Environment for Medical Device Development
in Japan and the USA: Current Activities &Roles of Clinical Engineers
June 5 | 10:00 AM
Thomas Judd, MS, CCE, FACCE
National Project Director, Kaiser Permanente Clinical Technology (KP CT)
IFMBE Clinical Engineering Division Secretary

Mario Castañeda, BS, MBA, CBET
President, HealthiTek, Inc.
Past President, American College of Clinical Engineering
Former KP CT Executive© 2016 Association for the Advancement of Medical Instrumentation www.aami.org

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Overview• Japan & USA Clinical Engineering Comparison• Medical Device Development Environment– USA Health Needs, Regulatory, Industry, & Innovation– Japan Health Needs, Regulatory, Industry, & Innovation• How the Environment Impacts CE Roles– USA– Japan• Conclusions
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Comparison of Japan and USA
Clinical Engineering (CE) PracticeJapan•••

Operate high technology medical
equipment such as life support
systems, with specialty-specificcertifications.

USA•

Manage a wide variety of medical
equipment through its life cycle, including
life support, imaging and laboratory.

•Conduct other HTM activities, andoversee technicians who maintainequipment.

Conduct other HTM activities, andoversee technicians who maintainequipment.
•Conduct patient safety activities,
not including device alarmsystems.

•Conduct patient safety of medicaldevices and associated systems, such asalarm management
Conduct CE-IT, device integration withelectronic medical records and other
Health IT activities.

•Not yet•• Facilitate a CE Body of Knowledge
Facilitate different certifications
certification.
related to equipment operation.
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USA Healthcare in 2016
USA: Chronic Disease Management(CDM) – medical devices needed!
• USA Centers for Disease Control: 75% of healthcare
expenses devoted to CDM, particularly for the ageing• Need for national legislation to align incentives between
providers, payers, patients

Can innovative technology help?
Precision Medicine Initiative1•

An emerging approach for disease treatment andprevention that takes into account individual variability ingenes, environment, and lifestyle for each person.

Google X Moonshots2•

A variety of approaches for CDM, cancer, andhealthcare resource management

1h#ps://www.nih.gov/precision-medicine-ini5a5ve-cohort-program

National Moonshot3: Cancer

2h#p://www.techinsider.io/20-moonshot-projects-by-google-turned-alphabet-2016-2•

3h#p://www.cancer.gov/research/key-ini5a5ves/moonshot-cancer-ini5a5ve

Marshalling national resources for early detection andbest treatment, and data sharing among experts
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USA Industry & Medical Devices
CEs managed rising complexity of devices & users• Interoperability• Between devices and the Electronic Health Record (EHR)• Wireless• Particularly for SmartPhones & mobile medical devices• mHealth• Care driven by SmartPhone use & as platform for device functions• Device Security• Medical device cybersecurity a growing concern• Human Factors• As device complexity grows, clarity for & ease of use major challenges
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USA Medical Device Regulation•FDA & HTM Issues (2016)–•

FDA & Health IT Issues (2012-present)–•

ACCE giving feedback to FDA on proposed new directive1: Refurbishing,Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicingof Medical Devices Performed by Third- Party Entities and OriginalEquipment Manufacturers

ACCE helps address FDA’s Safety & Innovation Act (FDASIA)2• A nationwide health IT (HIT) infrastructure• Risk-based framework for HIT• FDA to focus its attention/oversight on device health IT functionality

How devices are used in EMR/EHR Workflows

1https://www.regulations.gov/#!documentDetail;D=FDA-2016-N-0436-0039
2http://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FDASIA/ucm20027187.htm

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Japanese Healthcare in 2016
• Ageing population; a major MHLW (Ministry ofHealth, Labor, and Welfare) focus on caredelivery innovation to create sustainable healthcost• Moving to evidence-based medical practice, withfocus on preventive care, with improvedgovernance• Health leaders propose a move from healthcare
government regulation to professional selfregulation
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Japan’s Medical Device Industry• Market remains the 2nd largest in the world, behind only
USA– $27B USD in 2016; or 3.2T Yen– Strained government health expenditure due to a rapidly ageing
population will hinder market growth; like the USA resulting in Chronic
Disease Management– Market to grow at 3.6% in USD in 2016, a faster pace than theeconomy• World’s 3rd largest device importer, behind USA & Germany– AMDD (see Appendix) facilitates the work of 62 USA companies in Japan• Among the world’s top 10 device largest exporters– Imaging powerhouse Toshiba was acquired by Canon in March 2016

Espicom Business Intelligence report 2016: h#p://www.espicom.com/japan-medical-device-market.html

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Japan’s Medical Device Regulations•Japan’s Pharmaceutical and Medical Devices Agency (PMDA) changed in2014 via The Pharmaceutical and Medical Device Law (PMDL)1– Previously the law had greater focus on Pharmaceuticals than Devices– PMDL directed improved … Medical device industry in-country representation; Industry quality
system compliance; Third party certifications, and Regulation of medical software– EHR development lags behind the USA••

Protection of personal data is not defined in law; see recent development since 2011 in Appendix

Device Reimbursement in Japan2– All residents are mandated to have healthcare insurance under the country's universal
health insurance system. The health plan is strictly regulated by the government to keep
the monthly premium affordable, via the MHLW. Device use as part of recognized
medical practice is a component of prospective payment/reimbursement.
– A medical device recognized by the universal health insurance system means that theavailability of the device must be ensured immediately after the enlistment in the system.
Also, the law mandates that a sufficient supply of devices be available until replacement
by a successive device.
1http://www.meddeviceonline.com/doc/what-the-new-japanese-medical-device-regulations-mean-for-you-0001
2http://www.mddionline.com/blog/devicetalk/demystifying-device-reimbursement-japan-03-21-16

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USA Clinical Engineering
ACCE’s CE-HTM National and Global Focus•

Government/Advocacy: address HTM & CE-IT concerns– e.g., Regulatory (FDA) and Accreditation (The Joint Commission) HTM issues•

Patient Safety: Partner with other health leaders/stakeholders to improve•

Influence: over 800 individual leaders, 20 key hospital systems in USA, as
well as over 150 international CE leaders from 40 countries•Certification: oversee professional body of knowledge certification•Youth: 60% of ACCE membership is 40 years old and younger as wecontinue to grow and to attract younger members•

Education: Historical strong USA role; often for leading edge topics andkey professional conference venues.
– Provide monthly educational on-line training as well as at major conferences– 25 years of global HTM seminars to 80 countries
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Japan Clinical Engineering
JACE’s national / global focus• Certification: Facilitate for life support equipment• Education: Internally through annual Congress (800+ in 2016);

externally through Japan Overseas Cooperation Volunteer Program,
Japan-based Kids Programs, etc.

• Membership/Promotion: estimated 20K+ JACE members andongoing growth of profession• Advocacy: Tsunami and Earthquake response efforts• Innovation: VOLT BANK (battery charge management system);

IPDC tester, Automatic Surgery Shoe Cover quick release box,...etc.

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Tampa, FL11Conclusions• External to CE (at society & organizations level)– Gain visibility/influence• Get involved in government innovation, mHealth initiatives, andJACE advocacy activities.
• Communicate your value to health leaders– Through demonstrating impact on country health priorities• Internal to CE (at individual & departmental level)– Practice of Clinical Engineering• Recognize CE activities that contribute to priority health issues
and address health leader concerns– Quality of care, outcomes-based care
– Emerging e-Health (Health IT or CE-IT) opportunities– Continuing Education• Prepare for addressing HTM gaps
– Both individually and at the society level
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Appendix• USA Examples– Kaiser Permanente (KP) Clinical Engineering• Medical Device & Care Delivery via Health IT• KP-Industry Quality & Health IT Case Studies/Challenges– Infusion Devices– Alarm Management– Integrated Digital Operating Room

– USA Regulatory-Industry Medical Device Example• Japan Examples– AMDD in Japan: American Medical Devices andDiagnostics Manufacturers’ Association– Japan’s Healthcare Environment and EHR Status
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KP Care Delivery in All Environments

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Case Study 1: Infusion Pump Systems
Quality Challenges
••
•
•
•

Requirements Challenges

Several FDA alerts re design, SW/ •firmware, cleaning/infection
control, equipment PM, & otherissuesOver-infusion Incidents supplier•follow-up
Warranty & Post-warranty support
concerns
Add additional alarms, eg tubing •setup
Artifact interference in certain
clinical settings

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Wireless challenges for CQI
downloads and SW change
management ; took 2 years to redesign and correct wireless card
Eventually hit limit and needed toexceed 2500 programmable drugs
for all use cases
Security protocols for all device
use cases

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KP Case Study 2: Alarm Management
Systems (AMS)AAMI 2016 Conference & Expo

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Case Study 2: Alarm Management
Systems (AMS)
Quality Challenges•••

Scalable solutions not fully developed so
initially server overloads & intermittent
system shutdowns; supplier purchased
smaller company but had not fully
assessed current product and its thencurrent capabilities

Requirements Challenges•

A secondary alarm notification tool;
not optimized for primary notification•

KP conducted end-to-end testingand invested significantly to build up
IT infrastructure to support
enterprise-wide approach

Reduction of monitoring techs byCustomer before Alarm response protocols •worked out became a patient safety issue
Different subsystems gaining significant
national scrutiny as The Joint Commission
National Patient Safety Goal emerged
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More readily monitor and adjust
individual device AMS
configurations

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KP Case Study 3: Integrated OR Systems

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Case Study 3: Integrated OR Systems
Quality Challenges

Requirements Challenges

Device interoperability•ensuring image quality whenusing different DOR and Rigid
Endoscopy suppliers

Different image capture /management strategies for different
surgical sub-specialties•Storage and retrieval ofsurgical images withappropriate privacy andsecurity compliance•

Sending images to mHealthplatforms, eg, SmartPhones, Tablets
while meeting needed privacy andsecurity•Reliability, reprocessing, and •durability of surgical video•Endoscopy

Wireless image transfer and fidelity•AAMI 2016 Conference & Expo

Ongoing testing of image quality
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USA Medical Device Quality Example→

Baxter Recall 2010

• Numerous design flaws• USA Food & Drug Administration-FDA
Total Product Life Cycle

FDA 7 opportunities, 2011
1.
2.
3.
4.
5.
6.
7.

Design & reliability
Monitoring & feedback
Supplier management
Quality metrics & systems
Quality organization
Performance management
Quality culture→

Industry response 2013

•Challengesa) quality costsb) problem preventionc) low-quality supplier performance•Transformationa) reduce quality-related costs while
increasing capacityb) reorganization of the quality functionc) Introduce proactive quality, system fortracking, dialogues around key
indicators, and root-cause problem
solving•Resultsa) Reduction in cost of Q by 35%b) improved profit by 2.5% revenues

Pew Charitable Trust to FDA, 2014•.

•New approach to device developmenta) ensure timely pre-market studiesb) robust post-market surveillance infrastructurec) unique device identifier (UDI) capture in EHRsd) and use of clinical registries
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Japan’s AMDD: American Medical Devices
and Diagnostics Manufacturers’ AssociationPurpose• AMDD represents1: 62 companies that provide medical devices and in-vitro
diagnostics (IVD) and other advanced medical technology in Japan.
•AMDD addresses2: Device Lag (leading edge products getting to Japan later); Device Gap (products notyet introduced because of price restrictions) & the Japan Reimbursement rule-FAP3 (not consistent withmarket reality); see next slideGoals
1. Implement appropriate evaluation of innovation to limit medical costs––

For better value to the patient, andpolicy recommendations

2.

Activities to accelerate the Pharmaceuticals and Medical Devices Act (PMDA)
with the global medical device industry

3.

Promotion of Japan medical device industry in the USA

4.

Partnership with the USA Advanced Medical Technology Association (AdvaMed)
1https://amdd.jp/en/

2AMDD Comparison of market environment for medical devices in Japan, China, and Korea, 20113http://www.mddionline.com/blog/devicetalk/demystifying-device-reimbursement-japan-03-21-16

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Japan’s Healthcare Environment
OECD 20151•

One of Japan’s foremost policy challenges is to create an economically-active ageing society.

•Japan needs to shift to a more structured health system, separating out more clearly different health carefunctions (primary care, acute care and long-term care, for example) to ensure that peoples’ needs can be
met by the most appropriate service, in a coordinated manner if needed.

•As this differentiation occurs, the infrastructure to monitor and improve the quality of care must
simultaneously deepen and become embedded at every level of governance –institutionally, regionally andnationally.

EHR/EMRs Japan•Despite a number of initiatives over the past decade, EHR networks have developed only as experiments inselected areas. Interoperability between providers has not been generally established.2–•Example: University hospitals (2014)3––•

In 2013, almost all hospitals used electronic billing, compared with 85.6 percent of medical clinics, 47.2 percent of dental clinics, and 94.8 percentof pharmacies. The government has made electronic billing obligatory in the public health insurance system for all providers except those without
the necessary staffing and instruments. Protection of personal data is not defined in law

Bioinformatics studies are started for genome cohort and EMR data combination analysis.
Kyoto university BIC (Biobank & Informatics for Cancer) projectJapanese government3–––

1http://www.oecd-ilibrary.org/social-issues-migration-health/oecd-reviews-of-health-care-quality-japan-2015_9789264225817-en

The 2011 earthquake changed the atmosphere; “Japanese-NIH” under preparation“Next generation medical ICT” working group tends to connect “pencil building” services with fully support of fund, legalforce, and authority establishment of personal information management.
Principle of national healthcare insurance shifts the coverage from acute care hospital to home care
2Commonwealth 2014: http://www.commonwealthfund.org/~/media/files/publications/fund-report/2015/jan/1802_mossialos_intl_profiles_2014_v7.pdf
3ISPOR 2014, Naoto Kume, PhD, Kyoto Prefecture

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