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Medtech POV Podcast | Top Medtech Venture Investor Says MCIT Rule Would Be “Transformative” for Seniors, Patient Care

Top Medtech Venture Investor Says MCIT Rule Would Be “Transformative” for Seniors, Patient Care

WASHINGTON, D.C. – In the most recent episode of the Medtech POV Podcast, a top medtech venture capital investor argued that if a medical device has received FDA approval as safe and effective and would serve a unique population for whom existing medical options have either already been tried unsuccessfully or are virtually nonexistent, that device should be covered by Medicare. The Medicare Coverage of Innovative Technologies, or MCIT, rule was delayed earlier this year by the Center for Medicare & Medicaid Services (CMS) and would have allowed access to “breakthrough” medical technologies under Medicare so that seniors suffering from such conditions could decide with their own doctors whether these devices would be right for them.

Justin Klein, cofounder and Managing Partner at Vensana Capital, a top venture capital and growth investment firm focused on funding innovation in the medical technology world, told Whitaker: “I think what people don’t appreciate is that there is a long path to get from an innovation as a concept through rigorous product development, meet the FDA’s high quality standards, and then, through work with FDA, execute on a clinical evidence plan that really validates a medical technology’s safety and efficacy. And then to get that FDA approval, that process alone can take seven to 10 years depending on the nature of those clinical trials.”

Klein argued that today, even after the high standard of safety and efficacy has been met when FDA approval of a device is granted, an approved medical technology will still then subject to years of additional scrutiny by CMS in order to be covered under Medicare. “The extra time it takes to then develop new reimbursement codes and insurance coverage policies so that patients can actually receive the care from this innovation can take another five to seven years,” he said, “all of which is capital intensive.”

The MCIT rule, Klein said, would “at least create a window in time where we have coverage for Medicare patients. Our companies can start to get those physicians and patients to engage with our technologies. We can treat patients who have a significant unmet need, and frankly, typically no alternatives. That’s why they’re ‘breakthrough’ in the first place. If we can get that four-year window where MCIT provides that coverage, and we can further validate cost effectiveness along the way, it is transformative.”

Klein and Whitaker also discussed the role venture capital firms like his play overall in the process of bringing promising new medical technologies to market. He and his firm take a very personal approach to their work: “I think about it like I’m a patient or my family member is going to be eligible for one of these products. I think trust in that system is incredibly important.”

To listen to the full conversation, download the Medtech POV podcast on Spotify, Apple Podcasts or wherever podcast streaming is available. Visit AdvaMed’s website for more information on the podcast and past guests.

The Medtech POV podcast is hosted by Scott Whitaker, President and CEO of AdvaMed, the world’s largest medical technology association. It premiered in April 2021 and has featured medtech and health care policy leaders such as Dr. Steven Hahn and General James Mattis. In each episode, guests and host Scott Whitaker cover the intersection of medtech and policy from every perspective, including current issues in business, policy and current events.

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AdvaMed member companies produce the medical devices, diagnostic products and digital health technologies that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit