When G. Wayne Moore founded Sonora Medical Systems, he wanted to transform the way medical ultrasound probes were tested. Now, 18 years later, he is continuing that mission as president and CEO of Acertara Acoustic Laboratories, known as the country’s only ISO17025:2005-accredited acoustic testing laboratory.
The company’s R&D team has been together for 10 years, devising technologies like the FirstCall probe testing device and the newer Active-Z and Aureon systems. Based in Longmont, Colo, Acertara also offers 510(k) submission testing services, and has participated in more than 800 successful FDA submissions to date.
Moore recently spoke with 24×7 about new technologies coming down the pike, staying nimble in a competitive market, and how to resolve the conflict over the right to repair.
24×7: How did you get where you are?
Moore: In late 1996, I was finishing a 3-year employment agreement with Siemens Medical Solutions, where I was the director of marketing and business development for the ultrasound group based in Seattle. At the end of my time there, I signed an agreement with Siemens to form a company that would take in the ultrasound trade-ins they would receive for the three new ultrasound products we had just introduced. With that agreement in hand, I moved back to my home state of Colorado and founded Sonora Medical Systems.
24×7: What were you hoping to do by starting your own company?
Moore: One of the things that I learned while working for a large multinational corporation is that the ability to get things done quickly can sometimes be an extreme challenge. I am not a huge fan of nonvalue-added meetings that tend to drone on without a decision being made, except to agree to have another meeting. I also recognized that amazing things were happening in the development of technology and that ultrasound systems and probes were about to become an order of magnitude more complex.
The old paradigms of how systems and probes were tested and repaired were about to go away. I was very interested in starting a company that would be focused on developing new and novel test devices that would objectively test the performance of the new probes and systems coming on the market. There was not a company like that on the market at that time. I decided to take my nearly 20 years of experience in ultrasound product development, assemble a veteran team of ultrasound-experienced electronic design engineers, and create a new test and repair paradigm for the ultrasound market.
24×7: How has your company’s focus changed over time?
Moore: Our company’s focus has not changed, but we have evolved our thinking process relative to product design. The evolution of what we create mirrors what the ultrasound original equipment manufacturers (OEMs) are designing and the technology they are using. Our initial probe test product, FirstCall, which we introduced into the market in 2001, is still a viable product to this day; our design of the device addressed the technologies and technological approaches relative to probes that were dominant in the market at that time.
A lot has changed in the intervening 13 years since we introduced FirstCall, and in 2014 there are multiple new probes on the market that go beyond FirstCall’s ability to test them. Our approach in deciding what types of probe test devices to create and what types of technology to use is always centered around one key question: How can we objectively and cost-effectively test a broad range of probe models using a novel device that could easily and affordably be integrated into a hospital’s evidence-based quality assurance program and be a useful daily tool for clinical engineering personnel?
24×7: What activities do you primarily focus on now?
Moore: The epicenter of our product development activities and the source for many of our ideas is our ISO17025:2005-accredited acoustic testing laboratory. In our laboratory, we perform acoustic power and intensity testing for ultrasound device OEMs on a worldwide basis. This testing is necessary as part of a 510(k) submission for product clearance in the United States and is also required for international standards such as IEC60601. In that role, we have close contact with most ultrasound OEMs globally, ranging from start-up companies to large multinationals. The United States Food and Drug Administration (FDA) is also one of our customers.
Our activities in this area often provide us with a glimpse of what new and exciting technologies may be entering the commercial market over the next 2 to 5 years. That preview informs our decision-making on what questions the next generation of probe and system test devices will need to answer. We have a rapid product development cycle and always strive to be on the market with an appropriate test device concurrently with the introduction of these new ultrasound systems and probes. It is a challenge we love.
24×7: How do you encourage innovation in-house?
Moore: The OEMs provide us with all the encouragement we need by creating exciting new ultrasound products and probes. Just to name a few recent examples, Siemens’ new portable system called the Freestyle uses probes that don’t have cables or connectors; it uses wireless transmission of data. That posed a whole new series of challenges for my design team. For example, how do you perform electrical leakage testing on a probe that doesn’t have a cable, a connector, or an earth ground? Although there is no device currently on the market to do that, we are designing one that will be introduced soon.
Several new handheld ultrasound models have the probe hardwired into the device, so we needed to develop a method to acoustically test these probes. That led to the design and development of our Aureon test system. OEMs are also using a wide range of new probe connectors, including, for example, simple USB cables. To address all these variant connectors, we created a new device, Active-Z, that can test probes using nonstandard as well as standard connectors.
Ultrasound technology is changing rapidly, and the clinical applications of ultrasound are expanding exponentially. That is what spurs us on. I can’t wait to get to our lab every morning, and I discourage vacations [laughs] so that we can stay on top of all the challenges of this vibrant market. Our focus is on the patient, making devices that ensure the performance of the devices being used so that the patient will receive a safe and efficacious ultrasound study, and the physician will receive the diagnostic information he or she needs to make good patient-management decisions.
24×7: How long is your development process for a new device?
Moore: Here is the beauty of a small, highly focused R&D team: While at a large OEM it may take a year just to decide what they should do, we can have a new product on the market in the same amount of time! Our latest product, Active-Z, was conceived, designed, and introduced, with patents filed and first articles to stock, in 12 months. So in the time it may take for a large corporation to discuss the topic, we’re already in the market.
We have also become the de facto R&D group for many third-party ultrasound service and probe repair companies. We are frequently contacted by these companies for assistance in designing some special tool or device to solve a particular problem they may be having.
We also receive multiple phone calls and emails every week for FirstCall technical support and related testing questions. We don’t mind sharing our expertise or devices with companies that some would say are our competitors. Listen, they are going to repair probes anyway, and I’d rather they did it right with the right equipment.
24×7: You’re active in the right-to-repair movement and serve as a board member for the Digital Right to Repair Coalition. Where does responsibility lie for resolving this issue?
Moore: This is a complex issue that lies at the intersection of multiple competing interests: The OEM obviously wants to protect its service revenue stream, hospitals need to save scarce resources, third-party service providers want to offer less expensive repairs to hospitals, regulatory bodies are concerned about devices being repaired correctly, and HTM personnel within the hospital would, in many cases, like to maintain and repair the devices under their charge.
I see good arguments on all sides. For example, third-party ultrasound service in the United States is not regulated by the FDA, but OEMs, as part of their requirements as manufacturers, must comply with FDA-mandated service rules. OEMs argue, with some validity, that they are being held to a higher standard of care, and this creates a nonlevel playing field. Non-OEM service entities, whether in the hospital or third party, argue that if they had access to system self-test diagnostics, and appropriate parts, then they could repair the system with the same degree of care as the OEM.
24×7: What do you think is the solution?
Moore: I would like to see a bridge that would at least foster meaningful dialogue among all the stakeholders. If it continues as an adversarial relationship, it will only ultimately end in litigation. I am a strong advocate of the FDA regulating third-party service providers. My sense is that if that were to occur and third parties were held to the same standard as OEMs, that would take a big chip off the table.
There is an ongoing dialogue between members of the Medical Imaging Technology Alliance (MITA), the medical arm of the National Electrical Manufacturers Association (NEMA), and the FDA regarding this issue, but the wheels of government often turn slowly. My instinct tells me that this issue will eventually be decided in a court case revolving around OEMs providing the documentation, etc, necessary for repair of their equipment to owners of the equipment. This issue will go on for many years.
24×7: Where else do you see the industry and Acertara going?
Moore: The ultrasound industry and the service industry will continue to grow at a robust rate. With the diffusion of ultrasound imaging and Doppler technologies into more and more nontraditional clinical environments, the number of systems and probes on the market, and their necessary service, will expand. We recently tested and profiled a probe in our acoustic laboratory that was used on the International Space Station; it doesn’t get more far out than that!
We also have seen some dynamic new players enter the ultrasound market, like Samsung of Korea. They represent new thinking and new technologies for the ultrasound market and bring a brilliant consumer market-oriented R&D team into the fray. We have seen as well a dramatic rise in start-up companies entering the ultrasound market with some very clever, clinical applications-specific devices. We watch the ultrasound market like a hawk, we stay at the forefront of new technologies, and we will continue to develop test devices and probe repair capabilities that match whatever the OEMs throw at us.
24×7: What challenges does this growth pose for your company, since you have to address both ends of the market spectrum?
Moore: We focus on developing the technology that can test and validate the performance of probes and systems regardless of how technologically complex they are, or are not. If the device is being used on a patient, we want to make sure we can test it. We have a full range of products to accomplish this, and we have several more on the drawing board or currently under development. We have sophisticated devices such as Aureon and day-to-day testing devices such as Active-Z. We offer advanced probe repair at our laboratory and thoroughly test every probe that comes in to our lab to determine not only the failure, but the root cause of the failure. We provide customers with a detailed report in this regard. I am always amazed that some hospitals still send probes to third-party repair companies that we know cannot test the probe! How can you repair something if you don’t know what is wrong with it?
Jenny Lower is associate editor of 24×7 magazine. Contact her at [email protected]