TechNation’s Guide to the 2024 AAMI eXchange

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Vol. 15 1technation.com ADVANCING THE BIOMEDICAL / HTM PROFESSIONAL MAY 2024 GUIDE TO THE AAMI E CHANGE JUNE 14-17, 2024 DIGITAL SUPPLEMENT PHOENIX, AZ

GUIDE TO THE AAMI EXCHANGE 2024

Here’s What you Need to Know

AAMI eXchange is back!

The 2024 edition of the premier healthcare technology management conference will be held in Phoenix, Arizona from June 14-17, 2024. With a schedule packed with speakers, trainings, and expo hall events. AAMI eXchange 2024 is a must-attend event for anyone involved with healthcare technology community

We expect to host over 2,100 health technology professionals, and eXchange24 will feature over 165 exhibitors including leading manufacturers and service providers, over 10 hours of exhibit time including networking events on the expo hall floor, and more than 80 educational sessions and workshops offering content and training tailored to various technical fields and professional areas. Coming on the heels of AAMI eXchange 2023, held in Long Beach, California, AAMI eXchange 2024 is expected to exceed its previous iterations.

AAMI President and CEO Pamela Arora said, “It’s always a joy to bring together members and friends from all corners of the healthcare technology community for our annual AAMI eXchange conference. eXchange 2024 will provide the training, comradery, and spectacle of years past, while equipping us all with the knowledge necessary to drive safe and effective health care toward a brighter future.”

WHO SHOULD ATTEND EXCHANGE24?

If you work directly with medical devices or in a field that is related to health technology, AAMI eXchange is for you. Not only will attending allow you to make face-to-face

connections with peers from across the country, but eXchange24 is a brilliant chance to hear from experts, discover new professional opportunities, and learn from the best. You should attend eXchange24 if you:

• Work in a hands-on capacity with medical devices. This will include biomedical and clinical engineers, biomedical equipment technicians, and more.

• Work in management at healthcare delivery organizations, such as hospitals and other facilities.

• Serve in the U.S. government, especially at agencies like the Department of Defense, in a capacity related to medical care and medical devices.

• Are an expert in cybersecurity, or work in risk management or systems engineering.

• Are involved with standards development through AAMI or organizations like the International Organization for Standardization (ISO).

• Belong to the trade press corps and cover medical devices, sterilization or standards.

WHAT’S AT EXCHANGE24?

Like previous years, eXchange24 will feature a wealth of training, educational sessions and informative keynote sessions alongside the AAMI expo hall where attendees can view the latest and greatest in health technology.

Keynote speakers include Herman McKenzie, director of the Standards Interpretation Group at The Joint Commission (TJC). McKenzie returns to eXchange to present the latest on TJC’s priorities and requirements, address any new requirements, and take questions directly from the audience. Don’t miss it! eXchange24 will also feature a keynote on Saturday, June 15th from comedian and television personality Scott Bloom on “The Power of Laughter, the Language of Business.”

In addition to the keynote sessions, eXchange will feature several concurrent symposiums. These include the Clinical Engineering Symposium presented by the

Digital Supplement | TechNation 3

American College of Clinical Engineering and an Industry Symposium presented by Palo Alto Networks.

A special thanks to this year’s sponsors, including Asimily, Crothall Healthcare, GE Healthcare, Ordr, Siemens Healthineers, Sodexo, TRIMEDX, and USCO Biomedical Services. The American College of Clinical Engineering is also acting as a contributing organization at eXchange24.

The eXchange expo hall will feature over 165 exhibitors from the medical device industry, alongside service providers, associations, trade press, and more. Expo hall activities will include an AR/VR Theater, and exhibitor in-booth theaters from the Siemens Healthineers, STERIS Corp, TRIMEDX, Avante Health Solutions, and GE HealthCare. Also, Live @AAMI eXchange, sponsored by GE Healthcare, will be returning this year, and AAMI staff will take the chance to cover the conference and dialog with AAMI Awards winners, eXchange24 attendees, and conference presenters on key issues related to healthcare technology management.

TRAINING AT AAMI EXCHANGE

of AI tools.

“eXchange24 is a brilliant chance to hear from experts, discover new professional opportunities, and learn from the best ”

Training at eXchange24 will cover a number of technical areas and is divided into several distinct tracks.

• Iot and AI Interoperability Track, sponsored by Ordr: This track will feature experts like the Mayo Clinic’s Kurt Griggs and Axel Wirth of Medcrypt, Inc., on the new threats and challenges that medical devices face due to increased interconnectivity and the implementation

• Cybersecurity Track sponsored by Asimily: The Cybersecurity Track features experts like Jeff Hooper, Ph.D., of the Children’s National Medical Center and Priyanka Upendra of Asimily on a host of issues such as FDA requirements, risk management, and more.

• Patient Safety Track: Taught by experts like ECRI’s Erin Sparnon and researchers from the University of Massachusetts Amherst, this track will address issues like AI in relation to health equity, human factors, and new tools like smart pumps.

• Professional Development Track: This track will feature experts such as AAMI board member Heidi Horn, and individual sessions will address management best practices, dealing with career obstacles, job searching, and building leadership skills.

• Sterilization Track: The Sterilization Track is taught by experts such as Nupur Jain of Intuitive and Samuel Tobin of Nemours Children’s Health, and will include sessions on borescope inspections, cleaning robotic surgical instruments and more.

• Home Health Track: This track features experts from groups like the MITRE Corporation and the Mayo Clinic and will focus on issues such as cybersecurity and the inpatient digital experience.

• Equipment Management Track: This track will feature experts such as Russell Lang of Agiliti, Brian McLaughlin of Massachusetts General Hospital, and will address medical equipment planning, real-time location

Phoenix Convention Center 4 TechNation | Digital Supplement

services, service contracts, and capital planning.

• VR/AR Track: This track will feature experts such as Richard Ludwig and Matthew Kwiatkowski of GE Healthcare, and will include sessions on video training in HTM, augmented reality surgical navigation, and more.

• Regulatory Track: The Regulatory Track will feature speakers such as Scott Trevino of TRIMEDX, Binseng Wang of Sodexo, and others on regulatory compliance and the tradeoffs of regulating medical device sorting. Further, eXchange24 will feature the return of last year’s technical trainings. The training sessions are hands-on and geared towards biomedical technicians. Technical trainings will include:

• Virtual-reality-enabled training for portable X-Ray devices

• Metrology

• Defibrillators

• X-Ray Tube Handling

• Diagnostic ultrasound

• Picture archiving and communication systems (PACS) Ultimately the technical trainings are designed so that BMETs can build their resume by learning from AAMI experts and earning CEU credits.

NETWORKING AND SOCIAL EVENTS

But AAMI eXchange isn’t just about business! eXchange24 will feature multiple opportunities for attendees to relax and network. On Friday, June 14, the expo hall will open with a welcome reception, and Crothall Healthcare has also sponsored a happy hour on the expo floor on Saturday, June 15.

This year’s edition of the annual AAMI Party will be held at The Duce, a bar and restaurant just a short walk from the convention center, and will feature music, games, food, and drinks. The closing reception will be held at three connected venues named Ghost Donkey, Cham Pang Lanes, and Palma.

Last, after rave reviews at last year’s eXchange, the AAMI Golf Tournament is making a reappearance. This year’s edition of the tournament will be held at the Legacy Golf Club in Phoenix. There are only 72 spots available for this friendly, four-person scramble style tournament, so register early if you’re interested.

In short, AAMI eXchange24 is set to be an excellent opportunity for training, learning, and connecting with HTM professionals in your niche or further afield. Questions about registration, the expo hall, or other issues? Contact events@aami.org.

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AAMI EXHIBITOR SPOTLIGHT

Alco Sales and Service Co. alcosales.com

Booth #1030

ECRI Institute ecri.org Booth #5111

HTM jobs htmjobs.com

Avante Health Solutions avantehs.com

Booth #431

BC Group International, Inc. bcgroupintl.com

Booth #722 Capital i capitali.us Booth #825

#843

Booth #323 IMT Analytics imtanalytics.com

Booth #310

#928

#629

College of Biomedical Equipment Technology cbet.edu Booth
FSI fsiservices.com
hmark.com
Elite Biomedical Solutions elitebiomedicalsolutions.com Booth #733 EQ2, LLC eq2llc.com Booth #737
Booth #717 Healthmark Industries
Booth #630
Integrity
Maull
Be sure to visit these exhibitors!
8 TechNation | Digital Supplement
Innovatus Imaging innovatusimaging.com Booth
Biomedical Services, LLC integritybiomed.com Booth
Biomedical Training, LLC maullbiomedical.com Booth #944

SPOTLIGHT

MedWrench medwrench.com

Booth #323

MultiMedical Systems multimedicalsystems.com

Booth #213

PM Biomedical pmbiomedical.com

Booth #329

Probo Medical probomedical.com

Booth #343

Pronk Technologies, Inc. pronktech.com

Booth #422

QRS Solutions/ Datrend Systems Inc qrs-solutions.com

Booth #943

Radcal radcal.com

Booth #823

RSTI/Radiological Service Training Institute rsti-training.com

Booth #1007

RTI Group North America rtigroup.com

Booth #333

Southeastern Biomedical Associates, Inc. sebiomedical.com

Booth #915

TechNation 1technation.com

Booth #323

Tenacore Holdings, Inc. tenacore.com

Booth #316

SOLUTIONS

Tri-Imaging Solutions triimaging.com

Booth #349

TruAsset, LLC truasset.com

Booth #614

USOC Medical usocmedical.com

Booth #523

Vizzia Technologies vizziatech.com

Booth #542

MEDICAL EQUIPMENT SALES AND SERVICE
Advancing the Biomedica /HTM Professional
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AAMI eXchange attendees participating in MedWrench’s scavenger hunt have the chance to win over $2,400 in prizes!

To begin the scavenger hunt, pick up a scavenger hunt card at the TechNation booth #323 or any of our participating sponsors.

Completed cards must be turned in at the TechNation booth before June 16th at 2:00 pm MT.

The drawing will be on Sunday, June 16 at 2:00 pm MT at the TechNation booth.

JOIN THE HUNT medwrench.com AAMI eXchange June 14–17, 2024 Phoenix, AZ Good
everyone!
luck
213 324 FOOD & BEVERAGE/ NETWORK SEATING 2 EXHIBITOR SERVICE DESK PRODUCT SHOWCASE I RESERVED RESERVED AAMI EXHIBIT SALES OFFICE FOOD & BEVERAGE/ NETWORK SEATING 1 FOOD & BEVERAGE/ NETWORK SEATING 3 PRODUCT SHOWCASE II AR/VR XPERIENCE 233 323 329 349 423 523 629 808 817 916 422 822 928 943 MMS - 213 Interlight - 233 TechNation - 323 Multi-Medix - 324 PM Biomedical - 329 Tri Imaging - 349 Pronk - 422 PartsSource - 423 USOC - 523 Integrity Biomedical - 629 Block Imaging - 808 Sage - 817 Rigel - 916 Adepto and Pio Bio/ Prescott’s - 822 Innovatus - 928 QRS - 943 MAP KEY *Based on the live AAMI eXchange floor plan as of May 3rd. RESERVED RESERVED RESERVED RESERVED ENTRANCE

GUIDE TO AAMI

TOP PHOENIX ATTRACTIONS FOR VISITORS

As one of the largest cities in the U.S., you’ll find every kind of attraction in Greater Phoenix: food, nightlife, outdoors and more fill every nook and cranny of the metro. If you’re not sure where you should start, we’ve rounded up the top attractions everyone — visitors and locals — should check off their Greater Phoenix bucket list. Photo credit: VisitPhoenix.com.

For more information, visit VisitPhoenix.com.

MUSEUMS & ATTRACTIONS

THE MUSICAL INSTRUMENT MUSEUM

See, hear and even play instruments from every corner of the world in a one-of-a-kind collection. The Musical Instrument Museum (MIM) tunes you into thousands of instrument sounds with a headset that syncs seamlessly as you move through its galleries. Take a world tour of cultural instruments and pop culture artists, and return for a live music experience at MIM Music Theater, a yearround concert series hosting more than 200 international acts.

The tradition, culture and history of 22 regional American Indian tribes converge in the Heard Museum ‘s immersive exhibits and authentic art shop, as well as annual events like the World Championship Hoop Dance Contest. Through art and cultural objects, the museum’s ongoing exhibits tell the stories of native people of the Southwest, from early history to powerful memories of boarding schools.

THE DESERT BOTANICAL GARDEN

The winding paths of this 50-acre desert garden showcase a fantastic variety of arid plants, from towering saguaros to delicate blooms. This beautiful landscape is also the backdrop for the garden’s seasonal events. During the winter months, thousands of luminaria bags and twinkling lights transform the garden for Las Noches de Las Luminarias, a holiday tradition. The garden also features art installations intertwined with the flora each year.

One of the nation’s largest nonprofit zoos is home to more than 1,400 animals. See Sumatran tigers roam the savanna, feed giraffes in an up-close encounter and discover the local flora, fauna and critters of the Sonoran Desert on the zoo’s Arizona Trail.

TALIESIN WEST

Tours of Taliesin West, Frank Lloyd Wright’s winter home, offer insight on how the masterful architect was inspired by the desert surroundings. Visitors walk through rooms, gardens, walkways and Wright’s entertainment pavilion on the grounds while learning about his organic architecture. Taliesin West was inscribed to the UNESCO World Heritage List on July 7, 2019, after being submitted for nomination by the National Park Service in November 2018.

The Southwest’s largest fine art museum features a collection of contemporary work and global masterpieces. Complementing the museum’s galleries of fine art and objects from Asia, America, Europe and beyond are rotating exhibitions. Want to see the permanent collections for free (and the special exhibitions at a discount)? Visit Wednesdays from 3 p.m. to 9 p.m. during voluntary donation time, or the second Sunday of the month from noon to 5 p.m. for Free Family Sundays

PHOENIX ZOO
HEARD MUSEUM
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PHOENIX ART MUSEUM
VisitPhoenix.com

CAMELBACK MOUNTAIN

The panoramic view from the “hump” of this iconic landmark, named for its resemblance to a kneeling camel, is worth scaling its two tricky trails, Echo Canyon and Cholla. Hikers gain 1,200 feet in elevation to the summit, which looks out over the city and Phoenix Mountains Preserve. Camelback is one of the most popular urban hiking spots in Phoenix, so expect trail traffic and consider hiking on weekdays. During hot-weather months, hike in the early morning and drink plenty of water. See our outdoor safety tips page for more info before you head out.

PAPAGO PARK

Just minutes from downtown is iconic Papago Park, home to red rock buttes looped with trails, scenic views from the intriguing rock formation atop Hole-in-theRock Trail and two of the city’s top attractions: Desert Botanical Garden and Phoenix Zoo. The park is also a popular hub of recreation, including fishing in seven acres of stocked lagoons, the Hall of Flame Museum of Firefighting and scenic Papago Golf Course , set at the base of Papago’s buttes.

OUTDOOR ADVENTURES & HIKES LOCAL DISTRICTS

ROOSEVELT ROW

The creative beat of the city’s urban heart is in Roosevelt Row, home to galleries, mural-splashed business walls and a monthly art walk. This arts district is a prominent stop for visitors and the downtown community along the First Friday self-guided art tour.

MELROSE DISTRICT

SOUTH MOUNTAIN PARK AND PRESERVE

Boasting 50 miles of trails through 16,000 acres of the Sonoran Desert, this municipal park is perfectly suited for outdoor adventure just minutes from the city. The skyline views and Sonoran Desert flora aren’t the park’s only perks. Keep a lookout for ancient petroglyphs carved into the rocks (we’ve got details in this blog post on petroglyphs in Phoenix). If you’d rather drive than hike, bike or hoof it up the trails, hop on the 5.5-mile Summit Road up to Dobbins Lookout, the highest accessible point in the preserve.

OLD TOWN SCOTTSDALE

Southwestern arts and hip eateries line the streets of Old Town, a popular destination for Greater Phoenix shopping and nightlife. If you’re hunting for a souvenir, you’ll find your fill of old-fashioned flair (think cowboy hats and turquoise jewelry) alongside upscale art galleries and trendy boutiques in the Fifth Avenue district. The area is also a hot spot for after-dark dancing, lounging and libations.

This 1-mile stretch of Seventh Avenue, between Indian School and Camelback roads, is home to some of the best antique shops, art, dining, patio cocktailing and dancing around. Also known as “The Curve” for its winding nature in an otherwise grided city, and the “gayborhood,” thanks to its high concentration of LGBTQ+ bars and rainbow flags perched outside allied businesses, this neighborhood is an absolute must for a sense of this city’s pride as well as its midcentury roots.

HERITAGE SQUARE

Like the 19th-century homes nearby, a restaurant in downtown’s Heritage Square is making history: Pizzeria Bianco (heralded as the best pizza in the nation) is James Beard Award winner. The area is also home to the Arizona Science Center , featuring more than 350 hands-on exhibits.

Digital Supplement | TechNation 13

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SCHEDULE

WEDNESDAY, JUNE 12

1:00 PM - 5:00 PM — Exhibitor Set-up (by appointment only, for booths 600 sq. ft. or larger ONLY)

THURSDAY, JUNE 13

8:00 AM - 4:30 PM — Set-up for all Exhibitors

8:00 AM - 5:30 PM — Registration Open

FRIDAY, JUNE 14

7:30 AM - 7:00 PM — Registration Open

7:30 AM - 2:00 PM — 2nd Annual Golf Tournament (buses to depart at 6:00am from the Sheraton Hotel)

8:00 AM - 12:00 PM — Set-up for all Exhibitors

5:30 PM - 7:00 PM — Opening Reception in the Exhibit Hall

SATURDAY, JUNE 15

6:30 AM - 6:00 PM — Registration Open

7:15 AM - 10:15 AM — Concurrent Education Tracks Sessions

7:15 AM - 10:15 AM — Clinical Engineering Symposium

7:30 AM - 11:00 AM — AAMI’s Career Center

10:30 AM - 12:00 PM — Keynote Speaker - Scott Bloom presents “The Power of Laughter, the Language of Business” & Awards Presentations Part I

12:00 PM - 1:00 PM — Lunch in the Exhibit Hall

12:00 PM - 5:00 PM — Exhibit Hall Open

12:00 PM - 5:00 PM — Exhibitor In-Booth Theaters, Exhibitor Product Showcases, and AR/VR Theater in the Exhibit Hall

3:30 PM - 4:00 PM — AAMI’s Annual Business Meeting

4:00 PM - 5:00 PM — Happy Hour in the Exhibit Hall

5:00 PM - 6:15 PM — Industry Symposium

6:00 PM - 8:00 PM — AAMI PARTY! @ The Duce

SUNDAY, JUNE 16

7:30 AM - 6:00 PM — Registration Open

7:30 AM - 11:00 AM — AAMI’s Career Center

8:00 AM - 10:15 AM — Concurrent Education Tracks/Sessions

10:30 AM - 12:00 PM — Keynote Speaker & Awards Presentations Part II

12:00 PM - 1:00 PM — Lunch in the Expo Hall

12:00 PM - 4:00 PM — Expo Hall Open

12:00 PM - 4:00 PM — Exhibitor In-Booth Theaters, Exhibitor Product Showcases, and AR/VR Theater in the Expo Hall

4:15 PM - 5:15 PM — Concurrent Education Tracks/Sessions

6:00 PM - 8:00 PM — AAMI’s Closing Reception @ Palma/Champ Pang Lanes/Ghost Donkey

MONDAY, JUNE 17

7:30 AM - 12:00 PM — Registration Open

8:00 AM - 10:15 AM — Concurrent Education Tracks/Sessions

10:30 AM - 12:00 PM — Keynote Speaker & Awards Presentations Part III

*as of February 27, 2024 - schedule is subject to change

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WELCOME RECEPTION

AAMI will take over these three venues that are all connected. It is a short stroll from the convention center. Come enjoy the last evening of the conference with friends new and old. *Please note this event is open to these registration types: Full Conference, Exhibitor, Sunday Full Conference and those who purchased individual tickets to this event. Expo Only will need to purchase a ticket to attend.* Saturday, June 15 • 6:00-8:00 PM • Palma/Champ

Digital Supplement | TechNation 17
Pang Lanes/Ghost Donkey CLOSING RECEPTION
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HTM WEEK contest

MAY 19-25 2024

TechNation celebrates HTM professionals every day, but the magazine wants to do something special for HTM Week! Each weekday during HTM Week one lucky biomed will win a $100 gift card.

Scan this QR Code and fill out the form to enter for a chance to win. Entries accepted through the end of HTM Week.

Each day a winner will be announced on social media so follow TechNation on Facebook and LinkedIn to see if you win.

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GUIDE TO AAMI

AAMI UPDATE

AAMI Hosts HTM Week 2024

AAMI is pleased to announce that it will host its annual HTM Week from May 19 to 25, 2024. Planned and hosted by AAMI’s Technology Management Council (TMC), HTM Week promotes awareness and appreciation of the professionals who manage and maintain the vast assortment of health technology found in healthcare delivery organizations.

HTM professionals fundamentally support our health care system by servicing and maintaining healthcare technologies for hospitals and other health care facilities, manufacturers and third-party organizations.

Danielle McGeary, vice president of HTM at AAMI, believes that the trainings and programming planned for May are an ideal chance promote the field and recognize the profession as a whole. “AAMI’s strategic plan is dedicated to helping increase the HTM personnel pipeline of professionals entering the field and providing continuing education to the HTM field at large. This year’s HTM Week contests and events are focused on these initiatives.”

HTM Week 2024 will feature:

1. Three free webinars taught by HTM subject matter experts

2. The “Best HTM Sticky Notes” contest

3. The BMET 101 high school giveaway contest

HTM WEEK WEBINARS

AAMI will host three webinars during HTM week. These sessions are free for both AAMI members and non-members and will address key topics that are vitally important to the HTM profession.

• HTM Cybercraft: Navigating the Cyber-Physical Maturity Journey: Taught by Ty Greenhalgh, industry principal, Healthcare at Claroty, this webinar addresses

the Cyber-Physical Security Maturity scale, and the key role of the HTM in risk management and ensuring patient safety. The webinar will be on May 21, 2024, from 2-3 p.m. ET.

• Adding to the Toolbox – Tips to Grow into a Better Leader: Greg Czajka, support services operations director at Advocate Health, will present on what it takes to cultivate leadership skills, and what it takes to add new tactics to your professional development toolbox. The webinar will be on May 22, 2024, from 2-3 p.m. ET.

• Next-Level HTM: Advancing Your Program through Data and Tech: Sponsored by PartsSource, this session will be taught by Dave Brennan of SVP Clinical Solutions, and will discuss how HTM leaders have evolved to become best-in-class using AAMI’s HTM Levels Guide. The webinar will be on May 23, 2024, from 2-3 p.m. ET.

BEST HTM STICKY NOTES CONTEST

HTM week also features the return of the HTM Sticky Notes contest. Have you seen or received a hilarious sticky note from a clinician on a broken medical device? We want to see it! Share it on social media using hashtags #BiomedNotes and #HTMWeek or email us a photo at htm@aami.org. The winner will get a pizza party for their department, and AAMI will keep all device manufacturers anonymous!

HIGH SCHOOL GIVEAWAY CONTEST

To promote the HTM field to the next generation, high school students are invited to participate in a special HTM Week giveaway. Three winning students will be awarded access to AAMI’s new BMET 101 course, which will give them the opportunity to learn more about the different career paths within HTM. All high school students are eligible, and they can enter the contest here. Submissions are due by May 17, 2024.

In short, AAMI’s HTM Week 2024 has plenty of opportunities, whether you’re a seasoned veteran, new to the field, or simply looking to learn about whether the

Digital Supplement | TechNation 23

HTM profession is right for you. AAMI also has HTM Week posters and an HTM Week Proclamation on its HTM Week Webpage that can be used to enhance the celebration. Questions? Reach us at htm@aami.org.

FDA EXPLAINS MEDICAL DEVICE CYBERSECURITY REQUIREMENTS

On the last day of AAMI/FDA neXus, Jessica Wilkerson, senior cyber policy advisor and Medical Device Cybersecurity Team Lead at FDA presented on regulatory requirements for medical device cybersecurity.

Wilkerson opened her talk with a simple “why.” “Cyber threats can, have, and very much do pose patient safety risks to the health care sector,” and FDA’s regulatory priorities are driven out of concern for patient safety.

The most relevant legislation to medical device cybersecurity is the Food and Drug Omnibus Reform Act (FDORA), which was passed into law as part of the Consolidated Appropriations Act of 2023 and signed into law on December 29, 2023. This incorporated Section 524B - Ensuring Cybersecurity of Medical Devices into the Federal Food, Drug, and Cosmetic Act (FD&C).

Section 3305 of the Omnibus, Ensuring Cybersecurity of Medical Devices, applies to prospective submissions for “cyber devices” under the 510(k), de Novo, PDP, and PMA pathways. It came into effect 90 days after signing, on March 29, 2023. Section 524b of the Act defines a “cyber device” as a device that has these three concurrent characteristics:

• Includes software validated, installed, or authorized by the sponsor as a device or in the device.

• Has the ability to connect to the Internet; and

• Contains any such technological characteristics validated, installed or authorized by the sponsor that could be vulnerable to cybersecurity threats.

This definition can include devices that do not have Internet connectivity but do have something like a USB port. Wilkerson stated that the Act also includes notable requirements for device manufacturers. Section 524B(a) requires that a sponsor do the following:

• Provide a plan to monitor, identify, and address, postmarket cybersecurity vulnerabilities and exploits, including coordinated vulnerability disclosure and related procedures.

• Design, develop, and maintain processes and procedures to provide a reasonable assurance that the device and related systems are cybersecure, and ensure that a device has postmarket patching capability.

• Provide a software bill of materials (SBOM) including commercial, open-source and off-the-shelf software components.

• Comply with other regulations and demonstrate reasonable assurance of cybersecurity.

FDA’s final premarket guidance was published last

year, on September 26, 2023, capping a nearly six-year development process. Wilkerson stated that guidance is “intended to help manufacturers comply with requirements under Section 524B of the FD&C Act.” Critically, the scope of the premarket guidance is much broader than the scope of 524b and will apply to more devices. Resources include a publicly available webinar hosted in 2022, and eSTAR’s incorporation of the guidance.

The guidance addresses how cybersecurity fits into Quality System Requirements and updated the 2022 draft by including CBER submission types, considerations for combination products, and elements associated with Section 524B requirements. Structural changes include subsections in Security Risk Management meant to clarify premarket submission documentation deliverables including Cybersecurity Risk Assessments and interoperability. Citing patient concerns, Wilkerson stated that cybersecurity should not stand in the way of interoperability. Last, the document address software bill of materials (SBOMs) and aligns with the 2021 National Telecommunications and Information Administration (NTIA) SBOM Framing Document. However, FDA still asks for supporting materials, which can be submitted separately from an SBOM.

Of course, the total product life cycle includes both the premarket and postmarket phases, and FDA’s findings in one will influence the other. “When we see an issue in the post market, we will go back to the premarket cybersecurity guidance … and we will update our review criteria,” Wilkerson said.

Regarding cybersecurity review, Wilkerson drew a key distinction, stating, “software engineering is about ensuring that certain things happen … security is about ensuring that they don’t.” The ideal question to ask is, “What can the device do?” Further, past performance does not equal future security. Cybersecurity threats evolve quickly, so past security is no guarantee of future safety. Wilkerson indicated that asking, “Who is ever going to do that?” in reference to a potential cyber threat, is neither relevant nor helpful. Cybersecurity concerns apply:

• If the device is or contains software

• If the device meets the definition of a Cyber Device.

• Regardless of whether the software or software component was designed by a medical device manufacturer or a third-party.

• Cybersecurity considerations apply to the entire system, not just the end device.

Wilkerson finally noted that your risks increase if the device has wired capabilities such as USB, ethernet, SD, CD, or RGA, as well as wireless capabilities such as Wi-Fi, Bluetooth, RF, inductive, or cloud connectivity. Cybersecurity considerations also apply to the entire system rather than just the end device, and will include software update infrastructure, cloud applications and commercial devices.

24 TechNation | Digital Supplement
GUIDE TO AAMI

webinars, podcasts, and product demos are eligible for 1 CE credit from the ACI.

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All webinars, podcast, and product demos are eligible for 1 CE credit from the ACI.

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Enhancing Value of Outsourced Biomed Programs with RTLS Solutions

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Securing Patient Care: Insights from the State of CPS Security Report

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THE TOTAL PACKAGE HAS ARRIVED.

Tech Choice Awards (The Wrenchies)

Nominations for the 2025 Tech Choice Awards are open! Scan the QR code below to nominate your choice for the following 13 categories. Top 5 nominees will be announced in the October issue of TechNation .

The 13 Tech Choice Award Categories are: 1. Lifetime Achievement Award, sponsored by Renovo Solutions 2. Professional of the Year, sponsored by 626 Holdings 3. Department of the Year, sponsored by USOC 4. YP of the Year 5. ISO Employee of the Year 6. Director/Manager of the Year, sponsored by MW Imaging

Military BMET of the Year, sponsored by College of Biomedical Equipment Technology

Humanitarian Award 9. Women in Leadership Award, sponsored by Avante Health Solutions

Industry Influencer of the Year, sponsored by Soma Tech Intl.

Outstanding Vendor of the Year

Association of the Year, sponsored by Multimedical Systems

Educator of the Year

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Advancing the Biomedical /HTM Professional NOMINATE SOMEONE TODAY! 1technation.com/tech-choice-awards
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