As Neurodiagnostic professionals, our work requires us to be innovative, to think critically and to troubleshoot, troubleshoot, troubleshoot. For those of us who can think on our feet and be creative, there are many benefits, both personally and professionally. We are able to meet a need in a timely manner, improve a process, and enhance a patient’s (or friend’s, or loved one’s) experience or outcome. The art of effective troubleshooting is mentally healthy. When we focus on solving a problem and accomplishing a goal, the outcome, whether successful or not, is a learning experience. When shared, our achievements can grow into so much more.
Our professional niche is relatively small, and our supply options may not always include the ideal product to fill a need. Therefore, we learn to be creative in how we use the supplies available to us, while also conforming within the boundaries set forth by facility policies and procedures, OSHA regulations, Joint Commission standards, etc. COVID-19 required all of us to rethink and reinvent the way we do our work and interact, while maintaining the highest quality studies and keeping our patients and ourselves as safe as possible.
For Tabitha Althoff, COVID-19 had her rethinking reusable supplies and ways to minimize patient/technologist interaction time. It is likely that you, too, have learned to work creatively over the past year. Maybe you invented a new process or need a different kind of product that is not currently available. Do you have a ‘million-dollar’ idea? In this Tech Tips article, we will share the steps Althoffs took to turn her idea into a tangible product: a disposable single-use applicator designed to eliminate cross-contamination when doing long-term monitoring EEG hookups using collodion.
For decades there has only been one option for collodion application, a metal, reusable applicator. The problem with this metal aerator is that it is difficult to fully clean, especially considering the increased infection prevention measures now in place because of COVID-19.
“If you disassemble the metal, you actually break the seal, and you can’t sterilize the inside,” said Althoffs. “When the pandemic hit, we had to throw our metal ones out because they went into COVID rooms. We were losing supplies rapidly. Being a manager, I thought ‘This is killing my budget.’”
So, Althoffs sketched out a collodion applicator and jokingly told her husband, Kyle, that she would buy him a 3-D printer (something he’s wanted for a long time), but he would need to re-create her applicator design with it. They ordered a 3-D printer from Amazon and within a few days her team was testing out beta versions of her design.
The team first started using the disposable devices only on patients in COVID-19 rooms to keep cross-contamination down. Shortly after, with the increasing and cyclic surges in COVID-19 cases, Althoffs quickly realized she could not print enough to keep up with the demand. “I had our 3-D printer running around the clock because we could only make so many at a time; it took 14 hours to print six,” said Althoffs. “I didn’t even think of getting a patent. I was just thinking of how to make my team safe. I was printing these at home to give to my team so they could use it in the COVID rooms.”
Then one day, one of her senior techs asked Althoffs if she was getting a patent. “I went home that night and looked on LegalZoom for a patent.”
Before applying for a patent, it is important to do some research and planning. First and foremost, you will want to confirm that a similar product is not already patented. It would also be prudent to do a simple internet search for similar devices, using keywords from the materials used to make the product, the utility of the product, the audience (i.e., EEG technologists), etc. A good resource to help you in your search is Google Patents which helps you search and read the full text of patents from around the world.
For Althoffs’s device, the type of plastic needed for 3-D printing would need to be well considered. The type of plastic used depends on the type of 3-D printer, so it was important for the Althoffs to consider early on. Costs need to be kept in consideration for hospitals and labs to afford bulk purchases, and the plastic also has to be durable enough for collodion application. There are a lot of things to consider — from researching product options, like how the manufacturer would process it and how to keep the price down, to researching types of packaging. Before applying for a patent, all of these things need to be planned. Research and planning can make or break a patent approval.
The Althoffs tested the plastics’ interaction with collodion since it has been shown to damage some plastic devices and tubing used in the ICU (Fitzgerald et al., 2019). They also needed to determine how quickly the applicator could be used once printed (i.e., how long to cool before use). In the end, they determined the applicators would take 14 hours to print with an additional 2 hours to cool properly before use. This information is important to plan out because it may drive business decisions later.
“I had to figure out what type of patent I wanted. Did I want a Utility Patent? Did I want a Provisional Patent? Did I want a Trademark Patent?” said Althoffs. “I had to research to see if something like this already exists. And if so, what does their patent entail? And if their patent has limits, what am I changing to make it a new patent?”
LegalZoom guides you to either a utility or provisional patent. A provisional patent allows a full year to complete the plan and a utility patent is a completed concept and plan. The cost for a utility patent in the US is approximately $2400 and, in the UK, $7000. The European patent can be bundled to include many countries, or by individual countries. It is important to get a patent in a country or countries where your manufacturer has representative offices.
Patents in the US take approximately two years to go through. With COVID-19 surging on into 2021, Althoffs didn’t want to wait that long. The process for a European patent is much less time-consuming, but it requires applying for and receiving a “Patent Pending” status in the US first. The Althoffs’ invention is now patented in 47 European countries.
After acquiring the European patent, Althoffs then worked with manufacturers to produce a mold to mass manufacturer the device. Because her US patent was still pending, she consulted with device manufacturers in Europe, where her patent is already protected.
The next step was to create a company to formally distribute her device. With COVID-19 surging around the globe, time was of the essence and impacted much of their decision making. As sole proprietors, all they had to do was open a business bank account, and they could get started right away. Opening a business was a brand-new experience with more responsibilities, such as developing a company name, part numbers, a logo, etc.
A fixed business loan helped cover extra expenses that were beginning to add up. For example, they needed an industrial printer to develop packaging, business cards and other business materials. The new business owners also found they needed to cover the cost of floating inventory, since money from sales would generally not be received for 30–45 days after shipping the product out.
The business loan also helped with the cost of creating the casting mold for mass production. One mold will produce approximately 140,000 applicators, so the Althoffs had to put on their business hats to determine the cost of supply from a business standpoint. Once the mold is used to its limit, the quality of the product is decreased, and a new mold would be needed. Projecting costs over time is essential.
The Althoffs also found they needed liability insurance to cover themselves financially when the product is being used in the US. Insurance coverage will also protect them from other types of loss, such as lost manufacturer inventory and cost of the mold if it breaks.
If all these costs sound intimidating, Althoffs recommends partnering with an investor or a device/supply company to help with the financial burden of bringing a product to market. Most manufacturers in our profession are eager for input on existing or innovative ideas for new products.
The FDA website lists all products and any required clearance for similar products. To obtain FDA clearance, a series of questions must be answered in order to determine the type of FDA clearance, if any, that is required: How is the product going to be used? Does it contain chemicals? What is its purpose? How does it assist in the field or in this type of work? While Althoffs’s product did not require FDA clearance, it is still recommended to seek FDA approval and going through the process to determine necessity.
Once the US patent was pending, the Althoffs began to network with companies that sell medical and EEG supplies. They reached out to salespeople, such as those who exhibit at ASET conferences, and cold-called or emailed to solicit interest in selling their device. They then needed to develop a business plan, a product presentation, and non-disclosure agreements (NDAs) to protect themselves and their invention.
It’s a lot of work to bring an idea to mass distribution but the rewards of accomplishment and achievement are invaluable lessons. Maybe it is time for you to think outside of the box, to imagine the unexpected and to improve upon the currently acceptable. Althoffs is already working to bring a second invention to the market What is your ‘million dollar’ idea?
Fitzgerald MP, Donnelly M, Vala L, Allen-Napoli L, Abend NS. Collodion remover can degrade plastic-containing medical devices commonly used in the intensive care unit. 2019. Neurodiagn J. 59(3): 163–8.
Authors: Anna M. Bonner, BA, R. EEG T., RPSGT and R. Bliss Mishler, MS, PT