"I Have an Idea:" The CRNA Inventor
Congress Daily: Jean, how did your invention of the Error Recovery and Mitigation Aide (ERMA) come about?
Jean Snyder: In 2008, The Joint Commission (TJC) released a national patient safety goal (NPSG 03.04.01) that all vials and syringes were to be saved for the duration of an anesthetic. I noticed that CRNAs were saving these items in baggies and emesis basins, which were not safe for sharps disposal. A short time later, TJC removed this requirement for anesthesia. The rule made sense, we just did not have a way to comply.
A few years later, I read an online blog where a mother recounted the death of her son during a routine surgery because of an anesthesia medication error. As a mother, my heart grieved for her loss. As an anesthesia provider, I knew I needed to find a solution. Providers are human and despite every attempt otherwise, we make errors. I wanted to find a way to provide an anesthesia provider the ability to recognize an error and hopefully mitigate the error. From this, I developed the ERMA (Error Reduction and Mitigation Aide) prototype.
Congress Daily: Diane, how did your invention of the Pediatric Device for Induction of Anesthesia (PeDIA) come about?
Diane Miller: On a cold winter morning, I walked into my patient's preop room and was met by a blood-curdling scream. There, in front of me, stood my pediatric patient with her hand in a stop-right-there position, tears running down her face, repeating the same thing over and over, "No mask, no mask!" None of my child-whisperer tricks worked on this veteran of the operating room. At the ripe young age of four, "Patient Z" had seen her fair share of ORs. She knew all too well what was coming: the stinky, scary claustrophobic anesthesia mask and the brutane needed for her to accept it. She cried the whole way back to the operating room and struggled through the induction: kicked, punched and tried to push the mask away. It took three adults to hold her down and, as I held the mask over her face, her pleading eyes stared up at me and broke my heart. At that moment, I knew there had to be a better way.
Pediatric anxiety during induction of anesthesia is well studied and documented. I knew what could happen during induction but I didn't know how far reaching its effects were. Over 50% of children have anxiety during induction; half of those develop maladaptive behavior changes at home that can last two weeks to a year or, like little "Z," for years. With research, I found many pharmacological and non-pharmacological approaches to deal with this century-long problem, but none were satisfactory for one reason or another and studies contradicted each other. Kids continued to have anxiety with the mask induction so I thought to myself, "Well, let's just get rid of the mask." And since we always promise them a balloon (the reservoir bag) in the operating room, why not just give them one?
Congress Daily: If someone has a good idea for a new anesthesia device of some kind, is there a ballpark timeframe that they will have to invest to bring their device to fruition? There is the process to patent the idea, as well as a finding a company that can manufacture the device, the actual manufacturing process itself, bringing the product to market, and then marketing it. If all the stars align and everything goes without a hitch, these processes have the potential to be streamlined. But what would a more realistic timeframe look like?
Snyder: There is no set time frame because of so many variables. The thought behind a patentable device must move from tacit knowledge to explicit knowledge, meaning the inventor needs to solve the issue of the logistics of what problem you are solving and how you envision your design. The second variable is the path: will you travel the path alone or use a medical incubator? The third issue is the complexity of the device. More complex devices require more time to travel through regulatory agencies. It is important to know that the first time has a steep learning curve. The speed at which an inventor can realize their patent and market the device is also influenced by how much time and money you have to devote to the process.
Miller: The patent is the only part of that equation with a relative timeframe. From patent-pending to full patent, an inventor can count on at least 3 1/2 years, but it could take much longer. You file your patent-pending and about 18 months later, it will be published at the United States Patent and Trade Office (USPTO). Another 18 months will go by before you hear a peep from the USPTO. That is when your examiner will try to discredit all your patent claims and basically get it thrown out. This is the job of the USPTO, to discredit claims that may infringe on another's patent rights. As annoying as it is to defend your claims, be glad they are as thorough as they are. It's the reason the United States has the best reputation in the world for patent rights. After that, you go to work to prove your claims. This process goes back and forth for a while until the examiner:
- Lets you keep some/most/all of your claims.
- Denies your patent.
- Grants you a full patent.
Only 40% of patent-pendings go to full patent for medical devices.
You don't need a full patent to manufacture and sell but you do need a few other things, i.e., to build your team (engineers, companies to do your end-product testing, quality managers, regulatory affairs consultant...) and get through the Food and Drug Administration (FDA).
I assume most CRNAs will have medical devices, so, with very few exceptions, they will need premarket notification from the FDA. The timeframe for FDA clearance is dependent upon funding (investors, savings, loans...), testing (biocompatibility, compliance...), and how experienced your regulatory affairs consultant is. It took me two years to get all my testing done but it could be much faster with the proper know-how and funding. FDA clearance can happen in under six months once the requirements for the submission are complete. However, 89% of all submissions are immediately rejected by the FDA, so be prepared to resubmit if needed.
Here's the rundown from my experience:
- Patent: 3-7 years.
- FDA: Varies for data gathering, but the actual submission process could be done in six months
- Manufacturing prototypes: Less than one month for first-run, more for adjustments.
- Manufacturing low-run molds: About a month.
- Manufacturing large-run molds: Depends on your parts, but say 3 months.
- Getting investors (if needed): Varies.
- Marketing: Ongoing.
Congress Daily: What was the biggest thing you each learned about a) the invention process and b) about yourself from going through all of this?
Snyder: I learned that I am a serial inventor. In terms of the process, using a medical incubator associated with my hospital system was my biggest mistake. It doesn’t have to be a bad choice, but I didn’t know what to look for and I thought I was doing my due diligence.
Miller: I learned the most helpful characteristic for an inventor is GRIT: Guts, Resilience, Initiative, and Tenacity.
When you fall down during this process (and you will), just get right back up. I learned invention is an all-or-none endeavor. You can't just "do it part-time." It consumes you. It has to, or it dies. There are too many things to learn about the process and business, and you can't just "hire it out." You have to get your hands dirty. It's risky, so you have to be a risk-taker. You have to eat, sleep, dream your invention. Passion may start your engine, but you'll need plenty of perseverance to get you to your end-goal.
Congress Daily: What advice would you give someone who may come up with something that could prove helpful to the healthcare professions?
Snyder: The first bit of advice is to keep quiet. Don’t share your idea.
The second thought is, and forgive the bluntness of the message, your invention is not about you. It’s not even about the patient. Really. That’s not to say a “good story” of how and why you thought of the idea doesn’t sell. Your future distributors (or investors or partners) will use that as a jumping board to “how will this help me (or our business)." Like it or not, patient care is secondary. So find a way to focus on the business, marketing and margins—at least when presenting. Know in your heart, you are doing this because you believe it will make healthcare safer, higher quality, or whatever inspired your idea in the first place.
Miller: You can't go into invention for the money. Your invention will cost you a lot of your own money and may never pay off. You have to know and accept that up front. Even if you invent the greatest product the world has ever seen, you won't have big companies knocking down your door to buy it or license it. You won't have Group Purchasing Organizations lining up to buy your product either. And you need to start calling it a product because, let's face it, it is a product. That's the only way it will go from the USPTO to market shelves.
You need to know that you will assume all the risk, put up your own capital, and prove viable margins before anyone even glances your way. Studies show that over 50% of inventors expect to make millions of dollars. The reality is that only about 5% of patents go commercial. There were more than 600,000 patents (10,000 medical devices) submitted to the USPTO in 2015, according to the last USPTO census.
So why do it? Because invention is in your blood.
Congress Daily: Is there anything else you would like our members to know? Thank you for your time!
Snyder: An invention is like having a baby. You spend a lot of time dreaming about what you are inventing, you pour a lot of love and tears into the process, and you keep going even when you want to quit because it is your “baby.” No one will love your idea like you do, so you have to be committed to weather the ups and downs.
Miller: There are quite a few CRNA inventors and manufacturers out there already. From my experience, these people have been my saving grace. I've reached out to a few of them and gotten answers or encouragement. Also, CRNAs are a brilliant group of individuals with the intelligence, drive and personality to handle this road. It's a tough terrain but you can traverse it. You can do it!