TechNation’s Guide to the 2024 AAMI eXchange

1technation.com

Vol. 15

MAY 2024

ADVANCING THE BIOMEDICAL / HTM PROFESSIONAL

GUID E TO THE

AAMI E CHANGE

JUNE 14-17, 2024

PHOEN IX , A Z

DIG ITA L SU PP LE ME NT

GUIDE TO THE AAMI EXCHANGE 2024

A

Here’s What you Need to Know AMI 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.

of AI tools.

• 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

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

TRAINING AT AAMI EXCHANGE 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

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.

Digital Supplement | TechNation 5

AAMI EXHIBITOR SPO Be sure to visit these exhibitors!

Alco Sales and Service Co. alcosales.com Booth #1030

ECRI Institute ecri.org Booth #5111

Avante Health Solutions avantehs.com Booth #431 Elite Biomedical Solutions elitebiomedicalsolutions.com Booth #733

BC Group International, Inc. bcgroupintl.com Booth #722

Capital i capitali.us Booth #825

College of Biomedical Equipment Technology cbet.edu Booth #843

8 TechNation | Digital Supplement

EQ2, LLC eq2llc.com Booth #737

FSI fsiservices.com Booth #717

Healthmark Industries hmark.com Booth #630

HTM jobs htmjobs.com Booth #323

IMT Analytics imtanalytics.com Booth #310

Innovatus Imaging innovatusimaging.com Booth #928

Integrity Biomedical Services, LLC integritybiomed.com Booth #629

Maull Biomedical Training, LLC maullbiomedical.com Booth #944

OTLIGHT Advancing the Biomedical/HTM Professional

MedWrench medwrench.com Booth #323

QRS Solutions/ Datrend Systems Inc qrs-solutions.com Booth #943

TechNation 1technation.com Booth #323

Tenacore Holdings, Inc. tenacore.com Booth #316

MultiMedical Systems multimedicalsystems.com Booth #213

PM Biomedical pmbiomedical.com Booth #329

Probo Medical probomedical.com Booth #343

Radcal radcal.com Booth #823 SOLUTIONS

Tri-Imaging Solutions triimaging.com Booth #349 RSTI/Radiological Service Training Institute rsti-training.com Booth #1007 TruAsset, LLC truasset.com Booth #614

RTI Group North America rtigroup.com Booth #333

USOC Medical usocmedical.com Booth #523

MEDICAL EQUIPMENT SALES AND SERVICE

Pronk Technologies, Inc. pronktech.com Booth #422

Southeastern Biomedical Associates, Inc. sebiomedical.com Booth #915

Vizzia Technologies vizziatech.com Booth #542

Digital Supplement | TechNation 9

J O I N

T H E

H U N T

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.

Good luck everyone!

medwrench.com

AAMI eXchange

June 14–17, 2024

Phoenix, AZ

PRODUCT SHOWCASE II

AR/VR XPERIENCE

213

FOOD & BEVERAGE/ NETWORK SEATING 3

233 324 323

329

349

RESERVED

422

ENTRANCE

423

RESERVED

523

RESERVED

629

RESERVED

RESERVED

808

822

928

916

943

PRODUCT SHOWCASE I

MAP KEY

FOOD & BEVERAGE/ NETWORK SEATING 1

AAMI EXHIBIT SALES OFFICE

EXHIBITOR SERVICE DESK

MMS - 213

Integrity Biomedical - 629

Interlight - 233 TechNation - 323

Block Imaging - 808 Sage - 817

Multi-Medix - 324 PM Biomedical - 329

Rigel - 916 Adepto and Pio Bio/

Tri Imaging - 349 Pronk - 422

Prescott’s - 822 Innovatus - 928

PartsSource - 423 USOC - 523

QRS - 943

RESERVED

817

FOOD & BEVERAGE/ NETWORK SEATING 2

*Based on the live AAMI eXchange floor plan as of May 3rd.

GUIDE TO AAMI

TOP PHOENIX ATTRACTIONS FOR VISITORS VisitPhoenix.com

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.

M US E U MS & ATTR ACTIO NS THE MUSICAL INSTRUMENT MUSEUM

THE DESERT BOTANICAL GARDEN

TALIESIN WEST

The winding paths of this 50-acre desert

Tours of Taliesin West, Frank Lloyd Wright’s

See, hear and even play instruments from

garden showcase a fantastic variety of

winter home, offer insight on how the

every corner of the world in a one-of-a-kind

arid plants, from towering saguaros to

masterful architect was inspired by the

collection. The Musical Instrument Museum

delicate blooms. This beautiful land-

desert surroundings. Visitors walk through

(MIM) tunes you into thousands of instrument

scape is also the backdrop for the

rooms, gardens, walkways and Wright’s

sounds with a headset that syncs seamlessly

garden’s seasonal events. During the

entertainment pavilion on the grounds while

as you move through its galleries. Take a

winter months, thousands of luminaria

learning about his organic architecture.

world tour of cultural instruments and pop

bags and twinkling lights transform the

Taliesin West was inscribed to the UNESCO

culture artists, and return for a live music

garden for Las Noches de Las Luminar-

World Heritage List on July 7, 2019, after

experience at MIM Music Theater, a year-

ias, a holiday tradition. The garden also

being submitted for nomination by the

round concert series hosting more than 200

features art installations intertwined with

National Park Service in November 2018.

international acts.

the flora each year.

HEARD MUSEUM

PHOENIX ZOO

PHOENIX ART MUSEUM The Southwest’s largest fine art museum

The tradition, culture and history of 22 regional

One of the nation’s largest nonprofit

features a collection of contemporary work and

American Indian tribes converge in the Heard

zoos is home to more than 1,400

global masterpieces. Complementing the

Museum ‘s immersive exhibits and authentic art

animals. See Sumatran tigers roam the

museum’s galleries of fine art and objects from

shop, as well as annual events like the World

savanna, feed giraffes in an up-close

Asia, America, Europe and beyond are rotating

Championship Hoop Dance Contest. Through

encounter and discover the local flora,

exhibitions. Want to see the permanent

art and cultural objects, the museum’s ongoing

fauna and critters of the Sonoran

collections for free (and the special exhibitions

exhibits tell the stories of native people of the

Desert on the zoo’s Arizona Trail.

at a discount)? Visit Wednesdays from 3 p.m. to

Southwest, from early history to powerful

9 p.m. during voluntary donation time, or the

memories of boarding schools.

second Sunday of the month from noon to 5 p.m. for Free Family Sundays.

12 TechNation | Digital Supplement

O UT DOOR ADVENTU R ES & HI KES CAMELBACK MOUNTAIN

PAPAGO PARK

SOUTH MOUNTAIN PARK AND PRESERVE

The panoramic view from the “hump” of

Just minutes from downtown is

this iconic landmark, named for its resem-

iconic Papago Park, home to red

Boasting 50 miles of trails through 16,000

blance to a kneeling camel, is worth

rock buttes looped with trails,

acres of the Sonoran Desert, this municipal

scaling its two tricky trails, Echo Canyon

scenic views from the intriguing

park is perfectly suited for outdoor

and Cholla. Hikers gain 1,200 feet in

rock formation atop Hole-in-the-

adventure just minutes from the city. The

elevation to the summit, which looks out

Rock Trail and two of the city’s top

skyline views and Sonoran Desert flora

over the city and Phoenix Mountains

attractions: Desert Botanical

aren’t the park’s only perks. Keep a

Preserve. Camelback is one of the most

Garden and Phoenix Zoo. The park

lookout for ancient petroglyphs carved into

popular urban hiking spots in Phoenix, so

is also a popular hub of recreation,

the rocks (we’ve got details in this blog

expect trail traffic and consider hiking on

including fishing in seven acres of

post on petroglyphs in Phoenix). If you’d

weekdays. During hot-weather months,

stocked lagoons, the Hall of Flame

rather drive than hike, bike or hoof it up the

hike in the early morning and drink plenty

Museum of Firefighting and scenic

trails, hop on the 5.5-mile Summit Road up

of water. See our outdoor safety tips page

Papago Golf Course , set at the

to Dobbins Lookout, the highest accessi-

for more info before you head out.

base of Papago’s buttes.

ble point in the preserve.

LOCAL DISTRICTS OLD TOWN SCOTTSDALE

ROOSEVELT ROW The creative beat of the city’s urban heart is in

Southwestern arts and hip eateries line the streets of Old Town, a

Roosevelt Row, home to galleries, mu-

popular destination for Greater Phoenix shopping and nightlife. If you’re

ral-splashed business walls and a monthly art

hunting for a souvenir, you’ll find your fill of old-fashioned flair (think

walk. This arts district is a prominent stop for

cowboy hats and turquoise jewelry) alongside upscale art galleries and

visitors and the downtown community along the

trendy boutiques in the Fifth Avenue district. The area is also a hot spot

First Friday self-guided art tour.

for after-dark dancing, lounging and libations.

MELROSE DISTRICT

HERITAGE SQUARE

This 1-mile stretch of Seventh Avenue, between Indian School and Camel-

Like the 19th-century homes nearby, a restau-

back roads, is home to some of the best antique shops, art, dining, patio

rant in downtown’s Heritage Square is making

cocktailing and dancing around. Also known as “The Curve” for its winding

history: Pizzeria Bianco (heralded as the best

nature in an otherwise grided city, and the “gayborhood,” thanks to its high

pizza in the nation) is James Beard Award

concentration of LGBTQ+ bars and rainbow flags perched outside allied

winner. The area is also home to the Arizona

businesses, this neighborhood is an absolute must for a sense of this city’s

Science Center , featuring more than 350

pride as well as its midcentury roots.

hands-on exhibits.

Digital Supplement | TechNation 13

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SCHEDULE WEDNESDAY, JUNE 12

SUNDAY, JUNE 16

1:00 PM - 5:00 PM — Exhibitor Set-up (by appointment

7:30 AM - 6:00 PM — Registration Open

only, for booths 600 sq. ft. or larger ONLY)

7:30 AM - 11:00 AM — AAMI’s Career Center 8:00 AM - 10:15 AM — Concurrent Education Tracks/Sessions

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

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

7:30 AM - 7:00 PM — Registration Open

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

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

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

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

MONDAY, JUNE 17

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

16 TechNation | Digital Supplement

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

D ON ’T MISS THESE EVENTS! W E LCO ME REC EPTI O N Friday, June 14 • 5:30–7:00 PM • Expo Hall Join us in the Expo Hall for the first look at all our exhibitors have to offer this year! This is the place to see and be seen while enjoying drinks and lite fare. Mingle and catch up with your colleagues, make new acquaintances, and be sure to visit AAMI Booth for the signature AAMI photo op! The event is open to all registered attendees.

SPONSORED BY:

H A P PY HO UR Saturday, June 15 • 4:00-5:00 PM • Expo Hall Celebrate the first full day at the AAMI eXchange! Network with exhibitors and other attendees in the Expo Hall. This event is open to all registered attendees, but Expo Only registrants will not receive drink tickets.

T HE A AMI PARTY Saturday, June 15 • 6:00-8:00 PM • The Dulce This is a can’t-miss event! Join the AAMI Community at The Duce, which is located a short walk from the convention center, to the warehouse districts most unique retro-chic venue! You will be able to enjoy music, games, food, and drinks. *Please note this event is open to these registration types: Full Conference, Exhibitor, Saturday Full Conference and those who purchased individual tickets to this event. Expo Only will need to purchase a ticket to attend.*

C LOS I NG RECEPTI O N Saturday, June 15 • 6:00-8:00 PM • Palma/Champ Pang Lanes/Ghost Donkey 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.* Digital Supplement | TechNation 17

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HTM WEEK t s e t on

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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.

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GUIDE TO AAMI

AAMI UPDATE

A

AAMI Hosts HTM Week 2024 AMI 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

GUIDE TO AAMI 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 24 TechNation | Digital Supplement

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.

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