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    Date submitted
  • 09-Oct-2017

SonoShield

Abstract

Ultrasound imaging is a diagnostic tool used in Trauma Units, Emergency Departments, Intensive Care Units, and many other medical settings. Ultrasound probes contain highly sensitive components including the piezoelectric element (the signal transducer), the acoustic lens, and the acoustic matching layer. Each critical part is subject to fracture when the probe is dropped or impacted during use, transport, or storage. Broken components result in reduced ultrasound image quality which can lead to misdiagnosis or prolonged procedures for patients.

Market research and conservative estimates indicate that at least 100,000 ultrasound probes are broken every year in the United States. The average cost to repair an ultrasound probe is around $2,500 while the average cost to replace a probe is around $10,000. Furthermore, the downtime associated with broken probes results in a higher machine inventory requirement (and thus higher costs) to hospitals. Costs associated with repair/ replacement, machine downtime, and potential for misdiagnosis are ultimately passed on as increased expenses for patients.

Sono Shield is developing an impact resistant cover for ultrasound transducers (think otter box for ultrasound). This case is designed to be ultrasound transparent and to protect against impact damage. The case remains in place during procedures, storage, and transport. It is cleaned with the same disinfecting procedure currently used to clean ultrasound transducers themselves.

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Additional Questions

Who is your customer?

Ultrasound continues to be one of the most widely utilized medical imaging techniques due to its ease of use and lack of associated risks. While ultrasound has been used in obstetrics since the 1950s to image the developing fetus, its use has since extended to other diagnostic settings, including emergency rooms, anesthesiology, interventional radiology, physiatry, and veterinary medicine. The use of ultrasound is finding greater utilization in other areas of healthcare including in general medicine clinics, and medical student education. Currently expanding segments and technologies include increased use and popularity of 3D/4D ultrasound as well as hand-held units. In light of this information, Sono Shield's customers include various hospital departments and medical clinics.

What problem does this idea/product solve or what market need does it serve?

Ultrasound imaging is a diagnostic tool used in Trauma Units, Emergency Departments, Intensive Care Units, and many other medical settings. Ultrasound probes contain highly sensitive components including the piezoelectric element (the signal transducer), the acoustic lens, and the acoustic matching layer. Each critical part is subject to fracture when the probe is dropped or impacted during use, transport, or storage. Broken components result in reduced ultrasound image quality which can lead to misdiagnosis or prolonged procedures for patients. Market research and conservative estimates indicate that at least 100,000 ultrasound probes are broken every year in the United States. The average cost to repair an ultrasound probe is around $2,500 while the average cost to replace a probe is around $10,000. Furthermore, the downtime associated with broken probes results in a higher machine inventory requirement (and thus higher costs) to hospitals. Costs associated with repair/ replacement, machine downtime, and potential for misdiagnosis are ultimately passed on as increased expenses for patients.

What attributes will make this idea/product successful? Why do you believe that those features will create success?

This product is an easy sell because it creates value for hospitals and clinics by eliminating existing costs. Hospitals will want to adopt it because the cost savings will far exceed the cost of implementation. Furthermore, the product is designed to have a minimal effect on current ultrasound procedure workflows (i.e. it is cleaned with a detergent wipe, the same way ultrasound transducers have always been cleaned). As such, the product is an all around win for our customers and will successfully be implemented in the market. The simplicity of the product is also an important feature. FDA approval will be relatively straightforward (class 1 device, with predicate identified for 510(k)). Once process development is complete, part fabrication will be inexpensive. Sono Shield has a provisional patent on the concept - providing and important barrier to entry for potential competitors.

Explain how you (your team) will execute to make this idea/product successful? What gives you (your team) an advantage over others already in the market or new to this market?

Sono Shield currently has a working relationships with the Innovation Department at Intermountain Healthcare and the Ultrasound Director in the Emergency Department at the University of Utah Hospital. After product development is complete, Sono Shield intends to engage in a beta testing period with IHC and the U of U hospital to collect data on the effectiveness of the product. This data will then be used to support claims for further sales. The relationships that are already in place with IHC and the U of U Hospital, the provisional patent on the technology, and the combined backgrounds of our team members (students in medicine, nursing, mechanical engineering, and business) are all factors that contribute to the advantage that Sono Shield has in this market.