Research has shown that an individual’s thought processes change under stress, becoming more erratic as the allotted (or perceived) response time is shortened. When decision time is compressed, we narrow our focus and our ability to assess and respond appropriately to risk changes. The only way to counter this is via training. If you look at professions that require very fast response times to urgent situations, you see professions with a heavy emphasis on training. This includes the military, health personnel, and self-defense experts.
When, as a society, we experience intense circumstances that urge us towards emergency action, we need to pause and consider our thought processes. The more time we give ourselves before we act, the better the odds are that our actions will be the right ones. This is as true for supplying vital medical supplies as it is for buying toilet paper and hand sanitizer. When we are fearful today, we want immediate action, but the wrong actions can have serious repercussions for the long months ahead. I don’t advocate lengthy pondering in a crisis, but every project manager knows that an hour or two of careful planning can save months (if not years) of effort.
In times like this, I go back to my own training. I may not be able to intubate a patient or deploy a military special-ops team, but I do know how to design and manufacture medical products. Design has its own set of steps that are drilled into its practitioners over and over.
Floating in a sea of broadcast panic and worst-case scenarios, it can be easy to lose site of the reality of the situation we are trying to improve. You may find yourself seeking solutions for worst-case scenarios, rather than the situation at hand.
For example, we are at the start of the pandemic. While we are seeing escalating numbers in the US, and have watched the virus ravage other countries, we are still at a point where shortages are limited to a few hard-hit areas. The terrifying numbers that are expected have not happened yet, and every day we are implementing policies to drive those patient numbers down. We aren’t just working with what we can throw together in days from the existing contents of a closet, so we can pull together the resources for long-term solutions. Pandemics also come in waves. There will be a very rapid increase in cases that will overwhelm our health resources for a time, but we will also see that peak disappear. Unlike Polio, where survivors of the disease needed ventilation equipment permanently, the equipment that is produced to address the immediate need will have to be dealt with in the aftermath. Products whose value lies solely in the fact that “there is nothing else” will become worthless once the crisis ends. If they are not well made enough to refurbish and store, they will not be there during potential “rebound” waves of the virus, they cannot be shipped to other countries yet to battle the virus, and they cannot be warehoused against future needs.
Besides understanding the timing of the challenge, we need to remember where we live. The United States is one of the wealthiest and best resourced countries in the world, with extensive heavy manufacturing and raw material resources. While many products have been sourced from overseas to reduce costs, there remains a large US manufacturing base to allow us to remain autonomous in situations just like this. We are not alone on Mars or enclosed in a space-bound shuttle with a faulty air supply, so we should not be restricting our solution options as if we were.
Finally, every good designer needs to know their users. In the case of an epidemic, we are talking about front line health providers. While they are highly educated and skilled, they are also working at their extreme physical and mental limits. Medical products need to operate with minimal oversight, be easy to setup and move, and require minimal deviation to the muscle memory training these individuals are relying on through their fatigue and constant stress.
This is a heavy argument against radical, dispersed invention to address the large-scale challenge. The effort to retrain personnel in a crisis environment, or to ask personnel to work with a dozen unfamiliar versions of a piece of equipment, is a recipe for tragedy.
During a sharp rise in a single infectious disease, we need to rapidly increase the availability of medical products to prevent infection, aid detection, and treat critical patients. In some cases, like in the creation of new tests and vaccines, this requires invention. But for most of the shortages we are experiencing, we don’t necessarily need new products, just access to what is needed, when it is needed.
This should give us pause when encountering the wide range of medical product design challenges that are currently being issued by different groups and organizations. There is something glamorous about inventing physical things that causes society to focus on design to solve our challenges, even when we don’t need new designs. America has a long (and I think totally awesome) romance with hacking and jury-rigging solutions to immediate problems. Even now, we have inspiring clinical MacGuyvers who are working miracles to take care of their patients with whatever they have on hand in their hospitals. There will continue to be (again, context specific) challenges that will need to be met wherever they occur. But this is not an answer to a large-scale availability challenge.
Medical products are not in short supply due to a lack of designs. Amazing, extensively tested and heavily manufactured designs for masks, respirators, latex gloves, IV pumps and ventilators, all of which our clinical workers are used to working with, already exist. In the last 20 years alone, the FDA has approved over 128 different ventilator designs, developed by 40-plus companies. There are “luxury” versions, home models, highly portable models, electricity independent models, the list goes on. As such, coming up with new, untried designs is unlikely to address the challenge of product availability.
What will increase medical product availability is addressing the many challenges that come in sourcing, manufacturing, warehousing, distributing, and transporting those designs . The path from raw material to product in a doctor’s or patient’s hand is a long one, with many potential links that can be interrupted or slowed by efforts to minimize the spread of the virus. Innovation is badly needed to find workarounds to these broken chains, and to greatly improve the supply chain capacity of those that remain intact.
Logistical infrastructure (factories, warehouses, distribution centers and transportation conduits) typically evolve to keep costs low while meeting consumer expectation for delivery times. In this new context, these systems need to be reworked for speed to meet the urgent demand, while keeping the workforce safe. This will pose a significant challenge, since industrial workspaces are designed for ergonomics and efficiency, and not interpersonal isolation.
Only once we have stepped back, checking our assumptions and identifying what the challenges really are, can we turn to finding solutions.
Like the outcome of any good brainstorming session, we will need a wide range of specific solutions from many different directions to evaluate and implement.
A lot of media attention has been given to President Trump’s recent invocation of the Defense Production Act, a move that would allow for direct intervention of the US government in critical goods manufacturing during a national crisis. However, little is known at this time as to what those interventions might be. Meanwhile, my email inbox is filled with newsletters and announcements from regulatory bodies, trade groups, industry organizations, all listing the many ways that this problem is being attacked. These include the following:
All these steps minimize base level demand for medical supplies from non-virus applications.
The FDA is reducing the burden of reporting changes to existing critical product designs by medical manufacturers. Usually, ANY change to a product (whether a material, design, or key supplier) involves a long test, documentation and approval process before it can be implemented. This is giving manufacturers maximum flexibility to find new part sources, as well as changing or even eliminating components to allow them to get functional product out the door. In addition to working with manufacturers, the FDA is providing guidance to providers. While medical manufacturers usually face hefty penalty for advertising off-label, the FDA itself is providing cautious advice on using home care ventilators, sleep apnea devices, and industrial N95 respirators for hospital use.
Existing US ventilator companies are ramping their production at unheard-of rates. Ventec Life, a small manufacturer of a portable, low cost ventilator that was approved by the FDA 2 years ago, is planning on going from 150 units per month to nearly 2000 per month by the middle of the year. Every ventilator manufacturer in the US (and worldwide) is reporting similar high-intensity efforts to build capacity. Ethylene Oxide sterilization companies, hard hit with changing environmental regulations over the last several months, have petitioned to reopen recently closed sterilization factories to address the increased sterile product demand.
Even companies that don’t typically work in the medical products space are assessing their capabilities to contribute. In some cases, this means becoming direct manufacturers of key products, as with several instances of alcohol producers turning to the production of hand sanitizer. While not quite the same, requirements for food safety and pharmaceutical production have enough similarities to make this less bizarre than it may seem.
3M, a major manufacturer of personal protective equipment, recently announced a partnership with Ford Motor Company to produce their PAPRs (powered air-purifying respirators). This is after 3M had already doubled its global production to over a billion N95 masks a year. While there have been talks about US car companies joining in the effort, they will likely not be following the classic World War 2 example of building tanks in automotive factories.
What corporate giants like Ford bring to the table are their resources. Companies the size of Ford are heavily vertically integrated, controlling every logistical element in their supply chain. They don’t just make cars; they make the materials and tools needed to make the cars as well.
While most people are aware of the high costs of healthcare in the US, most may not realize that the infrastructure that supplies the physical products is nowhere near the scale of industries like automotive, aerospace, construction, or gas. Partnering with larger companies give medical manufacturers access to resources most could only dream of outside a national crisis.
Considering these many high energy efforts, there is still a need to retain capacity for non-Covid-19 specific medical supplies. Individuals are still having heart attacks, breaking bones, and battling cancer. There are many medical manufacturers whose supply chains have been affected by the virus, even if their products are not as high profile at the current time. These suppliers will need to focus their efforts on reinforcing their supply chains as well to prevent shortages in the upcoming months. If we divert all of them to masks and ventilators, we rob our future selves of other critical products.
Finally, while public urgency is driving immediate actions, there are groups looking towards what can be done long-term about future interruptions to medical supplies, A group of US Senators recently submitted a bill requesting resources to analyze the United States’ current reliance on foreign manufactured drugs, chemicals, and medical supplies. This would provide an expert resource to consult with multiple branches of the government in addressing nation-wide medical emergencies.
I recently commented in another Xinova blog that what will be remarkable about innovation efforts in the next couple of months will not be what is invented, as how quickly and brutally ideas will be tried and discarded. The efforts of both industry novices and experts alike at this point are still “prototypes.” They are all first attempts to address a situation that has never been experienced by our society. This is the biggest challenge in trying to design new products or systems under an extreme time commitment: there is no time to understand the limits of a design before it is put into use.
There will no doubt be multiple failures in our leaders, our systems and our technologies as they undergo what is essentially highly publicized field testing. What will be crucial is that we learn, and how we process and adjust to arrive at improved solutions as rapidly as possible in the aftermath.
I have been incredibly proud to see the rapid, wide-spread response across my industry to this challenge. At every turn, I see policy changes, resource re-allocation and scaling at a speed I would never have thought possible two months ago, let alone under the trying conditions we find ourselves. That pride extends to everyone trying to be part of the solution, for every problem we face in the coming months. Thank-you.
Bio: Xinova’s own medical device Jedi, Dr. Kate Stephenson is a Stanford University Mechanical Engineering PhD with over 20 years of design experience, 15 of those spent exclusively in new medical device products. An additive manufacturing expert with advanced supply chain management expertise, she is the founder of Dyad Engineering, a consulting firm that provides highly personalized, technical consulting services for clients seeking strategic medical device expertise. Built on both deep technical knowledge and broad industry experience acquired from over 60 device projects, Kate focuses on short-term, high-value projects that de-risk new initiatives, and provide clear, actionable pathways for growth. Previous clients include startup founders, investors, industry suppliers, academic groups, and corporate innovation programs.
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