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How to Invent a Medical Device and Not Go Crazy in the Process

O'Malley, Patrick MD

doi: 10.1097/01.EEM.0000581484.16696.1b
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Emergency physicians are often called the MacGyvers of medicine because we often make do with the limited tools at our disposal, which leads to rigging up new contraptions to solve a problem. It's part of what makes emergency medicine fun.

Back in residency, when I was doing tons of laceration repairs, wound irrigation always seemed tedious and time-consuming. We didn't have anything better than a syringe and splash guard, so I tried to rig something with items I could get from a hardware store. I even met with a local medical device rep to brainstorm. Time commitments and a lack of funds, however, left my idea in never-never land.

Later, after I became an attending, I met an entrepreneur with whom I discussed the idea. We tinkered around and found a patent attorney who gladly took our money and did an elaborate patent search. We came up with a crude model for something that resembled a caulk gun that could squirt out saline from premade bottles. This also went nowhere, and I put the idea on the back burner.

Fast-forward to 2013. I was an avid paddleboarder and convinced that I had the best idea in the world for a paddleboard training machine. I had prototype ideas, and even put something together that worked pretty well. My wife was eight months pregnant and less than thrilled about my excitement over this new idea. She and I had lunch with two men who were helping with the paddleboard machine when she mentioned the wound irrigation device. Their ears perked up, and we came up with a design on a napkin. (See photo.) Within two weeks, we had a 3D prototype.

We found a patent attorney and quickly submitted a provisional patent. I highly recommend letting a patent attorney handle this process. The one we used charged just the filing cost. He knew that providing this service for free would make me return for the full patent application.

I reached out to some friends and colleagues from residency, and we held a focus group to get feedback about the product. The 3D prototype worked well, and gave us a starting point. I reached out to my local university engineering department, and found a biomedical engineer who agreed to test it. He developed a protocol, and was able to show that our device provided consistent, reliable pressure compared with a syringe and splash guard.

One of our team members, an orthopedic surgeon, was faculty at a local university and connected us with a professor who studied our device. This helped us validate our theory that the device was better than a syringe and splash guard in reducing bacterial counts.

Then we had to decide whether to do this ourselves or sell it to a medical device company. The latter choice made much more sense, so we contacted device reps to get contact information for the right people. I connected with people on LinkedIn, sent lots of emails, and made cold calls. We set up meetings, traveled to corporate headquarters, and made our pitch. We got good feedback but no deal.

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Persistence Wins Out

Finally, we got an audience with a company that specialized in single-use instruments and had a big footprint in emergency medicine. We were able to show how our product could improve patient flow and patient outcomes. Several years of work had gone into the device by this time. We signed a deal, and they became owners of the product and took over all aspects of development, FDA regulation, manufacturing, and marketing.

It was a lot of fun to see something we had developed being used to care for patients. The patent was finally approved in January 2018, more than four years after we started. It is now commercially available as IRIG-8.

What did it cost? Hundreds if not thousands of hours, multiple trips to companies to pitch the product, tens of thousands of dollars, lots of frustration but also a lot of fun and excitement. I cannot disclose the terms of the agreement, but it was worth it.

Having a great team is something I would recommend to help share the burden and capitalize on the skill sets of others. Be prepared for it to take a long time if you want to do it all alone. Be careful if you want to develop, manufacture, and sell the product yourself. I know several physicians who have, and it has the potential to drive you crazy and break you financially and personally.

The medical device development process is difficult and painful. It's expensive, and there is no guarantee of success. Have a team. Expect to spend a lot of time and money. Have a good patent attorney. Be careful with whom you share the idea. Don't be afraid to make cold calls to device reps and device companies. Keep your day job. Be realistic and understand that your product has a one-in-100 shot of being successful.

One last word of advice. Get permission from your employer. Have an attorney go through your contract with a fine-toothed comb—twice. I was amazed to find what some hospital systems will do to take anything you develop. Get written permission that this idea is yours, and they have no stake in it. Avoid working on the idea when on the clock and using hospital resources.

My wife has labeled me as a millionizer, someone who has a million ideas and can't stop thinking about ways to do something better. It's a blessing and a curse. My 5-year-old son has the same affliction, which is funny, fascinating, and scary to watch. I think it is part of what drew me to emergency medicine, and I am proud to have created something that will hopefully make your laceration care a little easier.

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Dr. O'Malleyis a practicing emergency physician in Newberry, SC. See him using the product athttps://youtu.be/gh1O4UdwJXg.

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