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Building a solid business case for new medical technology bears fruit for hospitals, doctors and patients

August 19, 2022
Business Affairs

Focal HIFU was the answer. It had been used in Europe and Asia since 1995, with encouraging clinical results. It finally received FDA clearance in the U.S. in 2015 and has become an attractive non-invasive alternative for men who qualify. Focal HIFU is a transrectal procedure done on an outpatient basis, and it works by directing concentrated sound waves to destroy diseased tissue in the prostate. Using a combination of MRI imaging fused with biopsy data and ultrasound-guided imagery, urologists can precisely pinpoint and ablate the cancerous tumor, and avoid damaging surrounding healthy tissue and nerve bundles that control sexual function and urinary continence.

We also believed focal therapy for prostate cancer had a role to play, especially because UCSF is a historical leader of active surveillance in the country with thousands of prostate cancer patients being closely monitored by our urologists, using established protocols.

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Many active surveillance patients are unsettled by a cancer diagnosis but are reluctant to have invasive surgery. Others see their cancer slightly progressing and get understandably nervous about continuing surveillance, but also worry about the potential risks of side effects from surgery and radiation. We knew that many patients would be eligible for focal HIFU. Also patients with localized, low to intermediate risk disease whose quality of life would be negatively impacted after surgery qualified for this procedure.

Our two urologic oncologists, Hao Nguyen, MD, PhD and Katsuto Shinohara, MD who had been pushing for the device had already been performing transrectal procedures, including cryotherapy, which meant the learning curve for focal HIFU would be shorter.

Dr. Nguyen, Dr. Shinohara and I, along with the help of Laurel Bray-Hanin, our chief operating officer and vice president of cancer services, drafted a proposal, which Laurel brought to our capital committee. We projected the return on investment of focal HIFU as a first to market outpatient procedure; we addressed how the device would improve clinical outcomes and efficiencies, and other criteria. Thankfully the committee was convinced of the financial projections and clinical benefits of this technology and allocated funding for 2020 -- the following year.

Benefits outweighed the cost
The focal HIFU device was installed in April 2021 and Drs. Nguyen and Shinohara spent the first few months getting comfortable with the new procedure after receiving ample training from physician proxies who had achieved long term experience and positive results from using this device.
(1)

Jeff Wooley

HIFU

August 23, 2022 05:12

The company that makes HIFU focal one is EDAP based in France. This is going to save many lives and will make quality of life much better!

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