From Bench to Bedside: The State of Cardiovascular Innovation

• Cardiovascular medicine has made remarkable strides — but the path from bench to bedside remains complicated. The gap between a promising medical device startup and something that reaches patients often comes down to reimbursement complexity, inconsistent government funding, and the institutional inertia that slows tech transfer.

• In a recent Think Tank, the Science Center convened a cardiologist, medtech founder, and venture capitalist for a cross-sector conversation on FDA medical device regulations, the shifting funding landscape, and what's actually moving the needle on patient care.

• A pivotal moment for new medical technologies: as government backing grows less reliable and AI enters the diagnostic toolkit, the cardiovascular field is being pushed to innovate not just scientifically, but structurally.

Together, their perspectives – spanning clinical medicine, academic research, medtech entrepreneurship, and venture capital – offered a 360-degree view on the state of innovation today. The conversation explored the barriers preventing the latest discoveries from reaching patients – as well as what’s threading the needle in improving patient care.

Today’s Cardiac Medical Device Development

The conversation started off with an acknowledgement of just how far cardiovascular medical care has come over the past several decades.

“We’ve gotten much better in terms of preventing really devastating heart attacks, especially with all the new cholesterol drugs,” explained Dr. Jain. “The frequency by which we see patients with massive heart attacks that I used to see when I was just starting to train has gone down.”

Instead, patients today are much more likely to experience terminal heart failure or debilitating arrhythmias – often for years. “We’ve gotten much better at preventing aspects of heart attacks, but there’s a new challenge of: ‘how do we prevent the worsening of heart dysfunction?’” he said.

Dr. Baumlin asked whether health systems are incentivized to treat bad outcomes of heart disease, rather than prevent bad outcomes in the first place. Health systems, after all, only receive money when they treat people – and nothing for the patient who bypasses surgery completely and stays healthy.

For the most part, the panelists didn’t feel that the system actively disincentivizes treatment, but thought that reimbursement and CPT coding were a quagmire that may be standing in the way of innovation.

O’Donnell said that one of the best examples recently is the percutaneous heart valve – previously, it was a medically-intensive process that involved cracking open the chest and long hospital stays that would cost around $350,000 per patient.

“Today, you can go into the hospital and have your heart valve replaced through a catheter through your leg or arm, and you stay in the hospital for two or three days,” he said, with a total closer to $100K – while also being a safer procedure overall.

O'Donnell noted that the reimbursement system's complexity has turned it into a game – and the ones who profit most aren't necessarily the doctors, but the consultants who specialize in navigating the billing maze. “Recently, it’s getting better,” he explained.

Federal Funding: Tech Transfer is Shifting

The government’s SBIR/STTR grants are no longer the stable, reliable funding source they once were for medical device startups – after congress halted billions in research for innovative technologies this year, many found themselves in a bind (SBIR/STTR has since been reauthorized).

According to the panelists, reduced government backing isn't just squeezing budgets: it's pushing innovators toward a new model, one built on strategic partnerships with academic institutions rather than traditional pharma relationships.

The panelists agreed that over the past decade or so, the long-standing divide between academic medicine and industry is breaking down – eliminating the siloes that previously held innovating doctors at an arms-length from commercialization. “[Collaboration is] not only encouraged – it’s part of the process,” explained Dr. Jain.

Dr. Post said that institutional support has been increasingly important for companies like hers; The Texas Heart Institute demonstrated forethought in how they set up her technology transfer, giving both great terms and no money upfront. “They knew that if they’re super grabby at the beginning and mess up your cap table, you’re not going to be able to fundraise,” she said.

She mentioned that other institutions within her ecosystem were more predatory – and some innovations failed to make it past the idea stage as a result. “Some of those things are changing, though,” she explained. “And what’s accelerating some of it is the lack of reliability in certain government funding mechanisms.”

At the same time, institutions navigating cuts in government funding themselves are realizing the untapped value in their IP portfolios — and are only now learning how to leverage those assets and bring them to market. Term sheets and licensing agreements are becoming much friendlier to founders – in contrast to 10+ years ago, when institutions were far more leery of mixing research with commercialization.

“The way that tech transfer and the funding scheme is evolving is accelerating a lot of change: around not just how things are functioning, but the attitudes around it too,” posited Dr. Post.

Dr. Jain agreed that the landscape has grown far more supportive of cardiology innovators over the past several years. “If I wanted to spin something out of my lab, Penn has its own incubator space that we could have access to with significant support for investigators,” he said. “And you can pitch through Penn to other ventures. That has really changed over the last few years.”

Innovation vs. FDA Medical Device Regulations

Government regulation is a significant trajectory throttle for innovation – but it’s unavoidable. Dr. Baumlin asked the panelists, and specifically Dr. Post as a startup founder dealing with this regularly, about their experience working alongside the government to bring innovations to market. The group discussed how a reduced turnover at the FDA compared to years previously has resulted in a transformational change in the department.

“Five years ago, the FDA had 30% turnover every year. Reviewers frequently had no more than three or four years' experience,” explained O’Donnell. Persistent turnover meant that incoming reviewers lacked the institutional knowledge required to deeply understand and vet the incoming technologies. “We, the Avomed group, went in there and really elevated that problem through Congress and exposed all of that, and they reacted great,” he said. “They incentivized the reviewers to stay in their jobs, they paid for higher education; the goal now is to stay, and the FDA is a better place.”

The result: better reviewing teams.

“I’ve actually really enjoyed working with the FDA through these programs; they’ve been highly responsive to me,” shared Dr. Post about her recent experiences. “But I know that team is under extreme duress, I’m very concerned that someone is going to work them to death and I need my review team to stay intact and not quit.”

About 20% of reviewers left in 2025 due to government cuts, representing a future risk and slow-down if current reviewers end up burning out and leaving the field.

The Centers for Medicare & Medicaid Services, or CMS, was another point of contention.

“They’re still a mess. The amount of paperwork they want from you to prove something - it’s not safety and efficacy, it’s economic models you have to provide to them, and it’s a lot of work,” opined O’Donnell. “You’re sitting there saying, ‘Gosh, we invented the heart valve, this wasn’t enough? Now we have to prove that this is a $30,000 device when I spent $6 million dollars developing it?’ And that’s the frustrating part.”

But the team had a bullish attitude towards future government oversight, citing an overall improved experienced over the past several years and confidence in the FDA department.

“The new ways that therapies are emerging are fundamentally changing the landscape of how we are going to be thinking about drugs being cleared by the FDA,” observed Jain. “Many investigators are thinking about genome editing, and how do we get that to the masses? And I think the FDA is thinking about setting up new protocols to do that. And with all the clinical data and AI-related aspects, that will have to get addressed.”

Any discussion of modern medtech innovation eventually leads to artificial intelligence — and this one was no exception.

The Advent of AI: Useful, but Limited

Artificial intelligence is changing the frontier of new science and innovation, and the panelists debated the ways in which AI would ultimately transform the cardiovascular field. The discussion circled around two key questions: were they afraid of it, and did they find it useful?

“I’m not afraid of AI: there are lots of different really great things that we use it for all day in, day out in the lab, and I know all of my colleagues are as well,” said Jain. “But I think there are some real concerns about it as well. It is naïve to think it will be all unicorns and rainbows.”

The topic of cardiovascular disease in women was raised — and for good reason. Women have been historically underrepresented in CV innovation research, and the field has long defaulted to diagnostic criteria developed predominantly from male patient data, leaving women's symptoms and risk profiles routinely overlooked. AI models that draw from historical data will often continue to reinforce the bias.

Dr. Post agreed, noting that AI’s reliability is limited to the quality of the original data. “I have a deep, heathy skepticism,” she explained. “It’s garbage in, garbage out, and there’s a lot of garbage in. It’s very useful for specific curated tasks, and I think we can leverage that to all of our benefit. But we cannot intrinsically trust the output of so many of these things.”

They ultimately agreed that, while AI can shorten discovery-to-clinic cycles for specific tasks, data quality and “black box” risks mean AI must be applied cautiously and transparently.

Cardiovascular Innovation: What the Future Holds

“You all seem hopeful for the future of cardiovascular discovery —that great changes and improvement will happen in the near future,” Dr. Baumlin observed.

Despite the challenges of CPT coding, shaky government funding, and hiring freezes at the very institutions meant to overlook and approve new medical technologies, the overall tenor of the discussion was optimistic. Translation from bench to bedside is happening more quickly than ever, allowing more patients to live longer, healthier lives. The panelists collectively felt that far more opportunities for cardiovascular innovation exists today as compared to the limited avenues available in the not-so-distant past.

“There’s no better time than today to take something from the bench to the bedside as fast as possible,” said Dr. Jain. “The technology is here, the different discovery platforms that one can use are here, the ability to tap into so many resources even over the last five years, has exponentially increased. It feels like we are at an inflection, and it seems like it will only go faster.”

And Dr. Post noted that when it comes to healthtech and healthcare, resiliency is the name of the game, because the goal is greater than dividends and valuations. “This is not the easy moneymaker, entrepreneurial path to go,” she said. “We’re all doing this because we’re intrinsically motivated by a specific patient population, or even a specific person that we know in our lives.”

And for cardiovascular entrepreneurs coming down the pike, O’Donnell had this to say:

“Find mentors that are going to give you their time. Not mentors who have great resumes, but people who are going to give you their contacts and help you.”