Clearing the Bench-To-Bedside Hurdle: Why Translational Medicine Needs to Start Earlier

Contributed Commentary by Michael Canney, Ph.D., Chief Scientific Officer, Carthera   

September 4, 2026 | There’s an enormous graveyard for medical innovations that showed tremendous promise in the lab yet stalled out in early clinical trials and never reached patients at scale. 

We've largely come to accept this high failure rate as an inevitable reality of translational medicine. But over the past 17 years developing an implantable ultrasound platform for blood-brain barrier modulation, I've come to a different conclusion: we're asking translational medicine to solve problems that should have been addressed much earlier in development. 

Translational medicine is the “bridge” between the laboratory and clinic, but we traditionally see translation as a distinct practice with a distinct phase. The problem is we typically don’t start building that bridge until after a technology is engineered — when many of the clinical roadblocks are already baked into the design, making them much more challenging to correct.   

If we want more medical breakthroughs to clear the bench-to-bedside hurdle, we need to start building that bridge much earlier — seeing translational medicine as an interdisciplinary practice that begins long before the first clinical trial and shapes the entire development process from lab to clinic. 

Translation Starts at the Drawing Board  

In the preclinical phase, it’s natural for innovators to focus on proving that a new technology works. But every engineering decision shapes how easily that technology can be reproduced, scaled and integrated into clinical practice later.  

As we developed our implantable ultrasound platform for blood-brain barrier modulation, we quickly realized we needed to think beyond the laboratory — to consider that our ultimate goal was designing a practical, scalable clinical procedure. 

That meant asking questions that traditional engineering teams don't always ask early enough: can clinicians realistically use the technology? Does it fit existing workflows? Does it require new infrastructure? Can patients participate without dramatically disrupting their lives? 

Those questions shaped several major design decisions. We designed an implant that could be placed during a tumor resection patients were already undergoing, instead of requiring a separate procedure. We mounted it on a titanium mesh neurosurgeons already knew how to work with. We designed the treatment workflow so that trained nurses and physician assistants — not just physicians — could administer treatments. And we simplified the hardware and software so clinical teams could become comfortable using the system in less than an hour. 

None of those decisions were scientific breakthroughs, but they fundamentally changed how practical the technology became in the clinic. 

The takeaway here is that translation can’t begin after engineering is complete —reproducibility and scalability need to be core design objectives that guide engineering from the very beginning. 

Clinical Trials Should Improve Technologies — Not Just Validate Them 

Like many innovators, we initially viewed clinical trials primarily as the stage where a technology proves itself. Instead, they became one of our most valuable sources of learning. 

Our earliest clinical studies demonstrated that implantable ultrasound could safely and reversibly open the blood-brain barrier in patients. Scientifically, that was the milestone we had been working toward. 

But clinicians also revealed something we couldn't fully appreciate during preclinical development. The treatment area was too limited for the infiltrative biology of glioblastoma. While the technology successfully opened the blood-brain barrier, the area we could treat didn't adequately reflect how the disease behaves clinically. 

That insight completely changed the next generation of the technology, leading us to substantially expand the treatment footprint. 

It's an experience that changed how I think about clinical research. Clinical trials can’t be viewed solely as the final test of whether a technology works. They frequently generate new biological, engineering, and clinical insights that are impossible to obtain in the laboratory alone. 

That points to another important insight I often share with peers: at some point, you can’t advance a technology through further laboratory testing. Some of the most valuable insights come from clinicians using a technology in the real world and telling you where it needs to improve. 

Translational Medicine Happens Between Disciplines 

Perhaps the biggest lesson I’ve learned through the experience of developing a new medical technology is that translational medicine is not a solitary practice or a single discipline. Effective translation requires collaborating with experts across multiple disciplines to challenge your priors and put your engineering to the test. 

In our case, translation began with ultrasound physics and biomedical engineering, but it also brought in other disciplines very early on. Neurosurgery shaped procedural integration, imaging guided treatment planning, clinical trial operations determined how the technology could be implemented consistently across hospitals, and regulatory science established the framework for evaluating safety and effectiveness. 

Some of our most important questions emerged where those disciplines intersected: could an engineering decision simplify a surgical workflow? Could clinical observations improve device design? Could regulatory expectations influence engineering priorities years before pivotal studies began? 

As emerging therapeutic platforms become increasingly sophisticated, from biologics and cell therapies to precision oncology, I believe success will depend less on excellence within any single discipline than on how effectively those disciplines work together from the earliest stages of development. 

Building Better Bridges to get Better Treatments to Patients at Scale 

Blood-brain barrier modulation is entering an exciting new phase with a phase 3 pivotal trial, but I believe the lessons learned getting to this point extend well beyond our own technology. 

We all feel the frustration of seeing promising scientific breakthroughs fail to mature into treatments that reach patients at scale. As medical innovations grow more complex, that failure rate will only go up, unless we think translationally from the outset. 

As therapies become increasingly sophisticated, from biologics and cell therapies to precision oncology, the limiting factor will increasingly shift from scientific discovery to successful translation. The question won't simply be whether a new technology works. It will be whether it can be reproduced, integrated into clinical practice, and deployed consistently across healthcare systems. 

Innovators need to consider the practical realities of reproducibility and scalability as core design principles from Day One. They also need to move past the urge to endlessly perfect a technology in the lab before testing in the clinical world, because some of the most critical design inputs only reveal themselves under real clinical pressures. Moreover, successfully integrating these translational principles from the start requires taking a more interdisciplinary approach to engineering and development, collaborating with experts to pressure-test design decisions. 

By expanding the scope of translational medicine to include more of the design lifecycle and a broader team of collaborators, we can more successfully build the translational bridges needed to allow more medical innovations to clear the bench-to-bedside hurdle and reach patients at scale. 

Michael Canney, Ph.D., is chief scientific officer at Carthera, a clinical-stage medtech company advancing brain therapy through innovative ultrasound-based devices. A co-author of more than 50 peer-reviewed articles, he specializes in neuro-oncology, glioblastoma and neurodegenerative diseases. At Carthera, he is responsible for leading scientific collaborations with academic institutions, organizing U.S. clinical trials and more. He can be reached at [email protected].