ICE - January 2018

ADVANCING THE IMAGING PROFESSIONAL

JANUARY VOL.2 NO.1

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GETTING

APPROVAL THE FDA

AND BRINGING NEW DEVICES TO MARKET PAGE 36

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contents

ICE FEATURES GETTING

APPROVAL

January 2018

“ There’s pathways to get things down-classified but it takes quite a long time, and it can be quite an arduous process to actually get that done.”– TONY RODER

THE FDA

AND BRINGING NEW DEVICES TO MARKET

36 Getting Approval

22 Professional

The amount of time it takes to bring a medical device to market in the United

Kimmerley “Kim” Pulver is

States has been a subject of scrutiny and criticism among various manufac-

an imaging service special-

turers and industry watchers for years. We take a look at the process and

ist with an interesting story

how the goals of safety and efficiency impact it.

that shows how career and personal transitions can turn out for the best. She has progressed from the U.S. military to working for

RSNA Scrapbook

RSNA 2017, the 103rd Scientific Assembly and Annual Meeting, had a total advance registration of 48,445. We share some of the sights from the annual event.

Page 48

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an OEM and now works in a hospital.

ICEMAGAZINE

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contents

ICE DEPARTMENTS

11

24

January 2018

28

42

news

people

products

insight

10 Industry News

22 Professional Spotlight

41 Imaging Matters

18 People on the Move

24 Department Spotlight

27 Ultrasound Product Spotlight

20 Webinar Wednesday

28 Ultrasound Gallery 34 Tools of the Trade

42 Career Advice 45 Imaging Service 101 46 Daniel Bobinski 50 Index

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Circulation

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ICE Magazine (Vol. 2, Issue #1) January 2018 is published by MD Publishing, 18 Eastbrook Bend, Peachtree City, GA 30269-1530. POSTMASTER: Send address changes to ICE Magazine at 18 Eastbrook Bend, Peachtree City, GA 30269-1530.

For subscription information visit www.imagingigloo.com. The information and opinions expressed in the articles and advertisements herein are those of the writer and/or advertiser, and not necessarily those of the publisher.

Reproduction in whole or in part without written permission is prohibited. © 2018

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ADVANCING THE IMAGING PROFESSIONAL

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news

IMAGING NEWS A LOOK AT WHAT’S CHANGING IN THE IMAGING INDUSTRY FDA Approves First Ultrasound-on-a-Chip

Butterfly Network Inc. has received FDA 510(k) clearance for the world’s first ultrasound-on-a-chip based imaging system, the Butterfly iQ for iPhone. The clearance covers 13 clinical applications, the broadest ever for a single ultrasound transducer. By combining almost 10,000 sensors, 40 times more than systems costing 100 times as much, Butterfly ushers in a new era of acces-

sible, high-performance medical imaging.

“At less than $2,000, health care providers can purchase an easy-to-use, powerful, whole-body medical imaging system that fits in their pocket,” said Dr. John Martin, Butterfly Network’s chief medical officer. “By removing the barrier of price, I expect Butterfly to ultimately replace the stethoscope in the daily practice of medicine. We can now provide a diagnostic system to address the millions of children that die of pneumonia each year and the hundreds of thousands of women that die in childbirth, and these are just two examples of the impact this technology will have.”

To image the entire body, a traditional ultrasound system requires a large, expensive cart or box which connects to three or more piezoelectric-based transducers, each costing thousands of dollars. Butterfly’s ultrasound-on-a-chip technology combines the capabilities of the typical three probes into a single ultra wide-band, 2D matrix array comprised of thousands of microelectromechanical systems (MEMS). These sensors are directly overlaid on an integrated circuit encompassing the electronics of a high-performance ultrasound system. The acoustic bandwidth and processing power available from the MEMS and electronics fusion creates unprecedented diagnostic versatility, speeds, modes and resolutions. Moving the ultrasound machine to a chip allows it to be produced at unprecedented scales, at prices and rates of improvements that obey Moore’s law and will enable a series of future form factors.

Butterfly plans to release assistance and interpretation functionality in 2018 as a software add-on to the Butterfly iQ system. •

CIRS Acquires ATS Laboratories CIRS Inc. has announced the acquisition of ATS Laboratories. This merger brings together both companies’ technologies, providing a new level of choice in ultrasonic tissue mimicking materials while maintaining the same level of quality and customer service that ATS and CIRS customers have come to expect.

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ICEMAGAZINE | JANUARY 2018

ATS Laboratories Inc. was established in 1978 as a privately held corporation located in Bridgeport, Connecticut. ATS designs and manufacturers tissue-mimicking phantoms for the routine performance monitoring, training and in-process production testing of ultrasound imaging systems. Each company’s ultrasound prod-

ucts are similar but use different tissue mimicking materials providing the best choice for all customers.

Early this year ATS products will be manufactured and delivered by CIRS from Norfolk, Virgina. •

ADVANCING THE IMAGING PROFESSIONAL

news

Character Farms Transforms Medical Imaging Experience Character Farms is changing the way children and adults experience imaging.

“We ensure a one-of-a-kind interior design and theme settings to successfully transition the patient’s anxiety and fear into a positive, calming and stress-free treatment,” said Mark Sullivan, principal and senior design director.

Their custom themed interiors and de-

signs range from fun and imaginative for children, to calm or peaceful for adults.

They have turned MRI machines into sand castles or even bonsai trees. Character Farms recognizes all the focal points that a patient will come into contact within each environment.

“We’re able to create truly stunning rooms, not only the treatment areas but

the check-in, waiting, play and recovery areas as well,” Sullivan added. “We want to push the patient experience as far as possible. We allow for a completely immersive experience that patients and families remember long after the visit is over.” •

Alpha Source Acquires BC Technical Alpha Source Inc. has completed the acquisition of BC Technical Inc. The acquisition doubles the size of Alpha Source and creates one of the largest independent full-service imaging services and equipment repair solutions companies in the United States.

With this acquisition, BC Technical joins the Alpha Source family of companies bringing together a combined breadth, depth and experience to service an even broader continuum of health care providers’ service and repair needs for medical device, diagnostic and imaging equipment.

Earlier this year, Alpha Source purchased Medical Optics, an endoscopy services company providing repair for scopes, cameras and surgical tools.

The BC Technical deal will broaden imaging service offerings across the portfolio of companies, expanding the Alpha Source ultrasound and bone densitometry equipment service to now include maintenance, repair and refurbished equipment for CT, MRI and molecular imaging modalities. The broad scope of repair solutions, national scale and technical expertise across the three companies will allow its teams to quickly and effectively service health care providers around the country.

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The imaging service provider market is poised for substantial growth as quality and value based repair and replacement options continue to be sought out by health care providers looking for ways to better manage costs.

The addition of BC Technical to the portfolio of companies brings the total number of employees to over 350, with field engineers located in major markets around the country. Alpha Source headquarters will remain in Milwaukee, Wisconsin with additional BC Technical and Medical Optics locations in Chicago, Illinois; Fort Lauderdale, Florida; Louisville, Kentucky; and Salt Lake City, Utah.

In other news, Alpha Source Inc. was recently presented the Outstanding Corporate Growth Award by the Wisconsin Chapter of the Association for Corporate Growth. •

ICEMAGAZINE

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news

Varian Halcyon Treatments Available in Australia Representing the latest step in Varian Medical Systems’ efforts to expand the availability of high-quality cancer care globally, the company announced a 71-year-old male with prostate cancer became the first patient in Australia to be treated on the Halcyon system at Radiation Oncology Centres (ROC) in Toowoomba by Brisbane-based Icon Group. Halcyon simplifies and enhances virtually

every aspect of image-guided volumetric intensity modulated radiotherapy (IMRT), and is well suited to handle the majority of cancer patients, offering advanced treatments for lung, esophagus, brain, head and neck, and many other forms of cancer.

In addition to delivering high-quality cancer treatments, Halcyon was built with a human-centered user-friendly design

that makes this advanced cancer treatment system more comfortable for the patient while delivering ease-of-use for health care providers, accelerated installation timeframes, expedited commissioning, simplified training and automated treatment. •

AAMI Credentials Institute Pre-Approves Conquest Imaging Training Conquest Imaging has issued a press release announcing pre-approved Continuing Education Units (CEUs) by the AAMI Credentials Institute (ACI), for its 2018 training calendar.

“After seeing the recent growth (108 percent from previous year), I knew our quality training program was significantly impacting BMETs across the country,” explains Senior Director of Technical Services Jim Rickner. “Now that AAMI has approved our courses, we can easily offer a way for CBETs to keep up their credentialing requirements while providing a vetted, quality training option for any BMET.” ACI Certification for the Biomedical Equipment Technical (BMET) certification is a formal recognition by the AAMI Credentials Institute that individuals have demonstrated excellence in theoretical as well as practical knowledge of the principles of biomedical equipment technology. Once certified, continuing education credits can be obtained to maintain certification, and keep biomedical technicians and engineers up to date on the latest technology.

The ACI award qualification process includes evaluation of all curriculums, course materials, syllabi and testing. ACI’s pre-approval program awarded Conquest Imaging’s training courses with Category IV CEUs as follows: • Ultrasound Bootcamp – 40 CEUs • Toshiba Aplio Series – 16 CEUs • Philips iU22/iE33 or Philips EPIQ 5/7 – 16 CEUs • GE Logiq E9/Vivid E9 or GE Voluson E8/E10 – 16 CEUs • Siemens S2000/SC2000 – 16 CEUs • Ultrasound Basics or Multivendor Accreditation PM/DICOM – 8 CEUs

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ICEMAGAZINE | JANUARY 2018

Also, Conquest Imaging recently announced the acquisition of Acoustic Imaging Solutions (AIS), an Indiana-based Because Quality Matters company providing ultrasound ISO 9001:2008 CERTIFIED solutions to the health care industry.

The purchase of Acoustic Imaging Solutions will enhance the portable system repair capabilities Conquest provides to health care facilities nationwide. By purchasing AIS, Conquest Imaging will be offering their customers depot repair for their SonoSite systems beginning January 2018. Furthermore, immediate qualified field service engineering support is acquired to help provide ultrasound maintenance and repair to health care facilities in the Midwestern United States.

“This acquisition complements our portable ultrasound offering by allowing us to seamlessly provide direct portable depot repair for SonoSite systems that are no longer supported by the manufacturer,” Conquest President and Co-Founder Mark Conrad said. “With this ability, hospitals and imaging centers have a choice to extend the life of their SonoSites allowing them to service their patients with the same system, which lowers their expenses and total cost of ownership,” In addition to Conquest Imaging’s GE and Philips portable depot repair capabilities, in January, they are adding the SonoSite 180/180 Plus, SonoSite Titan, SonoSite MicroMaxx, SonoSite M-Turbo, SonoSite SII and Sonosite S Series. •

ADVANCING THE IMAGING PROFESSIONAL

news GET THE

POSITION

IU Installs New Imaging Device Indiana University Health is the first in the state to have a Siemens Healthineers Biograph mMR PET/MRI machine. There are about 30 of these scanners in the U.S. The PET/MRI scanner is housed at the IU Health Neuroscience Center at 16th Street and Capitol Avenue and will primarily be used for oncology and neuroscience. MRI does not use radiation, so patients are taking in less radiation than other hybrid scanners In oncology, this is a useful tool in patients who have received radiation therapy. After radiation, there is scar tissue,

YOU DESERVE

which can be hard to distinguish from cancer recurrence. This scan allows that area to be seen better, resulting in a more accurate diagnosis. The functional and physiological aspects of the scan allow differentiation between living and intact tissue versus radiologic necrosis.

“We have PET/CT but no one else in the state has PET/MRI. We believe the unit will be an excellent tool for prostate cancer, liver cancer, epilepsy and multiple other areas like MSK, neuro, breast and cardiac,” said Todd Stanley, director of radiology at IU Health. •

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Siemens Healthineers Announces First U.S. Installations Mallinckrodt Institute of Radiology at Washington University School of Medicine, St. Louis, recently became the first health care institution in the United States to install the MAGNETOM Vida, a 3 Tesla (3T) magnetic resonance imaging (MRI) scanner from Siemens Healthineers. The scanner features new BioMatrix technology that addresses patients’ anatomical and physiological differences as well as user variability. By expanding precision medicine through systems such as the MAGNETOM Vida with BioMatrix technology, Siemens Healthineers can help enable health care providers to achieve better outcomes at lower cost.

The 70-cm MAGNETOM Vida MRI scanner includes a new magnet design and up to 60/200 XT gradient performance to support high-end clinical applications. Its BioMatrix technology – a collection of sensors, tuners and interfaces – enables the scanner to adapt automatically to anatomical and physiological characteristics to provide consistent, high-quality imaging for all patient types. The scanner’s architecture and applications simplify and accelerate workflows while increasing exam precision

and patient comfort. Its GO technologies automate and simplify workflows from the start of the scan through quality control of the image data, resulting in increased productivity for routine examinations throughout the body. And the Eco-Power technology deactivates power-hungry components that are inactive for long periods, potentially lowering the total cost of ownership over the scanner’s lifetime.

In other news, the Center for Diagnostic Imaging (CDI) recently became the first health care organization in the United States to install the SOMATOM go.Up computed tomography (CT) system from Siemens Healthineers. The SOMATOM go.Up scanners are installed at two CDI outpatient imaging facilities associated with St. Luke’s Hospital in St. Louis. The SOMATOM go.Up is designed for highly diverse sets of user needs and provides automated, standardized workflows that help users reduce unwanted variations and achieve more consistent, profound clinical results at a lower total cost of ownership. •

FUJIFILM Receives Innovative Technology Designation FUJIFILM Medical Systems U.S.A. Inc. has announced that its FDR AQRO and FDR D-EVO GL Panel have received 2017 Innovative Technology designations from Vizient Inc. The designations were based on direct feedback from hospital clinicians who interacted with the FDR AQRO and FDR D-EVO GL Panel at the Vizient Innovative Technology Exchange.

The FDR AQRO is a mini point-of-care

digital X-ray system that combines a high performing and unique infection control design with the sensitivity of Fujifilm’s FDR D-EVO II detectors and latest highly refined image processing advancements to generate high-resolution images with low patient dose.

The FDR D-EVO GL Panel is the world’s first single exposure long-length detector.

FDR D-EVO GL enhances the workflow of

long-view radiography by capturing the entire image in a single exposure in just a few seconds, reducing the chance for patient motion-induced artifacts and time for the patient to remain still. This new DR imaging is further complemented with the ability to capture its images without a grid utilizing Virtual Grid simulation software, lowering dose up to 50 percent compared to grid exams. •

Trisonics Releases 2018 Training Schedule Trisonics has implemented 16 classes throughout the year covering a wide range of the most commonly used systems in the field. Taught directly by Trisonics field engineers, the classes will serve as learning tools to those within the industry.

Each system course is designed to provide an imaging engineer or biomed with a solid foundation from which to service a specific model of ultrasound equipment. Access to this level of experience provides an added benefit for any engineer who desires to service equipment in-house.

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ICEMAGAZINE | JANUARY 2018

The 2018 schedule includes “Basic Ultrasound Training” on January 30 and “Philips Epiq 5/7 Training Course” on January 31-February 2. February training classes incluce “Basic Ultrasound Training” on February 20 and “GE Logiq & Vivid E9 Training Course” on February 21-23. • For the complete 2018 schedule, visit Trisonics.com.

ADVANCING THE IMAGING PROFESSIONAL

news Alltech Medical Systems, RSTI Reach Training Agreement Alltech Medical Systems America and RSTI have reached a training agreement in which RSTI will offer an MRI service training program at Alltech Medical Systems America’s headquarters in Solon, Ohio.

Both parties cited a desire to expand their offerings and leverage their core competencies, and the goal of this program is to offer a complete spectrum of service solutions by adding MRI training courses. RSTI has offered diagnostic imaging training for over 27 years and brings a proven teaching method to this opportunity. Alltech has engineered and manufactured superconducting 1.5T MRI systems for 12 years with solid experience

in R&D, application, and service. Alltech will provide technical expertise on the MRI systems to assist the expansion of RSTI’s training program.

“As the number of MRI installation grows worldwide, it’s important that a quality service training is provided to customers so they can ensure the performance of MRI systems by lowering the costs over the lifetime of the MRI scanners,” said Alltech Medical System America President James Meng, Ph.D. “Our commitment to MRI innovation generates lots of market demand for our MRI products globally, which requires the efficiency and productivity of service utilization, including

troubleshooting either on-site or remotely, spare parts management, 24/7 online technical support and preventative maintenance.”

The collaborative agreement also provides the technical training on generic platforms of MRI systems commonly used at customers’ sites. Because many of the installed MRI systems are older, customers learn how to keep the uptime by taking care of the aged MRI systems.

For more information, visit www.rsti-training.com. •

FDA Clears the NeuViz Prime CT Scanner Neusoft Medical Systems USA has announced FDA market clearance and availability of a new 128-slice CT scanner for U.S. health care providers. The NeuViz Prime offers diagnostic images enhanced by several key features.

First, the system has spectral imaging capabilities. The ability to perform image acquisition and processing at multiple energy levels is improving visualization for computed tomography and enhancing patient care. Spectral imaging is field upgradable for the NeuViz Prime.

Secondly, the NeuViz Prime offers 0.259 second rotation speed, a critical feature for any application requiring high temporal resolution.

The subsequent motion suppression improves imaging in trauma, pediatrics and cardiac cases.

Lastly, a new X-ray tube with a liquid bearing design improves heat storage and dissipation. With the new tube, heat is removed faster than it is introduced, eliminating scanning delays. The tube also al-

lows 60 kV imaging at the maximum tube current of 833 mA. 60 kV imaging is ideal for pediatric studies.

The NeuViz Prime is the latest addition to the NeuViz family of CT scanners sold in the U.S. including the NeuViz 64In/En, and NeuViz 16. Each Neusoft CT system comes with a feature-rich configuration, eliminating expensive upgrades and is supported by an industry leading warranty package for exceptional technical support. •

MyVue Center Kiosk Now Shipping in Select Countries Carestream Health is shipping its MyVue Center Self-Service Kiosk that can enhance patients’ ability to access and manage their medical imaging exam records. Patients may use the kiosk to print or share radiology reports and output their medical images onto Carestream Dryview medical laser imaging film or a USB drive.

This product is currently available in France, Mexico, Argentina, Brazil, Peru and Colombia. Carestream plans to make it available in other countries in the coming months.

The kiosk was demonstrated at the Radiological Society of North America tradeshow.

Patients can use the kiosk to gain rapid, convenient access to their medical exam

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information by utilizing a secure method of identification to obtain their medical images or radiology reports.

The self-service kiosk also enables health care providers to enhance productivity and reduce operating costs by automating distribution of medical images and radiology reports to patients. The system is available on a monthly rental payment plan.

Facilities that integrate MyVue Center with Carestream’s MyVue patient portal will enable patients to share access to their medical images and reports with physicians, friends or family members. Patients will be able to view and share their medical images and radiology reports from a variety of web-en-

abled devices including laptops, tablets and mobile phones, or from a health care provider’s EMR portal. •

ICEMAGAZINE

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news

HyperMed Imaging Announces Availability of New Product HyperMed Imaging Inc. has announced that the company is now offering its new HyperView Imaging System for sale to customers in the United States.

The HyperView System is FDA cleared, and is a fast, handheld, battery operated, non-invasive and portable diagnostic imaging device that is used to assess tissue oxygenation without contacting the patient and without the need for injectable contrast.

The system uses proprietary technology to capture color-coded images containing data that provides the clinician critical information such as oxyhemoglobin levels (Oxy), deoxyhemoglobin levels (Deoxy) and oxygen saturation (O2Sat) in superficial tissue. Such information may assist clinicians when determining if a patient has adequate blood perfusion to heal a wound or maintain healthy tissue. Understanding both arterial and venous sufficiency in the surface tissue may enable clinicians to make more informed decisions regarding when to intervene. The HyperView

system also helps document perfusion levels before and after vascular interventional procedures such as: peripheral bypass, stent placement or balloon angioplasty. •

Dicom Systems Enterprise Imaging Unifier Earns RSNA Image Share Validation Dicom Systems Inc. successfully completed the RSNA Image Share Validation program that extensively tests the compliance of vendors’ systems to accurately and efficiently exchange medical images.

By earning the RSNA Image Share designation, the Enterprise Imaging Workflow Unifier and Archive 3.4.12-1 assures customers that the system supports convenient, standards-based image exchange

and has been shown to offer the benefits to patients and providers that include improved efficiency, cost savings, enhanced quality of care, standards-based interoperability to spur innovation, reduced radiation exposure and more.

“Since the first generation of Dicom Systems Unifier appliances launched in 2008, interoperability has been our foremost defining attribute,” said Florent

Saint-Clair, executive vice president of Dicom Systems. “Compliance with the RSNA Image Share Validation program not only constitutes a validation of our platform’s fundamental flexibility in Enterprise Imaging, it also expands our ability to bridge the gap of interoperability with the consumer side of image sharing.” •

Embrace Neonatal MRI System Receives CE Mark Aspect Imaging has received CE marking for the neonatal-dedicated MRI system, Embrace Neonatal MRI System, which enables preparation and scanning of newborns, without having to transport them from the NICU. Embrace Neonatal MRI can now be used and sold in EU countries and in non-EU countries that rely on CE certification.

Aspect Imaging developed Embrace Neonatal MRI System to be placed inside the NICU to reduce the time and risks involved with transporting infants to an external facility in which traditional MRI scanners are typically situated. Embrace Neonatal MRI System enables safer imag-

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ICEMAGAZINE | JANUARY 2018

ing of infants and provides easier access for medical staff during the scanning process. The system can prep and scan in less than an hour. Intubated infants can also be scanned without disconnecting and reconnecting the tubing from the infant, due to the unique design of Embrace. Embrace is acoustically quieter during scanning, compared to traditional whole-body scanners, and has a permanent magnet that is always active and thus requires no electrical, cryogenic or water cooling.

Embrace Neonatal MRI System does not require a special safety zone or an RF-shielded room, therefore, the system can be placed inside the NICU. Since the

system is fully enclosed, medical device implants in close proximity (outside the magnet bore), are not required to be “MR Conditional” or “MR Safe.”

The operating and maintenance costs of the Embrace Neonatal MRI System are much lower than conventional superconductor MRIs due to Aspect’s magnet technology, which requires no cooling system and has low power consumption.

Additionally, the Embrace Neonatal MRI system has an integrated, temperature-controlled incubator-like patient bed which minimizes movement of the baby. •

ADVANCING THE IMAGING PROFESSIONAL

Frost & Sullivan Recognizes Ziehm Imaging with Award Based on its recent analysis of the mobile interventional X-ray solutions market, Frost & Sullivan recognizes Ziehm Imaging as the 2017 Global Company of the Year for its success in proactively aligning its mobile C-arm systems product line with emerging needs in a fast-changing health care and medical imaging environment.

Established in 1972, Ziehm Imaging specializes in developing, manufacturing,

and globally marketing advanced mobile C-arm interventional imaging solutions.

The company has built a strong track record of industry firsts and innovations that have advanced the intraoperative imaging field.

Interventional radiology enables surgeons and interventionalists to perform a range of minimally invasive and image-guided procedures across various

therapeutic areas, including cardiac, vascular, endovascular, pain, trauma, urology, orthopedics, spine and neurology. These areas rely on powerful imaging modalities, including computed tomography (CT), magnetic resonance imaging (MRI), fixed interventional X-ray and mobile C-arms.

Each modality has advantages and limitations and differs in its mode of operation, level of complexity and price point. •

Philips Receives Clearance for ‘Small Parts’ Ultrasound Imaging Royal Philips has announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the new eL18-4 transducer with full solution for “small parts” assessment, which is an ultrasound exam to detect abnormalities in the small organs that are close to the skin.

The Philips Ultimate Small Parts Solution features four key innovations that work together to help improve patient care: the eL18-4 PureWave linear array

transducer, Philips MicroFlow Imaging, Philips Elastography and Philips Precision Biopsy. The new eL18-4 transducer can also be used to assess musculoskeletal injuries.

The new Philips eL18-4 PureWave linear array transducer allows fine-elevation focusing that delivers extraordinary imaging and extended depth of field performance to help clinicians evaluate small organs, including the thyroid gland, and

diagnose a variety of conditions.

The new Philips eL18-4 PureWave linear array transducer allows fine-elevation focusing that delivers extraordinary imaging and extended depth of field performance to help clinicians evaluate small organs, including the thyroid gland, and diagnose a variety of conditions. •

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ICEMAGAZINE

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news

PEOPLE ON THE MOVE

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By Matt Skoufalos

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Varian Medical Systems of Palo Alto, California has named Terilyn Juarez Monroe its chief people officer and senior vice president of human resources, replacing the retiring Wendy Scott. Monroe was most recently chief people and culture officer/senior vice president of human resources at Acxiom, and previously spent 13 years at Intuit where she was chief diversity officer and director of talent engagement.

KUBTEC of Stratford, Connecticut named Douglas Cline its vice president of clinical sales, North America.

Cline joins the company from Halyard Health, where he was regional vice president of acute pain management business.

Donald L. Kramer retired from the board of directors of Nobilis Health Corp. of Houston, Texas. Chief Executive Officer Harry Fleming has been named chairman of the board, “and will serve in an executive chairman capacity,” according to a statement from the company.

4.

Peyton Elliott has been named chief executive officer of the HCA Healthcare Gulf Coast Division-affiliated Park Plaza Hospital. Elliott was most recently vice president of operations and finance at Houston Methodist West Hospital; he’s worked at Houston Methodist Sugar Land Hospital, Houston Methodist Hospital System, and Trinity Mother Frances Hospital in Tyler.

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Millennium Health of San Diego has named Dave Henderson its chief information officer. Most recently, Henderson was chief information officer for GenomeDx Biosciences; he has also been chief information officer at Sequenom Inc.

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ICEMAGAZINE | JANUARY 2018

MemorialCare Miller Children’s & Women’s Hospital Long Beach of Long Beach, California has named Graham Tse its associate chief medical officer. Tse has worked in the hospital’s pediatric ICU for 17-plus years. He is boardcertified in pediatrics and pediatric critical care, is a member of the Society of Critical Care Medicine, and is a fellow of the Royal College of Physicians and Surgeons in Canada.

Empiric Health of Salt Lake City, Utah named Justin Schaper its chief technology officer. Schaper was most recently senior vice president of analytics for Intermedix, and had been chief information officer for PSR, which was acquired by Intermedix.

Northwell Health of New Hyde Park, New York has named Richard Miller its executive vice president and chief business strategy officer and Michele Cusack its senior vice president and chief financial officer. Both succeed executive vice president Bob Shapiro, who is retiring after 17 years at his position. Before joining Northwell in 2008, Miller was previously chief financial officer for NYU Hospitals Center, and will remain chair of the Northwell Health Plans Holding Company. Cusack is a CPA who has been with Northwell since 1996, and has been deputy chief financial officer and senior vice president of finance since 2016.

Find weekly installments of People on the Move at imagingigloo.com

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news

WEBINAR WEDNESDAY

Imaging Sessions Provide Clear Path to Knowledge

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he Webinar Wednesday series continues to deliver insightful knowledge to imaging service professionals around the world and most of the sessions provide 1 CE credit from the ACI. The recent webinar “Imaging – From Film to Digital” was sponsored by Technical Prospects. In the webinar, Technical Prospects Technical Trainer and Support Specialist John DiPasquale discussed the growth of the industry. He also examined how current technology relates to and is an outgrowth of older technologies. DiPasquale, a Certified Biomedical Equipment Technician (CBET) with more than 25 years of experience in the HTM industry, shared his insights with more than 200 HTM professionals.

The webinar received great reviews and positive feedback via post-webinar surveys.

“Excellent webinar by Technical Prospects. It was a fresh point of view showing you can still troubleshoot using older methods and not rely on diagnostics and service keys to pinpoint your problem,” MRI Service Engineer K. Saager said.

“The presentation provided a very good, historical description of the imaging field and how it progressed from the analog to the digital generation. His descriptions of the different types of problems and what things to check was excellent,” Senior Biomed Instructor T. Bracewell said.

“The imaging webinar was very informative for anyone in the medical profession dealing with radiology. John DiPasquale was very thorough and was able to answer highly technical questions with targeted precision. I was very impressed with the

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quality of this training. It was definitely worth taking time out of my day! Thank you so much and I look forward to attending more Webinar Wednesdays,” wrote Biomed E. Huynh.

Another Webinar Wednesday session also proved informative for imaging service professionals.

The RTI-sponsored webinar “Practical Dental X-ray QA Tips and Solutions” was

In a post-webinar survey, attendees did not shy away from saying how much they enjoyed Morrison’s presentation.

“Thank you for the excellent presentation. I found it not only interesting and relevant but also very informative. You did an excellent job on the way that you presented material and the presentation was by far the best webinar I have had the opportunity to view, not that any of the other webinars

“ Webinar Wednesday has become a staple of my Wednesday afternoons. With diverse presenters and intriguing topics, this series is great way to learn something new, or add on to the things you already know.” – H. Gonzalez presented by Rob Morrison, senior applications and product specialist at RTI Inc. Morrison has over 30 years experience working with and for RTI in the development, sales and support of non-invasive test tools for non-invasive QA measurements of diagnostic imaging X-ray generator parameters.

In the webinar, he discussed the challenges encountered, along with tips and solutions, for measuring on today’s dental X-ray imaging devices. Morrison’s presentation impressed attendees because of his knowledge and his use of videos to illustrate his points.

were not great because I enjoy all of the Wednesday Webinars. This was particularly interesting and I really enjoyed it. Thank you for sharing your expertise and knowledge as well as showing the setup of the test,” Senior Biomed Tech J. Harwood said.

“The presenter presented a lot of useful information. He was very knowledgeable on the subject matter. I really enjoyed the video presentations which really nailed down how to use the testing products and to obtain data,” Biomed D. Parham said.

The webinar series continues to receive amazing reviews.

ADVANCING THE IMAGING PROFESSIONAL

“If you are NOT involved in Webinar Wednesday, you are missing out on a golden opportunity to gain knowledge and experience without having to go to the manufacturer’s training,” said M. Bryant, Electronics, Service and Testing owner.

“Webinar Wednesday has become a staple of my Wednesday afternoons. With diverse presenters and intriguing topics, this series is a great way to learn something new, or add on to the things you already know,” Biomed H. Gonzalez said.

“Webinar Wednesdays get my standing ovation for presenting an avenue that the HTM field can easily grasp and use in spreading information of new technologies, services and how to improve our overall jobs in providing the very root of what started this industry, patient safety,” Biomed Manager A. Rock said.

“Webinar Wednesday is a great way to keep up with what is new and relevant in the world of healthcare technology. I have yet to attend a webinar where I didn’t at least learn one new thing from the presentation. Webinar Wednesday keeps me in touch with the latest and greatest methods, technology, and information of today,” Gonzalez added. ICE For additional information about the Webinar Wednesday series, including a calendar of upcoming webinars and recordings of previous presentations, visit 1TechNation.com/webinars.

A special thank you to the companies that sponsored this month’s webinars.

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people

By K. Richard Douglas

PROFESSIONAL SPOTLIGHT Transitions Turn Out Well: Kimmerley “Kim” Pulver

S

ometimes a series of events can lead a person to a place and profession that was not preplanned or expected. And, sometimes things just work out for the best.

Kimmerley “Kim” Pulver is a clinical engineering technician senior, imaging with Rochester Regional Health System in Rochester, New York. Her road to becoming an imaging service professional brought her from the military to where she is today.

“I was in the Navy for 13 years. In the military, I was an ocean system technician maintainer for antisubmarine warfare equipment, doing repair and preventive maintenance on electronic equipment and hardware,” Pulver says.

“I excelled in my field and became an instructor at the training facility in Norfolk, Virginia. I achieved the rank of E6 in the military, but was not making E7, and an overseas rotation without my kids was coming up, so I got out,” she says.

Before entering the Navy, she had attended Eastern Michigan University and earned a degree from Gavilan College through the military.

After leaving the Navy, Pulver went to work for GE Government Services in Norfolk and after a year with them, and most of it spent at sea with two infant children at home, her former husband said she needed a new job.

“GE Medical Systems had an MRI/CT engineer opening in Rochester, New York, 22

ICEMAGAZINE | JANUARY 2018

which is where my ex-husband was from, so I transferred to try and save the marriage and stay home more. This started my transition into the medical field. I had completed my electronics degree in the military and GE Medical trained me in the MRI and CT field from A to Z,” Pulver says.

She spent nearly the whole first year with GE Healthcare going through their MRI and CT training in Milwaukee.

“My first marriage failed shortly after.

Back then, they really did train the field engineers to repair/install systems. We could ramp/shim/fill MRIs and troubleshot MRI/ CT systems to component level. I worked for GE in field service repair for 16 years in the Rochester/Buffalo area doing MRI/CT service,” Pulver says.

During that period, Pulver saw the job of field service changing drastically, including longer hours, more driving and greater workload.

“At this time I looked to Rochester General in-house to become a biomed tech. Going in-house was quite a change. Reporting to the same site every day at first seem strange, but I found that no two days were ever the same in a hospital biomed department, just as it wasn’t in the field,” Pulver says.

Figuring it Out Pulver’s efforts have not gone unnoticed.

Earlier in her career, she was named Top Honor Recruit of her graduating class in January of 1984. She also won a management

award from GE for outstanding customer service to the Mobile Imaging Service in 2006.

Although Pulver is GE-trained on MRI, CT, ultrasound and patient monitoring and Philips-trained on Allura Aper cardiac cath labs and digital diagnostic systems, there is no amount of training that can change stature.

Pulver says that one challenge has always been “being a female in a male dominated modality such as MRI.” “A lot of having to prove yourself, [is] not only in the intellectual department but on the physical side. Gradient or RF amplifier changes were met with skepticism at first as to whether I would be up to the physical challenges involved,” she says.

“Keep in mind, I am all of four foot, eleven and 125 pounds, but luckily most of that is muscle. Once you prove you can push, pull, hoist and shove a crate and a heavy electronic component into its place, I guess your step goes up the ladder a little bit,” Pulver adds.

She says that the same goes for the CT modality with tube and DAS changes. She explained that once you do it on your own and prove you can, your stock goes up.

She has also learned that when powerful magnets are involved, a gun isn’t the best object to enter this environment.

“Many challenges in this profession over the years, each in retrospect, just look like another day in the life of an imaging techniADVANCING THE IMAGING PROFESSIONAL

Favorite part of being an imaging professional?

“Being able to see the life and death results from the machines you are responsible for.

Keeping my CTs/MRIs up 99.9 percent of the time and knowing my image quality is excellent and that it can diagnosis life-threating causes or find a reason for pain gives me an awesome feeling of accomplishment.”

GET TO KNOW THE PRO Favorite book The whole Harry Potter series.

Mostly because my youngest son and I read it together and then were able to talk about it over the years.

Favorite movie “Pride and Prejudice” Favorite food Mexican ... with margaritas!

Kim Pulver Imaging Professional

cian,” Pulver says.

“I have removed oxygen tanks that have flown into magnets due to a split second lapse of monitoring on a site, taken a call to remove a police officer’s service revolver from the bore of a magnet that had become lodged and fired in the process, had a floor cleaner sucked into the magnet because the janitor wanted to get that last speck of dirt just inside the magnet room door. All of these incidents required careful ramping of the magnet down to extract the items and repair the unit back to normal,” she adds.

Pulver also believes that there are steps that can be taken to mitigate any occurrence of MRI “white pixel.” “[During] every PM, we run our testing and that is the one test I dread the results of because I know that if it fails, I could be looking at weeks of troubleshooting ahead. For that reason, I do a lot of extra service work on my systems that GE does not now feel is required, but years ago we used to check all the time on PMs,” Pulver says.

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Hidden talent Have successfully won every daily challenge of Solitaire on my iPhone for the last 771 days! Scary!

“I schedule the day before my official PM to clean the bore of my magnet out of metal, and that includes lifting the bridge, vacuuming [the] dock assembly and taping all metal shavings out of the front and back of magnet face. I believe that helps eliminate rattling sources of metal, regardless of size, that can cause white pixel. I believe this is why my system performance and image quality on my systems are outstanding,” she adds.

The Post-Military Life When not on the job, Pulver enjoys travel with her husband, who is retired. They have started to attend NASCAR races annually together and enjoy taking cruises.

“I met my current husband, Larry Pulver, while I was in the Navy Reserves in Rochester. We have been together 25 years; married 18. He is retired military. My two sons, Raymond and Daniel Zimmer, were both in the Air Force. One is still active reserve. I have two step-children that live in Florida. Katie

5 things on my bench: Coffee cup full of coffee (a technician must have this in her tool kit!), my Pocket Sim with known good cables attached for troubleshooting ECG issues, my scrapper for opening boxes or cleaning stickers/tape off equipment before returning it to unit, my iPhone to get/make calls to vendors and customers, my laptop to access my emails, TMS, work orders, etc. that make the electronic work happen daily in the life of an imaging service professional

Reed, who has given us two grandchildren, Hunter and Chessie, and Joshua Pulver (married to Katherine) that gave us Jonathan and Branigan,” Pulver says.

This imaging specialist is proof that career and personal transitions can turn out very well. ICE

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people

By K. Richard Douglas

DEPARTMENT SPOTLIGHT BayCare Health System Imaging Service Team

B

ased in Clearwater, Florida, BayCare Health System has been serving the Tampa Bay and central Florida region’s health needs since 1997. The system includes 14 hospitals, four outpatient surgery centers, 14 urgent care centers and 27 outpatient imaging centers, with 3,511 hospital beds in total.

Servicing and maintaining the imaging equipment in those imaging centers, and all the other facilities, falls to BayCare’s 11-member imaging services team, which handles all imaging modalities along with ultrasound and radiation therapy. The team’s field imaging service specialists are a component of the larger 97-member clinical engineering department.

The imaging team is responsible for 28 MRIs, 45 CT scanners, 33 digital mammography systems and eight linear accelerators. They support 314 different fixed imaging modalities. They also support 157 mobile X-ray systems across all BayCare facilities, including 86 C-arms and mobile extremity units, 56 mobile X-ray units, 12 specimen units and five dental systems.

“All modalities within imaging are either serviced directly or have shared service responsibility. Other services are managed directly by our imaging staff with the original equipment manufacturer (OEM) or third-party vendor,” says Walter Barrionuevo, director of clinical engineering/medical device integration and

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security and end-user and infrastructure services (EIS) for BayCare Health System.

The imaging service team attempts to keep as much of the work in-house as possible. Barrionuevo says that all imaging devices are serviced directly or triaged by his team.

“Only a few of our systems have full-service contracts coverage. Full-service coverage is applied to assets that are considered mission critical,” he says.

“If they are down, the hospital would have to divert services and/or the cost liability related to the replacement parts and assemblies within the image chain is too great.”

Part of keeping devices operating smoothly is to make certain that clinical colleagues are fully trained on proper usage.

“BayCare’s quality model emphasizes education and training as well as continuous improvement. Our end-user training is provided in several ways, [including] manufacturer provided end-user training, negotiated at [the] time of purchase [and] one-on-one interactions with our staff,” Barrionuevo says.

He adds that his staff is highly skilled and trained to provide their customers with quality “on-time” service as well as any end-user training necessary to improve the competency of the user and allow for safe use of the equipment.

Training is also provided through clinical engineering-sponsored equipment in-services, education during clinical staff meetings and medical device training using six sigma methodology.

In addition to keeping as much service in-house, the imaging service team, and the larger CE department, is very involved in the capital purchase process.

“BayCare Clinical Engineering Services serves as an approving body on all new capital equipment purchases, replacement of capital equipment and capital equipment acquired through construction.

Additionally, BayCare Clinical Engineering provides our customers with asset management and consultative services to assist our customers with capital equipment purchases and budget forecasting,” Barrionuevo says.

The team’s imaging service engineers keep current on clinical and technical advances in several ways.

“Based on strategic decisions to either increase competency and/or reduce cost, our staff is provided with a combination of factory certification and third-party training,” Barrionuevo explains.

“We believe having the manufacturer’s certification, coupled with the analytical and engineering skills provided by select third-party training partners, provides our staff with a well-rounded knowledge base to perform required service on our imaging modalities.”

Tackling Projects The team’s projects have included everything from cybersecurity measures to helping patients protect themselves from receiving too much radiation.

Barrionuevo says that some of those projects include an enterprise-wide GE ADVANCING THE IMAGING PROFESSIONAL

The BayCare Health System’s 11-member imaging services team is responsible for the maintenance of 28 MRIs, 45 CT scanners, 33 digital mammography systems and eight linear accelerators. They also support 157 mobile X-ray systems across all BayCare facilities.

Dose Watch implementation which allows all CT scanners to report to the GE Dose Watch server, which collects patient dose information that can be used to identify outliers or standardize protocols across the system to achieve the lowest dose possible without compromising image quality.

He says that another project has included universal viewer/PACS upgrades with the implementation of a GE PACS upgrade and universal viewer which required adding or changing the modality’s network information.

The importance of cybersecurity remediation and hardening has found the team installing anti-virus, operating system patches, Access Control Lists (ACL) as well as monitoring their network via Network Access Control (NAC) and Zingbox which provides visibility into the nature and actions of all connected devices.

Barrionuevo also says that the team has been involved in an enterprise-wide Xcelera implementation. Xcelera is BayCare’s enterprise solution for cardiology. Xcelera provides image storage and reporting, which required adding destinations to all catheterization labs, and cardiology specific ultrasound systems.

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Mother Nature Creates a Challenge The area where BayCare’s facilities exist happens to also be one of the areas that were thought to be in jeopardy because of Hurricane Irma. The Tampa Bay area was buffeted with strong winds, experienced power outages, had problems caused by a storm surge and received lots of rain.

The imaging services team was all in with their efforts to help the health system prepare for any eventuality.

“Hurricane Irma swept through Florida leaving heavy damage and many residents without power — some for several weeks. Our hospitals and ancillary facilities were not immune to these issues,” Barrionuevo says.

“Prior to, during, and for several weeks after, our field service imaging specialists worked tirelessly to ensure patient care could continue,” he adds. “Our imaging specialists assisted in evacuating one of our hospitals and moving equipment to higher ground in areas susceptible to flooding.

They prepared our imaging departments for the storm by shutting down power on all modalities, except MRI, at the breaker.”

Barrionuevo says that the imaging team members stayed onsite at the hospitals for

24 to 36 hours during the storm to support emergency equipment issues, and they provided remediation services, day and night, over several weeks, servicing equipment affected by power loss or severe anomalies.

“Several MRIs experienced cold head compressor and chiller support issues once power was restored. Emergency cryogen/ helium fills were also necessary in some cases,” Barrionuevo adds.

The team also supports the HTM community while away from the workplace.

“Our clinical engineering services department is a corporate sponsor for our local biomedical society; Bay Area Association for the Advancement of Medical Instrumentation (BAAMI),” Barrionuevo says.

“Most clinical engineering team members, including our imaging specialists, are members of the local society (BAAMI), a chapter of the Florida Biomedical Society,” he says.

BayCare’s imaging service professionals keep the system’s diagnostic imaging capabilities up and running for the benefit of every patient, even in the worst of conditions. ICE

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continue learning all year with

Click, click, click and another hour of training in the bag.

Thank you Webinar Wednesday!!

- Janet P.

View upcoming webinars at www.1TechNation.com/webinars!

Webinar Wednesday has become a staple of my Wednesday afternoons.

With diverse presenters and intriguing topics, this series is great way to learn something new, or add on to the things you already know.

- H. Gonzalez, Biomed

REGISTER TO ATTEND www.1technation.com/webinars

products

PRODUCT SPOTLIGHT Ultrasound Continues Upward Growth

U

ltrasound continues to be a rapidly growing modality in the world of diagnostic imaging.

Numerous reports forecast continued growth in coming years as advances in ultrasound systems make this modality even more vital for health care facilities of all sizes.

A recent report with information sourced from Reportlinker states that the global ultrasound device market will grow at a compound annual growth rate (CAGR) of 4.9 percent over the period of 2017-2023.

The forecast is based on a study on the ultrasound device market that covers the analysis of the leading geographies such as North America, Europe, Asia-Pacific, and RoW for the period of 2015 to 2023.

A MarketsandMarkets report that

ultrasound market to reach new heights.

“Increasing prevalence of chronic and infectious diseases such as cancer and CVDs (cardiovascular diseases) are anticipated to drive ultrasound market over the forecast period. Rising demand for minimal invasive and non-invasive diagnostic procedures coupled with innovation in technology are anticipated to drive the market during the forecast period,” according to Grand View Research.

“Growing incidences of injuries in muscles, tendons, vessels, joints and other internal organs are anticipated to boost the market growth over the next decade. Increasing global geriatric population base, rising number of hospitals and rapid introduction of high-efficiency imaging products in the market are vital drivers expected to fuel the

“ Rising demand for minimal invasive and non-invasive diagnostic procedures coupled with innovation in technology are anticipated to drive the market during the forecast period.” – Grand View Research “analyzes and studies the major market drivers, restraints, opportunities, and challenges in North America, Europe, AsiaPacific, and the Rest of the world (RoW)” also predicts growth.

“This report studies the ultrasound market over the forecast period of 2016 to 2021. The ultrasound market is expected to reach $6.86 billion by 2021 at a CAGR of 5.2 percent during 2016 to 2021,” according to MarketsandMarkets.

Grand View Research provides some insights into why it expects the global WWW.IMAGINGIGLOO.COM

growth of global ultrasound market over the forecast period.”

“Furthermore, rising global population base (birth rate) is anticipated to trigger the advanced ultrasound devices demand over the forecast period,” the report adds. “Increasing expenditure in health care sectors, growing public and private sectors partnership funding for advanced ultrasound devices and miniaturization of ultrasound devices are expected to provide significant growth opportunity to ultrasound market.”

Mordor Intelligence also shares its insights regarding the global ultrasound market.

“Government and private funding for R&D in ultrasound imaging, aging population, increasing number of health care providers, curtailment in the size of ultrasound devices, and higher incidences of chronic diseases are some of the factors that are propelling the growth of the market. However, lack of skilled labor to handle the equipment and stringent FDA regulations are turning out to be restraints for this market,” according to Mordor Intelligence.

Mordor Intelligence agrees that the future holds continued growth for the ultrasound market.

“The global ultrasound devices market was valued at $5.7 million in 2015 and is projected to reach $7.03 million by 2021, at a CAGR of 3.7 percent during the forecast period from 2016 to 2021,” Mordor Intelligence states. “Improvements in the ultrasound technology are increasing the demand for ultrasound devices, globally.”

“Many players in this market are trying to expand their product portfolio to top the global market. Few companies have even adopted product innovation and new product launches as their key business strategies, to ensure their dominance in the market,” according to Mordor Intelligence.

The major players in this market include GE Healthcare, Philips Healthcare, Siemens Healthineers, Samsung Medison Co. Ltd, Toshiba Medical Systems Corp., Mindray Medical International Ltd., and Hitachi Medical Corp. ICE

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products

Carestream Ultrasound Touch Ultrasound Systems Carestream’s Touch Prime/Touch Prime XE Ultrasound Systems feature a sealed, all-touch control panel that combines the speed and flexibility of a soft user interface with the tactile feedback of traditional keys. Carestream’s advanced SynTek Architecture simultaneously provides enhanced spatial detail with increased frame rates for improved visualization of moving structures, while optimizing image formation to reduce noise and artifacts. Imaging and Doppler improvements allow for more consistent visualization of subtle tissue contrast differences and can increase the ability to see small structures. A single touch of a button on the transducer allows freezing, storing and printing of images. •

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ADVANCING THE IMAGING PROFESSIONAL

products

FUJIFILM SonoSite Inc. X-Porte SonoSite X-Porte represents an entirely new approach to clinical ultrasound. It’s imaging features and educational resources are fluidly brought together in a convenient, all-in-one kiosk design. Its slender profile makes it easy to maneuver alongside beds and exam tables for point-of-care visualization and procedures. For portability and durability during transport, its screen folds down and its stand lowers making X-Porte even more compact for navigating busy corridors. X-Porte was developed to incorporate a breakthrough, proprietary beam-forming technology: XDI (Extreme Definition Imaging), created to reduce clutter and enhance image contrast. The sleek touch screen helps with infection control, as the surface is easy to clean and disinfect. •

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products

GE Healthcare Venue Ultrasound The GE Healthcare Venue Ultrasound is designed with a focus on emergency and critical care, as such health care providers have unique needs but often contend with ultrasound equipment from other medical disciplines.

Specifically, Venue offers a Shock Toolkit of automated tools – developed on principles of machine learning – to gain information about the heart, lungs and inferior vena cava, automating the parts of shock evaluation that are the most tedious or difficult. The Auto VTI tool can help the user to visualize the patient’s trend and to determine a next course of action in treatment. The Venue features a seamless flat display; up to four-hour battery life; 19-inch articulating monitor; four probes with probe hangers and more. •

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ADVANCING THE IMAGING PROFESSIONAL

products

Mindray Resona 7 Mindray’s flagship, premium Resona 7 ultrasound system will be upgraded to enable significant new applications such as contrast enhanced ultrasound (CEUS), Sound Touch shear wave elastography and nine new transducer options.

Based on ZONE Sonography Technology (ZST), the company has been developing upgrades and new technology to ensure ongoing state-of-theart imaging for its clinical partners. Other imaging, software, and calculation enhancements include fetal CNS “Smart Planes,” “Smart Pelvis” and a dedicated pelvic congestion syndrome package.

In addition to the upgrade, the Resona 7 system features several unique advancements including an innovative imaging capability, HD Scope. •

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products Philips Affiniti Philips Affiniti is a versatile solution designed to address the challenges of the everyday clinical working environment, so clinicians can provide patients with the best possible care despite the demands of high patient volumes and significant cost pressures. Affiniti is affordable, easy-to-use and built-to-last, putting premium image quality and performance within reach. With Affiniti, clinicians can offer proprietary advances and exceptional image quality with the eL184 PureWave linear array transducer, aBiometry AssistA.I., TrueVue, TouchVue, Tilt imaging, precision biopsy guidance support, MicroFlow Imaging and AI Breast. •

Toshiba Medical Aplio i-series Platform As providers continue to expand their use of ultrasound to wider ranges of clinical applications, Toshiba Medical is showcasing upgrades (pending 510(k) clearance) across its premium Aplio i-series ultrasound platform. The Aplio i-series is a highly advanced and scalable ultrasound solution made up of the Aplio i700, Aplio i800 and Aplio i900. The Aplio i700 and Aplio i800 are ideal for radiology and shared service departments looking for outstanding imaging performance, advanced clinical features and superior comfort and workflow. The Aplio i-series platform includes iPerformance technologies that deliver extreme processing power and help health care providers give reliable, quick diagnoses. The upgrade features a wider range of transducers and new clinical features. •

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ADVANCING THE IMAGING PROFESSIONAL

products

Siemens Healthineers ACUSON SC2000 PRIME Ultrasound System The ACUSON SC2000 PRIME system provides next-level visualization on a versatile system that offers 2D, 3D and volume intracardiac echocardiography (ICE) imaging with the broadest portfolio of ICE catheters on the market today, based on competitive data available July 2017. A complete solution for electrophysiology needs, the ACUSON SC2000 PRIME can help improve the management of patients from diagnosis to pre-procedural planning and from treatment to follow-up. The ACUSON AcuNav V catheter advances the current ICE technology by bringing the first volume imaging capability in an ICE catheter offering a 90°x 24° field of view. •

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products

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GETTING

APPROVA FROM A COMPANY’S POINT OF VIEW, IF YOU DO YOUR HOMEWORK WELL, THEN YOU CAN PLAY THIS GAME BETTER AND YOU CAN HAVE A MUCH EASIER PROCESS.

36

ICEMAGAZINE | JANUARY 2018

_ MUKESH KUMAR

ADVANCING THE IMAGING PROFESSIONAL

AL

THE FDA

AND BRINGING NEW DEVICES TO MARKET

BY MATT SKOUFALOS

T

he length of time it takes to bring a medical device to market in the United States has been a subject of scrutiny and criticism among various manufacturers and industry watchers for years.

“On the one hand, there are concerns over the seemingly slow pace of introduction of new devices and drugs to the U.S. medical market,” wrote researchers Kyle Fargen, et al., in “The FDA Approval Process for Medical Devices,” a 2013 study published in the Journal of Neurointerventional Surgery.

“Simultaneously, the FDA faces criticism for allowing drugs and devices to enter the market prematurely,” the authors wrote.

“Ironically, the FDA is being criticized at both ends of the spectrum while remaining substantially under-funded for the difficult tasks that it must oversee.”

In 2013, Fargen, et al, argued that the amount of time it takes to develop new pharmaceutical products for approval by the U.S. Food and Drug Administration (FDA) may run on a 12-year timeline, while the development path for a medical device can run some five to nine years shorter than that, thanks to “separate fast-track routes of obtaining approval.”

Comparatively, in “Innovation under Regulatory Uncertainty: Evidence from Medical Technology,” a 2017 study published in the Journal of Economics, Harvard Business School professor Ariel Dora Stern discovered that being the first manufacturer to market in the medical device world can add an average delay of more than seven months and several million dollars to the FDA approval process over subsequent comparative entrants in that same category. Stern argued that clerical inefficiencies at the agency, not technological complexities, were to blame for putting technological pioneers at a disadvantage.

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“Considering potential explanations, I find that approval times are largely unrelated to technological novelty, but are meaningfully reduced by the publication of objective regulatory guidelines,” she wrote. “Small firms are less likely to be pioneers in new device markets, a fact consistent with relatively higher costs of doing so for more financially constrained firms.”

The criticism of being both too tedious in its evaluation of new technologies and not critical enough in follow-up comparisons neatly illustrates the tensions of the balancing act that the FDA must negotiate in addressing issues of quality control and consumer safety. As the agency pivots to address these concerns while fulfilling its charge, device manufacturers and technology developers have responded to these conditions in various ways while working to bring products to market.

FDA classifies medical devices based on “the degree of control necessary” to ensure their safe and effective use: the greater the potential risk of its malfunction, the higher the risk classification of a device, and the more closely it is scrutinized. Class I devices include dental floss and band-aids; they are considered low-risk, according to the agency, accounting for 47 percent of all medical devices. Ninety-five percent of these are exempt from the regulatory process for reasons of being lowest risk. Such devices don’t require FDA review as long as they are “suitable for their intended use, adequately packaged and properly labeled,” registered and listed with the FDA, and manufactured ICEMAGAZINE

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THE FDA

AND BRINGING NEW DEVICES TO MARKET

under a quality control system, the agency notes. Another 43 percent of medical devices – things like condoms – are Class II devices, which require a greater degree of regulatory control, particularly at the manufacturing level, in order to offer maximum safety and effectiveness.

Class III medical devices, such as implantables, account for just 10 percent of all FDA-approved medical devices in the country, yet pose the greatest potential risk of patient harm, and therefore face the tightest regulatory oversight.

Under section 510(k) of the U.S. Food, Drug and Cosmetic Act, any medical device manufacturer must notify the FDA and receive the approval of the agency prior to taking any such technology to market in the United States. Taking its name from the Act, that procedure is known as a 510(k) or premarket notification (PMN); through it, manufacturers must prove that their planned technology is as safe and effective – the standard is “substantially equivalent” – as another FDA-approved device. Products “that contain new materials or differ in design from products already on the market” must apply for pre-market approval (PMA), a much higher standard of review than the equivalency test of the 510(k) designation. PMA requires that manufacturers offer valid scientific evidence of the safety and effectiveness of their devices, including data from human clinical trials.

For manufacturers that prefer to launch their products in Europe, the CE Mark, which is the official stamp of approval from the unified regulatory bodies of the European Union, offers an alternative pathway to device approval. Like the U.S. Food, Drug, and Cosmetic Act, the EU Medical Device Directive (MDD) offers standards against which the safety and effectiveness of medical devices may be judged. The MDD rates devices according to five classes of risk; each product must meet technical and safety standards as well as a risk analysis. Under EU law, the CE Mark must be renewed annually, and for manufacturers that follow a full quality assurance pathway, the CE Mark is a self-certification, meaning that they must provide a Declaration of Conformity affirming that the product is manufactured to those specifications.

Tony Roder, Regulatory Affairs Executive for GE Healthcare, said that for manufacturers bringing medical devices to market in a global economy, there are always variations in regulatory approvals from one country to the next. In the 175 national markets in which GE competes, there are few standardized classification schemes aside from those shared

by EU countries, he said. Aside from that, each process has its own timeline, which only increases with the severity of the potential for patient harm associated with increasing risk. The PMA process can take more than twice as long as the 90-day 510(k) timeline, whereas the CE mark process for a given technology can be completed within mere days depending upon the thoroughness of the technical documenta38

ICEMAGAZINE | JANUARY 2018

ARTICLE CONTRIBUTERS

MUKESH KUMAR

TONY RODER

CEO OF FDAMAP.COM

REGULATORY AFFAIRS EXECUTIVE FOR GE HEALTHCARE

tion available.

“No matter how many markets you look at, we’re not going to get any globally harmonized risk classification of products,” Roder said. “There’s pathways to get things down-classified but it takes quite a long time, and it can be quite an arduous process to actually get that done.”

In the field of medical imaging, the majority of technologies currently on the market are “established, long-term-accepted, very mature technologies,” Roder said. Device-makers may offer iterative improvements upon them that don’t really reinvent the core elements of the technologies at work therein, but may open them to potentially new clinical applications. That means that the bulk of new products will follow the 510(k) pathway to market, which, for imaging devices “is probably one of the better ones around the globe,” he said.

He believes that new EU medical device regulations issued this year are intended to more closely approximate the PMA approach to handling high-risk devices, which involves a greater deal of close collaboration with industry groups to overcome process and systems issues.

“There’s a lot of engagement with industry to proactively resolve issues that are problems for FDA and manufacturers, and alignment issues,” Roder said. “That has less of an impact on medical imaging technology than it does on other devices.”

However, FDA still “struggles a little bit from having to navigate historic or archaic systems,” he said, including mandatory physical copy filing requirements that nonetheless accompany much more comprehensive, fast, and portable ADVANCING THE IMAGING PROFESSIONAL

electronic filings. Roder also believes that the agency will need to determine how it handles medical devices that inform courses of treatment through the use of big data and similar analytical models, if for no other reason than that’s where the field is headed.

“Where you’ll see a lot of focus in place is what to do with all this information,” he said. “How do you leverage the information that’s generated and gathered by a hospital network or a group of imaging systems? Are there different ways to look at AI? That’s going to drive a necessity to think about things potentially differently and how the regulatory schemes deal with that.”

Mukesh Kumar, CEO of FDAMap.com of Gaithersburg, Maryland, helps a variety of medical device manufacturers earn FDA approval or a CE Mark for products. He believes many of the next technological developments in medical imaging will come in the area of analytical software that provides secondary analysis of medical images. Mature modalities like X-ray, ultrasound, MRI and CT are not evolving as much or as quickly as the software algorithms that enhance or analyze the images they capture, Kumar said.

“When you think about the cutting-edge developments in imaging, most of it is in analysis software,” he said. “Almost all the imaging software is approved as a device.”

He pointed to FDA’s recently announced Digital Health Innovation Action Plan, an initiative that focuses on speeding the pathway to FDA approval for low-risk medical devices intended for education or general awareness – things like health apps, and smart watches, with which FDA doesn’t want to be involved particularly. But the agency document does cite a need to support the “new innovation and manufacturing processes” of new-tothe-market medical device manufacturers in the digital space. Its action plan outlines the benefits of “products WWW.IMAGINGIGLOO.COM

that leverage connectivity” for continuous improvement and safety updates while noting that those benefits can be checked by “challenges of cybersecurity and interoperability.”

“Because they can impact the health of millions of Americans, the U.S. public should be able to trust that these products are high-quality and do what they are supposed to do,” the FDA document notes. “FDA recognizes that an efficient, risk-based approach to

storing data, or provides limited clinical decision support.” Kumar says he has several clients who are operating in this space, and who welcome the opportunity of getting their products into use as quickly as possible. When they’re not sure the best tack to take, he recommends that his clients have an exploratory meeting with the agency to discuss the best course of action.

“In general, the trend is to go and talk to FDA as many times as you can,”

“N O MATTER HOW MANY MARKETS YOU LOOK AT, WE’RE NOT GOING TO GET ANY GLOBALLY HARMONIZED RISK CLASSIFICATION OF PRODUCTS.” – TONY RODER regulating digital health technology will foster innovation of digital health products. FDA’s traditional approach to moderate- and higher-risk hardware-based medical devices is not well suited for the faster iterative design, development, and type of validation used for software-based medical technologies. Traditional implementation of the premarket requirements may impede or delay patient access to critical evolutions of software technology, particularly those presenting a lower risk to patients. For the American people to see the full potential of digital health technologies, FDA must lean forward and adapt our processes.”

Under that approach, the 21st Century Cures Act is meant to remove FDA oversight from the process of regulating “certain software that supports administrative functions, encourages a healthy lifestyle, serves as electronic patient records, assists in displaying or

Kumar said. “I see a lot of companies going for an exploratory meeting than they would have five years ago. It’s always very hard to clean up somebody’s mess than to not make a mess in the first place.”

Even with a two- to three-month waiting period to schedule with FDA, the results of a meeting with the governing body can really help shape the development of a product and set it on the path to clearance, Kumar said.

In 20 years working with the medical device industry, he said FDA processes “are pretty decent,” and a one-on-one meeting can reinforce their value to device-makers.

“From a company’s point of view, if you do your homework well, then you can play this game better and you can have a much easier process,” Kumar said. “FDA has no stake in this game.

But you have to know the rules, and you have to play within the rules.” ICE ICEMAGAZINE

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IMAGING MATTERS The Digital Age and Nuclear Medicine

I

t is common knowledge that medical imaging by X-ray is moving to 100 percent digital detectors. There are a large number of hospitals converting CR, and a few film, to DR due to reimbursement being lowered for institutions that do not have digital detectors. The idea behind the change is to provide all patients with the latest technology and the best images possible. The best images being part of the best care possible. What about nuclear medicine?

There have been digital nuclear medicine detectors in service since 1997. They have been used in a number of specialty applications including cardiac cameras and women’s health. Yet the digital detectors are still a niche item. But to understand why all nuclear medicine cameras are not yet digital detectors, there are a number of factors to consider.

The most common studies performed by nuclear medicine cameras are functional heart tests that measure how the heart works while looking for damaged tissue. Typically by circling the patient with two detectors, a three dimensional reconstruction is created and measured. This is called Single Photon Emission Computed Tomography (SPECT).

Radioactive isotopes that have been injected into the patient send gamma photons into the sodium iodide crystal face on the camera detector causing it to glow. This faint quick glow

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is amplified by vacuum tubes called Photo Multiplier Tubes (PMT) and that electronic signal is deciphered into an image via computer.

The image is created by a computer and easily made into a DICOM compliant format.

The technology of nuclear medicine is well understood. There have been improvements in the various parts that make up the nuclear medicine camera, but the technology is basically the same as it has always been. The exceptions are the digital detectors that were previously mentioned.

The question is, why are nuclear medicine cameras still using vacuum tubes instead of being digital? The technology of the flat detectors works well enough, the current problem lies in physics. The digital detectors themselves generate a great deal of heat and require robust cooling solutions. This has limited the practical size of the detector to date.

To create larger detectors, the heat increase is geometric in nature. The ability to cool larger detectors is not practical with the current technology. The original detectors were designed for satellites to monitor radiation on the Earth. In space, cooling is not a challenge.

Will nuclear medicine cameras move to all digital? With technology developments moving at the current rate the answer is “maybe.” It is entirely possible that the same move to digital will happen in the nuclear medicine world.

Written by John Garrett Manager, Clinical Engineering at Catholic Health Initiatives

If a cooling solution, or a lower heat detector is created, it is likely. However, it is also possible that new imaging technology will make nuclear medicine as a field obsolete. ICE John Garrett has 20 years experience in imaging service including general radiation, mammography, CT and nuclear medicine. He has worked for third-party service companies, manufacturers, sales companies and in-house imaging teams. Currently, he is manager of clinical engineering at Catholic Health Initiatives.

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insight

CAREER ADVICE The Art of Networking

I

n light of the ICE Conference coming up in February in Las Vegas here are some “Networking Tips” to empower you to make the most of your time and investment.

Have concrete goals in mind. You can’t talk to everyone at a conference, so it’s a good idea to go in knowing what you want to get out of it. Do you hope to find a connection that will eventually lead to a job offer? Do you want to garner more business for your company? Perhaps you simply want to meet people in your line of work and foster a deeper connection with others in your industry.

Your goals will influence which sessions you attend and which people you seek to meet. Instead of just going with the flow, plan out your time so you’re working toward your goals.

Remember that you’ll be more successful if you’re open to other people’s pitches instead of just trying to push your own agenda on people. Getting to know people is a good goal since it leads to long-term relationships that just don’t happen if you’re tossing out as many business cards as possible without taking time to have real conversations.

Research the attendees. It’s important to know who your fellow attendees will be and what their specializations, business, or expertise is. In particular, look up the people who will be presenting or exhibiting at the conference. They are the influencers 42

ICEMAGAZINE | JANUARY 2018

who can help you get better connected to your industry or who may even be able to share ideas with you or talk through projects you’re working on.

Take the time to visit their LinkedIn page to learn about their backgrounds. If you’re aiming to network with someone working for a company, research the company’s background, including its history and age, mission, achievements, and principal staff.

Consider emailing people you want to meet. Introduce yourself to key people and let them know that you look forward to hearing their talks or meeting them in person. They will, most likely, email you back and thank you. Now you’ll have a bit of history to fall back on when you see them at the conference.

Dress for the occasion. At conferences, business attire is the norm even if this industry tends to be more casual. In any case, aim to look polished and stylish so you make a good first impression on people.

Bring business cards. Passing out business cards is an effective way to give out your contact information. You should also plan to carry a business card binder so you can keep track of other people’s cards, too.

There’s nothing worse than having a great conversation with someone only to realize you lost their card and don’t remember their name.

If you don’t have business cards, it’s

Written by Cindy Stephens Stephens International Recruiting, Inc.

worth it to get some made. Keep the design understated and professional. Make sure the cards have your name, email address and phone number, the name of your company/hospital and/or your occupation.

Create a schedule. Once at the conference, figure out which presentations and other conference events you want to attend. You can also do this before you arrive by visiting the conference’s website at AttendICE.com.

Set appointments with people you know you want to meet. Everyone will have a busy schedule, but you could coordinate a coffee break or breakfast meeting with people you definitely want to have a conversation with.

Plan to take advantage of parties and cocktail hours instead of going back to your hotel or room. This is when people get a little more loose, and the conversation is less stiff.

Introduce yourself to people effectively. No matter who you’re talking to, whether it’s the person sitting next to you at a seminar or someone with whom you’re riding the elevator, be friendly and introduce yourself. When first introducing ADVANCING THE IMAGING PROFESSIONAL

insight “its about the patient”

DEPOT REPAIR DONE RIGHT yourself, limit your introduction to stating your name, who you work for and a bit about your background.

Presenters and others associated with the conference may be time-limited at that particular moment.

Practice what you’re going to say at home to make sure to include all pertinent information. However, try not to sound rehearsed when you give your “spiel.”

Ask people meaningful questions and really hear them out. A good networker is a good listener. When you’re talking to someone, focus on that person’s answers to your questions. Limit your own talking and encourage the other person to talk. Whatever you do, no matter how excited or enamored of this person’s expertise or importance you are, don’t jump to conclusions about what he or she will say next and try to fill it in.

Maintain eye contact, nod and unfold your arms.

Enjoy talking to the other person. Remember that networking is a wonderful opportunity to get to know people, so make the most of it by enjoying it as well as trying to connect.

Be receptive to others. Plan to accept as many business cards as you give out.

Talk to presenters. Go to the talks of those presenters you want to meet (especially if you emailed them prior expressing interest in doing so). Arrive early and sit in the front row so that you’re in a good position to reach them after the talk. Listen attentively and take notes so that you can raise particular points with them afterward during your discussion. When the presentation has concluded, introduce yourself, compliment their presentation and ask relevant questions.

Bear in mind that you might be able to arrange to see the person later at a dinner event or similar event during the conference if they’re not free straight after their talk. Give them your business card and be sure to set a time to catch up again during the period of the conference. This applies also to any exhibiting companies you wish to meet!

Enjoy the moment. Instead of thinking ahead too much about what talking to this or that person will get you, be in the moment and try to truly enjoy the process of meeting new people. If you like the industry we’re in, it should be fun to talk to other experts in the field. You’ll come across as someone worth getting to know better if you seem like you’re genuinely enjoying yourself. You should have as much to offer others as they have to offer you. ICE

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AUE

ADVANCED ULTRASOUND ELECTRONICS

DEF IN IN G THE STAN DAR D

IMAGING SERVICE 101 T

he point of our job and the primary responsibilities of every imaging engineer is to make repairs and perform tests so that the scanners we service are producing scans the clinicians can use for diagnoses and are, at the same time, safe for the patients and the technologists who use them. Mistakes we make or things we overlook while doing our job can lead to a patient or technician being hurt. Training you receive during your career should provide information on how a mistake that causes or misses the existence of a defect in the system can negatively impact uptime and patient safety. As usual, once you are trained it is your responsibility to heed and follow the instructions.

The original equipment manufacturers (OEMs) also have major responsibilities for patient and user safety. They are required to design the systems to reduce hazards, and to publish user and service documents that warn of potential dangers and explain how to mitigate the risks. They are also supposed to provide tools and documentation for testing the system so that we can make sure it is operating as designed. The compliance of OEMs with that FDA law varies a lot, depending on the modality and the OEM. We have to be able to assure proper system performance, so in those cases where we can’t get a password to access some tools or if the tools are not adequate for the job, we have to employ alternative testing methods and use third-party test equipment.

Many of us carry several pieces of test equipment that we use to make sure a system is working properly and safely. Phantoms, electrical safety analyzers (ESAs) and dosimeters are some of the more common ones.

Almost all scanners have some electrical safety concerns. In ultrasound, electrical leakage testing of the transducers often uncovers problems that present a cross-contamination risk to patients as well as the potential for shock.

One could even argue that an ESD field kit, used to minimize damage to components due to electrical static discharge, also contributes to patient safety by minimizing downtime.

WWW.IMAGINGIGLOO.COM

Some hospitals certainly think so. There have been MedWatch reports filed with the FDA regarding possible harm and at least one death because of an imaging system not being available to scan a critical patient because they were waiting on a password!

There are several aspects to the hazards presented by imaging systems, not the least of which is the risk of a misdiagnosis or a missed diagnosis if the scanner is not operating properly. The safety hazards of some scanners include mechanical assemblies that can break or fall off, such as injectors. Falling injectors are reported to FDA on a regular basis, and the OEM response in almost every case is “failure by user to follow the instructions.” If the OEM has made the information available, then the liability for failing to follow it is on the service engineers and the technologists.

Keeping the levels of ionizing radiation at known limits and within a defined beam are a major concern with CT scanners and other X-ray systems. Oscilloscopes and dosimeters have been part of the X-ray service tech’s tool bag for many years. Spiral CT scanners have been driving innovation in the detectors and measurement methods. The fancy, Bluetooth connected X-ray measurement systems available today do more than check for levels of radiation. They are used to check for proper operation of the scanner and formation of the X-ray beam, and can be a key tool for ongoing quality assurance.

Written by Jim Carr Director of Services and International Operations for AUE

As an imaging engineer, our reputation and livelihood depends on doing our best to assure the systems are safe and working properly. Despite FDA law that says they are supposed to do so, the OEM may not provide adequate instructions or may lock us out of diagnostic tools that are needed to properly maintain the system. The most specific and stringent requirements are for systems that emit radiation, such as CT scanners, which are covered in Part 1000 of 21 CFR. Part 1000 has some valuable benefits for those working on X-ray systems, primarily because in section 1020.40 (9) it requires the manufacturers to provide the AIAT information (for assembly, installation, adjustment, and testing) at a reasonable cost. Unfortunately for those of us working on MRIs, endoscopes, gamma cameras and ultrasound systems, there is not such specific verbiage. The FDA could do more to assure patient safety and reduce maintenance costs by forcing OEMs to follow the existing rules to provide tools and documentation for AIAT on all imaging modalities. Until that happens, we must continue to be innovative and resourceful in our profession to go beyond the sometimes limited resources we are provided to protect our patients and hospitals. ICE Jim Carr is Director of Service and International Operations for AUE. He may be contacted via email at JCarr@auetulsa.com.

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insight

GOALS, RESOLUTIONS, AND WHAT TO DO WITH THEM P

erhaps you’re one of those managers or supervisors who sets new goals for your teams at the beginning of each year. For many, it’s a tradition. Millions of people make “New Year’s Resolutions.” Some are work related while others are personal. Unfortunately, come springtime, many people cannot recall the resolutions they made just a few short months earlier.

As we start off the new year, you may have a desire to change the way you’re doing something. Or perhaps you want to start doing something altogether new. If so, what follows are three techniques that have proven themselves valuable whenever they’re used. They are: 1. Clarify your goals in writing every day.

2. K eep your focus on the path you must take.

3.

Find someone you trust and stay accountable.

Let’s start by talking about clarifying your goals in writing every day. One famous success story here is Scott Adams, creator of the Dilbert cartoon strip. As noted in Priorities magazine, Adams wrote out by hand the following sentence 15 times a day: “I will become a Syndicated Cartoonist.” Yes – 15 times a day!

Writing down goals is an important part of the process, but writing them out every day by hand is ultra-powerful, and neuroscience backs that up. According to Bottom Line publications, “Writing down goals is better than just thinking about them. It stimulates the ‘filtering’ part of the brain called the Reticular Activating System (RAS).” This RAS is the same activator that notices when someone whispers your name 46

ICEMAGAZINE | JANUARY 2018

and you can pick it out from across a crowded room. Your RAS cues your attention and helps direct your focus.

Bottom Line goes on to say that, “When you write your goals, the RAS begins collecting pertinent information and routes it to the conscious part of your mind. You become aware of opportunities you would never have noticed otherwise.” Then, when you recognize those opportunities, it’s much easier to step into them.

So step one is to establish specific, measurable goals and write them out every day.

The second step, picturing yourself doing the activities needed to achieve your goals, also has a strong influence on your RAS. It’s powerful because people go where they are focused. Think back to when you learned how to drive. Driver’s education instructors tell their students to focus on where the car will be in the next 10 to 12 seconds, not on the road right in front of the car. It’s looking at where you want to be.

Focusing on where you want to be will help you even when things aren’t moving as fast you’d like. For example, years ago I used to ride my bicycle to work, and on the way home I had to ride up a long hill. Near the top it was everything I could do just to keep peddling. My goal was always to reach the top without stopping, and that precluded taking in the scenery. Instead, I was giving it all I had, and my focus was the ground a few feet in front of me. Sometimes I would see a small rock in my path and I would think to myself, “I’m going to miss that rock.” Except I didn’t. When I was looking at the rock, I usually ran over the rock, even though my thoughts were “I’m going to miss that rock.”

After a few times of that happening, I

Written by Daniel Bobinski Workplace Consultant

remembered that we go wherever we’re focused. From then on, whenever I saw a rock in my path I would simply focus on the ground a few inches away from the rock, and behold, my bike tire would go where I was looking, thus avoiding the rock.

This same practice is powerful for achieving goals. One glance in the right direction doesn’t do it. To achieve our goals, we need to focus on the path between us and our goals and not look away for too long.

Finally, let me talk about having an accountability partner. A word to the wise: Choose this person carefully! It should not be your spouse (too close to you) nor someone who is not concerned about your success.

A good accountability partner should ADVANCING THE IMAGING PROFESSIONAL

insight be someone you trust, and someone who has experience in pressing through obstacles to reach their goals. It is probably best if this person is outside of your chain of command, but still has an appreciation of what you’re trying to achieve. It should also be someone whom you don’t want to let down.

Finding the right person can take some time, but it’s important to find someone who meets this criteria, plus someone who has time to connect with you regularly. Meetings don’t have to be long, just consistent. You can even meet over the phone or online.

Once you’ve identified your accountability partner, connect with that person a minimum of twice a month. Weekly is even better. Talk about your progress, but also talk about the obstacles you’re facing. It’s also best if your accountability partner does not lecture you. Ideally, he or she should patiently ask you pertinent questions to help you think through your own solutions and actions, offering advice and pointing out cautions only as needed.

Also, don’t feel like you need to lim-

it yourself to one accountability partner.

There is a proverb that says, “Plans fail for a lack of counsel, but with many advisors they succeed.” Still, if all you have is one, that’s way better than none.

Bottom line: There’s no reason to be shrugging your shoulders three months from now for why you didn’t make progress on your goals. You will go where you’re focused, so if you want the best chances of success, write out your goals every day and get focused on the path for what needs to be done. Then get an accountability system in place, and soon you’ll be achieving your goals and thoroughly enjoying the success. ICE – Daniel Bobinski, M.Ed. runs two businesses. One helps teams and individuals learn how to use Emotional Intelligence. The other helps companies improve their training programs. He’s also a best-selling author and a popular speaker at conferences and retreats. Reach him at daniel@eqfactor.net or 208-375-7606.

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ICEMAGAZINE

47

RSNA Scrapbook

2017 RSNA SCRAPBOOK T

he Radiological Society of North America (RSNA) is an international society of radiologists, medical physicists and other medical professionals with more than 54,000 members from 136 countries across the globe. RSNA hosts the world’s premier radiology forum.

RSNA 2017, the 103rd Scientific Assembly and Annual Meeting, was held November 26-December 1 at McCormick Place in Chicago, Illinois. Official final statistics were not available at press time, but RSNA 2017 had a total advance registration of 48,445 and professional advance registration of 23,097. The 2017 technical exhibition consisted of 695 companies. Watch ICE videos from RSNA trade show floor on the MD Publishing YouTube channel at tiny.cc/MDPyoutube.

1. Members of the Ampronix staff welcome visitors to the company’s booth at RSNA 2017.

4. The exhibit halls at RSNA 2017 were packed with imaging professionals from around the world.

2. MD Publishing’s Jayme McKelvey, third from left, networks with TriImaging Solutions’ MIchael Tripp, Wanda Legate and Chris O’Toole at the IAMERS cocktail party.

5. The Siemens Healthineers booth included the the MAGNETOM Terra – the first 7T MRI cleared for clinical imaging.

3. The latest technologies, including 3D printing, were on display at the annual event.

6. Attendees fill the grand concourse as they make their way to the exhibit hall and educational events.

1 48

7. The learning center was a popular destination at RSNA 2017.

10. The RSNA President’s Address was well attended.

8. GE Healthcare offered impressive demonstrations of equipment in action.

11. IAMERS’ Joe Cassidy is seen in the exhibit hall.

9. Jena Mattison, star of the ICE videos, is seen with a copy of ICE magazine at RSNA 2017. Watch Jena’s videos from RSNA on the MD Publishing YouTube channel at tiny. cc/MDPyoutube.

2 ICEMAGAZINE | JANUARY 2018

ADVANCING THE IMAGING PROFESSIONAL

RSNA Scrapbook

3

5

7

10 WWW.IMAGINGIGLOO.COM

4

6

8

9

11 ICEMAGAZINE

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index DIAGNOSTIC IMAGING & SURGICAL SOLUTIONS

Stephens International

Multi Diagnostic Adel Lawrence Associates, INC. p. 13

Injector Support &

Imaging Solutions p. 2

Recruiting Inc. p. 40

Service p. 19

Summit Imaging p. 3 InterMed Group p. 47 ATS A CIRS Company

MW Imaging Corp. p. 5

p. 40

Technical Prospects

THE JDIS GROUP

AUE

ADVANCED ULTRASOUND ELECTRONICS

D E F I N I N G TH E S TA N D AR D

p. 13

CT • MRI • PET/CT • MOBILE

JDIS Group p. 4

Advanced Ultrasound

PM Imaging

Electronics p. 45

Management p. 40 SOLUTIONS

Tri-Imaging Solutions p. 6

KEI Med Parts p. 21 Carolina Medical Parts p. 35

Radon Medical LLC p. 43

Trisonics, INC. p. 19

KEI Medical Imaging Services p. 47 Diagnostic Solutions p. 21

Ray-Pac® Ray-Pac p. BC

MEDICAL

SYSTEMS TECHNOLOGIES LLC

Webinar Wednesday

Medical Systems

p. 26

Technologies p. 43 Global Medical

RSTI/ Radiological

Imaging p. 35

Service Training Institute p. IBC MedWrench p. 44

50

ICEMAGAZINE | JANUARY 2018

X-ray Parts, Inc p. 17

ADVANCING THE IMAGING PROFESSIONAL

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