To be clear from the start—we are not discouraging anybody from trying to help. Feeling the weight of the current global crisis, many people are compelled to do their part and are making sacrifices to contribute to the effort to save lives. It’s an admirable quality and it is encouraging to see people come together for a positive goal. However, we also live in a complex world and good intentions with poor direction may not have the desired impact.
We’re not here to say we have all the answers though. We’re only writing to share some advice based on our product development experience and work for the medical industry.
The first thing we can say, is that panic never helped anybody. Especially in a time of crisis. Yes, time is of the essence, but there is still a need for level-headed thinking right now. It’s a time for ingenuity, creativity, and hard work, but the big picture must be kept in frame. Sewing a mask won’t help if it never gets to the hands of a nurse or doctor. Designing a ventilator won’t help if it can’t be made, or worse, if it fails in the field because corners were cut.
Consider the surge of blood donations after 9/11. Citizens were filled with a desire to help and waited in lines for hours to donate. But despite the sudden catastrophe, the infrastructure hadn’t changed. Blood can only be stored for a limited time, and there ultimately proved to be enough blood in the existing reserves to treat victims. The Red Cross was able to distribute excess donations around the country to save lives, but as many as 200,000 units eventually needed to be destroyed. While this was apparently not an overly dramatic uptick in unused donations, it does highlight how established systems can be overwhelmed in unusual circumstances.
Now consider the infrastructure of an ordinary hospital. Hospitals are typically stocked by buyers, many of whom supply multiple hospitals. The collective inventories and the amount of related information controlled by a small number of individuals can be enormous. These buyers know how to acquire supplies in a normal time, but this is far from a normal time.
Supply chains have been devastated. Many of the products used in the United States are manufactured and shipped from China, which has been locked down or limited for months. The producing countries also need the same supplies for themselves. Inventories of common items are sold out across the board.
On top of that, buyers are being overwhelmed with offers from Good Samaritans and scammers alike. They are being bombarded with calls and emails from people they do not know. Staple products are not available, prices are all over the map, and it is impossible to determine which sources are credible, which products are safe, and whether any of it is even real. Likewise, well-meaning Good Samaritans are unknowingly price-gouging medical facilities because they don’t have the resources, staff, and supply chains of larger manufacturers, and subsequently they are further contributing to the confusion at the buyer stage. (See an interesting NY Times article on the topic Here)
Then there’s the other elephant in the room that has been frequently overlooked in the last few weeks… The FDA still exists and its rules and regulations are still in effect. There have been a handful of emergency exemptions made, and an expedited review process has been established for COVID-19 related products, but it’s still far from the Wild West (See the FDA’s FAQs on COVID-19 equipment shortages). While it seems unfortunate that there is so much red tape in medical product development, particularly in times of need, the reality is that there are reasons the rules exist. And like them or not, they do still exist.
Medical professionals and patients still need to be protected, and they need to know the products they purchase and use are going to work. When it comes to a genuine life or death situation, is the donated or hastily manufactured equipment actually effective? Does the hospital have somewhere to store it? Does the staff have enough inventory of things that are actually needed? How long will it last? Who made it? Were corners cut? Were any toxic materials used? Was it contaminated by whoever built or delivered it? If the hospital doesn’t know where it came from, how it was made, or what it’s made out of… things can get problematic.
However, we are not saying to stop producing, to stop creating, to stop ideating. We’re only saying that the full supply chain needs to be considered, along with any rules and regulations that will constrain charitable endeavors when reality comes to the table. We are not looking to make a stand on politics, rules, or regulations—we’re only relaying our understanding of the current situation and what can be done to get the most out of relief efforts.
If you want to make and donate masks, by all means do so, but make sure you’re using the right materials and sanitation practices, that your construction will be effective and reliable, that masks are needed where you can deliver them, and that you know who needs to receive them so your efforts can be put to use. If you want to design a ventilator, just realize that mass production is slow to start—tooling takes time, assembly will require manpower, and in the end, these machines will still require time consuming FDA review. If you bypass the right channels, your device may never see the light of day, or you could be litigated, even if your intentions were good.
It should also be understood that there are stringent guidelines on the classification of medical products. For example, “surgical apparel” that is used to prevent infection in the operating room is not just clothing. It is considered a Class II device, which involves a tremendous amount of work to clear with the FDA and put on the market. It’s packaging also needs to be designed and passed through sterilization validation. The supply chain needs to be traceable and documented. And if you’re selling a product directly to a hospital, even if it’s at a financial loss, you are liable for that product.
Currently, there are some unique scenarios coming to light where the normal rules have been bypassed. For instance, an individual in Italy began 3D printing needed ventilator valve components and supplying them to a nearby hospital without permission from the device manufacturer. The public became outraged as word spread that this individual was being sued for infringement by the device company, who was also price gouging hospitals for the same part. The twist was—there was no lawsuit OR price gouging—updated reports explain that the company is, in fact, struggling to keep up with demand due to supply chain constraints, and to date has taken no legal action against the printed part supplier. Those printed parts likely saved lives, but they could also fail or cause contamination. Remember, they were reverse engineered, built using less a robust process, and have not been tested or approved by anyone. Down the road, individuals like this could be heralded as heroes or fined and sued into financial ruin. We just don’t know. (Full Article)
Closer to home, SPARK is currently working with First Wave Technologies on a rush project to adapt their anesthesia device to function as a ventilator during the crisis. The project had previously passed through initial FDA reviews, but lacked capital for tooling. Now funding has become available and a production vendor has been secured, so they hope to contribute to the effort while still complying with federal regulations. On the other hand, we are also working with a local physician and inventor on the development of a face shield product. Given time constraints and the regulatory process, the product may or may not be completed in time to help with the current situation. That doesn’t mean it’s a wasted effort though. All we can do is keep our clients informed, make clear the realities of the process, and do our best to be expedient, but thorough in our work.
At the end of the day it is unfortunately impossible to have an infinite supply of every life saving device available at all times. Hindsight will always be 20/20 and every detail of a global event will undoubtedly be analyzed and hopefully learned from. But regardless of history, policies, decisions, accidents, or coincidences, we are where we are. Individuals and companies will find interesting and inspiring ways to re-purpose and redirect their knowledge and skills. Some will fail, but some just might change the game. The key is to make sure your efforts are helping and not hurting, because in times of crisis, all any of us can do is our best with what we have.
Be smart and stay safe!