As we begin this new year, we are awed by the resilience of the entire focused ultrasound community despite the unpredictable nature of the past 12 months. The COVID-19 pandemic has had a dramatic impact on all our lives – our homes, our families, our businesses, and our health have all been affected. The focused ultrasound community is no exception.
As the SARS-CoV-2 virus began to spread globally in early 2020, focused ultrasound laboratories around the world shut down, clinical trials were halted, and employees of the many focused ultrasound companies moved to remote work. Because most focused ultrasound procedures were deemed “elective,” for many months most patients were unable to access focused ultrasound treatments for essential tremor, pain or even cancer.
The COVID-19 pandemic has impacted everyone to some degree, but many who were already struggling have been more severely affected. During these trying times, we at the Foundation have aspired to help those less fortunate than ourselves.
In June, the Foundation team launched an internal campaign focused on feeding the hungry and raised $11,500 for the local Blue Ridge Area Food Bank. We set our sights on more national food shortage issues in July, supporting No Kid Hungry.
As August approached and we considered where to direct our continued giving, a dire situation arose very close to us. Our next-door neighbors at the Cedars Healthcare Center, a skilled nursing facility, became a COVID-19 hot spot. The virus raged through the facility, infecting 96 of 112 residents and 44 staff members. Tragically, 20 people lost their lives and more than 40 were hospitalized. In an attempt to mitigate the spread, residents were confined to their rooms most of the late spring and summer, with doors closed for several weeks when the situation was at its worst.
It was on the checklist that day. My yearly screening mammogram was scheduled at 7am on September 1, 2015.
The first patient slot assures a departure time of 7:30am. I would arrive at work by 8am, giving me just enough time to stop for a coffee on the way. I had a full day planned – two Zoom meetings, neuroradiology imaging studies, a 6pm Peloton class, and finally a walk with my two best friends and our dogs.
Little did I know that by 7:16am that day, my life would change. Typically, following my scan on the way to check out, I sit for five minutes with the radiologist – my roommate from medical school – and catch up on life. This time, however, there would be no small talk. I needed an emergent ultrasound and biopsy for a mass deep near the chest wall. Neither of us could even feel it on physical exam.
I have learned many lessons through my involvement in commercially successful and unsuccessful medical technology startups. Most of these lessons are clear and evident, but it is easy for even the most wise and conservative of leaders and investors to drink one’s own Kool Aid. Three of these lessons follow.
FALLACY #1 – Regulatory approval is the main hurdle. The tacit and voiced assumption is that gaining regulatory authorization in the US is THE major achievement required to realize commercial success. In some cases, this is correct – where reimbursement codes, payment, and coverage exist already, and where the new technology is not an entirely different way of doing things, FDA authorization is key. Where this is not the situation, the real challenges lay elsewhere.
Written by Karun Sharma, MD, PhD, and AeRang Kim, MD, PhD
Improvement in cures for pediatric cancer is one of the true success stories of the past century, with approximately 80 percent of children with cancer cured of their diseases with contemporary cancer therapy. However, this success comes with cost. Many pediatric patients suffer from the acute and late toxic effects of our multi-modal therapy which often includes surgery, chemotherapy, and radiation treatments. In addition, success in childhood cancer has not been distributed equally among all types of pediatric cancers. Many children with metastatic, refractory, or relapsed cancers are still without much improvement in survival outcomes over the past 20 years.