Founded by George Keilman in 1989, Sonic Concepts began as an ultrasound transducer development consulting business. Today, the company develops and manufactures premium ultrasonic systems to the biomedical, industrial, marine, and research markets. Everything developed and manufactured by Sonic Concepts has an ultrasound component – from small ultrasound catheters to large focused ultrasound devices.
In 2015, Kyle Morrison succeeded Keilman as the President of the Bothell, Washington based company. We recently interviewed Kyle Morrison about Sonic Concepts’ current work and what he sees for the future of the company and the field of therapeutic ultrasound.
How did you get involved with Sonic Concepts?
In 2004, I began working at Sonic Concepts as a mechanical engineering contractor for several ultrasound-related projects. Two of these projects were medical technologies:
- An ultrasound sensing implantable device to monitor pulmonary artery flow. This technology spun off into a separate company called CardioMetrix, Inc.
- In collaboration with the University of Washington’s Bioengineering Department, we developed an ultrasound-guided focused ultrasound system to treat uterine fibroids noninvasively. This technology transferred to a new company – Mirabilis Medica, Inc – and is currently in clinical trials.
Tell us about your company.
Sonic Concepts is a privately held S-Corporation. Over the last 30 years, we have developed and manufactured products across four major sectors: pre-clinical, clinical, life sciences, and industrial fields. We currently have 20 employees within a 6,000-square-foot facility, which includes a process laboratory, a full-scale machine shop, and electrical and acoustic laboratories. In December 2017, Sonic Concepts received ISO-9001 certification and is recognized in both the domestic and international ultrasound markets.
As President, I aspire to three general objectives for the company: maintain its overall fiduciary health, ensure that it remains a worldwide leader in transducer design of novel ultrasound products, and support our customers with premium technology, service, and ultrasound expertise.
Theresa Forseth is Sonic Concepts’ Director of Operations. She manages our production lines, quality (including ISO-9001:2015 compliance), and general business administration. Theresa also plays a key role in Sonic Concepts’ customer relations.
George Keilman, the founder, and CTO of Sonic Concepts, actively supports the design and development of new transducers and systems. George continuously shares his expertise, wisdom and guidance within the company.
Discuss Sonic Concepts’ offerings within the therapeutic ultrasound field.
We have supported a variety of focused ultrasound device manufacturers, including those using ultrasound guidance, magnetic resonance imaging guidance, X-ray guidance, and without guidance. These companies range in size from smaller angel investment start-ups to publicly traded institutions and are aiming to treat deep veins, nerves, kidneys, liver, heart, brain, uterus, and the prostate.
Over the years we have also spun off and are shareholders of a few therapeutic ultrasound companies. We currently consult for several high-intensity therapeutic ultrasound medical device companies. We provide these customers with flexible services from design to development to manufacturing.
What is your process for developing a product for a focused ultrasound device company?
When designing a transducer and system commercially for human-use, the device manufacturer will often present to Sonic Concepts an engineering requirements specification (ERS). If not, we help by participating in the mitigation risk analysis and ERS with respect to their clinical and marketing requirements specifications. Once we have specifications, we design the transducer and system, and test to ensure that the design meets these specifications. We build the transducers under our ISO 9001 quality system, but it’s the device manufacturers’ responsibility to meet their ISO 13485 (or FDA) design and manufacturing requirements.
How are your transducers used in customers’ applications?
Our transducer and systems are used for pre-clinical investigation and in clinical platforms covering the entire therapy spectrum from thermal ablation, mechanical ablation (histotripsy), mechanical non-ablative uses (drug delivery), boiling histotripsy, to low-power therapy (neuromodulation). We have developed focused ultrasound transducers for ultrasound guidance and MR guidance throughout the human body.
What challenges do you have to tackle moving forward?
We are constantly learning and fine-tuning our craft in transducer and system design to the evolving field of focused ultrasound. With industry collaboration, I see a need to reduce the acoustic output uncertainty of clinical and pre-clinical turn-key focused ultrasound systems. Sonic Concepts’ in-house metrology and calibration capabilities have evolved and improved with developing turn-key systems, but we need to get better at reducing measurement uncertainty without it being cost prohibitive.
It’s important to perform Design Failure Mode and Effect Analysis (DFMEA) for transducer designs beyond the requirements set forth in the ERS. We are developing a calibrated multi-channel and real-time monitoring system to record, under fine temporal resolution, transducer breakdown. This technology also aids in burn-in and defining transducer operation specifications when driven at high power.
A complete safety mitigation hazard analysis isn’t a pre-clinical requirement, but integrating safety monitoring equipment early on is ideal. We need to encourage the focused ultrasound community to invest in safety mitigation early on. Integrating an independent high-power meter, thermal monitoring, single-fault failure shock hazard redundancy and leakage current detection to a pre-clinical system will demonstrate best safety practices. When calibrated with the full system, these safety peripherals may be used for investigational device exemptions (IDE) clinical studies and for institutional review board (IRB) approval.
What are the benefits of your technology?
Sonic Concepts uses transducer stack designs and processes that have surfaced through design and experimentation over the past 30 years. We also benefit from our exposure in developing transducers across different industries. Our in-house acoustic expertise and experience, in combination with creativity, and modeling through our custom software, gives us an edge in tackling requirements that seem to defy the laws of physics.
Our therapeutic transducers offer a high-transmit efficiency over a reasonable bandwidth, which is uncommon to conventional composite transducer design. We also go to great lengths in sustaining the transducer stack’s efficiency and bandwidth using unique interconnection, cabling, and tuning network designs. At frequencies <1 MHz, we’re able to sustain 90% transmit efficiency over a 40% bandwidth into a perfect 50 Ohm source impedance. Therefore, heat transfer requirements of the device are nearly eliminated in using our technology.
Do you partner with other companies?
In 2017, we formally announced our collaboration with Verasonics, Inc., which promotes the turn-key HIFUPlex™ portfolio. Our two companies have been casually collaborating since 2012 toward a turn-key focused ultrasound system. HIFUPlex™ was born to provide a flexible turn-key solution for endless applications. In combining Verasonics’ Vantage with our multi-channel focused ultrasound transducers, we collectively developed a product specification and upgrade package intended to save the researcher on prohibitive capital expenses. The beginning focused ultrasound researcher can start with an upgradable and calibrated single-channel turn-key HIFUPlex™ for less than $20,000. Our collaboration with Verasonics offers the ability to upgrade this single-channel package up to an USgFUS 256-channel system with treatment planning.
Our hope is for the therapeutic ultrasound research community to embrace the HIFUPlex™ platform as the gold standard. We believe it will greatly reduce overall costs and time to reach first-in-man. We’re seeing clinical momentum in focused ultrasound, and the efficacy statistics are young. Now is the ideal time to introduce a golden standard platform.
What are your future projects?
We are listening to the focused ultrasound community and observing emerging trends in research that drive our novel technology development. For example, we are partnering with academia, industry, and philanthropic individuals and organizations to develop 2D transducer arrays and systems.
Seattle Collaboration Creates HIFUPlex, A New Research System June 2017
Company Profile: Sonic Concepts January 2015