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New Episode of MedTech POV Podcast: Vibrato CEO Calls for Reauthorization of the Federal Small Business Innovation Funding Program

MedTech POV Covering the intersection of medtech and policy from every perspective

Elstad: Without SBIR, “you either don’t have innovation” or you have “an even more expensive health care system”

Juliana Elstad, President and CEO of Vibrato Medical, recently joined AdvaMed’s Scott Whitaker on The MedTech POV podcast for a conversation on several policy initiatives that are important for patient care and innovation, including the Transitional Coverage of Emerging Technologies (TCET) proposal before CMS and the Small Business Investment Research (SBIR) program, which is set to expire in September unless Congress acts. They also discussed Elstad’s upbringing in the Soviet Union, her views on the current crisis involving Ukraine and Russia, and her advice for those aspiring to lead a company someday.

On the Small Business Innovation Research (SIBR) Program (17:00-24:00)

“Medical technology gets more and more sophisticated, which means it takes more time and more money to bring it to market,” Elstad told Whitaker. “And as a society, I think we have three choices.

“One is: Increase the payoff at the end for private investors so that they take all this risk, which means more expensive health care costs as a society, which we don’t want. 

“Option two is: Do nothing, which will let other countries lead, and limit U.S. innovation to only incremental improvements in technology.

“Or: We can help small businesses early on with a highly competitive, very selective grant process. And so, given those choices, I think SBIR is a great choice.”

Elstad explained that Vibrato wasn’t her first experience at a medtech company whose innovative technology was helped to market in no small part through the SBIR program.

Elstad said the “science and initial data were really promising” for Vibrato’s technology “but it was still just an idea, and if it were not for that phase-one, small NIH grant, I don’t think we would be where we are today. And then with that grant, we demonstrated good results, and we got a bigger phase-two grant. And then after that, we got private investments that are several times the grant money that we received in those early days. This is a great example of collaboration between the private and public sectors. That is very important because innovation, especially disruptive innovation with lots of risks, can only go so far if funded only by private sector.”

On the Transitional Coverage of Emerging Technologies (TCET) Program (11:00-17:00)

Elstad and Whitaker also discussed the Transitional Coverage of Emerging Technologies (TCET) proposal now under consideration at CMS, which stemmed from an initiative implemented by the prior administration and rescinded by the current administration called the Medicare Coverage of Innovative Technologies (MCIT) program.

“You could think, ‘Why, as an early company that doesn’t have FDA approval yet, are we even talking about TCET?’ But investors identify reimbursement as the main risk. And think about it: It’s not whether we can develop [the technology]. It’s not whether it works clinically. It’s not if we get FDA approval—it’s about reimbursement.”

Elstad went on to say medical technology companies “are not asking to guarantee [Medicare coverage/payment], but to have a more predictable process … a process that is fast and efficient. If we can shift the mentality a little bit from talking about health care cost to talking about disease burden, it’s a slight change in mentality, but it’s important, because there is a cost of not covering new technologies.”

To listen to the episode, 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 health information systems 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  www.advamed.org.