It is now becoming more widely recognized that focused ultrasound has the potential to both improve the lives of millions of people with a wide variety of serious medical disorders and to propel the creation of a new multibillion-dollar industry.
Highly disruptive therapeutic technologies like focused ultrasound evolve exponentially from laboratory research to widespread utilization as a standard of care. In the case of focused ultrasound, the inflection point in the clinical adoption curve has recently been reached, and the dialogue has shifted from "if" the technology will have an important role in the therapeutic armamentarium to "when."
While strong progress has been made in achieving this vision in the last several years, it is also becoming increasingly apparent that the pace of progress needs to be accelerated. Every month that transpires where the technology is not available translates into unnecessary death, disability, and suffering for countless people. Saving time equals saving lives.
As the potential of focused ultrasound becomes more generally known, I am being asked with increasing frequency what can be done or what is necessary to push the technology across the finish line – to transform our vision into a reality and establish focused ultrasound as a mainstream standard of care accessible and utilized globally. To this end, I have identified five elements that need to be accomplished: 1) evidence, 2) awareness, 3) capital, 4) partners, and 5) businesses.
The key and most fundamental element to achieving widespread, mainstream use of focused ultrasound is rigorous, scientific evidence of its feasibility, safety, efficacy, accessibility, and cost – supported by research findings published in the medical and scientific literature. For each clinical indication, this evidence must provide a compelling case for a diverse group of stakeholders including:
- medical societies
- research funders in the public and private sectors
- government and private payers
- facilities that purchase the equipment
There are currently more than 130 clinical indications for focused ultrasound in various stages of development; sufficient evidence has led to regulatory approvals around the world for more than 30 indications, seven of which are in the United States. Reimbursement has been achieved for many of the approved indications, but not all. And focused ultrasound commercial treatments are now available in approximately 800 facilities around the world – with 180 in North America – out of a potential worldwide of perhaps 10,000. Although the pace of adoption has been accelerating, it is not rapid enough.
Awareness amongst all stakeholders of the potential of focused ultrasound to improve outcomes and decrease the cost of care for an array of disabling and life-threatening medical conditions remains essential for advancing the field.
While focused ultrasound is no longer "medicine's best kept secret," the fact is that most people still have not heard of it. Media coverage of the technology, once limited to industry publications and scientific journals, is now appearing in mainstream consumer press – but we still have a long way to go. Increasing awareness is a shared responsibility for all in the field and will continue to derive from: scientific presentations and publications; media placements via print, broadcast, and digital platforms; thought leadership pieces and white papers; meetings with key opinion leaders, thought leaders, and influencers; Focused Ultrasound Foundation resources including our robust website, biweekly newsletter, webinars, podcasts, and blogs; and even word of mouth.
All community members – from patients to scientists to donors to treatment centers – are encouraged to take an active role in helping to spread the word about this life-changing technology.
The field has an enormous appetite and is hungry for both financial and intellectual capital.
While there has been a significant influx of capital to the manufacturers of focused ultrasound equipment in recent years – including for the first time vital interest from strategic investors – additional funding is needed from government, philanthropic individuals and foundations, and industry to support research and development. Additional financing is also needed for new businesses including seed, venture, growth, and private equity. Strategic investors have begun to come in off the sidelines and make investments in the field, but there is an urgent need for more.
More intellectual and human capital is needed and can be derived from educational and training programs from medical and scientific societies, manufacturers, and the Foundation. And the role of collaboration – the ultimate force multiplier for intellectual capital and a powerful stimulus for innovation – cannot be overstated. Collaboration is essential to advancing the technology by rapidly achieving a critical mass of knowledge and results through shared experiences, information and ideas; coordinating activities; and avoiding duplication of effort. Lives are at stake, and there is no time to waste.
No single entity can drive the acceleration of focused ultrasound. To rapidly scale the technology, partners are needed – including the US FDA and NIH; disease specific foundations; advocacy and trade organizations; pharmaceutical manufacturers; medical and scientific societies; financial institutions; academic institutions; commercial insurance companies; regulatory and reimbursement consultants; and more.
And finally, for the vision of focused ultrasound to become a reality there needs to be successful commercial organizations to manufacture and distribute the equipment.
Currently the commercial sector is highly fragmented with more than 55 manufacturers. Most are small and virtually none have revenue much more than $50 million per year, and are not profitable. Many are in need of financing.
For focused ultrasound to advance, there needs to be a consolidation to approximately four to eight major manufacturers, each with a critical mass to drive adoption globally, in addition to a number of smaller niche players.
The vision is that by 2035 more than one million patients will be treated with focused ultrasound each year in at least 10,000 facilities. Our goal is clear. Our tasks are many. By banding together, working hard, and taking risks – while collectively directing our efforts on evidence, awareness, capital, partners, and businesses – the focused ultrasound community can and will cross the finish line, changing the future of healthcare and improving the lives of millions of people around the world.
Neal F. Kassell, MD, is the founder and chairman of the Focused Ultrasound Foundation.