In our recent Medtech POV podcast episode, Dr. Lishan Aklog, the CEO and founder of two medtech companies himself,  brought a unique and deep perspective to the complex issues faced by medtech companies and the patients they serve. His experience as a cardiac and thoracic surgeon, a medtech entrepreneur and small medtech company CEO, and immigrant to the U.S. from war-torn Ethiopia at age 13 inform his views on the power of medtech to save lives. Below are a few highlights from our conversation: 

Early cancer detection is good. Detection of pre-cancer is even better.

Medtech entrepreneurs are always chasing the Holy Grail of serving patients: less invasive and more comfortable procedures; more precise, personalized treatments; and prevention whenever possible. 

Dr. Aklog chose to focus on “incredibly deadly” esophageal cancer. He explained how the cancer can develop asymptomatically. A person with heartburn, or acid reflux, takes medicine to treat those symptoms. Meanwhile, esophageal precancer cells could be growing. Dr. Aklog and his team target the earliest detection of those cells with cellular diagnostics.   

“You’re trying to pick up as it progresses from an early stage precancer to a late stage precancer, but not yet cancer.” At the right stage, “you can actually destroy those abnormal cells before they develop into cancer, and therefore you can reliably prevent the progression.”  

His company’s two technologies on this process are commercialized, and testing is under way on thousands of patients. “We’re focusing on firefighters because they have a particular elevated inclination there [based on their exposure to smoke and other harmful gases], and there’s a lot of opportunity to have a big impact.”  

Even though many potential esophageal precancer patients are Medicare beneficiaries, and Dr. Aklog’s devices have earned FDA breakthrough status, meaning they address pressing unmet needs, Medicare doesn’t cover the technologies.   

That’s only one of many instances where Medicare reimbursement lags the rapid pace of remarkable, proven medtech development.  

Medtech innovators demonstrate the effectiveness of their products with extensive data, having raised capital to develop and test the technologies, and then gain FDA clearance. Then they are only able to treat as many patients as their own funding allows while waiting for a “creaky” Medicare reimbursement system to catch up. Dr. Aklog jokes that the process is like making an electric car and giving it away for free until an organization says, “Okay, now we’ll start paying for it.” 

You don’t see that business model anywhere, because it makes no sense. And yet so many medtech companies are forced to operate that way because CMS reimbursement decisions, in many cases, take many years after a given technology receives FDA approval.   

Patients suffer unnecessarily as Medicare reimbursement contributes gaps in access to proven medtech.

The lack of access worsens health disparities among patients already experiencing them: Black patients, women, and those in under-resourced communities, such as rural areas where hospitals are struggling.  

Companies, including Dr. Aklog’s, that develop successful technologies with federal grants – “the people’s money,” as he calls it – have a fundamental obligation to ensure all patients have access to those technologies, he said. Health equity is a “moral imperative that we should all take seriously.”  

Importantly, companies are not asking for a Medicare handout.

When clinical studies show a medtech product could help thousands of patients who would die without it over a demonstrated interval, and the FDA agrees, Dr. Aklog explained, “We just need sensible, reasonable thresholds that are balanced by the fact that these are often life-or-death” issues.  

Dr. Aklog also covered heart disease, high blood pressure, and pre-diabetes as connected conditions that remarkable medtech is helping patients manage, with the potential to reach many more.  

“People want to get healthier. Medtech offer them tools so they have the information that relates very closely to the underlying biology and understanding of that so they can.”  

To listen to the full episode, download the Medtech POV podcast on Spotify, Apple Podcasts, or wherever podcast streaming is available. Visit AdvaMed.org/podcast for more information on the podcast and listen to past episodes.