689

Knowledge Area: Healthcare Systems

Engineering

Healthcare Systems Engineering

This article provides an overview of the role of systems engineering in the engineering or re-engineering of
healthcare systems to meet a number of modern day challenges. The role of SE in medical devices, healthcare IT,
pharmaceuticals, and public health systems are considered and contrasted to "traditional" SE practices discussed
elsewhere in the SEBoK. See Overview of the Healthcare Sector for details of the stakeholders and constraints of the
these different parts of the sector.

Topics
Each part of the SEBoK is divided into knowledge areas (KAs), which are groupings of information with a related
theme. The KAs in turn are divided into topics. This KA contains the following topics:
• Overview of the Healthcare Sector
• Systems Engineering in Healthcare Delivery
• Systems Biology
• Lean in Healthcare

Healthcare and Systems Engineering

Healthcare today faces many challenges related to safety (e.g. Hospital Safety Score 2013, Andel et al. 2012,
Institute of Medicine 1999), affordability, access, and the means for reliably producing positive outcomes for all
patients of all ages and across all care environments.  Furthermore, the health of individuals is challenged by many
threats such as environmental and behavioral norms, emerging natural infectious diseases, and acute and chronic
conditions that are becoming more prevalent because of longer lifespans.  Re-engineering today’s healthcare to
address these challenges requires a systems approach – an approach that develops solutions to contend with the
complexity of healthcare-related policy, economics, social dynamics, and technology.  Systems Engineers are trained
to grapple with this kind of complexity by thinking holistically and to work with trans-disciplinary teams to develop
solutions making re-engineering healthcare a natural fit for systems engineers and the tools of systems engineering.
The disciplines involved in re-engineering healthcare are far reaching across academia, government, industry,
private, and public sectors including the patients and families the healthcare field serves. Systems Engineers
involved in this re-engineering draw on several tools when working with these stakeholders to develop solutions. In
doing so they follow the general systems principles described in the Systems Approach Applied to Engineered
Systems knowledge area in SEBoK Part 2. First, with so many diverse stakeholders involved in this field, it is vitally
important for the Systems Engineer to help clarify the problem or opportunity and to conceive of the objective of the
re-engineering. They need to “envision the solution” without being entirely prescriptive of the solution’s specific
implementation, see Identifying and Understanding Problems and Opportunities.  Then, drawing from best practices,
the Systems Engineer guides the stakeholders through the synthesis of possible solutions and the analysis and
selection between alternatives. Systems engineers are also involved in the implementation and testing and the
deployment, use and sustainment of healthcare systems to provide stakeholder value. The systems approach in
healthcare must be particularly mindful to not exclusively focused on technical aspects of the effort since the
solutions to healthcare’s challenges exist not only in technical areas but the integration of culture, workflow and
Healthcare Systems Engineering 690

processes, with technology as a tool to support the delivery of safe, affordable, and accessible care.
To achieve this system approach healthcare projects follow a version of the SE life cycle described in SEBoK Part 3.
This included the creation of Stakeholder and System Requirements, Systems Architecture and Design and System
Integration, Verification and Validation. The SE life cycle extends to include System Deployment, Operation,
Maintenance and Logistics. Healthcare project will also follow some of the Systems Engineering Management
processes described in Part 3.
It is vitally important for the healthcare systems engineer to ensure socio-technical integration and interoperability
among system components are part of any project – the last thing healthcare needs is another standalone innovation
that perpetuates the silos that exist in the field today.  Remaining focused on the objective and problem to solve,
managing scope creep, disciplined design, implementation, and project management are key activities the Systems
Engineer is responsible for in healthcare systems engineering.

Systems Engineering for Medical Device Development

Systems Engineering for medical device development is essentially an application of Product Systems Engineering
as described in SEBoK Part 4 with a few customizations:
• The life cycle has to comply with specific healthcare regulations, which constrain aspects of the life cycle, as
exemplified by FDA regulations in the US (21CFR 820.30)
• The products are market driven, with little customization allowed by the manufacturer at the customer site
• The markets are midsized, with the market for a given technology or product line often being in the $1-10B range
• Medical device development programs are mid-sized…many from 10-100 man-years of development, lasting 1-2
years
• Time to market is critical, with the first mover or first with a complete solution capturing the majority of the
profits
• Most products are cyber-physical, with software becoming a larger part of the product.  Many products include
significant aspects of physiology or chemistry
• There is a special tension between “efficacy” and “safety”. Efficacy requires the vast majority to be helped. Safety
is compromised if only a very small minority is adversely affected. Truly safe systems require a special approach
to systems engineering . (Leveson 2011)
• Customer feedback may be constrained by safety issues as well as HIPAA regulations

Device Development in a Market Environment

One critical difference between many “traditional” systems engineering industries (defense and aerospace) and
healthcare device development is that most healthcare device development is market driven, rather than contract
driven.  Some key differences between market and contract systems engineering:
• The program size (budget) and dates are not ‘fixed’, they are set by the business leadership designed to maximize
return on investment across a portfolio of product programs
• Program scope and requirements are not fixed externally; they can be changed fairly rapidly by negotiation
between functions and the executive committee.
• The goal for the product development isn’t necessarily a feature set, it is a market share and price premium
relative to the competition…which can be a moving target.  A competitive announcement will often force a
change in the program scope
• In a contract based program there is an identified customer, with a set of applications and workflows. In a market
driven program the workflow and use cases are defined by the developer, and the buyer needs to ‘own’ the
integration of the offering into their specific systems and workflows.
• For specific medical products the FDA can require pre-market trials and post market studies . (FDA 2014)
Healthcare Systems Engineering 691

• The different types of healthcare reimbursement across the world (universal coverage private insurance, national
single provider, national single payer, private insurance, and out of pocket) creates dramatically different market
dynamics (for individuals, healthcare providers, and product developers) . (Reid 2010)

Regulations for Medical Device Development

As with all regulated products, there are many regulations governing the development of medical devices.  The
medical device industry specific regulations are primarily driven by the US (FDA), Europe (European Commission),
and Canada (Health Canada).  Within the US, the FDA governs medical devices primarily through 21 CFR 820.30
(Quality Systems Regulation, Subpart C Design Controls) , which contains requirements similar to ISO 13485. The
sections of the Quality Systems Regulation for Design Controls can be mapped fairly directly to ISO/IEC/IEEE
15288 (2015) and the INCOSE SE Handbook (INCOSE 2015).
Table 1. Comparison of Healthcare Safety Regulations with ISO/IEC/IEEE 15288 and the INCOSE SE Handbook.

21CFR820.30 ISO/IEC/IEEE 15288:2015 INCOSE SE Handbook

(b) Design and 6.3.1 Project Planning Process 5.1 Project Planning Process
development planning

(c) Design input. 6.4.2 Stakeholder needs and requirements definition process 4.2 Stakeholder needs and requirements definition process
6.4.3 Systems requirements definition process 4.3 Systems requirements definition process

(d) Design output 6.4.5 Design definition process 6.4.7 Implementation 4.5 Design definition process 4.7 Implementation process
process

(e) Design review 6.3.2 Project Assessment and Control process 5.2 Project Assessment and Control process

(f) Design verification 6.4.9 Verification Process 4.9 Verification Process

(g) Design validation 6.4.11 Validation Process 4.11 Validation Process

(h) Design transfer 6.4.10 Transition Process 4.10 Transition Process

(i) Design changes 6.3.5 Configuration Management Process 6.4.13 5.5 Configuration Management Process 4.13 Maintenance
Maintenance Process Process

(j) Design history file 6.2.6 Knowledge Management Process 5.6 Information Management Process

In the biomedical and healthcare environment, an important differentiator in Risk Management activities compared
to other industries (see Risk Management) is that the users and patients are the center of risk analysis rather than
technical or business risks. Risk management is an important element of the design control process, as preliminary
hazard analysis drive initial design inputs. Traceability between identified risks, risk mitigations, design inputs, and
design outputs is a key factor in product clearance through regulatory agencies. Most regulatory bodies have
recognized ISO 14971: Medical devices -- Application of risk management to medical devices as a methodology for
assessing and documenting product safety and effectiveness.
Usability Engineering is an important subset of risk management activities.  ISO 62366-1 Medical devices – Part 1:
Application of usability engineering to medical devices provides a “process for a manufacturer to analyze, specify,
develop and evaluate the usability of a medical device as it relates to safety. This usability engineering  (human
factors engineering) process permits the manufacturer to assess and mitigate risks associated with correct use and use
errors, i.e., normal use.“ . (IEC 62366-2015)  For example, for a device designed for home care use, there are many
complex interfaces that product designers must consider. Patients may be physically or cognitively affected (age,
medication, injury, etc.); they may be untrained or cared for people who are untrained; they are not professionals
used to technical systems, etc. Even in the hospital setting, untrained patients may have physical access to systems.
This puts a critical focus on usability and human factors considerations and the complexity of the use environment.
Further, as medical devices incorporate more software and become cyber-physical devices, the regulators are also
focusing on privacy and security (ISO 21827) and software life cycle management (ISO 62304).
Healthcare Systems Engineering 692

Figure 1 Overlap of Regulations and Standards for Medical Device Development. (Modified from (Malins et al. 2015). Used with
Permission. All other rights are reserved by the copyright owner.)

Medical Device regulations, guidance, and technical standards are constantly changing, adding a complex dynamic
to manage and incorporate throughout the product development life cycle.

Systems Engineering for Healthcare IT

Systems Engineering for Healthcare Information Technology is very similar to other IT developments, with the
addition of medical regulations.  Healthcare Information Technology is critical to efficient flow of information and
delivery of services . (Presidents Council of Advisors on Science and Technology 2010) The product development is
a mix of contract driven development (with a target customer, such as healthcare.gov), and market driven (where
there are more standard products, with minimal customization).  Much of the market, especially for hospitals and
hospital chains, is a mix of standard products with large amounts of customization to the customer’s specific needs,
terminology, and workflows.

Systems Engineering for Pharmaceuticals

The pharmaceutical industry leverages systems that include hardware, software and sometimes single-use
components in different part of their value chain, for example complex analytical systems during drug discovery,
complex bioreactors and downstream filtration and chromatography systems in manufacturing and drug delivery
devices for the use of their drugs. These systems are subject to very different regulations, e.g. GMP or medical
devices, depending on the use. One challenging aspect of these systems is that the users have different skill sets and
 working under different environments. And in all of the examples below, biological and/or chemical processes run
on these systems, requiring deep domain knowledge of the system development teams.
Healthcare Systems Engineering 693

The in-vitro diagnostic industry also uses many systems, small devices (e.g. self-testing blood glucose or coagulation
monitoring systems) all the way to large, fully automated, high throughput systems for the use in centralized
laboratories. Very often, these systems operate as a closed system, so that the reagents used for the diagnostics tests,
are proprietary and the vendor of the system only guarantees high quality results only when using the proprietary
chemistry. This enables the vendors to often ‘place’ the instruments as highly competitive prices when the actual
profit is generated through the consumables.
For the chemistry part of pharma, understanding the scientific method, using a systems thinking approach, and using
six sigma approaches to managing variation and interdependencies is critical.  Once you create a product which
includes software and physical parts (including manufacturing equipment), systems engineering of the functional
design, design analysis, and integration and verification of the solution become critical.

Systems Challenges for Public Health

Summits and inquiries into problems or shortcomings in the public health space have consistently uncovered the
same issues: systemic failures in the way that public health is approached that make it nearly impossible to
adequately respond to major health events. Examples can be seen from the US response to Hurricane Katrina (e.g.
The White House 2006), the 2011 Thoku tsunami (e.g. Carafano 2011, The Heritage Foundation 2012), or even the
2014-2015 Ebola outbreak in West Africa (e.g. GHTC 2015).
The White House report provides insights into just a few of potential challenges for the health aspects of disasters or
large-scale emergencies (2006, Chapter 6):
• Tens of thousands of people may require medical care.
• Large portions of a population with chronic medical conditions may themselves without access to their usual
medications and sources of medical care.
• Hospitals and other healthcare facilities may be totally destroyed or otherwise rendered inoperable and the area’s
health care infrastructure may sustain extraordinary damage.
The types of public health challenges will also change over time: Immediate challenges include the identification,
triage and treatment of acutely sick and injured patients; the management of chronic medical conditions in large
numbers of evacuees with special health care needs; the assessment, communication and mitigation of public health
risk; and the provision of assistance to State and local health officials to quickly reestablish health care delivery
systems and public health infrastructures. (The White House 2006) As time passes, longer-term infectious disease
outbreaks may occur or environmental impacts may cause health risks (e.g. Fukushima nuclear meltdown after the
2010 tsunami). And over time, the public health and overall healthcare infrastructure must be re-established and
repaired.
But the public health “system” in most countries, as currently structured, is not prepared to deal with these types of
challenges. In talking about the US, Salinsky and Gursky state, “Despite recent attention to the biodefense role of
public health, policymakers have not developed a clear, realistic vision for the structure and functionality of the
governmental public health system. Lack of leadership and organizational disconnects across levels of government
have prevented strategic alignment of resources and undermined momentum for meaningful change. A transformed
public health system is needed to address the demands of emergency preparedness and health protection. … The
future public health system cannot afford to be dictated by outmoded tools, unworkable structures, and outdated
staffing models.” (2006)
The framing of the challenge as a systems one requires the application of a systems approach, and the use of tools
capable of supporting systems views, to enable better understanding of the challenges for public health and for
creating ways to address these challenges. The SEBoK knowledge areas on Enterprise Systems Engineering and
Systems of Systems (SoS) at least partially consider some of these challenges from a systems engineering
perspective.
Healthcare Systems Engineering 694

Systems Biology for Healthcare

As systems science is a foundation for system engineering, systems biology is becoming recognized as a
foundational discipline for healthcare systems engineering. Systems biology is an emerging discipline and is
recognized as strategically important when tackling complex healthcare problems. The development of systems
biology is also an emerging environment for systems engineers.
According to Harvard University, “Systems biology is the study of systems of biological components, which may be
molecules, cells, organisms or entire species. Living systems are dynamic and complex and their behavior may be
hard to predict from the properties of individual parts. To study them, we use quantitative measurements of the
behavior of groups of interacting components, systematic measurement technologies such as genomics,
bioinformatics and proteomics, and mathematical and computational models to describe and predict dynamical
behavior. Systems problems are emerging as central to all areas of biology and medicine.” (Harvard University 2010)
As systems biology matures, its integration into healthcare approaches is expected to lead to advanced practices such
as personalized and connected healthcare and the resolution of complex diseases.

Conclusion
While systems engineering practices apply to the healthcare domain, they face different challenges than other
industries and need to be tailored.  In fact, different segments of the healthcare industry can take significantly
different approaches to effective systems engineering and systems thinking.

References

Works Cited
21 CFR 820.30. “Part 820 – Quality System Regulation: Subpart C – Design Controls.” Title 21 – Food and Drugs:
Chapter I – Food and Drug Administration, Department of Health and Human Services: Subchapter H – Medical
Devices. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=820.30
Andel, C., S.L. Davidow, M. Hollander, D.A. Moreno. 2012. “The economics of health care quality and medical
errors.” Journal of Health Care Finance. 39(1):39:50. Abstract available at: http:/ / www. ncbi. nlm. nih. gov/
pubmed/ 23155743 200,000 Americans die from preventable medical errors including facility-acquired conditions
and millions may experience errors. In 2008, medical errors cost the United States $19.5 billion.
Carafono, J.J. 2011. The Great Eastern Japan Earthquake: Assessing Disaster Response and Lessons for the U.S.
Washington, DC: The Heritage Foundation. Special Report #94 for Japan. May 25, 2011.
FDA. 2014. “Premarket Approval (PMA)”. Washington, DC: U.S. Food and Drug Administration (FDA). Accessed
February 17, 2016. Available at: http:/ / www. fda. gov/ Medicaldevices/ Deviceregulationandguidance/
Howtomarketyourdevice/Premarketsubmissions/Premarketapprovalpma/Default.Htm
GHTC. 2015. “Will We Learn from the Lessons of the Ebola Outbreak?” 2015 Policy Report. Washington, DC:
Global Health Technologies Coalition (GHTC).
Gursky, E. 2005. Epidemic Proportions: Building National Public Health Capabilities to Meeting National Security
Threats. Arlington, VA: Analytic Services Inc. (ANSER).
Harvard University. 2010. “Department of Systems Biology.” Cambridge, MA: Harvard University. Accessed
February 17, 2016. Available at: https://sysbio.med.harvard.edu/ 
Hospital Safety Score. 2013. “Hospital Errors are the Third Leading Cause of Death in U.S., and New Hospital
Safety Scores Show Improvements are Too Slow.” Washington, DC: The LeapFrog Group. Accessed February 17,
2016. Available at: http:/ / www. hospitalsafetyscore. org/ newsroom/ display/
hospitalerrors-thirdleading-causeofdeathinus-improvementstooslow
Healthcare Systems Engineering 695

IEC. 2015. Medical devices – Part 1: Application of usability engineering to medical devices. Geneva, Switzerland:
International Electrotechnical Commissions. IEC 62366-1:2015. Available at: http:/ / www. iso. org/ iso/
catalogue_detail.htm?csnumber=63179
INCOSE. 2015. “Section 8.2.2.” Systems Engineering Handbook: A Guide for System Life Cycle Processes and
Activities, version 4.0. Hoboken, NJ, USA: John Wiley and Sons, Inc, ISBN: 978-1-118-99940-0
Institute of Medicine. 1999. To Err is Human: Building a Safe Health System. Washington, DC: The National
Academy Press, The National Academy of Sciences. Novermber 1999. Available at: https:/ / iom.
nationalacademies. org/ ~/ media/ Files/ Report%20Files/ 1999/ To-Err-is-Human/
To%20Err%20is%20Human%201999%20%20report%20brief.pdf
ISO/IEC/IEEE. 2015. Systems and Software Engineering -- System Life Cycle Processes. Geneva, Switzerland:
International Organisation for Standardisation / International Electrotechnical Commissions / Institute of Electrical
and Electronics Engineers. ISO/IEC/IEEE 15288:2015.
Leveson, N.G. 2011. Engineering a Safer World: Systems Thinking Applied to Safety. Cambridge, MA:
Massachusetts Institute of Technology (MIT).
Presidential Council of Advisors on Science and Technology. 2010. Report to the President: Realizing the Full
Potential of Health Information Technology to Improve Healthcare for Americans: The Path Forward. Washington,
DC: Presidential Council of Advisors on Science and Technology, The White House. December 2010. Available at:
https://www.whitehouse.gov/sites/default/files/microsites/ostp/pcast-health-it-report.pdf.
Reid, T.R. 2010. The Healing of America: A Global Quest for Better, Cheaper, and Fairer Health Care. New York,
NY: Penguin Books.
Salinsky, E. and E. Gursky. 2006. “The Case for Transforming Governmental Public Health.” Health Affairs. 25(4).
1017-2018. Available at: http://content.healthaffairs.org/content/25/4/1017.full
The Heritage Foundation. 2012. One Year Later: Lessons from Recover After the Great Eastern Japan Earthquake.
Washington, DC: The Heritage Foundation. Special Report #108 on Asia and the Pacific. April 26, 2012.
The White House. 2006. The Federal Response to Hurricane Katrina Lessons Learned. Washington, DC: The White
House. February 2006. Available at http://library.stmarytx.edu/acadlib/edocs/katrinawh.pdf

Primary References
None.

Additional References
None.

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SEBoK v. 2.2, released 15 May 2020
Overview of the Healthcare Sector 696

Overview of the Healthcare Sector

Lead Author: Chris Unger, Contributing Author: Cyrus Hillsman

This article describes some of the stakeholders of the healthcare sector and the factors which influence the
application of systems engineering within it. For an overview of healthcare systems engineering and how it deals
with these influences see the Healthcare Systems Engineering article.
The healthcare sector is a complex system made up of people, facilities, laws and regulations. It addresses current
health, tries to ensure wellness, treats medical problems; creates new medication and medical devices; manages the
health both individuals and populations; and helps determine regulations for safety, privacy, the environment, and
healthcare delivery itself.

Stakeholders
There are many types of stakeholders in the healthcare sector. The space covers everyone from the general public –
who have a stake in their own health and the health of those around them for issues like infectious disease – to the
individual researchers who investigate current healthcare problems. The high-level groups of stakeholders include:
• The general public;
• Healthcare providers (such as doctors, nurses, clinics, and hospitals);
• Payers (such as insurance companies);
• Public health organizations;
• Researchers, scientists, and corporations in the pharmaceutical industry;
• Medical device manufacturers;
• Policy makers (particularly those with interest in public health, healthcare safety or privacy policies);
• Healthcare information technology technicians and organizations; and
• Professional organizations and societies relevant to the various aspects of the space.
The healthcare sector is an enormous area financially as well. For example, out of $2.87 trillion on healthcare spent
in the US in 2010, the breakdown of components is:

US Healthcare Expenditures in 2010 (information from Emmanual 2014)

Hospital Care $921B

Physician Services $555B

Prescription Drugs $280B

Nursing Home Care $151B

Other Medical Products $113B

Dental Services $93B

Government Public Health $84B

Other Professional Services $79B

Home Health Care $77B

Research $48B

The sections below provide insight into the landscape for these the stakeholder groups where there is sufficient
information currently available. More detail will be added as the healthcare aspects of the SEBoK mature and the
team will take particular care to incorporate additional information from outside the US going forward.
Overview of the Healthcare Sector 697

Healthcare Delivery
The largest share of the money spent on healthcare in the US healthcare is in hospitals (almost a third). The number
of hospitals has been relatively flat for the last 20 years. However, due to the growing cost pressures and increasing
paperwork, there has been a general consolidation of hospitals into chains, and independent physician providers into
hospitals or group practices. (Emmanuel 2014)

Overall Hospital Landscape (information from (AHA 2014))

Total Number of All U.S. Registered * Hospitals 5,627

Total Number of U.S. Community ** Hospitals 4,926

Total Number of Nongovernment Not-for-Profit Community Hospitals 2,870

Total Number of Investor-Owned (For-Profit) Community Hospitals 1,053

Total Number of State and Local Government Community Hospitals 1,003

Total Number of Federal Government Hospitals 213

Total Number of Nonfederal Psychiatric Hospitals 403

Hospitals range from small community hospitals to the New York-Presbyterian Hospital/Weill Cornell Medical
Center with 2,259 beds (Becker 201)], or the University of Pittsburgh Medical Center Presbyterian with $12B in
revenue in 2013. (Becker 2013).
Hospital chains tend to be less than 10 hospitals, with less than 10 chains having more than 10 hospitals (Becker
2015). The largest two have almost 200 hospitals (Community Health Systems with 188 and Hospital Corporation of
America with 166). The largest systems by revenue are Kaiser Permanente and the Veterans Health Administration
with revenue or budget of slightly over $50B each.

Medical Devices Manufacturers

The medical device development landscape is diverse, composed of many markets of intermediate size (many being
above $10B in size, with high single digit to double digit growth rates). Some examples are, with projected market
sizes in 2020, are:

Types of Medical Devices and Projected Market Share (Emmanuel 2014)

Medical Device Type Projected Market Share

In-vitro diagnostics (IVD) $75B

Endoscopy $33B

Interventional Cardiology $27B

Infection control $17B

Minimally invasive surgery $14B

Defibrillators $13B

Dental Implants $10B

Infusion pump $ 7B

Magnetic Resonance $ 7B

Digital Xray $ 5B
Overview of the Healthcare Sector 698

As described in Healthcare Systems Engineering, this is the area of the healthcare sector that is most closely aligned
with classic product-focused businesses.

Healthcare IT
There is a large uncertainty in what constitutes Healthcare IT. The most visible segment is the Electronic Medical
Record (EMR) or Electronic Health Record (EHR), but there is also large markets in billing management, clinical
decision support, image management, etc. But there is a divergence of market sizes with estimates around $60B
[Bain, FierceIT] and some around $104B [Markets and Markets, MedGadget, and PRNewswire].
An EHR installation at a hospital is similar to an Oracle database installation at a company, where much of the cost
is customizing the database and workflows to the institution’s policies and workflows, and in training the users to the
new system and standardized practices which come with IT and automation.

The top 10 Healthcare IT solution providers in 2015 (information from (Healthcare

Informatic 2015))
Company 2015 Revenue

Optum $5.2B

Cerner Corp. $3.4B

McKesson $3.1B

Dell $2.9B

Cognizant $2.7B

Philips $2.7B

Xerox $2.4B

Siemens $2.0B

Epic Systems Corp. $1.8B

GE Healthcare $1.5B

Public Health Systems

The World Health Organization (WHO) defines public health as “all organized measures … to prevent disease,
promote health, and prolong life among the population as a whole. Its activities aim to provide conditions in which
people can be healthy and focus on entire populations, not on individual patients or diseases. Thus, public health is
concerned with the total system and not only the eradication of a particular disease.” (WHO 2016) Governments at
each level define exactly what “public health” will encompass, but typically there are three areas: epidemiology,
provision of health services, and workplace and environmental safety and policy. Epidemiology is the study and
control health-related events, including disease. Various methods can be used to carry out epidemiological
investigations: surveillance and descriptive studies can be used to study distribution; analytical studies are used to
study determinants.” (WHO 2016, “Health topics: Epidemiology”). Health services may include services such as
preventive vaccinations, disease screening, or well-baby or well-child programs. Environmental safety can include
developing policies for automobile or workplace safety, monitoring the quality of drinking water, or even conducting
restaurant health inspections. In addition to these wide varieties of work, public health organizations are increasingly
expected to be responsible for the health-related aspects of disaster and emergency response efforts.
In the US, the public health “system” is really a patchwork of independent healthcare departments. Each state or
territory defines the scope and responsibilities of its own public health “department”, requiring information and
cooperation from hospitals, private physicians, emergency personnel, laboratory networks, and sometimes public
Overview of the Healthcare Sector 699

health organizations from other states. (Gursky 2005)

Conclusion
In addition to each group of stakeholders being complex in itself, these stakeholders then interact and work together -
or sometimes contradict one another. This makes the landscape of the healthcare systems engineering space itself
complex and highlights the need for systems thinking and systems approaches when attempting to address any
health-related issues or challenges.

References

Works Cited
AHA. 2014. "Fast Facts on US Hospitals." Chicago, IL: American Hospital Association (AHA). September 2014.
Available at: http://www.aha.org/research/rc/stat-studies/fast-facts.shtml
Becker's Healthcare. 2015. "10 largest for-profit hospital systems | 2015". Becker's Hospital Review. June 30, 2015.
Available at: http://www.beckershospitalreview.com/lists/10-largest-for-profit-hospital-systems-2015.html
Becker's Healthcare. 2014. "100 Largest Hospitals in the US". Becker's Hospital Review. August 7, 2014. Available
at: http://www.beckershospitalreview.com/lists/8-7-14-100-largest-hospitals-in-america.html
Becker's Healthcare. 2013. "100 Top-Grossing Hospitals in the US". Becker's Hospital Review. June 24, 2013.
Available at: http://www.beckershospitalreview.com/lists/100-top-grossing-hospitals-in-america-2013.html
Eliades, G., M. Retterath, N. Hueltenschmidt, and K. Singh. 2012. Healthcare 2020. Amsterdam, The Netherlands:
Bain & Company. Available at: http://www.bain.com/Images/BAIN_BRIEF_Healthcare_2020.pdf.
Emmanuel, E.J. 2014 Reinventing American Health Care: How the Affordable Care Act will Improve our Terribly
Complex, Blatantly Unjust, Outrageously Expensive, Grossly Inefficient, Error Prone System. New York City, NY:
PublicAffairs.
Gold, A. 2014. "Global healthcare IT market projected to hit $66 billion by 2020." FierceHealthIT. April 1, 2014.
Available at; http:/ / www. fiercehealthit. com/ story/ global-healthcare-it-market-projected-hit-66-billion-2020/
2014-04-01.
Gursky, E. 2005. Epidemic Proportions: Building National Public Health Capabilities to Meeting National Security
Threats. Arlington, VA: Analytic Services Inc. (ANSER). Healthcare Informatics. 2015."2015 HCI 100." Available
at: http://www.healthcare-informatics.com/hci100/2015-hci-100-list
Markets and Markets. 2015. North American Healthcare IT Market by Product (EHR, RIS, PACS, VNA, CPOE,
mHealth, Telehealth, Healthcare analytics, Supply Chain Management, Revenue Cycle Management, CRM, Claims
Management) by End User (Provider, Payer) - Forecast to 2020. October 2015. Available at: http:/ / www.
marketsandmarkets.com/Market-Reports/north-america-healthcare-it-market-1190.html
MedGadget. 2015. "Global Healthcare IT Market 2020 - Industry Survey, Market Size, Competitive Trends: Radiant
Insights, Inc". November 2, 2015. Available at: http:/ / www. medgadget. com/ 2015/ 11/
global-healthcare-it-market-2020-industry-survey-market-size-competitive-trends-radiant-insights-inc.html
PRNewswire. 2015. "Healthcare IT Market Size to Reach $104.5 Billion by 2020: Grand View Research, Inc."
October 15, 2015. Available at: http:/ / www. prnewswire. com/ news-releases/
healthcare-it-market-size-to-reach-1045-billion-by-2020-grand-view-research-inc-533012831.html
WHO. 2016. "Health Topics: Epidemiology." Geneva, Switzerland: World Health Organization. Available at: http:/ /
www.who.int/topics/epidemiology/en/
WHO. 2016. "Trade, foreign policy, diplomacy, and health: Public Health." Geneva, Switzerland: World Health
Organization. Available at: http://www.who.int/trade/glossary/story076/en/
Overview of the Healthcare Sector 700

Primary References
None.

Additional References
None.

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SEBoK v. 2.2, released 15 May 2020

Systems Engineering in Healthcare Delivery

Lead Author: Cyrus Hillsman, Contributing Authors: Chris Unger, Nicole Hutchison

The healthcare system is complex and adaptive and confronts significant challenges for which systems engineering
tools are useful and necessary.  The President’s Council of Advisors on Science and Technology (PCAST) prepared
a report concluding that healthcare improvement could be accelerated with the use of systems engineering. (PCAST
2014) They noted that they key incentives are wrong (fee for service vs. fee for outcomes), and key enablers are
missing (access to useful data, lack accepted systems techniques and people trained in systems engineering)
This article provides an overview of healthcare delivery with some historical context, and describes some different
approaches to systems engineering which have been found helpful in addressing healthcare delivery problems.

Human Centered Design

Healthcare delivery is not a product but a service and that makes it different than typical hardware or software design
that may be seen in aerospace, defense, or even medical devices. There are three primary factors for these
differences. First, quality in services can be difficult to measure objectively. Second, in this service system, care
providers are continually making risk, cost, and quality of care decisions at the time of service. Each patient is
unique and multiple pathologies and value streams are possible based upon any given patient’s needs. Those needs
are complemented by a care team that is unique and complex and includes the patients themselves, family support,
medical professionals, hospitals, and even the industry in which it resides. Third, if returning to or maintaining
wellness is considered to be the core value for a healthcare delivery system, then the patient’s behaviors both within
and outside any designed care plan has a significant role to play, because roughly half of all healthcare cost is
derived from preventable disease. (Conover 2012)

Structure of the Healthcare Delivery Industry

The healthcare industry is large, diverse, and fragmented and this causes considerable complexity. This complexity
is experienced both at the macro and micro levels.
At the macro level the healthcare industry is highly fragmented with over 50% of all healthcare workers employed in
companies with less than 500 employees. (Griffith & White 2007) Nearly 1 million physicians practice medicine in
the US; roughly half of these are in primary care and the rest are in over 30 specialties and many more subspecialties
and clinics. In addition to physicians, some 5 million others in some 50 other specialties provide care to patients.
At the micro level, the complexity and pace of change make care difficult. Healthcare is a rapidly developing field
with over 700,000 publications produced annually and the pace in fact is increasing. (Smith et al. 2013). That there
are already 14,400 codes in the World Health Organization's International Statistical Classification of Diseases and
Related Health Problems (ICD) complicates the issue. Add to this the regulatory and administrative burden of
Systems Engineering in Healthcare Delivery 701

primary care providers interacting with approximately 200 specialists in any given year and the complexity that care
providers face on a daily basis becomes clear.
In short, the healthcare delivery system is itself a complex adaptive system and represents a wicked_problem_,
whereby any changes to the system intended to solve an issue will likely create other issues.

Improving Ongoing Operations

As mentioned, above caregivers are faced with many challenges and the goal of in systems engineering in healthcare
delivery is to lessen that burden in a systematic way without significant disruption of current operations. To do this
successfully requires several factors:
• First, as stated above, systems engineers have to acknowledge that they are dealing with a complex adaptive
system that includes many wicked problems. An analogy is that what systems engineers experience in healthcare
is like rewiring a house with the power turned on because whatever changes are made are to an existing system
that must operate while the changes are being made.
• Second, “the system” in place is difficult to define. The "healthcare system" is actually a combination of many
open systems and interdependencies with the system of interest may be unknown.
• Third, patient safety is always a concern and any actions that could affect patient safety must be very carefully
considered. Often, "optimizing" a system may introduce a potential risk to patient safety. These system aspects
are always in tension.
• Fourth, there is a bias towards the current (known) system versus a change leading to an unknown system. Any
change will create a certain amount of disruption to an operational system that may be currently operating at or
beyond capacity.
• Fifth, healthcare delivery systems are combinations of patients, providers, process, and products and therefore
uncertainty is a daily reality. This level of uncertainty may not be amenable to typical agile approaches of 4-6
week sprints nor traditional waterfall methods.
• Sixth, local factors could play a significant role; therefore no two sites may perform an operation in exactly the
same way.
• Seventh, the entire industry acts as a complex adaptive system with multiple intelligent agents working sometimes
in partnership and sometimes in conflict with the goals of the system or patient.
Because of these factors and others the tradition of healthcare systems engineering has been to use adaptable
human-centered methods. (Checkland 1999)

History of Healthcare Improvement Research

There have been many attempts to understand and improve healthcare both in the public and private domains.
Examples include the National Healthcare Service Change Model, the efforts of the Agency for Healthcare Research
and Quality, and the Institute for Healthcare Improvement. Here we outline some representative efforts.
Healthcare improvement has been shaped in part by four seminal works by the Institute of Medicine (IOM). To Err
is Human reported that up to 98,000 patients were killed by healthcare each year. (Kohn, Corrigan, & Donaldson
2000) This put an emphasis on safety as a key quality of care metric. The following year the Institute of Medicine
(IOM) broadened the concept of quality beyond safety to include six measures of quality. They determined that
healthcare should be safe, effective, patient centered, timely, efficient, and equitable. (Institute of Medicine 2001)
This report called Crossing the Quality Chasm included an appendix that documented poor quality and the severity
of the issues of under use, over use, and potential for harm in medicine. A search for the underlying reasons for poor
quality led to three primary reasons for poor quality. The three reasons were the growing complexity of science and
technology; the increase in chronic conditions; and the failure to exploit information technology.
Systems Engineering in Healthcare Delivery 702

To address these concerns the IOM partnered with the National Academy of Engineering (NAE) to see what could
be done from a systems engineering perspective to address the real challenges facing the industry in Building a
Better Delivery System. (Compton et al. 2005). That was followed by the realization that standard systems
engineering needed to be modified and healthcare was and would remain a human centered endeavor as stated in
Best Care at Lower Cost (Smith et al. 2013)

Three Approaches
Although there are many accepted approaches to healthcare systems engineering and improvement, here we outline
three that share common characteristics and are representative of most of the other methods.
The first approach is Lean Six Sigma which is a combination of two methods. Lean has its roots in the Toyota
Production System (Ohno 1988) and the work of the International Motor Vehicle Program (Womack, Jones, & Roos
1990). Six-Sigma has its roots at Motorola and the work of Bill Smith. These two methods were combined by
Michael L. George (see (George 2002) and (George 2003)). It includes techniques like value stream mapping, waste
elimination, root cause analysis, and voice of customer. For additional information see Lean Engineering and Lean in
Healthcare.
The second approach is based on industrial engineering, which has its roots in the work of Frederick Taylor and
others. This approach includes tools such as discrete event simulation, ergonomics, production control, and
operations research as shown in Figure 1. For additional information, see Systems Engineering and Industrial
Engineering.
Insert Table ES-1 from Building a Better Delivery System here once we obtain the proper permissions.
The third approach is healthcare systems engineering. Traditional systems engineering uses a functional
decomposition approach; see for example (Defense Systems Management College 2001). However, healthcare
problems are often classified as wicked and complex and not amenable to traditional decomposition methods found
in other areas of engineering. (Rouse & Serban 2014).
There are many tailored approaches to improving healthcare delivery, but almost all are based on one of these three
approaches, or a combination of these.

Healthcare Systems Engineering

The basic systems engineering steps are similar to those for any industry specific applications, but the steps are
tailored for healthcare. The traditional waterfall model of requirements, design, implementation, verification, and
maintenance is interrupted in favor of almost continuous support. In many cases the closeout and transfer of the
project to operational staff is more challenging in healthcare than in many industries.
Below is outlined a general methodology used by the US Department of Veteran's Affairs (VA) that may suit a wide
variety of situations and programs, composed of 4 pillars: Define the Problem, Investigate Alternatives, Develop the
Solution, and Launch and Assess the Solution. These 4 pillars are similar to classic mistake avoidance, development
fundamentals, risk management, and schedule oriented approaches. (McConnell 1996); they are also similar to the
Plan/Do/Check/Act methodology.

Define the Problem

As mentioned above, the patient is augmented by a care team consisting of family, friends, clinical staff, and many
other support staff the patient will not directly encounter. This care team may not be familiar with the rigors of
traditional engineering design. Because of this, a systems engineer may use a paired partnership model where
engineers are embedded with clinical and administrative staff, family, and the patients themselves. In this concept,
everyone is a designer and our goal is to provide them with the tools to contribute to the system design process. Even
at this early stage, configuration management would be considered. Depending on the size of the rollout one alpha
Systems Engineering in Healthcare Delivery 703

site and several beta sites may be used at any phase to avoid local optimal solutions that don’t work globally.

Investigate Alternatives
During the proof-of-concept phase, visualizing the result is important for the reasons mentioned above. Therefore,
one or more initial prototypes may be developed with the alpha site. The goal is to get to a minimally viable product
as soon as possible to demonstrate the viability of the product or methodology. After the initial conversations and
meetings, participants have a need to have a common understanding of how the system will work. The systems
engineer would embrace the concept of operations with rich pictures, model based systems engineering, story
boards, customer journey maps and other tools so that we all have a common understanding of the proposed system.

Develop the Solution

Using what has been learned from the minimally viable product feedback and incorporate that into the future state
optimization, one would continue developing the prototype at the initial paired partner alpha site and then the trusted
beta demonstration sites. In our case, stakeholders are a part of the development team and not an ancillary function.
For this reason, demonstration is considered a key element of the communication plan when developing the solution.

Launch the Solution and Access the Performance

During evaluation and deployment phase, a systems engineer would have considered the future state optimization
with corresponding alpha and beta sites. Live implementation would then be used for further testing and evaluation.
At any phase feedback is encouraged and reflected in the next iteration of the solution. As mentioned previously
abandonment and closeout even during the live phase may not be practical and in fact could be disadvantageous
because not all possible needed configurations or situations would have been encountered.

Example Systems Engineering Tools

Below is a list of systems engineering tools which could be used at each of the four steps.
1. Define the Problem
1. Establish the scope and context of the problem (define boundary conditions)
2. Stakeholder identification and management
3. Lifecycle mapping
4. Value Stream Process Mapping
5. SWOT analysis (Operational Deficiencies and Technological Opportunities)
6. Workflow/Usability/Use Case analysis
7. Observation Research
8. Root Cause Analysis (Fishbone diagrams, 5 whys, …)
2. Investigate Alternatives
1. Requirements management
2. SE Evaluation Methods (Decision Trees, Quality Function Deployment (QFD))
3. Trade-off Analysis
4. Model-Based Systems Engineering (MBSE)
5. Technical Risk Management
3. Develop the Solution
1. Concept Development
2. Architecting the solution (functional analysis, subsystem decomposition, interface definition and control,
modeling)
3. Define the implementation
Systems Engineering in Healthcare Delivery 704

4. Process Redesign Techniques (including Lean Six Sigma)

5. Active Integration
6. Agile / Lean Development Principles (iterative development)
4. Launch and Assess the Solution
1. Managing Change in Organizations
2. Stakeholder Management, Change Management Techniques
3. Spiral, Agile, and Lean Startup Delivery Practices (Minimal Viable Product delivery)
4. Business Risk Management
5. Metrics and benchmarking
During all phases, elements of cognitive & organizational psychology, industrial engineering, usability engineering,
systems engineering, and other facets may be critical to implement a solution. Humans are the major part of the
system and even the system of systems approach in healthcare.

Conclusion
Systems Engineering for Healthcare delivery shares many aspects with traditional SE, but differs significantly since
healthcare delivery is a service (not a product) and due to the domain specific challenges. In particular, problem
definition is a particularly ‘wicked’ problem, and measuring successful outcomes in a clear and objective fashion is
challenging.

References

Works Cited
Checkland, P. 1999. Systems Thinking, Systems Practice. Hoboken NJ: John Wiley.
Compton, W.D., G. Fanjiang, J.H. Grossman, & P.P. Reid. 2005. Building a better delivery system: a new
engineering/health care partnership. Washington DC: National Academies Press.
Conover, C.J. 2012. American health economy illustrated. Washington DC: American Enterprise Institute.
Defense Systems Management College. 2001. Systems engineering fundamentals: Supplementary text. Fort Belvoir,
VA: The Press.
George, M.L. 2002. Lean Six Sigma. New York, NY: McGraw-Hill.
George, M.L. 2003. Lean Six Sigma for Service. New York, NY: McGraw-Hill.
Griffith, J.R., & K.R. White. 2007. The Well-Managed Healthcare Organization. Chicago, IL: Health
Administration Press.
Institute of Medicine. 2001. Crossing the quality chasm: A new health system for the 21st century. Washington DC:
National Academy Press.
Kohn, L.T., J. Corrigan, & M.S. Donaldson. 2000. To err is human: Building a safer health system. Washington DC:
National Academy Press.
McConnell, S. 1996. Rapid Development. Redmond, WA: Microsoft Press.
Ohno, T. 1988. Toyota Production System. Portland OR: Productivity Press.
PCAST. 2014. Better Health Care and Lower Costs: Accelerating Improvement through Systems Engineering.
Washington DC.: President’s Council of Advisors on Science and Technology (PCAST).
Rouse, W.B., & N. Serban. 2014. Understanding and managing the complexity of healthcare. Cambridge, MA: The
MIT Press.
Systems Engineering in Healthcare Delivery 705

Smith, M.D., R.S. Saunders, L. Stuckhardt, & J.M. McGinnis. 2013. Best care at lower cost: The path to
continuously learning health care in America. Washington DC: National Academies Press.
Womack, J.P., D.T. Jones, and D. Roos.1990. The machine that changed the world. New York, NY: Harper Collins.

Primary References
PCAST. 2014. Better Health Care and Lower Costs: Accelerating Improvement through Systems Engineering.
Washington DC.: President’s Council of Advisors on Science and Technology (PCAST).

Additional References
None.

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SEBoK v. 2.2, released 15 May 2020

Systems Biology
Lead Authors: Bridgette Daniel Allegro, Gary Smith, Contributing Authors: Chris Unger, Nicole Hutchison

Systems biology is the computational and mathematical modelling of complex biological systems. Systems biology
is a biology-based inter-disciplinary field of study that focuses on complex interactions within biological systems,
using a holistic approach to biological research. From year 2000 onwards, the concept has been used in the
biosciences in a variety of contexts. For example, the Human Genome Project is an example of applied systems
thinking in biology which has led to new, collaborative ways of working on problems in the biological field of
genetics. One of the outreaching aims of systems biology is to model and discover emergent properties of cells,
tissues and organisms functioning as a system whose theoretical description is only possible using techniques which
fall under the remit of systems biology. These typically involve metabolic networks or cell signalling networks.
(Wikipedia Contributors 2016)

Systems Biology: A Vision for Engineering and Medicine

Organisms and Hosts Interact in Communities of Life

There is an increasing appreciation that microbes are an essential part of the ecologically-important traits of their
host. Organisms do not live in isolation, but have evolved, and continue to evolve, in the context of complex
communities and specific environmental conditions. Evolutionary biologists are increasingly able to integrate
information across many organisms, from multiple levels of organization and about entire systems to gain a new
integrated understanding that incorporates more and more of the complexity that characterizes interdependent
species associations. Only when we begin to understand the molecular base for adaptation and interactions of
communities of life, can we start to comprehend how ecosystems are functioning.

Addressing Different Levels of Organization of Organisms

Understanding the function of complex biological systems is one of the greatest challenges facing science. The
rewards of success will range from better medicines to new engineering materials. The sequencing of the human
genome, although of fundamental importance, does not even provide a complete parts list of the protein molecules
that exist in a biological organism because of complexities of downstream processing and complex folding required
to make a functioning receptor or enzyme from a long chain of amino acids. Furthermore, protein molecules do not
Systems Biology 706

function alone but exist in complex assemblies and pathways that form the building blocks of organelles, cells,
tissues, organs, organ systems and organisms, including man. The functioning of brain or muscle, liver or kidney, let
alone a whole person, is much greater than the sum of its parts.
Figure 1 - Levels of Structural Organization of the Human Body (source - https:/ / cnx. org/ contents/
Xh_25wmA@7/Structural-Organization-of-the#fig-ch01_02_01)'''

Internalizing the Complexity – Pushes the Boundary of Systems Thinking Capability

To tackle this problem (understanding biological systems) requires an iterative application of biomedical knowledge
and experiment with mathematical, computational and engineering techniques to build and test complex
mathematical models. Systems and control engineering concepts, a modular approach and vastly increased
computing capacity are of critical importance. The models, once developed and validated, can be used to study a
vastly greater range of situations and interventions than would be possible by applying classical reductionist
experimental methods that usually involve changes in a small number of variables. This new approach is now termed
"Systems Biology". It allows insight into the large amount of data from molecular biology and genomic research,
integrated with an understanding of physiology, to model the complex function of cells, organs and whole
organisms, bringing with it the potential to improve our knowledge of health and disease. Systems Biology will
inevitably become an approach that pervades scientific research, in much the same way that molecular biology has
come to underpin the biological sciences. It will transform the vast quantities of biological information currently
available into applications for engineering and medicine.

Natural Patterns and Engineered Patterns Can Be a Source of Inspiration - in Both

Directions
Biological organisms are much more complicated than any machine designed by man. However, there are
similarities between the way in which organs and whole organisms are assembled from molecules and cells and the
design methods used by engineers in the construction of complex systems. The application of such methods to
biology will, however, require novel engineering tools to be developed since biological systems possess key features
that artificial ones do not. Specifically, biological systems have an exceptional capacity for self-organization and
assembly, using rules and mechanisms that have been shaped by natural selection. Biological systems also have
significant capacity for continuing self-maintenance through turnover and renewal of component parts. Perhaps the
property that distinguishes biological systems most is their ability to auto-adapt their organization to changing
circumstances through altered gene expression, or more directly, through signal transduction and modification of
proteins. This adaptation culminates at higher levels of organization as evidenced by phenomena such as the
development of resistance to antibiotic therapy or tolerance to recreational drugs. The mechanisms by which
component parts interact are often highly stochastic in nature; that is, susceptible to the play of chance, which
becomes particularly important when only a few components are being considered. Nevertheless, biological systems
are robust.

Advancements in Methods for Predicting “What If” in the Behavior of Complex Adaptive
Systems
Advances in engineering design and techniques carry a significant potential in driving the progress of Systems
Biology. Interventions to biological systems intended to improve health, whether environmental, pharmacological or
clinical, need to be carefully thought through and carried out to maximize benefit and reduce harm. The refinement
of techniques and tools enables devices and systems to achieve a defined performance within precise tolerance
limits, potentially allowing better interventions to complex biological systems. They will be increasingly necessary
to permit more reliable system-wide predictions of the effects of biomedical advances and to achieve desired clinical
results to a predefined tolerance, or at least to have a quantitative bound on the biological uncertainty.
Systems Biology 707

Transdisciplinary Approaches are Needed to Address the Complex Bio-system Problems

Research in the field of Systems Biology requires close interactions and collaborations between many disciplines
that have traditionally operated separately such as medicine, biology, engineering, computer science, chemistry,
physics and mathematics. Systems Biology demands a focus on the problem as a whole and therefore a combination
of skills, knowledge and expertise that embraces multiple disciplines. The success of leaders in the field of Systems
Biology will depend strongly on the extent to which they accomplish the creation of the environment that researchers
need to develop an understanding of different working cultures, and manage also to implement strategies that
integrate these cultures into shared working practices.

Systems Biology: Relevance to Healthcare

Complex Diseases Demand Systemic Approaches

Over the past few decades, pharmaceutical R&D has focused on creating potent drugs directed at single targets. This
approach was very successful in the past when biomedical knowledge as well as cures and treatments could focus on
relatively simple causality. Nowadays, the medical conditions that affect a significant proportion of the population in
industrialized countries are more complex, not least because of their multifactorial nature. The sequencing of the
human genome has led to a considerable increase in the number of potential targets that can be considered in drug
discovery and promises to shed light on the etiology of such conditions. Yet, the knowledge of the physiological
properties and the role that these targets play in disease development is still limited.

Diminishing Returns in the Single Target Approach to Disease

In terms of drug targets, there is a case that much of ‘the low hanging fruit’ was picked in the period between the late
1940s and the mid-1980s. The decline in output of new molecular entities and medicines recorded over the last 20
years, despite the steadily growing R&D expenditure and significant increase in sales, bears testimony to the fact that
advances with new targets are more difficult and that R&D projects have become much more prone to failure. A
basic problem is that the many factors that predispose to, and cause, complex diseases are poorly understood let
alone the way in which they interact. The very fact that there are multiple drivers for these conditions suggests that a
reductionist approach focusing on individual entities in isolation is no longer appropriate and may even be
misleading. It is therefore necessary to consider ‘novel’ drugs designed to act upon multiple targets in the context of
the functional networks that underlie the development of complex diseases. Many of the new developments are
likely to turn into effective medicines when combinations of drugs are used to exert a moderate effect at each of
several points in a biological control system. Indeed, many common diseases such as hypertension and diabetes are
already treated with a combination of two or three medicines hitting different targets in the control network that
underlies the condition. Investigating the possible combinations by trial and error in man is onerous but feasible with
two components. However, it quickly becomes extremely complicated with three components and well-nigh
impossible with four or more. Systems Biology, promises to assist in the development of more specific compounds
and in the identification of optimal drug targets on the basis of their importance as key ‘nodes’ within an overall
network, rather than on the basis of their properties as isolated components.

Individualized Medicine, Tuned to the Individual and Their Circumstances

Increasingly powerful drugs will be aimed at a decreasing percentage of people and eventually at single individuals.
Modelling can be used to integrate in vivo information across species. Coupled with in vitro and in silico data, it can
predict pharmacokinetic and pharmacodynamics behavior in humans and potentially link chemical structure and
physicochemical properties of the compound with drug behavior in vivo. Large-scale integrated models of disease,
such as diabetes and obesity, are being developed for the simulation of the clinical effects resulting from
manipulations of one or more drug targets. These models will facilitate the selection of the most appropriate targets
Systems Biology 708

and help in planning clinical trials. Coupling this approach with pertinent genomic information holds the promise of
identifying patients likely to benefit most from or to be harmed by, a particular therapy as well as helping in the
stratification of patients in clinical trials. Symptoms that diagnose a disease do not necessarily equate to a common
cause.
Systems Biology is arguably the only research approach that has the potential to disentangle the multiple factors that
contribute to the pathogenesis of many common diseases. For example, hypertension, diabetes, obesity and
rheumatoid arthritis are known to be polygenetic in origin although individual genes may not have been identified.
Ultimately, the prevention of these conditions rests upon a comprehensive approach that engages with each of the
more important predisposing factors, genetic and environmental, that operate upon individuals. A systems approach
is already proving valuable in the study of complex scientific subjects and the research aimed at the prevention and
management of medical conditions. Illustrative examples are neuroscience, cancer, ageing and infectious diseases.

A Healthcare Paradigm Reinforcing the Causes of Health and Not Just the Treatment of
Disease
Notwithstanding the hugely important role that Systems Biology plays in understanding disease and designing drugs
that treat them, the greatest opportunities may lie in health maintenance and disease prevention. Even modest
measures that could retard the effect of ageing on brain, heart, bones, joints and skin would have a large impact on
the quality of life and future healthcare demands of older people and consequently on the provision of health
services. Young people are vulnerable too. Multifactorial diseases such as diabetes, obesity, allergies and
autoimmune conditions are becoming prevalent in younger people and unless effective measures are taken to prevent
an early and significant decline in their health, healthcare demand will increase exponentially. It is apparent that
multiple and diverse factors interact in determining health, quality of life and ageing. These include genetic makeup,
microbiota, diet, physical activity, stress, smoke and alcohol, therapeutic and social drugs, housing, pollution,
education, and only a systems approach will permit the understanding of how best to prevent and delay health
decline.

References

Works Cited
Wikipedia contributors. "Systems biology." Wikipedia, The Free Encyclopedia. Wikipedia, The Free Encyclopedia,
20 Aug. 2016. Web. 12 Sep. 2016.

Primary References
None.

Additional References
Bosch, T.C.G. and M.J. Mc-Fall-Ngai. 2011. "Metaorganizsms as the new frontier." Zoology. 114(4): 185-190.
September 2011. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3992624/
Dollery, C. and R. Kitney. 2007. Systems Biology: a vision for engineering and medicine. London: The Academy of
Medical Sciences and The Royal Academy of Engineering. Available at https:/ / www. acmedsci. ac. uk/ viewFile/
publicationDownloads/1176712812.pdf
Endy, D. 2005. "Foundations for engineering biology." Nature. 438(7067): 449-453. 24 November 2005. Available
at: http://www.nature.com/nature/journal/v438/n7067/abs/nature04342.html
Harvard Medical School. 2010. "Department of Systems Biology." Cambridge, MA: Harvard Medical School,
Harvard University. Available at: https://sysbio.med.harvard.edu/
Systems Biology 709

Kitano, H. 2002. "Systems Biology: A Brief Overview." Science. 295(5560): 1662-1664. 01 March 2002. Available
at: http://science.sciencemag.org/content/295/5560/1662.
Sauser, B., J. Boardman, and D. Verma. 2010. "Toward a Biology of Systems of Systems." IEEE Transactions on
Systems, Man, and Cybernetics, Part A: Systems and Humans. 40(4): 803 - 814. Available at: http:/ / ieeexplore.
ieee.org/document/5467221/
Wikipedia contributors. "Systems biology." Wikipedia, The Free Encyclopedia. Wikipedia, The Free Encyclopedia,
20 Aug. 2016. Web. 12 Sep. 2016.

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SEBoK v. 2.2, released 15 May 2020

Lean in Healthcare
Lead Author: Bohdan Oppenheim, Contributing Authors: Chris Unger, Nicole Hutchison

Lean Thinking, or Lean for short, originated in Toyota factories in the 1960s, was “transplanted” to the U.S. in 1992
with the publication of Womack and Jones' Lean Thinking: Banish Waste and Create Wealth in Your Corporation
(2003), and evolved globally to practically all work domains: healthcare, engineering and systems engineering,
science, administration, supply chain, government, banking, aviation, and many others (Oppenheim 2011). Lean has
proven itself as the most effective methodology for improving operations identifying and eliminating waste from
work processes. (E.g. Womack and Jones 2003; Oppenheim 2011; Graban 2012; Toussaint and Gerard 2010; and
Oehmen 2012) Since 2003, Lean has established itself in healthcare operations.

Overview of Lean in Healthcare

Entire medical organizations (e.g., Theda Care, WI; Jefferson Healthcare, WA; Virginia Mason, WA; Geisinger
Health (now called ProvenCare), PA; St. Elizabeth, Tilburg, The Netherlands, and numerous others (e.g. Graban
2012; Toussaint and Gerard 2010)) have been transformed with Lean. These sources contain rich data on specific
improvements. Most leading healthcare institutions now have Lean centers of excellence or use Lean consultants,
including Kaiser Permanente, Mayo Clinic, UCLA, Veterans Administration, and others. Lean has proven itself in
reducing turnaround time of clinical tests, the time spent by patients in emergency departments, operating suites,
pharmacies and clinics. Lean improvements in healthcare on the order of 30-50% are routine because traditional
healthcare operations are burdened with this much waste, which remains “unseen” by the employees unless they are
trained in Lean. Lean is now an established paradigm for improving healthcare delivery operations: increasing
quality of healthcare, delivering care faster, shortening patient time in the system, increasing the time of medical
professionals with the patient, reducing bureaucracy, increasing capacity of operations, and reducing healthcare costs
and frustrations. (Graban 2012; Toussaint and Gerard 2010)
Lean does not mean that people have to work faster or "attach roller blades to move around faster". In Lean, systems
employees work at their regular ergonomic and intellectual speeds. The time savings come from finding and
eliminating idle states (e.g., waiting in numerous queues in the emergency departments), reduction of mistakes and
rework, elimination of non-value adding tasks, and more streamlined movements of patients, staff, equipment, and
supplies. And, most emphatically, Lean does not mean “mean layoffs”. Quite the opposite is true: Lean improves
human relations at work and changes the culture from the traditional "blaming and shaming" to teamwork and
cooperation focused on the good of the patient. (Graban 2012 (in particular see the endorsements from eight medical
professionals on pages ii and iii) and (Toussaint and Gerard 2010)
Lean in Healthcare 710

With the endorsement of Lean for Systems Engineering with Lean Enablers for Systems Engineering in the Wiley
Series, (Oppenheim 2011) the International Council on Systems Engineering (INCOSE) has effectively adopted
Lean as one of its essential competencies. This book was followed with a major joint Project Management Institute
(PMI)-INCOSE-MIT publication of (Oehmen 2012) integrating Lean with Systems Engineering and Program
Management. Indeed, when applied with Systems Engineering and Systems Thinking, Lean becomes a powerful
weapon in bending the healthcare cost curve and improving the quality of care.
Three concepts are critical to the understanding of Lean: value, waste, and the process of creating value without
waste, which has been captured into the so-called Six Lean Principles, as follows.
• Value: M. Porter (2010) suggested that patients value three levels of care: (1) survival and the degree of recovery;
(2) the time required to get back to normal activities, and (3) the sustainability (individual and social cost) of
treatments.
• Waste: Table 1 lists the eight categories of waste used in healthcare. (Graban 2012; Toussaint 2010)

Table 1. Eight Waste Categories Used in Lean Helathcare (SEBoK Original).

Waste Type Healthcare Examples

1. Waiting Patients wait in numerous queues in clinics, test facilities, ERs, pharmacies, and for insurance approvals; MDs wait for
next activity to occur (e.g. test results, information, approvals.)

2. Over-processing Performing work that is not valued or needed, e.g. MDs and RNs spending time on computer filling out bureaucratic
forms that nobody will review.

3. Over-production Performing more work than needed for value. Transport of a patient in a wheelchair performed by expensive medical
professionals because of the lack of transporters.

4. Inventory Excess inventory costs. Expired supplies that must be thrown away.

5. Transportation of Transportation of patients over long distances to test offices in hospitals. Poor layout of hospitals, EDs, or test facilities.
Patients

6. Motion of Staff Staff walking over long distances to fetch supplies, and between patients and central hospital stations.

7. Defects Treatment of hospital infections. Failed and repeated tests, repeated paperwork. Surgical cart missing an item. Wrong
medicine.

8. Waste of Human Burnout of medical staff. Frustrated employees quit making suggestions for improvements.
Potential

Table 2 lists the six Lean Principles (Graban 2012) and provides healthcare examples.

Table 2. Six Lean Principles (SEBoK Original)

Principle Explanation
Name

1. Value Specify value from the perspective of the customer: the patient.

2. Value Identify all the value-added steps across the entire process, crossing all departmental boundaries, linking the steps into a seamless
Stream process, and eliminating all steps that do not create value.

3. Flow Keep the processes flowing smoothly through all the steps, eliminating all causes of delay, such as batches of patients or items, and
quality problems.

4. Pull Avoid pushing work onto the next step or department; let work and supplied be pulled, as needed, when needed.

5. Perfection Pursue perfection through continuous improvement, Kaizen events, implement best work standards, checklists, training, and
promote improvement teams and employee suggestions.

6. Respect Create work environment based on synergy of cooperation, teamwork, great communication and coordination. Institute leadership.
People Abandon the culture of blaming and shaming.
Lean in Healthcare 711

Lean Practices
Lean healthcare strongly promotes engaging and leading employees. Lean places a big value on continuous
education and training of employees at all levels. Lean management promotes standardization of best practices (“the
best known way of doing it”, but not necessarily “identical”), checklists, redundancies, patient safety and privacy
rules, and patient data security and cybersecurity. Lean advocates visual management, with electronic or “black”
boards updated in real time and displaying all information important for the local employees to manage their
operation efficiently. Patient safety is still a significant problem in the U.S., in 1999 causing almost 250,000 deaths
(Institute of Medicine, 1999) and medical errors occur in one of three admissions. Instead of “blaming and shaming”
Lean promotes error and harm prevention and deep root-cause analysis, implementing processes and tools that make
it impossible to create an error.

Systems Thinking and Lean

Healthcare is the most complex socio-technological system in our society, consuming nearly 20% of the U.S. GDP.
Healthcare should be safe, effective and evidence based (Berwick 2011), as well as affordable and accessible,
efficient, patient centered, timely, well integrated, and inclusive of latest science. (Oppenheim 2015) Healthcare has
many stakeholders: the patients, medical professionals, medical facilities, hospitals, clinics, labs, medical equipment
makers and users, pharmaceuticals, healthcare researchers and academia, insurances, employers, federal & state
governments and international disease prevention centers, military and veteran’s administration, fire departments and
ambulances and others. The number of potential interactions (interfaces) in this hyper-system is extensive, and many
interfaces are nonlinear, “wicked” (interacting with unpredictable humans), often creating unintended consequences
and emergent behaviors. Because of these vast complexities, healthcare leaders (e.g. Kanter 2015) point out the need
for intensive application of systems thinking and Lean when addressing these challenges. Attempting to solve the
complex healthcare problems without systems thinking risks myopic and unsafe attempts which create more
problems than they solve. Attempting to solve the challenges without Lean inevitably promotes excessive wastes,
costs, and inefficiencies. Good healthcare needs both, Systems Thinking and Lean, to be applied simultaneously.

Lean and Agile in Six Healthcare Value Streams

The Healthcare Working Group of INCOSE identified six following value streams for HSE: A. Systems Engineering
for medical devices B. Systems Engineering for healthcare informatics and medical records C. Healthcare delivery
(operations) D. Biomedicine and big data analytics E. Pharmaceutical value streams F. Healthcare public policy
As described above, Lean is extraordinarily effective and well established in improving healthcare delivery
operations (C). Agile is highly effective in (B) because this value stream works with software, the domain from
which Agile originated. Since the stream (A) is the most similar to traditional systems engineering, Agile is expected
to be effective therein, although Agile is not yet highly popular in healthcare outside of the software domain.
Elements of Lean improvements which are localized and weakly convoluted (e.g., Kaizen events) have strong
overlap with Agile/Scrum methodology. (Medinilla 2014)

MBSE and Lean

A highly powerful Model Based Systems Engineering (MBSE) is clearly the tool of choice for those applications
where the benefit from multiple use of a standardized (reference) architecture and standard model compensates for
the significant effort of creating such a model or architecture. (OMG 2016) In healthcare the value streams (A), (B),
(E) and potentially F are the most conducive to the application of MBSE. Lean thinking is applicable to any
healthcare operation without limitation. The Lean improvements always begin with the so-called Gemba waste
walks, during which experts together with local process stakeholders walk along all the process steps, interviewing
stakeholders and identifying and measuring the wastes wherever they occur. The rich menu of Lean thinking
Lean in Healthcare 712

processes and tools is then applied to eliminate the wastes. Training and active participation of local stakeholders is
always required.

Examples of Lean Improvements

1. In Jefferson Healthcare, WA: (Murman 2010)
• In Acute Myocardial Infarction (a severe heart attack) time is critical as the greatest loss of heart muscle is in
the first two hours. Recommended treatment is catheter insertion of balloon within 90 min of the contact with
the patient (wherever the patient happens to be located). The Lean approach has reduced the treatment time
from 165 min to 20-60 min at the patient site, vastly increasing patient survival rate.
• The five Jefferson Healthcare clinics increased the cumulative available clinic hours from 1400 to 5600 in two
years of Lean improvements which were focused on reorganizing medical staff schedules and eliminating
wasted times, with no staff additions. The available clinic hours directly translate into billable visits: 1175
additional patients have been seen in 2009 compared to 2008 across the five clinics.
• The Operating Room daily “on time start” of actual operations went from 14% to 96% using Lean tools for
process planning and workplace organization.
• Harder to measure is the culture change, although the staff participation at Lean improvement events was at
50%.
2. In Kaiser Permanente Southern California: (Oppenheim 2015)
• In nine regional clinical laboratories Lean improvements cut the turnaround time for laboratory results by
between 30 and 70%, with significant corresponding reductions of cost, rework, errors and work morale, and
without hiring new staff or adding equipment.
• In two Emergency Departments (ED) the average patient length of stay was reduced by 40% by the elimination
of various idle states. The ED capacity increased accordingly.
• The amount and cost of inventory of supplies on hand was reduced by nearly 30% by introducing the
Just-in-Time tools of Lean.
3. In Alegent Health, NE (Graban 2012) the turnaround time for clinical laboratory results was reduced by 60% in
2004 without adding new staff or equipment; and by another 33% from 2008 to 2010.
4. In Kingston General Hospital, Ontario (Oehmen) the instrument decontamination and sterilization cycle time was
reduced by 54% while improving productivity by 16%.
5. In Allegheny Hospital, PA the central-line associated bloodstream infections were reduced by 76%, reducing
patient death from such infections by 95% and saving $1 million.
6. In UPMC St. Margaret Hospital, PA (Graban 2012) the readmission rates for chronic obstructive pulmonary
disease (COPD) patients were reduced by 48%.
7. In ThedaCare, WI [3] the waiting time for orthopedic surgery was reduced from 14 weeks to 31 hours (from first
call to surgery); improved inpatient satisfaction scores of “very satisfied” rose from 68% to 90%.
8. In Avera McKennan, SD [3] the patient length of stay was reduced by 29%, and $1.25 million in new ED
construction was avoided.
9. In Denver Health, CO [3] the bottom-line Lean benefit was increased by $54 million through cost reduction and
revenue growth, and layoffs were avoided.
10. In Seattle Children’s Hospital, WA $180 million in capital spending was avoided through Lean improvements.
These examples demonstrate that Lean is successful in cost and throughput time reductions, and improvements in
quality and patient and staff satisfaction. The improvements of this level are possible, even routine – because the
amount of initially-invisible waste in traditional healthcare organizations is so high. The broad range of operations
described in the examples manifest that Lean is applicable across the board to healthcare operations, without
limitations.
Lean in Healthcare 713

Education in Lean Healthcare

Increasingly, Lean Healthcare becomes an inherent part of Healthcare Systems Engineering (HSE) Master’s
Programs, e.g. (Loyola Marymount University 2016) which has been developed in collaboration with Kaiser
Permanente. The program includes two courses in Lean, basic and advanced, focused on improving operations in
clinics, hospitals, emergency departments, clinical laboratories, radiology testing, operating rooms, pharmacies,
supply chain, and healthcare administration. After the basic courses in systems engineering, project management,
and systems thinking, the students also take courses on healthcare system architecting, modeling and simulations;
medical data mining and analytics; systems engineering for medical devices, healthcare enterprise informatics; and
healthcare delivery systems. All these advanced courses contain elements of Lean thinking because all these
subdomains risk being burdened with waste and poor quality if Lean is ignored. Simply put, Lean is not really an
optional extra if you want to achieve efficiency and effectiveness.

References

Works Cited
B.W. Oppenheim, B.W. 2015. “Lean Healthcare,” INCOSE Healthcare Working Group webinar. San Diego, CA:
International Council on Systems Engineering. April 30, 2015. Available at: https:/ / onedrive. live. com/
redir?resid=147E5C4249DA0EFB%21142
Berwick, D. 2009, “National Forum Keynote, Institute for Healthcare Improvement.” Cambridge, MA: Institute for
Healthcare Improvement. Available at: http:/ / www. ihi. org/ IHI/ Programs/ AudioAndWebPrograms/
BerwickForumKeynote2009.htm (accessed July 4, 2011)
Graban, M. 2012. Lean Hospitals; Improving Quality, Patient Safety, and Employee Engagement. Boca Raton, FL:
CRC Press.
Kanter, M.K. 2015. “Strategic Partnership of Healthcare and Systems Engineering.” San Diego: INCOSE Healthcare
Working Group presentation, 2015
Loyola Marymount University. 2016. “MS Degree Program in Healthcare Systems Engineering.” Available at:
CSE.lmu.edu/graduateprograms/systemsengineering/healthcaresystemsengineeringms/
Medinilla, Á. 2014. ‘’Agile Kaizen: Managing Continuous Improvement Far Beyond Retrospectives.’’ New York,
NY: Springer, 2014
Murman, E. 2010 “The Lean Aerospace Initiative.” Boston MA: Lean Advancement Initiative (LAI) Annual
Conference.
Oehmen, J. 2012. The Guide to Lean Enablers for Managing Engineering Programs. PMI-INCOSE-LAI MIT. May
2012.
OMG. 2016. “MBSE Wiki.” Available at: http:/ / www. omgwiki. org/ MBSE/ doku. php (last accessed March 29,
2016)
Oppenheim, B.W. 2011. Lean for Systems Engineering with Lean Enablers for Systems Engineering. Hoboken, NJ:
Wiley Series in Systems Engineering and Management.
Porter, M. 2010. “What is Value in Healthcare?” New England Journal of Medicine. 363: 2488-2481. 08 December
2010.
Toussaint, J. and R. Gerard. 2010. On the Mend: Revolutionizing Healthcare to Save Lives and Transform the
Industry. Cambridge, MA: Lean Enterprise Institute. 06 June 2010.
Womack, J.P. and D. T. Jones. 2003. Lean Thinking: Banish Waste and Create Wealth in Your Corporation.
Washington, DC: Free Press.
Lean in Healthcare 714

Primary References
None.

Additional References
None.

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