Garrett Powell, MD, based at the Eglin Air Force Base in Florida, is a neurosurgeon who commonly performs spinal surgeries, for the Department of Defense. Dr. Powell has worked with several spine device companies throughout his career to bring his ideas from concepts to working tools in the operating room. He explains six things innovative spine surgeons should always do to ensure that they build relationships with medical devices company and create opportunities to contribute to the development of surgical tools that will positively impact patient care.
1. Research and prepare your idea. It all begins with an idea. "How many times has a surgeon been using something in the operation room and thought 'This could be made better,'" asks Dr. Powell. After that initial spark occurs, the idea should be thoroughly researched. Is it original or derivative of an existing device? This is the first question a device company will ask.
A large part of a surgeon's initial encounter with a device company will be based not only on the idea itself, but the presentation of the idea as well. "If someone has a great idea, instead of drawing it in a napkin, they should meet with a medical illustrator," says Dr. Powell. Medical illustrations generally cost around a few hundred dollars, but these renderings create a professional, impressive image to present to the company.
2. Decide how you want to proceed with your idea. Many surgeons bring their ideas directly to a device company. A device company represents a wealth of resources, which are easily capable of bringing an idea from infancy to fruition. On the other hand, when spine surgeons place an idea directly in the hands of a device company they relinquish a level of control over what is done with that idea and its results.
Dr. Powell chose instead to bring his idea to a patent attorney first. "I felt like it was my idea. I conceived it on my own and I wanted to secure the rights for myself," says Dr. Powell.
Spine surgeons should weigh each approach and decide which approach most suits them. "If you have a novel idea, it will cost you a minimum of $10,000 in legal fees to get it patented," says Dr. Powell. Obtaining a patent before approaching a device company provides the spine surgeon a measure of control over the idea, but entails a certain amount of personal financial responsibility. Directly presenting an idea to a device company will result in the absorption of this financial obligation, but detract from the surgeon's authority over the idea.
3. Determine whether or not the company's goals align with your own. Both the spine surgeon and device company need to understand one another's goals. The device company representatives will want to know that the surgeon will work well with the company. Spine surgeons need to know if the company has an innovative, collaborative attitude.
Spine surgeons that patent their own ideas need to find a company that is willing to build a smooth working relationship with them. "Device companies like the idea of a shared resource," says Dr. Powell. If a spine surgeon already holds a patent, a device company may see this as an impediment. Before embarking on an in-depth relationship, spine surgeons should find a company that works well with their goals.
4. Meet with company representatives face to face. Once spine surgeons have decided upon a company to work with, it is critical that they meet with the company's representatives. The surgeon should meet with the executives of the company and the engineers. If possible, visit the facility where the idea will be taken from the design stage to a prototype. "This gives you an appreciation of how things get to market," says Dr. Powell.
After the initial meeting, be sure to keep in touch to see how the device is moving through the stages of development and testing.
5. Understand the testing and clinical trials processes. Once a device has reached the testing stage it has become a prototype. The prototype is analyzed for strength, flexibility and any possible design flaws. Though surgeons are not directly involved, they should meet with the company to examine the data gathered from testing. If the surgeon and company deem the device efficacious and safe, the expensive and labor-intensive process of clinical trials can begin.
Dr. Powell has developed both a fixation device and a shunt. Though he found the process surrounding the shunt device to be more difficult than the fixation device, he says that a device will generally move through clinical trials within a year. The device will begin this process overseas, following that the clinical trials will expand for approval in the United States. The device company will have relationships with physicians that have worked in the various countries in which the clinical trials will take place. These physicians will be familiar with the countries' bureaucratic protocols and have contacts with the hospitals that will host the trials of the device. The engineers responsible for making the device a reality will travel to the clinical trial sites and explain in detail the mechanics of the device to the physicians using it.
"The surgeon should understand that this is an expensive proposition for a company. The people they are sending to assist in the clinical trials are precious resources. They are lending out capital that may or may not pan out," says Dr. Powell.
6. Explore the benefits of the relationship. Though moving through the process of bringing a device to realization will require patience, surgeons should take advantage of the benefits stemming from their work with the company. "It has lead to important industry contacts. I met surgeons that I probably wouldn't have come into contact with otherwise," says Dr. Powell. "The device company brings resources to the table that are usually not available to surgeons outside of a university setting."
The essential goal of creating a new device is innovation. Spine surgeons shouldn't lose sight of this. "It is worth exploring those ideas. It is intellectually stimulating and fun to begin to understand how the process works," says Dr. Powell.
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