Creating a Medical Device in Birmingham: The Fulmer Instruments Story

Fulmer Instruments Develops Cordless Cautery Device

‍This video captures a roundtable discussion where we explore how practicing physicians and others can successfully develop a medical device right here in Birmingham, Alabama. We were joined by some great leaders, including:

• Ben Fulmer: A neurosurgeon and CEO and co-founder of Fulmer Instruments.
• Lloyd Cooper: Principal of Push Product Design and co-founder of Fulmer Instruments.
• Harper Harwell: A reporter for the Birmingham Business Journal.
• Greg Canfield: Former Secretary of Commerce for Alabama and board member for Hardware Park.
• Mark Conner: Executive Director at Hardware Park.

Solving a Problem in the Operating Room

Ben Fulmer has been a practicing neurosurgeon in Birmingham since 2000. For years, he thought about how the traditional bipolar and monopolar cautery devices—used in nearly every surgical case for roughly 100 years to stop bleeding and perform dissection—could be made cordless.

The standard device requires a cord that is thrown from the sterile field off the end of the operating bed. A circulating nurse then catches the cord and plugs it into a large, suitcase-sized amplifier that uses radio frequency current.

From Idea to Prototype

The idea was simple, and about nine years ago, Ben connected with Lloyd Cooper, an industrial designer with Push Product Design. Lloyd then introduced Ben to an electrical engineer named Gene Amy, and the three became the founders of Fulmer Instruments.

The problem was that nobody had ever done this before. Gene, a very smart contract electrical engineer, knew he had to figure out how to put a lot of electronics into a very small package. The team focused on experimentation and trials to create what they called a "minimal viable product, an initially operatable device".

As the project grew, they created increasingly sophisticated prototypes, which they tested with Ben and other surgeons. Lloyd Cooper shared that the most enjoyable part for him was watching a surgeon's expression the first time they held a prototype.

Improving Safety and Sterility

Ben explained that the cordless device solves two major problems in the OR:

1. Safety Issues from Tangled Cords: Between the cautery devices, suction tubings, and drills, everything frequently gets tangled up, creating safety issues when things get pulled.
2. Infection Risk and the "Gray Zone": Throwing the cord from the sterile field to the non-sterile field creates a "gray zone" at the end of the bed where no one is certain where sterility starts and stops. In fact, when the team asked 12 people on the team where sterility started and stopped, they received 12 different answers. The cords themselves pose an infection risk, especially if they fall off and drop too low for sterility.

Building the Future in Alabama at Hardware Park

The team's goal is to not only create this device in Alabama but to produce it here as well. They stressed that the expertise is already available locally. The message to entrepreneurs is clear: Don't believe you have to go outside of this community or this state to launch your idea because you've got the expertise here. Come to Hardware Park!