Areas of Expertise
Clients and Projects
About Sonic Tech
Clients and Projects
Sonic Tech, Inc. generally works under confidentiality agreements which preclude us from disclosing a client list. However, the list below includes those who's work does not involve proprietary information, or whose products can be described in a way which does not violate our agreements:
Phacoemulsification System We have done work for a number of manufacturers of phacoemulsification (ultrasonic cataract removal) systems over the years. We have done work lately to quantify the relationship between cataract cutting and the ultrasonic drive parameters. While the exact design results remain proprietary to the clients, we have been asked to make numerous presentations to clinical audiences on this technology. These presentations have changed the thinking in how to conduct this surgery, and recent data points to methods of reducing patient exposure while maintaining or improving efficacy. Our work has ranged from measurement services, to design assistance, to marketing presentations. Along the way, we have been named on several of their patent applications for our direct contributions to their technology.
Consumer Products A manufacturer of a consumer product that has an ultrasonic component approached us for help in defending against a corporate lawsuit. We subsequently became involved in a design review process involving the ultrasonic transducer assembly. We suggested a new design which resulted in a 400% increase in effective ultrasound delivery, while reducing product variability by 300%. This was done with less than ten cents of incremental product cost (less than 1%). We supervised the design changes, trained the staff, implemented new quality control procedures (with an improved table-top ultrasound test tank), and monitored the results. The product is manufactured in China and sold worldwide.
Ultrasonic Cardiac Output Monitor We are working with a client who manufactures a cardiac output monitor for use during and after surgery. We have been involved in nearly all stages of this product's ongoing development. Some of our activities: developed new transducer specification; designed and implemented an in-house Acoustic Test Fixture to rapidly determine transducer characteristics; developed all procedural documents for the ATF; conducted a Design of Experiments campaign to validate changes from one version to the next; developed a software "virtual machine" to allow Marketing to design and approve all user interface screens and interactions before implementation on the target hardware; upgraded a pulsatile flow phantom system that provided compliant vessels of different diameter; designed a new detection algorithm using a patient database which dramatically improved reliability; coordinated all testing (acoustic, thermal, EMC) for regulatory submissions; conducted European clinical trials and analyzed the data for management review; edited User's Manual and other Device Master Record documents; advised on approaches to the FDA and assisted in the filing of the 510(k); developed an improved probe design (patent applied for); assisted in development of "next generation" product specifications; accompanied company personnel on due diligence, focus group, and clinical trial efforts.
Regulatory Compliance We have assisted a number of ultrasound companies with their regulatory needs. First of all, we have assisted literally hundreds of companies with their acoustic measurements for FDA 510(k) submissions, dating back to 1984. Dr. Schafer has probably signed more regulatory acoustic measurement reports (diagnostic, lithotriptic, or therapeutic) than any other individual in the industry. More recently, we assisted a major ultrasound manufacturer faced with a product recall issue. We audited the facility, investigated the root causes, isolated the problem, instituted procedural reform, and coordinated new testing processes across several locations. Another recent client was a start-up, where we developed a regulatory strategy unique to their product, assisted them with their first submission, and set up a compliant product testing program. Some of this work is as simple as an answer to a question about an IEC Standard during a phone call (often then at no charge), while other efforts have involved writing detailed documentation. Finally, we are quite accustomed to directly interfacing with the FDA on behalf of clients. We have often used our FDA contacts to ask questions anonymously for clients; this allows each side to get to a resolution without the matter "becoming official" before it has to be.
Sofware We have had an ongoing effort in the area of ultrasonic measurement software since the late 1980s. The software was continually being upgraded to account for new regulatory requirements and to incorporate improvements in technology and technique. Over the years, we had developed customized versions for lithotripsy and phacoemulsification systems. We were approached by a major diagnostic ultrasound company to upgrade their NTR tank and software so that it could be used for both product research and for manufacturing compliance testing. We upgraded the hardware to improve positional stability, designed new probe and hydrophone holders, and interfaced our software to the existing motor drivers and oscilloscope. A critical provision was the requirement that the measurement software control their device under test, adjusting pulse types, focal zones, drive levels and aperture conditions without user intervention. This allowed probes to be tested unattended in all relevant conditions. This dramatically improved the process turnaround time for this division of the company. The software is now fully compliant with IEC 60601-2-37 and NEMA UD-2 and UD-3. A full description of the software is available here. Additional versions were sold to Intertek, a major equipment testing laboratory, and to the U.S. Food and Drug Administration. Additional placements now on order worldwide, making the software, in the words of one client, a "Global standard".
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