Innovations in Medical Devices – Crisis as Motivation

By Helga Weires, Nerac Analyst

Originally Published May 1, 2023

“You never let a serious crisis go to waste” – Rahm Emanuel

Crisis, disaster, catastrophe.

The world has seen many, and there is no reason to think the world has seen the end of them. Since it is a given that somewhere, sometime another crisis will occur – be it natural or man-made, then why not always be in a state of intelligent preparation for it? Why put ourselves in a state of panic and hasty reaction rather than assessing conditions, recognizing opportunities and putting plans to action?

Times of crisis have been markers in history and will continue to occur. Armed conflict, natural disasters, and pandemics have a place in history not only for their direct impact but also for the innovations brought about because of them. According to an article in Science 2.0¹, the Black Plague, which devastated Europe in the 14^th century, resulted in the loss of approximately 1/3 of the population. This loss necessitated land owners to be more efficient and innovative, resulting in innovations in agricultural methods and devices. Similarly, the significant decrease in workers resulted in the need to innovate, eventually bringing about the advancements in renaissance technology which included the invention of the printing press in 1454.

With some natural disasters, there is little time to prepare. In others, conflict or changing weather patterns leading to raw material shortages provide a window of opportunity to act. Disasters, as in the Tohoku earthquake and tsunami, are often followed by equally disastrous repercussions – the Fukushima Daiichi nuclear disaster in this case. These repercussions can be catastrophic and should be expected; they require preparedness as much as the initial crisis.

Public health and natural disasters result in a common need. It is medical support – staff, supplies and devices which is a common denominator of need for natural and man-made disasters. A workshop held in 2018 by the Health and Medicine division of the National Academies had the goals of exploring the cause and effect of medical product shortages resulting from crises (public health or natural disaster) and of efforts and approaches to improve the prediction, prevention and response to medical product shortages.²

During the 2017 hurricane season an unexpected shortage of access and delivery devices for medical fluids IV saline solution and IV bags proved to be catastrophic. The greatest supply of IV bags for the US came from Puerto Rican facilities which were essentially shut down due to the devastation caused by hurricane Maria. The shortage was answered in part by encouraging imports from German and Spanish manufacturers.

The most recent world crisis, of course, is the COVID-19 pandemic. As of April 26, 2023 there were reported 764,474,387 confirmed cases globally and 6,915,286 deaths [WHO Coronavirus (COVID19) Dashboard]. The magnitude of this pandemic resulted in an unequalled challenge to and massive response of medical support.

Some companies were able to shift gears swiftly and innovate in the wake of the COVID-19 crisis. Beer makers and distilleries looked at their raw materials and equipment and decided to shift production to hand sanitizers. An Italian engineering company answered the desperate need for ventilators and used their 3D printing knowledge to manufacture ventilator valves.

These companies and a number of others have used the ingredients to innovate right where they stood. Recognizing a need prompting creativity, the ability to pivot from current development and utilizing current resources – these are some of the elements necessary for innovation in times of crisis.

Preparation for any catastrophic situation is key. A medical device manufacturer should investigate what types of medical devices are most important in times of public health/natural disaster emergencies. Durable medical equipment most needed in times of crisis include hospital beds, infusion pumps, oxygen equipment and accessories, suction pumps, ventilators, and airway pressure devices. The type of disaster, however, will influence medical support requirements. No matter what product the medical device manufacturer ordinarily makes, they can find a place and a way to respond to medical supply needs. Identification of resources leads to an understanding of limitations and of abilities. Inventory of finished products and of raw materials should be sufficient to last through challenging times. During a crisis is not the time for searching for alternate raw material suppliers – those relationships should be already set.

Times of crisis are perhaps the biggest challenge of just-in-time manufacturing practices and so a balance should exist so that shortages at critical moments do not occur. This is where creativity in finding supply chain solutions is paramount.

Flexibility in resource utilization is another important feature of a company prepared for crisis situations. Such a company is prepared to adapt manufacturing processes to accommodate equipment or workforce shortages. A medical device manufacturer has to understand the capacity of its available resources, be able to set realistic utilization targets for ongoing and new projects and modify the priorities of these projects as needed.

For the medical device manufacturer, regulatory requirements present a challenge in development of novel or modified devices during times of crisis. Understanding the regulatory exceptions which are possible when developing products during crisis is critical; these exceptions and guidelines are put forward in the FDA’s Emergency Use Authorization.

Probably the most important yet least concrete of the elements needed for responding to crisis involves a corporate-wide point of view. The beermakers and Italian engineers considered the COVID-19 crisis as an opportunity rather than just a problem affecting their own company. They were looking outside of their company’s situation, recognized a medical device shortage (unrelated to their businesses, incidentally), and used their knowledge, resources, and skills to develop a public health solution.

All catastrophes do provide powerfully positive opportunities – to learn about response, to dig deep into our collective creativity, to push us to answer a problem with novel solutions. In the words of Judy Smith, “There’s always an opportunity with crisis. Just as it forces an individual to look inside himself, it forces a company to reexamine its policies and practices.”

How Can Nerac Help?

Nerac’s resources and capabilities were not negatively impacted by COVID-19, as the work-from-home transition was quite seamless. We continue to be prepared as ever to assist our clients with their competitive intelligence, market research and technology research needs. We are eager to assist our clients as they address opportunities which may come about due to unexpected challenges, and in providing essential information to prepare for the future.

Contact us here to learn more about how we can help.

References

1. How the Bubonic Plague Made Europe Great https://www.science20.com/science_20/how_bubonic_plague_made_europe_great-29378
2. Medical Product Shortages During Disasters: Opportunities to Predict, Prevent and Respond (Proceedings of a Workshop – in Brief), https://www.nap.edu/read/25267/chapter/1
3. CDC Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html

4. WHO Coronavirus disease (COVID-19) Situation Report 105 https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200504-covid-19-sitrep-105.pdf?sfvrsn=4cdda8af_2