A Great Product vs. a Great Business

Driving Device Adoption: Training and Reproducibility

Focal One is still in the early adoption phase, but the key elements like clinical data, physician training, reimbursement, and a growing market strategy, are all coming together. Drawing from his experience at Intuitive Surgical, Ryan calculates he can position HIFU and focal therapy as the next major treatment category in prostate cancer.

One of Intuitive’s key successes was standardizing robotic surgery — making complex procedures easier for surgeons to perform step by step with predictable outcomes. The same principle applies to Focal One.

Ryan focuses on two critical factors:

1. Is the procedure teachable and easy to learn?

2. Can it be performed consistently with good clinical outcomes across different hospitals, ensuring reproducibility?

If a procedure isn’t teachable and reproducible, it simply won’t scale.

To drive adoption, Focal One uses a two-pronged approach: a dedicated capital equipment sales team sells the system to hospitals, while a clinical team supports physicians and encourages adoption.

Focal One is already in all five University of California teaching hospitals and major institutions like Memorial Sloan Kettering, Mayo Clinic, and MD Anderson. Academic centers play a critical role not just for validation and clinical data, but for training the next generation of urologists who will carry the technology forward: “Academic programs give you the benefit of teaching new young urologists, so they come out of training knowing how to use the technology. They understand both the value and use of HIFU and Focal One.” But community hospitals are just as crucial. They handle the bulk of prostate cancer cases and tend to be more competitive. Many look to adopt new technology early to gain a market advantage. That’s why institutions like Kaiser, HCA, and regional IDNs have already brought in Focal One.

“You run these in parallel. You want the academic centers as much as you want the community hospitals. They're both valuable as customers, yet there may be different beneficial market dynamics that play in each of them,” says Ryan.

One of the first questions any new medical technology faces is: Can hospitals afford to invest in it? In Focal One’s case, the answer is yes. Not only are hospitals reimbursed, but physicians have a dedicated CPT code, ensuring they’re compensated for performing the procedure.

Apart from marketing and support, reimbursement support is non-negotiable. Hospitals need to see a ROI before committing to new technology. With prostate cancer being the most prevalent cancer in males — nearly 300,000 new cases per year in the U.S. — the financial justification for hospitals is strong.

“Those who adopt early take the most risk, but they reap the most reward,” Ryan explains. He adds, “Identifying accounts that see themselves as innovation leaders in their community is always really important — especially when you’re selling premium-priced, disruptive capital equipment.”

Exploring New Use Cases (and Leveraging Academic Hospitals)

Great technology often extends beyond its original use case. That’s exactly what’s happening with Focal One. Initially designed to treat prostate cancer, the platform is now being explored for other indications, including rectal endometriosis and benign prostatic hyperplasia (BPH). These new applications emerged through both physician-driven insights and direct patient feedback in search of new, advanced non-invasive treatments that deliver improved clinical efficacy.

Dr. Gil Dubernard, a researcher from France, proposed that using Focal One’s transrectal HIFU imaging and energy delivery system could potentially ablate endometrial implants on the rectal wall in women with stage 4 deep infiltrating endometriosis — a condition that typically requires invasive surgeries. In March 2024, the FDA granted Breakthrough Device Designation to explore its potential.

Another potential indication emerged from patient feedback. After undergoing Focal One treatment for prostate cancer, some men noticed their urinary symptoms improved. That was because ablating prostate tissue naturally reduces pressure on the prostatic urethra, thus improving urinary flow. With that insight, Focal One launched a Phase I/II study in France to explore treating benign prostatic hyperplasia (BPH). Right now, three centers are actively recruiting and treating patients, with plans to define treatment protocols and seek FDA approval in 2026.

Beyond the clinical benefits, expanding indications is also a strong business strategy, especially for companies using a razor-razor blade model — where a core device (the "razor") is sold at a lower cost or break-even point, while generating ongoing revenue from consumables, services, or procedures (the "razor blades").

But new markets don’t build themselves. To succeed, HIFU and focal therapy need strong clinical data. EDAP has been investing heavily in research, including the HIFI study, a large-scale, government-sponsored trial in France. This study enrolled 3,328 patients across 46 centers to compare HIFU to radical prostatectomy - the gold standard for prostate cancer treatment. The results confirmed that HIFU patients had excellent cancer control with better functional outcomes, preserving both sexual function and urinary control more effectively than surgery.

Clinical trials not only validate safety and efficacy but also play a critical role in securing reimbursement, a key factor in hospital adoption. For Ryan, the question is, “How do you compare yourself to the existing gold standard treatment?” If your device is treating cancer (or any major condition), how does it perform relative to existing treatments? Identify key criteria that define standard-of-care outcomes. If your early data suggests strong results, it’s worth investing in larger studies sooner rather than later.

Another strategic move is leveraging academic hospitals for early validation. As Ryan says, “You always want more data. More clinical data that proves the efficacy of treatment, and you get that with academic centers because they're interested in advancing the science of clinical care while delivering improved patient outcomes.” The sooner you gather real-world evidence of clinical benefits, the faster you can build credibility, secure regulatory approvals, and improve reimbursement potential.

Without solid data proving both cost-effectiveness and patient outcomes, securing strong reimbursement is an uphill battle. And in medtech, reimbursement can make or break adoption.