Beverly Hills plastic surgeon Dr. Robert Kotler decided to become a small-time manufacturer to help patients breathe easy. But moving from rhinoplasties into medical device entrepreneurship was nothing to sniffle at as Kotler discovered while grappling with the design and manufacturing process. In 2007, he invented the Kotler Nasal Airway, a device consisting of two silicone tubes used to help patients breathe through their nose after surgery. Now, a decade later, he manufactures his product in Pacoima and sells it to distributors all over the world. “When you operate on the nose and throat, you always have to bear in mind the potential for obstruction,” he said. “This is a device that allows the airway to be cleared safely.” Kotler came up with the idea after a patient gave him an ultimatum. The patient essentially said he would rather opt out of the necessary procedure and not breathe properly for the rest of his life than undergo the same air-constricting discomfort he endured from his last nasal surgery. Kotler began brainstorming and found inspiration in a hospital breathing device that delivers oxygen through tubes that attach to the nose. He took the plastic tubing, cut it to size and sterilized it. When the operation concluded, he slipped the plastic tubes into the patient’s nose, and the patient could breathe despite swelling and secretions. Kotler began utilizing the tubes regularly during his operations, and in 2011 was granted two patents for the device’s design and function. That same year, he received approval from the Food and Drug Administration for his invention – the Kotler Nasal Airway. A nasal surgeon inserts the tubes after cosmetic procedures, sinus surgeries for deviated septum correction or other operations that block the airways. They can be used for up to five days following a surgery with or without nasal packing, which helps control bleeding and provides septum support. The Kotler Nasal Airway comes with a plastic-tipped 3 cubic centimeter syringe the patient fills with warm water to flush out and clean the tubing. “There has been no report of any product failure,” Kotler said. “Patients were surveyed, and 98 percent of them said it worked.” Tech-driven surgery To manufacture the device, Kotler partnered with KDL Precision Molding Corp., a Pacoima company that specializes in producing silicone rubber products. Half of KDL’s business is in the medical field as the company produces components for device developers like St. Jude Medical Inc., which was acquired by pharmaceutical giant Abbott earlier this year. KDL makes pacemaker assembly parts for St. Jude, which has its cardiac device manufacturing plant in Sylmar. However, the company’s sweet spot is servicing small- and mid-size companies like Kotler’s. “A lot of times, (small to mid-size) companies have difficulties getting product out of larger rubber mold companies, because they like orders in the millions,” said Ben Bensal, KDL’s general manager. “Since 2009, we’ve been proud to have made 20,000 Kotler Nasal Airways and will continue to support these types of medical companies.” KDL got its start in the aerospace sector making aviation-related products, but Bensal said he has seen an uptick in medical device demand over the last 10 years, shifting the company’s focus and customer base. More specifically, the ear, nose and throat specialty is on the rise as worldwide related device sales are estimated to reach $23 billion by 2022, according to business consulting firm Grand View Research Inc. Dr. Marilene Wang, a UCLA professor and head and neck surgeon, has also noticed an increase in available devices and equipment related to the ear, nose and throat specialty. “Nasal and sinus surgery is very technology driven,” she said. “We’ve seen many changes and improvements in the equipment we use in surgery as well as in the office, leading to improved outcomes in patients.” With the device and consumer market in place, KDL helped Kotler make minor design changes to help with cost and efficiencies and then began producing the product. Once the Kotler Nasal Airways are made, they are sent to Pro-Tech Design & Manufacturing Inc. of Santa Fe Springs, where the devices are sterilized, labeled and packaged with instructions and auxiliary tools like the cleaning syringe. From there, the product is shipped directly to distributors for sale. Expanding distribution Kotler has distribution deals with companies such as Indianapolis-based Anthony Products Inc., which sells about 3,000 Nasal Airways a year to surgical facilities. In addition, Kotler just signed a distribution deal with a company in South Korea, a country where nasal surgeries like rhinoplasty are quickly growing in popularity. Kotler estimated the potential market share for this deal could be twice as large as Anthony’s, which is Kotler’s main distributor. Doctors pay $69 per device; their distributors pay about half that. Kotler favors the distributor-dependent model as very little overhead is incurred by his company. Essentially, his distributors sign and pay for a certain amount of inventory, and Kotler tells KDL to produce it. He added that the just-in-time inventory model allows him to avoid large amounts of debt while providing the freedom and flexibility to continue to work at his Beverly Hills practice. “At this point, we are self-funded with positive cash flow,” Kotler said. “The only debt we have is some ongoing work being done by our patent attorneys.” Product awareness and marketing are Kotler’s primary hurdles as doctors are sometimes hesitant to try new medical devices for fear of unpredictable outcomes and liability lawsuits. But adoption is occurring as Kotler’s distribution channels are experiencing growth. He said he is signing bigger deals and has more companies interested in selling the device worldwide. To expand his company’s product line, Kotler is also working on another invention to ease nasal procedures. It is a surgical dressing designed specifically for nose operations to better catch blood and mucus. But in the meantime, mainstreaming the Kotler Nasal Airway is the company’s primary focus. “Breathing is number one, and establishing breathing is our main mission,” Kotler said.