Development Environment for Medical Devices
in Japan and the US: Impact on Current
Ac/vi/es and the Roles of Clinical Engineering
Sunday, June 11, 8:00 a.m. - 9:00 a.m.
Mario Castañeda, MBA, CBET
President, HealthITek, USA

Thomas Judd, MS, CCE, FACCE, FHIMSSIFMBE CE Division Secretary, USA© 2017 Association for the Advancement of Medical Instrumentation www.aami.org

ObjecOves• Review the pracOce of clinical engineering
profession in the US• Medical device market global overview and roles ofClinical Engineers in manufacturing and associatedtechnologies• OpportuniOes for clinical engineers in the current
innovaOve and fast-developing technology• Closing Comments© 2017 Association for the Advancement of Medical Instrumentation www.aami.org

US Clinical Engineers•

Profession by the .tle of Clinical Engineer (CE)– Coined in mid 1960s by Cesar Caceres, MD, later AAMI Board member•

American College of Clinical Engineering began in 1990
– "A Clinical Engineer is a professional who supports and advances pa8ent careby applying engineering managerial skills to healthcare technology." - ACCE
DeﬁniOon, 1992, see hVp://accenet.org/•Educa.on– Typically has at least a baccalaureate (4-year) degree in engineering orengineering technology from an accredited college or university– Of ACCE Individual members*, 60% have masters or doctoral degrees•

Cer.ﬁca.on & Licensing– CE CerOﬁcaOon desirable a]er 3 years of experience; 31%* have CCE– Licensing as a professional engineer (PE) not required© 2017 Association for the Advancement of Medical Instrumentation www.aami.org

US Clinical EngineersNumber*• USA CEs est. 20,000• ACCE members ~800

Work Place**••••

Hospitals 70%
Consultant 15%Industry10%
Academia 5%*Sources: PayScale.com, Bureau of Labor StaOsOcs, and CNNMoney research, 2012**ACCE Body of Knowledge (BOK) 2015 Survey re Health Technology (HT) DeﬁniOons & PracOces© 2017 Association for the Advancement of Medical Instrumentation www.aami.org

US CEs: Ac8vi8es & Knowledge Base
Categories of CE WorkCE Knowledge Category% Time

1.HTM

30

1.Regulatory Standards/Codes

2.Service Delivery Management20

2.Physiological Monitoring

3.General Management

15

3.General Med./Nursing Equipment

4.Risk Management / Safety

10

4.Surgical Equipment

5.CE-IT (InformaOon Technology)

8

5.Medical Device IntegraOon (CE-IT)

6. EducaOon of Others

7

6.Anesthesia

7. FaciliOes Management

6

8. TesOng, EvaluaOon, ModiﬁcaOon

4

7.PresentaOon Skills
8.Respiratory Therapy
9.Computers, Networking, InformaOon Tech. (CE-IT)
10.Medical Imaging

Source: ACCE Body of Knowledge (BOK) 2015 Survey© 2017 Association for the Advancement of Medical Instrumentation www.aami.org

Global Overview: Medical Device Market 2017
• US -- Companies are trying to ﬁgure out what will replace
the soon-to-be-dismantled Aﬀordable Care Act and what
this means for their long term sales prospects in theworld’s largest healthcare market (world market $398B(Visiongain, London) )• Europe -- The introducOon of strenuous new medical
device regulaOons and ongoing currency exchange
diﬀerenOal has some smaller American device companies
pulling out of the market• Brazil -- StagnaOng economy conOnues to take some shineoﬀ what used to be the brightest market in the western
hemisphere• China -- RegulaOons seem to appear out of nowhere withimmediate eﬀect, leaving many scratching their heads
about how to comply with the Chinese FDA (CFDA)© 2017 Association for the Advancement of Medical Instrumentation www.aami.org

EsOmated Growth inMedical Device Market© 2017 Association for the Advancement of Medical Instrumentation www.aami.org

Clinical Engineers’ Roles• Health Care Delivery• Health Care AdministraOon• Academia• Health Care Commerce• Health Care Manufacturing – Medical Devices• Health Care innovaOon –Start ups© 2017 Association for the Advancement of Medical Instrumentation www.aami.org

US Clinical Engineers in Diﬀerent Roles
Jenniﬀer Jackson

Carla Gallegos

Director of Clinical Engineering& Device IntegraOon at CedarsSinai Medical Center,Los Angeles, CAVice President of Healthcare
SoluOons Sales, at Enlighted Inc.
Advanced Technologies,
InnovaOon, and TransformaOon,
San Francisco Bay Area

Payman Roshan

James Welch

Senior Vice President at Kaiser
FoundaOon Hospital/Health Plan
Kaiser Permanente
Panorama City, California

ExecuOve Vice President
Product Development, Quality
Systems and Regulatory Aﬀairs
at Sotera Wireless, Inc.
Orange County, California Area

Frank R. PainterTracy Rausch

Healthcare Technology Consultant
and UCONN Professor
University of ConnecOcut - ClinicalEngineering Program
University at Buﬀalo,
Greater New York City Area

Founder, CEO of DocBox Inc.
InnovaOve plarorm that
integrates medical device andHealth IT,Greater Boston Area

© 2017 Association for the Advancement of Medical Instrumentation www.aami.org

Journal of Medical Devices - ASME

© 2017 Association for the Advancement of Medical Instrumentation www.aami.org

Role of Clinical Engineers inManufacturing• Point of care consultants and advisors –Individual, Focus Groups, Survey ParOcipants.
• Value added point of care – build upon
deployed technology. IntegraOon, formal
evaluaOon/assessment, purchasing process• Part of medical device life cycle teams –Design, producOon, market, productimprovement.
• Entrepreneurs, Innovators, Company
founders / owners© 2017 Association for the Advancement of Medical Instrumentation www.aami.org

Biggest Challenges for Medical Device
Manufacturers 2017

© 2017 Association for the Advancement of Medical Instrumentation www.aami.org

TradiOonal Role of ClinicalEngineering
Sustaining InnovaOon• Technology acquisiOon and installaOon• End user educaOon• Technical support• Life cycle management

DisrupOve InnovaOon• Same sustaining elements of support• New clinical applicaOon support• Performance feedback to developers© 2017 Association for the Advancement of Medical Instrumentation www.aami.org

US CE Case Study 1: Infusion Pump Systems
Emerging Role for assis.ng Disrup.ve
Innova.on CE-IT related devices

Delivery System CE Roles:
Design Challenges• Several FDA alerts re design, so]wareSW/ﬁrmware, cleaning/infecOon control,
equipment PM, &and other issues• Over-infusion Incidents supplier follow-up CE-IT Requirements Challenges• Warranty & Post-warranty support• Wireless challenges for CQI downloads andconcerns
SWchange management ; took 2 years to redesign and correct wireless card
• Add addiOonal alarms, eg ,tubing setup• Eventually hit limit and need to exceed• ArOfact interference in certain clinical2500 programmable drugs for all use cases
sesngs• Security protocols for all device use cases© 2017 Association for the Advancement of Medical Instrumentation www.aami.org

US CE Case Study 2:

Alarm Management Systems (AMS)
More Disrup.ve Innova.on

Delivery System CE Roles:
Design Challenges• Scalable soluOons not fully developed so
iniOally server overloads & intermiVent system
shutdowns; supplier purchased smaller
CE-IT Requirements Challenges
company but had not fully assessed current• A secondary alarm noOﬁcaOon tool; notproduct and capabiliOes
opOmized for primary noOﬁcaOon• ReducOon of monitoring techs by Customer
before Alarm response protocols worked out • KP has conducted end-to-end tesOng andinvested signiﬁcantly to build up IT
became a paOent safety issue
infrastructure to support enterprise-wide• Diﬀerent subsystems gaining signiﬁcantapproachnaOonal scruOny as The Joint Commission(hospital accreditaOon) naOonal paOent safety • More readily monitor and adjust
individual device AMS conﬁguraOons
goal emerged© 2017 Association for the Advancement of Medical Instrumentation www.aami.org

US CE Case Study 3:

Digital (Integrated) OR Systems (DOR)
Delivery System CE Role:
Design Challenges

More Disrup.ve Innova.on• Device interoperability ensuring image quality
when using diﬀerent DOR and Rigid Endoscopy
suppliers• Storage and retrieval of surgical images withappropriate privacy and security compliance• Reliability, reprocessing, and durabilityof surgical video Endoscopy

CE-IT Requirements Challenges• Diﬀerent image capture / management
strategies for diﬀerent surgical sub-specialOes• Sending images to mHealth plarorms SmartPhones, Tablets - while sOll meeOng
needed privacy and security• Wireless image transfer and ﬁdelity• Ongoing tesOng of image quality© 2017 Association for the Advancement of Medical Instrumentation www.aami.org

US CE Case Study 4: Tracy Rausch, CCE• Early CE-IT leader in her delivery system– Started own small company 10 years ago• Now has implemented a very innovaOve device
for intensive care …

– Being used in India integraOng clinical and CE-HTM
informaOon in a world-class fashion; presented atWHO’s recent Forum, approved in USA by FDA as well
– This system is changing how clinical pracOce and CEHTM combine together to improve quality &eﬃciency– Tracy is speaking in the 2nd hour for JSMI-JACE thismorning.
© 2017 Association for the Advancement of Medical Instrumentation www.aami.org

What is InnovaOon…?
Product Performance

serudnehghi
userlow end

TimeThe Innovator’s Dilemma. Clayton Christensen. HBRPress 1997

© 2017 Association for the Advancement of Medical Instrumentation www.aami.org

InnovaOon

The innovators dilemma

Sustaining InnovaOon• Adds new capabiliOes to exisOng users• Driven by most demanding customers• Dominated by exisOng market leaders

DisrupOve InnovaOon• Provides soluOons for new users• Developed by new entrepreneurial companies• Adds capability over Ome• Creates new business ecosystem© 2017 Association for the Advancement of Medical Instrumentation www.aami.org

DisrupOve Technology IntroducOon
Challenges
Disrup/ve technologies address the needs of new users(non-consumers)• TradiOonal device in-service (how to use) may not besuﬃcient• Are new user policies or pracOces required?
• What new risks are introduced into the system(unintended consequences)?
• What role does the clinical/biomedical engineer play?

© 2017 Association for the Advancement of Medical Instrumentation www.aami.org

Ultrasound Imaging
Product Performanceserudnehghiuser
low endTime© 2017 Association for the Advancement of Medical Instrumentation www.aami.org

OpportuniOes for Clinical Engineers inManufacturing• SpecializaOon In Regulatory aﬀairs• Professional AssociaOon parOcipaOon• Embrace innovaOon as part of Body of PracOce• ParOcipate in incubators for innovaOvetechnology and new product development• Embrace “leading from where you pracOce”© 2017 Association for the Advancement of Medical Instrumentation www.aami.org

Remaining part of the Future• InnovaOon in healthcare is unavoidable. If we are notprepared we may ﬁnd ourselves obsolete.
• IT enterprise with medical devices is a fact
• Ubiquitous wireless connecOvity rapidly becoming reality• New standards will follow innovaOon, not lead it.
• The creaOve destrucOon of the current healthcare model will
be replaced by the merging of wellness devices with medicaldevices.
• CEs can embrace the creaOon, producOon, and applicaOon of
the medical devices of the future.
© 2017 Association for the Advancement of Medical Instrumentation www.aami.org