What’s new in diagnostic ultrasound—and what it means for HTM professionals
By Elaine Sanchez Wilson
Suffice it to say that the global ultrasound market is hot—with recent projections anticipating the market to reach $6.86 billion by 2021 at a compound annual growth rate of 5.2%.
Ahead of this growth, Jim Spearman, MBA, president and CEO of Cary, Ill.-based Consensys Imaging; Nick Haralam, senior territory manager at Harrisburg, Pa.-based Trisonics; Vitor Rocha, Philips’ ultrasound business leader; Dave Dallaire, vice president of sales and marketing at Longmont, Colo.-based Acertara; Doug Adams, marketing specialist at Charlotte, N.C.-based Global Medical Imaging (GMI); and Mark Conrad, president of Stockton, Calif.-based Conquest Imaging, sat down with 24×7 Magazine to discuss the factors contributing to ultrasound demand.
24×7 Magazine: In last year’s roundtable on ultrasound, we discussed how improved image quality, along with the modality’s affordability, are driving its growth among hospitals and clinics. What are some of the emerging clinical applications in ultrasound on which you are keeping a close eye? How is ultrasound impacting these particular fields?
Doug Adams: GMI is seeing the largest growth and interest in musculoskeletal (MSK) ultrasound, which is at the forefront of the point-of-care market. The clinical applications of MSK ultrasound has increased exponentially over the last few years. The shift has been in the use of ultrasound as a true diagnostic tool versus primarily in needle-guidance.
We also see an uptrend in ultrasound aiding in-office procedures, such as the microinvasive carpal tunnel release. Procedures previously performed under fluoroscopy can now be performed without exposing patients to harmful radiation. This “outside-the-box” thinking is increasing the utilization of an already versatile and economic diagnostic tool.
Vitor Rocha: Automation, reproducibility, and portability continue to be primary trends that drive ultrasound. New tools are making ultrasound easier to use and more reproducible. One example of this is Philips ElastQ Imaging, which brings high-quality shear wave elastography for an easily executed, noninvasive method to assess and diagnose liver conditions.
In addition, we’re seeing a greater commitment to transducer innovations that allow clinicians to easily assess technically difficult patients, such as young children or individuals who are overweight. Philips’ PureWave technology, for instance, is specifically designed to allow deep penetration and excellent resolution on all patients, even those who are traditionally harder to image. And finally, we’re seeing innovations like Lumify, which brings portable ultrasound to your smart device.
Mark Conrad: Elastography—which allows physicians to evaluate the elastic properties and stiffness of soft tissue—has been one of the newer clinical applications gaining use, particularly in identifying potentially cancerous tumors. Tumors have a much harder density and/or stiffness, which ultrasound elastography can quickly identify. I believe the use of ultrasound in oncology has also significantly increased, helping patients gain earlier diagnoses of cancerous tumors and faster treatments.
MSK has also dramatically increased in clinical ultrasound. Patients are able to obtain a better, faster, less invasive diagnosis of potentially life-threatening diseases. To me, that is why ultrasound continues to expand its clinical applications—not so much from a lower-cost [perspective], but from increased patient comfort and better diagnoses.
Jim Spearman: Breast ultrasound is arguably the hottest emerging clinical application for ultrasound. Clinical efficacy is formidable compared to traditional technology, and acceptance is growing rapidly across the United States.
We’re seeing a notable rise in cases being conducted with breast ultrasound, but still significantly less than half of all cases. We’re also seeing breast ultrasound supplementing traditional screening method. And clinicians are finding breast ultrasound to be a valuable tool in specific applications with certain types of patients.
Dave Dallaire: Two that we are keeping an especially close eye on, and participating in, relate to newer ultrasound contrast media materials that facilitate higher levels of tissue absorption of therapeutic agents used in chemotherapy and the dramatic increase of handheld smartphone ultrasound devices, especially as it relates to point-of-care use on a worldwide basis.
With these new materials, modalities, and techniques, as well as the creation of novel acoustic biomarkers, the blending of diagnostic ultrasound with therapeutic ultrasound is becoming more pronounced and will continue to dramatically evolve over the next five years.
Nick Haralam: In a phrase, strain analysis in cardiac imaging. Cancer patients who will undergo chemotherapy benefit from strain imaging, combined with an echocardiogram when used before and after treatment. Strain imaging gives the ability to evaluate the function of the heart muscle and identify subtle changes in their heart’s performance even before they show up as clinical symptoms. This was an option only found in higher-end ultrasound units in the past, but is now available in many mid-level units.
24×7: How does today’s political and regulatory climate influence the use of ultrasound, if at all? And, as a followup, how does your company address these challenges?
Rocha: Every day, we remain focused on delivering high-quality, easy-to-use ultrasound solutions to support clinical decision-making. Philips has a rich history of innovations that redefine how care is delivered and of working with the medical community to create insight-driven solutions. As global cost pressure continues and regulatory complexity increases, we are leveraging three decades of experience in ultrasound innovation to find new ways that help our customers manage healthcare costs and deliver increased value to our customers.
Spearman: As you know from 24×7 Magazine’s May article on pending legislation at the time, H.R. 2430 was signed into law. This law sets things into motion for the FDA to formally close the gap with all third parties with respect to the servicing of medical devices. We’ve seen a trend over the last three years where customers have taken much more risk with respect to servicing and maintaining ultrasound units. Many have gone either in-house or used third parties for time-and-materials.
It appears that ultrasound will be hit hard if the FDA inserts itself with formal oversight, as there are many in-house and third-party service relationships for ultrasound—significantly more than higher-end imaging modalities, such as MR, CT, cath, and PET/CT. Consensys, however, has voluntarily adhered to all medical device regulations, including FDA requirements, since our inception. As a result, we represent three OEMs on their new products during the warranty period.
Haralam: Ultrasound is noninvasive and affordable, which makes it more attractive. Today, it is very difficult to predict what government will do in healthcare. As a small company, we are able to react quickly in the marketplace to any changes instituted by policy.
Dallaire: Reimbursement is always an issue, but ultrasound is so critical to diagnosis and patient management that it has been relatively immune to the lower reimbursement rates. Acertara’s CEO, Wayne Moore, is a fellow of the American Society of Echocardiography, and is always right in the middle of discussions with CMS and others relative to reimbursement rates.
Key to addressing these challenges is for Acertara to provide products and services to hospital HTMs that allow them to keep costs under control while maintaining high quality and patient safety. To ensure that, Acertara carries three ISO certifications, including our ISO17025 accreditation. Mr. Moore is also the 2017 chair of the Ultrasound Technical Committee of the Medical Imaging and Technology Alliance, and the American Institute of Ultrasound in Medicine co-chair of the Output Display Standard Committee. In these roles, he drives future standards and regulations as they apply to diagnostic ultrasound.
Conrad: In today’s regulatory climate, HIPAA is a very important part of not just ultrasound, but of all healthcare. With HIPAA-related technology violations on the rise, due to proliferation of health data breaches caused by cyberattacks, new tamper-resistant systems for storing patient data are potentially going to revolutionize healthcare and patient records through the use of Blockchain technology—providing a transparent record of transactional movements of secure data, such as medical records—and cryptography (constructing and analyzing protocols that prevent third parties or the public from reading patient data).
We need to keep our eyes on the use of this technology within healthcare electronic medical records and DICOMs—along with keeping an eye on how ultrasound OEMs meet the challenge to comply.
Further, Conquest Imaging is an ISO:9001 certified company, which allows us to manage any current HIPAA regulations now and into the future. Therefore, any pending additional regulations to our industry that may occur, including the FDA user-fee programs, will have less of an impact on Conquest Imaging than perhaps [some] other companies. We have established our quality management system and we continue to invest in research and development to meet any new challenges that may occur in the market.
Adams: The regulatory goal of reducing reimbursements continues to be a huge influence on how ultrasound is used in clinical applications, as has been the case for the last 20 years. In comparison, ultrasound is a more cost-effective diagnostic option than MRI, CT, and nuclear medicine. With that being said, diagnostic ultrasound both influences and is influenced by driving down those reimbursements.
GMI has always been a brand-indifferent ultrasound solutions provider. We listen to our customers’ wants, needs, and budget constraints and provide them a quality, economical diagnostic solution that fits their requirements regardless of the manufacturer.
24×7: Are you noticing any increased demand for ultrasound technology among a specific group of customers? If so, who is driving adoption?
Dallaire: Yes, we are, and adoption is currently being driven by nontraditional users of ultrasound for clinically specific applications, ranging from neuraxial anesthesiologists to nutritionists measuring muscle mass and glucose uptake. We are also seeing an upsurge of use in the primary-care market with the clinical use being determined by the primary care physician’s specific patient demographic. Home health care and assisted living are also two markets that although nascent, will grow dramatically over the next five years.
Adams: The point-of-care (POC) market is rapidly expanding its clinical uses for ultrasound. POC encompasses areas such as sports medicine, internal medicine, pulmonology, orthopedic, podiatry, nephrology, cardiology, family practice, pain management, and chiropractic applications. Technological advancements, such as strain and shearwave elastography, are helping clinicians assess and diagnose MSK injuries and provide focused treatments for better therapeutic outcomes.
Rocha: Ultrasound is more accessible today than ever before with portable solutions that streamline diagnostic processes and improve the quality of care for patients. We’re seeing wider adoption by a variety of providers who may not traditionally have used ultrasound, including nurses, midwives, and emergency medicine and critical care professionals.
For instance, Lumify, Philips’ smart device ultrasound solution, provides access to ultrasound at the point-of-care whether that is in the emergency department, the back of an ambulance, in a clinician’s office, or even on the sports field. The utility of ultrasound will continue to expand as it has become fundamental to providing cost-effective care for patients around the world.
Conrad: The increasing market for portable systems has moved ultrasound into areas not normally associated with ultrasound use: endocrinology, podiatry, ER, and nursing homes. Also, veterinary medicine continues to grow in its use of ultrasound; with systems decreasing in size, that market is really expanding. I think the driving forces are physicians utilizing ultrasound in these new clinical application areas and, really, the OEMs who continue to introduce new technologies that solve problems for the clinical community.
Spearman: Breast imaging has been the biggest driver, but we continue to see nice growth in traditional “radiology” (aka: general imaging) departments, as well as in OB/Gyn applications.
Haralam: We have seen an increased demand for newer ultrasound units from the cardiology side since it’s becoming more difficult to become an accredited facility with older, outdated ultrasound units. Newer cardiac measurements, imaging features, and advances in image quality are driving this.
24×7: What technological advancements in ultrasound do you anticipate in the next few years?
Conrad: I see continued growth in the portable market, with systems decreasing in size and increasing in performance. Developments such as wireless transducers are also in their infancy and are being engineered as we speak.
Systems are already in the market that incorporate MRI. Ultrasound is also being shown in the family practice market and general practice areas. The use of ultrasound could be a great screening device for general practitioners and family practitioners to catch early signs of hypertension and potential stroke.
Haralam: Yes, wireless transducers, specificially. Manufacturers are perfecting this technology as we speak. With this transducer technology, some of the obstacles to overcome are the size and weight, the number of channels that can be transmitted and received, the image framerate, and the runtime before having to charge the transducer.
Rocha: We expect to see faster advancements in software and hardware that will make ultrasound smarter, less dependent on the user, and more clinical relevant. We remain focused on cost-effective solutions that do not compromise high-quality imaging. My prediction is that ultrasound will become even more automated, definitive, and intuitive for users, making it an indispensable, everyday tool for patient care.
For example, the clinical applications of Philips’ recent acquisition, TOMTEC, will increase workflow efficiency and diagnostic quality through automation and quantification, enabling clinicians to see problems earlier, faster, and with more confidence.
Dallaire: We believe the primary areas of significant advancement will be with transducer development, as capacitive micromachined ultrasonic transducer arrays becoming more common, as well as in newer modes of ultrasound operation that will operate in concert with therapeutic applications.
Spearman: Because the technology is mature, I think we will see continued developments in the historical areas of incremental improvements—smaller, faster, less expensive with improved technical capabilities.
Adams: Diagnostic ultrasound has always paralleled the computer industry. Processing power will increase with the introduction of more powerful CPUs. Inevitably, we will see the introduction of high-definition monitors, such as current 4K monitor offerings.
[Also, we expect to see] continued improvements to the handheld diagnostic ultrasound systems in the way of better resolution, image clarity, and battery life. Ultrasound continues to improve every year thanks to technological advancements, and we are excited to see what the future holds for this highly functional diagnostic tool.
24×7: What can biomed departments do to best ensure the longevity of ultrasound systems?
Adams: Education, education, education. The most influential factor on the longevity of any medical device, including ultrasound, is the education of the end user and biomed staff. Educating the clinicians on proper care and maintenance of the ultrasound machine, transducers, peripheral devices, and network features will directly affect lifecycle of the equipment.
Biomed departments have more options than ever for in-depth, hands-on training, and support for maintaining the ultrasound equipment, transducer, and related devices. Implementing a quality control program at the department level will also ensure that proper maintenance procedures are followed and will greatly improve the diagnostic quality of current assets.
Spearman: Educate and raise awareness with end-users to avoid the known pitfalls of dropping probes, not using bite-guards in cardiac applications and running over probe cords. Specific to the devices themselves, timely and effective planned maintenance is an absolute must to ensuring longevity.
Dallaire: We have called for years to have an evidence-based quality assurance program in the hospital related to ultrasound probes. This is even more important now as the probe technology currently has sophisticated electronics, such as microbeamformers integrated into the acoustic stack. This is why we created our Aureon probe-tester, as it works with any ultrasound device and probe, regardless of technological sophistication, and will frequently detect performance variances long before a failure occurs.
Haralam: First is the frequency of the preventive maintenance. Most manufacturers have switched to an annual preventive maintenance requirement for their units. I believe semiannual PMs will address potential issues sooner and, in the long run, may cut down on repair costs. Second is making sure that end users are properly trained/informed on handling and cleaning of their transducers. Many times, we have found end users using the incorrect cleaning products on their transducers or incorrect cleaning products used on their system control panels.
In either case, this has caused premature failures or damage that could have been prevented. Always refer to the manufacturer’s website for approved cleaners. Third is instructing end users to keep archive storage on the units as low as possible.
One of the main reasons for software corruption and sluggish system response on a unit is an archive low on storage space. Please advise the end user that the unit is meant to be a temporary storage device. All studies should be transferred to a picture archiving and communication system or another media for long-term storage.
Conrad: I would advise HTMA departments to invest in training, including continuous training of new devices and ultrasound technology. Additionally, make sure you are performing thorough, compliant PMs. Look for any problems with your system or probes and get them repaired before they become a major issue.
You’ll save money and increase your hospital’s revenue stream by keeping downtime to a minimum. Finally, develop a rapport with your clinical users. They are the ones who will keep you informed of any problems. Working with them keeps systems operating as they should.
Elaine Sanchez Wilson is associate editor of 24×7 Magazine. Questions and comments can be director to chief editor Keri Forsythe-Stephens at [email protected].