Review

Agile Innovation to transform

healthcare: innovating in complex
adaptive systems is an everyday
process, not a light bulb event
Richard J Holden  ‍ ‍,1 Malaz A Boustani,1 Jose Azar2

1
Department of Medicine, ABSTRACT
Indiana University School of Summary box
Innovation is essential to transform healthcare
Medicine, Indianapolis, Indiana,
USA delivery systems, but in complex adaptive
2
Department of Medicine,
What is already known?
systems innovation is more than ‘light bulb
Indiana University Health, ►► Innovation is needed to transform
events’ of inspired creativity. To achieve healthcare delivery and its outcomes.
Indianapolis, Indiana, USA
true innovation, organisations must adopt ►► Innovation is too often envisioned
Correspondence to a disciplined, customer-­centred process. We in healthcare as occasional bouts of
Dr Richard J Holden, Department developed the process of Agile Innovation as an inspired creativity by so-­called disruptive
of Medicine, Indiana University
School of Medicine, Indianapolis,
approach any complex adaptive organisation can innovators, whereas innovation in
IN 46202, USA; ​rjholden@​ adopt to achieve rapid, systematic, customer-­ other industries is understood to be a
iupui.​edu centred development and testing of innovative participatory customer-­centred process.
interventions. Agile Innovation incorporates What are the new findings?
Received 19 October 2020
Revised 11 January 2021 insights from design thinking, Agile project ►► Agile Innovation is a customer-­centred
Accepted 11 January 2021 management, and complexity and behavioural innovation process for complex adaptive
Published Online First sciences. It was refined through experiments in systems that can be adopted in healthcare
28 January 2021
diverse healthcare organisations. The eight steps delivery organisations as an everyday
of Agile Innovation are: (1) confirm demand; process.
(2) study the problem; (3) scan for solutions; (4) ►► Agile Innovation’s eight steps uniquely
plan for evaluation and termination; (5) ideate combine best practices from design
and select; (6) run innovation development
thinking, Agile project management and
complexity and behavioural sciences.
sprints; (7) validate solutions; and (8) package for
►► Habituating Agile Innovation in everyday
launch. In addition to describing each of these
practice requires discipline, resources and
steps, we discuss examples of and challenges a psychologically safe culture.
to using Agile Innovation. We contend that
once Agile Innovation is mastered, healthcare
delivery organisations can habituate it as the
go-­to approach to projects, thus incorporating beyond biomedical discovery.3 Although
innovation into how things are done, rather than manufacturing-­ based change methodol-
treating innovation as a light bulb event. ogies such as total quality management,
lean and six sigma may eliminate waste
and variability, they will not transform
complex adaptive healthcare systems.4
INTRODUCTION Instead, healthcare delivery organisations
The scientific and technological evolu- are in dire need to innovate their delivery
tion of US healthcare delivery has dras- operations, following the lead of other
© Author(s) (or their tically improved longevity and quality of industries, which rely on innovation to
employer(s)) 2021. Re-­use
permitted under CC BY-­NC. No life.1 Evolution is accompanied by new survive and thrive.5
commercial re-­use. See rights challenges to deliver safe, high-­ quality, The problem with innovation is it
and permissions. Published by low-­ cost and positively experienced is often confused with invention and
BMJ. healthcare services to patients who are reduced to ‘light bulb events’ of inspired
To cite: Holden RJ, older, chronically ill and at higher risk of creativity pushed top-­down by so-­called
Boustani MA, Azar J. BMJ disability.2 Such challenges demand trans- disruptive innovators. Critics have
Innov 2021;7:499–505.
formation of healthcare service delivery, argued the healthcare industry overvalues

  
Holden RJ, et al. BMJ Innov 2021;7:499–505. doi:10.1136/bmjinnov-2020-000574 499
 Review
where teams work intensively over short-­cycle sprints
to produce working solutions, test them with clients
and obtain feedback to guide the next sprint.13 Agile
project management was originally positioned as an
eventual successor to lean, given Agile’s ability to
quickly respond to customer needs.14 Thus, Agile Inno-
vation is strongly focused on customer needs, collecting
and nimbly responding to customer feedback in sprint
cycles, and empowering teams to autonomously adjust
to demands rather than placing top-­down constraints
on the solution.
Complexity and behavioural sciences provided
the third foundation; these depict humans as agents
in complex adaptive systems.15 16 Specifically, Agile
Innovation drew on Holland’s theory of complexity,17
which posits signals and boundaries as the drivers
of behaviours in complex adaptive social organisa-
tions. Local, non-­linear exchanges of information and
resources between organisational agents and their
surrounding environment produce emergent and
Figure 1  The eight-­step Agile Innovation process. adaptive behaviour. This theory influenced Agile Inno-
vation’s non-­linearity and orientation towards lever-
aging, not reducing, complexity, by empowering local
creative or revolutionary solutions and ‘neglects one agents to be adaptive and responsive to their local envi-
of the essential elements of successful innovation, in ronment. Second, Agile Innovation was influenced by
both the technology sector and the broader economy: behavioural economics theories of human behaviour
a disciplined approach to meeting consumers’ needs’.6 under high levels of information uncertainty.18 These
Healthcare delivery organisations must shift their defi- theories propose that in conditions of uncertainty or
nition of innovation ‘from the generation of ideas to incomplete data, human action is largely driven by
rapid methods of running experiments to test them’.7 cognitive processes that are instinctive, emotional and
In other words, healthcare delivery needs a customer-­ automated rather than analytic and effortful. Thus,
centred and participatory process for innovation that Agile Innovation assumes people are adaptive and able
can be sustained: that is, replicated and repeated. to use cognitive short cuts, but those short cuts do not
Such a process must allow teams on the ground to use lead to what one might call ‘rational’ decisions.
rapid experimentation, respond to well-­characterised We used insights from these foundational practices
problems, evaluate solutions and manage the mess- and theories to construct a working version of the
iness of the complex adaptive healthcare delivery Agile Innovation process. We refined Agile Innovation
systems where innovative solutions will eventually be through numerous experiments in diverse healthcare
implemented.8 organisations.4 10 These included Eskenazi Health, a
safety net healthcare delivery system in Indianapolis;
METHOD Indiana University Health, a state-­ wide integrated
We developed Agile Innovation as a transformation healthcare delivery system; and the Great Lakes Prac-
approach for complex adaptive healthcare systems. tice Transformation Network, a cluster of 2100 prac-
Agile Innovation extended our work with Agile tices in rural, suburban and urban settings in Illinois,
Implementation, an Agile approach to implementing Indiana, Kentucky, Michigan and Ohio.
evidence-­ based healthcare practices.4 9 10 Our Agile
approach was rooted in industry best practices and RESULTS
Nobel Prize-­winning science. Agile Innovation has eight steps (figure 1), four for
The first foundation for Agile Innovation was design planning and four for execution. Innovation is non-­
thinking, a creative problem-­solving approach, popula- linear but the eight steps are generally done in forward
rised by Stanford University and the IDEO company.11 order with as-­needed repeating of parts of the process.
Several steps of Agile Innovation are influenced by Agile Innovation’s iterative and cyclical process flow
design thinking, namely steps for deeply understanding resembles other iterative approaches such as Plan-­Do-­
the context and problem to be solved, ideating and Study-­Act, where empirical findings influence future
prototyping solutions, and testing. Agile Innovation actions and result in further iterations of design and
also adopts design thinking’s iterative approach. evaluation. Assumed but not formally described is the
The second basic foundation was Agile principles vital step of forming a team, which includes estab-
for software development and project management,12 lishing participants, operating resources, expectations

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 Review
and timelines. Agile Innovation team roles generally this step. Patients and other consumers of healthcare
include team leadership, product ownership (commu- are a critical party to step 2, as their experiences, jour-
nicating the vision and setting priorities for the team) neys, needs and preferences contribute uniquely and
and roles responsible for studying/representing the consequentially to defining the problem.
problem and identifying/developing the solution.
The team engages stakeholders—including subject Step 3: scan for solutions
matter experts, leaders and end users (customers)— Innovators typically combine or modify elements
throughout the process. of existing solutions in novel ways and apply them
to novel problems, rather than inventing something
Step 1: confirm demand completely new.28 In this step, innovators scan for
To avoid investing in a solution no one needs, Agile existing solutions in typical and atypical repositories.
Innovation promotes early on defining the problem Typical sources are peer institutions, published liter-
whose solution stakeholders demand. Demand is a ature, online forums/sites and colleagues. Scanning
perception residing in the stakeholders’ minds, so atypical sources may be more innovative and inspiring;
confirming demand may require repeated stakeholder these include dissimilar disciplines or markets,
interaction to rule out fleeting interests. Innovators consumer or advocacy groups advocating changes to
might convince stakeholders by empirically assessing the status quo and history books or museum exhibits.
the problem (step 2) but should not proceed too far One can also crowdsource existing solutions from
until stakeholders agree on which problem needs outsiders or insource from overlooked current prac-
solving and commit to finding solutions. In modern tices and adaptations within the organisation. Such
healthcare, the question of ‘whose demand?’ is perti- clever but localised internal solutions may have been
nent; Agile Innovation promotes considering the uncovered in step 2.
demands of those in leadership positions because they
control access to resources and of patients and other Step 4: plan for evaluation and termination
consumers, as their outcomes are paramount and their Before creating the solution, one should plan how it
perspectives unique.19 will be evaluated and under what conditions its devel-
opment should be terminated.29 This is done to ensure
Step 2: study the problem progress towards specific goals, rather than innovating
Innovators can choose from and combine myriad for the sake of innovating.9 Having a termination plan
methods for studying systems, processes and outcomes makes it easier to overcome forward momentum; it
associated with the problem. Methods range from reframes the decision to stop as a gain—an opportu-
collecting broad ethnographic data while embedded nity to invest in better alternatives—not a loss (of prior
in the local context to pulling longitudinal quantita- investments). Moving on from a solution that meets
tive data on specific outcomes. Understanding how termination criteria is an occasion to celebrate. The
the sociotechnical system is currently designed helps termination plan should therefore include the release
develop innovations that will fit existing people, of additional resources to investigate what went wrong
tools, tasks and environments.20 Empirical process or could be recycled and to pursue new alternatives.
mapping—workflow analysis, value stream mapping, However, because early-­ stage or late-­stage project
user stories, journey maps—is especially useful because termination can be an emotional and political deci-
knowing how things are currently done reveals oppor- sion, specific termination criteria and timelines should
tunities for future (re)design.21–23 It is easy to sink time be documented in advance and outside stakeholders
in this open-­ended early stage, so we advise innovators should be consulted to verify that a solution meets
to: (1) rely on pre-­existing research and data when termination criteria before it is stopped. For any solu-
possible; (2) use methods designed for speed and effi- tion that is not terminated early on, formal evaluation
ciency, for example, rapid ethnography, personas or criteria should also be developed at this step, to be
surveys; (3) create clear data collection and analysis used in the next steps. Evaluation details—including
plans to avoid scope creep; (4) interleave analysis planned measures and analyses—will depend on the
during data collection; and (5) designate one or more specific project, but can include efficacy or effective-
Problem Masters, who deeply know the problem and ness (eg, health outcomes), cost (eg, expenses, savings),
related data, to be consulted throughout. Recent work efficiency (eg, amount of rework), acceptance (eg,
on Agile health information technology development satisfaction), reach (eg, per cent affected) and explana-
describes using rapid ethnography, surveys and other tory factors (eg, facilitating conditions).30
methods to study problems in clinical24 25 and commu-
nity settings.26 27 Moreover, innovators will never know Step 5: ideate and select
the problem completely and must be comfortable with Ideation is a hallmark of design thinking because it is a
an understanding that is ‘good enough’ to create solu- creative, non-­judgmental process that participants enjoy
tions whose testing will reveal whether the innovators and can easily associate with innovation.13 Generating
adequately understood the problem or need to repeat free-­form ideas, building on others’ early thoughts and

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Figure 2  The Innovation Forum process.

stepping outside the confines of present reality to ask testing also saves time for additional iterations, such
‘what if ’ questions can be stimulating and often lead to that more sprints can be run before time and resources
memorable ideas. As a result, ideation should be open are exhausted. A typical strategy to manage multiple
to many participants, including prospective customers sprints is to progress from less costly lower fidelity to
or end users.12 31 Broadening participation is mutu- costlier but more interactive higher fidelity prototypes,
ally beneficial given evidence that diversity during reducing fidelity for major adjustments. This applies
ideation produces better, more creative and a greater to prototypes of software (eg, from wireframe screens
volume of ideas.32 More mundane tasks accompany to field-­ready software), physical products (eg, draw-
ideation, including recruiting participants for ideation ings to 3D printed artefacts), physical space (eg, card-
sessions, facilitating these sessions and documenting board to stable architecture) and processes (eg, verbal
ideas. Figure 2 depicts the Innovation Forum, a struc- vignettes to dress rehearsals). One hospital-­based Agile
tured participatory design or codesign event that is project described their sprint structure:
fast, engaging and promotes the sharing of ‘time and The design team directly engaged clinician users to
space’ between the innovation team and local experts, ensure design decisions and software requirements
including healthcare professionals, administrators and fit the true needs of the users and their clinical
patient/family stakeholders. Other ideation session workflows. Using this approach, a new version of
strategies abound, including breakout groups, compe- software was released once every 2–4 weeks during
tition and reward (although participating in ideation active development. The design team meets on a
can be reward enough), story-­telling or role-­playing, weekly basis to review feedback from users, on-­going
sketching or collaging, questioning and tools for development tasks, and prioritize development
combining or contrasting ideas. activities including bug fixes and new features.23
Ideation is exciting and free of judgement, but
once ideas are generated, the hard work begins to use
clear criteria (preferably those established in step 4) Step 7: validate solutions
to narrow down the candidates to develop further. Sprints produce a high-­ fidelity minimum viable
Example criteria for selecting solutions to further product (MVP) or minimum viable service (MVS).
pursue include stakeholder support for the solu- These do not contain all possible functionality but
tion, production cost, likelihood that it will solve the their included functions are properly working. The
problem, scalability and feasibility or viability. The MVP or MVS can now be tested according to the eval-
selection or convergence process is difficult because uation plan established in step 4, preferably in real-
it means discarding ideas. We therefore recommend istic settings with actual end users. In Agile software
framing selection as a formal, scientific process to development, validation usually centres on acceptance
prioritise investments in the most promising ideas. criteria, or evidence that the product has met customer
needs.34 During validation, it is necessary to monitor
Step 6: run innovation development sprints for and address unintended consequences, unexpected
Sprints are self-­contained series of developing and benefits and emergent behaviours—an insight from
testing a prototype of the solution. There may be many complexity science. This can only be done by testing
of these before moving to the next step. Rapid proto- the innovation in practice and having adequate sensors
typing is often advisable to create something that is in place to collect data on all results, expected or not.
imperfect but ‘good enough’ to test. According to Agile Ultimately, an innovation is not valid unless it meets
philosophy, testing is a superior path towards progress customer needs, which increasingly include the needs
and design decisions compared with introspection or of the patients and families who coproduce care.35
polishing the design. This is true because testing allows
actual customers or end users to interact with the solu- Step 8: package for launch
tion, revealing how the solution performs in reality, not This step is necessary to ensure an innovative solution
theory, and obtaining feedback grounded in front-­line is implemented. The innovator creates the hand-­off
expertise.33 Reducing the delay between creating and package, which includes a business plan, MVP/MVS

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 Review
and minimal critical specifications for use. Innova- Masters’). Their evaluations leveraged quantitative
tors must clearly state the essential, non-­modifiable and qualitative results.
components of their solution, allowing the rest to Lastly, Indiana University researchers and clinicians
be customised for local use. Innovators can leverage at Eskenazi Health collaboratively developed a soft-
guidance for Agile software documentation36 37 and ware for clinicians and informal caregivers of persons
general advice on developing minimal standard oper- with dementia. They performed all eight steps of Agile
ating procedures.9 This is a difficult step for innova- Innovation, summarised in table 1. Clinicians partici-
tors tempted to view every aspect of the solution as pated in codesign sessions, providing input on software
important. However, end users will modify the design features before and after the software was clinically
regardless of innovators’ wishes, so innovators should deployed, while informal caregivers provided input
articulate vital components not to be changed. through usability testing and participating in a pilot
clinical trial.40
Examples of Agile Innovation in healthcare
Agile approaches have been used in healthcare,38
including developing customer-­ centred software via DISCUSSION
user-­centred and participatory design.23 One example We argued at the outset that a disciplined, customer-­
is work led by technology researchers at Oregon centred process is preferable to and more sustainable
Health & Science University to improve electronic than innovating from disruptive individuals’ flashes of
health records for primary and behavioural health- brilliance. Although lean, six sigma and other tradi-
care professionals.24 25 They used rapid ethnography tional quality improvement models also offer system-
to understand user needs and generate requirements. atic processes, they generally ‘fail to acknowledge and
Requirements were then addressed, leveraging existing account for the complex nature and unique character-
software tools and developing new ones. Iterative istics of individual healthcare systems’.41 Those who
prototype testing with end users allowed the team to view healthcare organisations as complex adaptive
assess whether actual customers (clinicians) found the systems criticise lean’s preference for standardisa-
software usable and acceptable, resulting in software tion over embracing needed variation.42 Traditional
refinements and eventually validated products pack- quality improvement systems fail to innovate when
aged for clinical implementation. they primarily strive towards efficiency and reducing
A second example is University of Texas South- complexity rather than adapting to customer needs.43
western Health System’s Agile development of clin- Although exceptions have been reported of innovative
ical decision support tools.39 The team developed lean manufacturing44 and healthcare delivery,45 46 Agile
user stories and diagrams to depict the problem, then Innovation is uniquely and purposefully designed for
created prototypes to represent potential solutions. sustainable, customer-­centred innovation in complex
They used a rapid sprint cycle to obtain customer feed- adaptive healthcare systems. It complements other
back on product iterations, deployed every 2 weeks. customer-­centred approaches, such as evolving move-
When the team could not gather feedback from ments to involve clinicians and non-­professional (eg,
actual clinicians, well-­informed surrogates served as patients, families) coproducers of care in health-
the ‘voice of the customer’ (a role we call ‘Problem care decisions.35 47 48 Like those movements, Agile

Table 1  Use of Agile Innovation to develop the Brain CareNotes mobile app for dementia care
Agile Innovation steps Example activity performed by design and clinical experts
1. Confirm demand. ►► Clinical leaders repeatedly assured designers of the need to better support family caregivers of persons with dementia.
2. Study the problem. ►► Clinicians shared existing data, documents and protocols.
►► Designers conducted rapid ethnographic study with clinical staff, patients and caregivers.
3. Scan for solutions. ►► Designers investigated existing solutions such as apps, telemedicine and educational materials.
►► Designers met with clinical staff, who reported what had been tried in the past and how well it had worked.
4. Plan for evaluation and termination. ►► Designers and clinicians defined success as a solution that is usable and acceptable to caregivers, free or minimal cost, and
improves well-­characterised clinical outcomes.
►► Designers and clinicians agreed to terminate the solution if it failed to produce the agreed-­upon outcomes or caused
significant harm.
5. Ideate and select. ►► Designers generated potential solutions, drawing on input from clinicians.
►► Designers, with clinician support, chose to pursue a mobile app, based on convenience, personalisation, visual nature and
scalability.
6. Run innovation development sprints. ►► Designers performed multiple rounds of design and testing of prototypes with caregivers and clinicians.
►► Designers made changes throughout the process, based on user feedback, observed barriers and clinician input.
7. Validate solutions. ►► Designers partnered with clinicians to pilot test the app’s usability, acceptability and efficacy for patients and caregivers.
8. Package for launch. ►► Designers worked with software developer to create tools needed to allow any clinical service to modify the app to their
needs.
►► Clinicians incorporated the app into their care delivery protocols.

Holden RJ, et al. BMJ Innov 2021;7:499–505. doi:10.1136/bmjinnov-2020-000574 503

 Review
Innovation promotes the voice and active involvement Provenance and peer review  Not commissioned, externally peer
reviewed.
of the customer. The customer is defined case by case,
but in most modern paradigms includes patients and Data availability statement  No data are available.
families.49 Open access  This is an open access article distributed in accordance
with the Creative Commons Attribution Non Commercial (CC BY-­
Like any process, Agile Innovation has its chal- NC 4.0) license, which permits others to distribute, remix, adapt,
lenges. Agile Innovation requires investing adequate build upon this work non-­commercially, and license their derivative
human resources, time and patience for iteration, works on different terms, provided the original work is properly
cited, appropriate credit is given, any changes made indicated,
apart from any material resources. Another practical and the use is non-­commercial. See: http://​creativecommons.​org/​
challenge is balancing creative thinking with the scien- licenses/​by-​nc/​4.​0/.
tific method, without letting either become a barrier to
ORCID iD
forward progress. A keen observer will also note that Richard J Holden http://​orcid.​org/​0000-​0002-​3603-​6158
Agile Innovation is a customer-­ centred process and
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