Across the medical device industry there is a very strong startup scene, and the field of focused ultrasound is no exception. According to our 2018 State of the Field Report, there are 70+ companies in the field globally; 42 of those companies are actively developing a device (or devices), with the remainder supporting other aspects of the field (OEM suppliers, distributers, etc.). The field comprises a vibrant community of innovators who are developing novel ways to solve important health problems using ultrasound technology as a therapeutic alternative to the standard of care.

Startup companies in the medical device space historically have excelled at the innovation and engineering portion of the product development process. However, they have not often been expected to go through the entire product development process. That paradigm is changing now, and again, this is true for the focused ultrasound startup community. The intricacies of getting a device through regulatory approvals and determining how to successfully commercialize it can be difficult. The challenges can be particularly difficult for novel products like focused ultrasound devices, where there is no established path for the regulatory authorities, let alone marketers.

Scott Whitaker is President and CEO of AdvaMed, the world’s largest medical technology association. AdvaMed members make the medical devices, diagnostic products, and health information systems that are transforming healthcare through earlier disease detection, less invasive procedures, and more effective treatments. Whitaker will deliver a keynote address on Oct. 24 at the Focused Ultrasound Foundation’s 6th International Symposium. The following is a conversation we had with him in advance of the Symposium.

What excites you about focused ultrasound?
There are so many new and emerging medical technologies, and focused ultrasound is one of them. The noninvasive therapeutic technologies and the benefits that come with them will transform patient care in tremendous ways.

Prostate disease, pain associated with cancer metastases to bones, essential tremor – focused ultrasound hits on so many different diseases. To be able to avoid the need for drugs in dealing with some of these conditions through use of noninvasive therapies … I think we’ve only touched the surface of what’s to come.

Gary Shapiro is president and CEO of the Consumer Technology Association (CTA), which owns and produces CES, the global stage for innovation. In January 2018, Shapiro interviewed Dr. Kassell and John Grisham from the CES stage about focused ultrasound.

On Oct. 23, Shapiro will deliver a keynote speech on the importance of innovation at the intersection of technology, business, and healthcare at the 6th International Symposium on Focused Ultrasound. The following is a conversation we had with Shapiro about what excites him about focused ultrasound, how it fits into the landscape of technology disruption, and what he sees ahead in medical and healthcare innovation.

What excites you most about focused ultrasound technology?
Focused ultrasound is as significant as anything I have ever seen in my lifetime in terms of changing human pain and suffering and healing people. This is technology for good. This is an innovation solving major problems in the world.

There are few diagnoses in medicine as dreaded for patients to receive, and for physicians to give, as brain cancer. Having shared this news countless times with patients, I can say two things with certainty: The responses are as varied as the patients themselves, and after the initial shock, the questions are almost universal: "How long do I have left?" "What do I do next?" and "How can I fight this?"

In medical school, we are taught to master knowledge of the common and the deadly. In the world of brain tumours, the two are one and the same with glioblastoma multiforme, the most common primary brain tumour in adults, and also the most aggressive. The last two decades, however, have seen major advances in imaging, genetics, neurosurgery, and adjuvant therapy that are now reshaping how we understand and treat these tumours. There is reason to believe that the next few years will offer hope to the many patients and families with this disease – a disorder that crosses all social, socioeconomic, educational, racial, and gender lines, and is able to fell even the most heroic among us.

Parkinson’s disease is an increasingly common nervous system disorder, with a growing list of high profile patients who are helping to lead the fight for better treatment options and creating hope for a cure.

Focused ultrasound is an early-stage, noninvasive therapy that is now in clinical trials to treat the motor symptoms of Parkinson’s. The Focused Ultrasound Foundation has funded and been involved with many clinical trials over the past 12 years, including a successful effort to find a treatment for essential tremor (ET), which is a movement disorder with symptoms similar to Parkinson’s disease. Our experience with ET has provided a base of knowledge that may be helpful as patients consider participating in a new clinical trial for Parkinson’s disease.

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