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Medical Device R&D: Innovation, Making a Difference for People, and Having Fun While Doing It

Wednesday, November 11, 2020

4:00 PM-5:30 PM

BIOMED Seminar

Medical Device R&D: Innovation, Making a Difference for People, and Having Fun While Doing It

David Toub, MD, MBA, FACOG
Medical Director
Gynesonics, Inc.

Medical device development is an active area involving biomedical engineers, clinicians and others to innovate, build, test, iterate and bring to fruition new tools and treatments that benefit people with various conditions and disorders. This is exemplified by a new device to perform transcervical fibroid ablation (TFA) in women suffering from uterine fibroids. Fibroids are benign tumors that most often arise in the muscle layer of the uterus and are highly prevalent among premenopausal women. Symptomatic uterine fibroids are the primary indication for hysterectomy in the US and most other countries, even though they almost always can be treated without removal of the uterus.

TFA with the Sonata® system is an incisionless outpatient treatment for uterine fibroids that does not involve incisions, can be performed without general anesthesia, and has short recovery times and is effective. It is CE marked and received FDA clearance in August 2018. The treatment device combines two existing and well-characterized technologies: sonography (for imaging) and radiofrequency (RF) ablation (for treatment).

The Sonata system is the first commercial device to employ high-resolution intrauterine ultrasound, and the tablet-based system provides a graphical overlay to display the size and location of the ablation along with a thermal safety border. This enables gynecologists to image, target and ablate a wide variety of fibroids without having to measure or input any data. Nearly 1500 women have been treated worldwide since 2011. This is but one example of how medical device development can make a significant difference in people’s lives, and the work involved is intellectually rigorous, fascinating and highly satisfying.

David Toub, MD, MBA, FACOG, is Medical Director at Gynesonics, a medical device company in Redwood City, CA that has developed a transcervical device (the Sonata® system) for radiofrequency ablation of uterine fibroids. Prior to joining Gynesonics in 2008, Dr. Toub received AB and MD degrees from the University of Chicago and earned an MBA with a concentration in management information systems from Drexel University’s LeBow College of Business. He is a Fellow of the American College of Obstetricians and Gynecologists and a Diplomate of the American Board of Obstetrics and Gynecology. Dr. Toub also served as an attending physician at Pennsylvania Hospital, where he held faculty appointments at both Thomas Jefferson University and the University of Pennsylvania.

Dr. Toub is an expert reviewer for the journals Obstetrics and Gynecology and The Journal of Minimally Invasive Gynecology (for which he has served on its Editorial Advisory Board). He recently contributed a chapter on “Radiofrequency Ablation – Fundamentals and Applications” to a textbook on hysteroscopy, edited by Ricardo Lasmar. Dr. Toub lives with his family in Wyncote, just outside Philadelphia, and composes music in his spare time.

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Lisa Williams

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