has brought home the message that relying on imports of essential medical devices is a huge risk and a serious threat to public health security. Bolstering domestic production capacity of medical devices and supplies is the major focus for many countries as COVID-19 continues to spread. Domestic manufacturing of essential medical devices is not affected by trade barriers, whilst being able to provide product quality and stability in the domestic ecosystem.

In parallel, regulatory bodies have taken steps to ease requirements for certification in the light of the pandemic. The European Union, for example, has postponed its forthcoming Medical Device Regulation (MDR) by one year. MDR will change the approval process for many new medical products and the re-certification of existing devices, but postponement will take pressure off medical device manufacturers and let them better grapple with the impact of COVID-19. In the United States, the Food and Drug Administration (FDA) can accelerate the approval timeline for selected diagnostic devices and tests. With Emergency Use Authorization (EUA), the FDA can speed up pre-market analysis to allow devices to enter the market faster.

Business visibility, understanding, and quality are vital

While collaboration between the public and private sector can boost prospects for the industry, the readiness of your medical device manufacturing supply chain will also be decisive for you to leverage the opportunity.

To tackle the constantly evolving situation, you need the ability to simulate any business scenario instantaneously and see the impact across multiple business functions. The COVID-19 pandemic is forcing changes across the board daily, invalidating traditional approaches of collating data over days or even weeks.

For example, in the face of operating constraints, you may have reduced the number and types of devices that your organization would otherwise have produced. You have tweaked the resources and the facilities available to you to focus the entire capacity of the organization on producing only the key devices required. Instantaneous simulation gives you visibility of your tentative output and the raw materials (RM) and suppliers needed to fulfill this. Now, suppose that one of your suppliers is unable to provide the RM to you in time. Is there an alternative source for the same RM? Can you work with that source? Immediate simulation can give you the answer and help you to be ready for any eventuality.

You also need the best understanding possible of your demand. Demand forecasting tools can now help you to identify trends, examine the impact of external factors on business previously, and project their effects in the current period of the COVID-19 pandemic. While perfection in forecasting may never be possible, the better you understand your demand, the better you can align your business operations.

Finally, remember that quality must still be the cornerstone of all your supply chain and business activities. Even during a pandemic like COVID-19, simple actions can help to concentrate on quality, like making sure your entire organization can access the same version of business data. By working with one version of the truth, visibility, understanding, and quality can all benefit. When that happens, you take a big step forward to greater patient wellbeing, healthcare customer satisfaction, productivity, and profitability.



Author: Krishna Mamidipaka