SAN FRANCISCO – The gastroenterology device field has matured technically in recent years, with plenty of innovation in applications to antireflux, obesity, and colorectal polyp detection, among others, but barriers to adoption remain. The most pressing is reimbursement, which is a process that is often opaque and off-putting, especially for small companies that lack the capital to bull their way through the obstacles.
Reimbursement decisions get made on a case-by-case basis, “and a lot of times there’s a finite number of dollars in the health care system, and CMS [Centers for Medicare & Medicaid Services] and other entities are trying to limit how many things we can have. They look at data and summaries that can be somewhat biased. Plus the way the methodology works in surveying physicians is not very clear, so the overall process needs more clarity,” said, professor of medicine and surgery at Northwestern University, Chicago, and vice chair of the AGA Center for GI Innovation and Technology, in an interview at the 2019 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.
The 2019 summit highlighted new technologies in its annual Shark Tank competition and brought experts from industry, academia, and regulatory agencies to San Francisco for 2 days of presentations on the challenges and opportunities in gastroenterology devices.
Lack of clarity is indeed a key challenge, agreed, director of endoscopy at the University of California, Los Angeles, Health System, professor of clinical medicine at UCLA, and chair of the AGA Center for GI Innovation and Technology. “Maybe you designed a trial that you think will be adequate but the person who is ultimately making the decision on coverage doesn’t think it’s adequate, so having societies and payers really speak together with industry and innovators to get this information early rather than late could save a lot of time and money, and ultimately get these products to patients sooner,” Dr. Muthusamy said in an interview.
And he insists that the technology is ready, as evidenced in part by the Shark Tank contestants and this year’s winner. There is more to come. In the immediate future, Dr. Muthusamy anticipates use of artificial intelligence to enhance polyp detection, and perhaps assessing larger polyps. “Computers can aid us in reading things, particularly in analyzing large amounts of data which may look similar to finding a needle in a haystack, whether that’s dysplasia in a field of normal tissue, or it’s identifying a small locus of blood in an otherwise bloodless field.”
He also expects more expansion of technologies that will allow endoscopists to perform techniques that were once limited to surgeons, such as making endoscopic submucosal dissection easier to perform. “We continue to see development of endoscopic platforms that are going to allow us to become endoscopic surgeons,” said Dr. Muthusamy.
Interventional ultrasound should continue to gain traction, and Dr. Muthusamy hopes to see an endoscopic antireflux device that could provide patients a middle-ground option between medication and surgery.
But these innovations still face many obstacles to reaching patients. Getting Food and Drug Administration approval, getting a code, and reimbursement are all daunting roadblocks. “You clear one hurdle only to run into another, and if you get one of these steps wrong, and they say you have to redo a trial, you’re talking potentially millions of dollars and several years,” said Dr. Muthusamy.
That could stifle innovation, particularly among small companies. “That may be why you see a lot of smaller companies get acquired early – they don’t have the sort of capital to sustain the long road to the finish,” he said.
However, Dr. Muthusamy believes there is room for optimism, as evidenced by progress at the FDA. “If we can make the level of changes in the next decade in the reimbursement process that we’ve made in the regulatory process in the last decade, we’ll have made some real progress.”
The AGA Center for GI Innovation and Technology is working behind the scenes to guide the FDA, payers, and industry in overcoming the overcoming the obstacles inherent in the device development, approval, and adoption process. The center’s goal is to continue to advance innovation in GI, while making sure the needs of gastroenterologists and patients are met with each new technology that comes to market.