New Wave Surgical: Making Waves in Surgical Device Innovation

R. Alexander (Alex) Gomez established New Wave Surgical in 2006 in response to a growing need for better laparoscopic surgical tools. “I was a surgical technologist 13 years ago,” says Gomez, who is now president of Coral Springs, Fla.-based surgical device company. “I was essentially passing tools in surgery and came across a number of inefficiencies in the procedures.” These experiences inspired the entrepreneur to find a way to improve on existing medical technologies.
When Gomez started attending medical school, he moonlighted as a surgical assistant, helping surgeons perform laparoscopic, or “keyhole,” procedures, a minimally invasive diagnostic method. Instead of open surgery, doctors made small incisions in the abdomen and insert a laparoscope (lens system) to identify medical conditions and diseases in the tissue of pelvic organs. The procedure is less intrusive and more efficient, although there are challenges to using the high-tech equipment. “The temperature difference between the room and the patient’s body would cause the lens to fog,” reveals Gomez, who decided to work on equipment to keep that from happening.
Gomez began to put together patents for a device to defog medical lenses. “I put together a business plan and started to raise some money,” he says. “The FDA approved my device, but I lost some money in the process. In 2006 I decided I either had to do my residency or launch my company. After my fourth year I went into the business side.” With the help of strategic partners, Gomez raised more money and the team went around to hospitals, carrying his sales bag and introducing his company’s product..
The Defogging Heated Endoscopic Lens Protector (D-H.E.L.P.) system cleans and defogs lenses, keeping a surgeon’s view clear and maintaining a better white balance. Many hospitals were immediately onboard for a trial and, after trying the device in the operating room, many began to routinely order the product for their procedures. “We started to expand as a company,” explains Gomez. “We’ve expanded our management and our sales staff.” Today, more than 800 hospitals use the D-H.E.L.P. in operating rooms.
Challenges of the Market
Changes in the healthcare industry combined with market fallout from the recession made 2008 a tough year for New Wave Surgical. “That was our worst year,” says Gomez. “It was hard raising money. We were getting a lot of word of mouth, with some traction in 40 to 60 accounts. However, this success didn’t generate the necessary cash flow to expand the company. There was a lot of uncertainty for a while.” Fortunately, Gomez kept working to push his product that he believed would help surgical teams worldwide and his persistence paid off.
“Our business has just exploded in the last three years,” he says. “We’re expanding dramatically. This laparoscopic procedure is done the same way all over the world with the same tools, so we’ve gone international.” New Wave Surgical currently has a significant presence in all 50 states, as well as Germany, the United Kingdom, Asia and Latin America . “It’s been a long journey getting to where we are now, but our product was used in more than 300,000 surgeries in 2012 with our first 40 customers still supplied as routine users today,” says Gomez.
Much of the company’s success comes through Gomez’s ability to translate his experiences as a surgical assistant into helpful technological innovations. D-H.E.L.P. and related New Wave Surgical technologies are designed by medical personnel, for medical personnel. In addition to being task-tailored, the easy-to-use cleaner and defogger only runs at around $40, making it both an efficient and cost-effective addition to any operating room.
The demand for the new wave of laparoscopic devices has resulted in the company, which employs 90, outgrowing its current ISO-rated facilities and Gomez is using a subcontractor with an equally controlled environment for backup manufacturing capacity. Meanwhile, a variety of worldwide suppliers keep New Wave Surgical and its associated facility stocked with materials. When it came to the selection of these contractors and suppliers, the company made decisions based on two main principles: highest quality and cost consciousness.
“Most of our suppliers are in the U.S., although we do have partnerships with a few companies in Asia,” says Gomez. “We’re looking to transfer more of that to domestic sources. We work with Phase 2 Medical in New Hampshire, who helped us in design and launching our product. We have lab testing through Nelson Labs. All of our assembly is performed in house.”
D-H.E.L.P. has been positively reviewed by several medical publications, including a Harvard professor in a GYN peer-reviewed journal. Inc. Magazine also included New Wave Surgical on its 2012 list of the top 500 fastest growing private companies, also declaring it the No. 1 fastest growing surgical device company. New Wave Surgical offers value and affordability in a product that makes a world of difference in surgical equipment performance, an unusual quality in the medical industry. Thanks to D-H.E.L.P.’s excellent design and its affordability, New Wave Surgical revenue continues to climb and the business is growing domestically and internationally.
Gomez has managed to produce a useful, innovative and accessible product. The team is improving operating room efficiency and accuracy and all signs point to continued growth for New Wave Surgical as it carves out it unique niche in the medical manufacturing industry.