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Systems thinking: the primacy of the whole

David Hodes, Founder

Recently, I wrote about Asset Constraint Management and the capabilities required to achieve remarkable results. None of that will amount to much if you don’t encourage a systems thinking mindset with behaviours to match. Systems thinking is at the heart of what we do, encapsulated in our mantra: ‘know the whole, focus on the constraint’. Knowing the whole and being able to focus on the constraint is not possible without a commitment to lifelong learning—another core tenet of the Ensemble Way.

[Listen to audio version, read by David Hodes]

In our consulting, we use a spaceship as a metaphor to highlight the aspects you need to consider when looking at your organisation as a complex and organic whole—a system, not a collection of parts. On the left is the head office where, amongst others, the executive sit. At the behest of the shareholders, they set the goal, define the strategy to get there and provide the governance around the planning and performance of all strategic, tactical and operational work. They are custodians of the culture, and the calibre of their managerial leadership determines the likelihood of the success or failure of the organisation.

Cape Canaveral

In our metaphor, the head office contains the usual group functions you would expect in any reasonably sized organisation. Functions such as Finance, HR, IT, Marketing, Engineering, Supply and Corporate Affairs. To the right of the head office sits ‘Cape Canaveral’ where we construct the spaceships and launch them. Each spaceship represents a big idea—perhaps a new product, a capital expansion, the development of a new operation or an acquisition. In this place, call it the shop floor, the work defined in head office is made manifest in the real world (although, in our age, the ideas may be made ‘real’ in digital form first, then in the material world). The shop floor is where we’ll find project managers, field engineers, supervisors, coordinators, tradecraft, storemen, safety officers and the like. Some spaceships may be brand new models, while others are in the shop being maintained, repaired and overhauled for their next mission.

Your value-creation engine

On the right, you see a spaceship that has launched, fired up with ‘Big Idea’ fuel. Your goal is to create additional value and wealth by applying expertise and leverage to the core domains of the spaceship—your value-creation engine. Once you have your Big Idea, our systems thinking approach calls on you to methodically examine each of the core domains, not only as individual entities but how they are interwoven one with the other:

1. STRATEGY: Strategise across every domain
How will your idea flow through the engine that powers your organisation? Each interlinked area is affected, whether or not you make intentional changes. Through strategic planning, you align your system in each field and exert positive influences to differentiate your strategy and maximise your competitive advantage.

2. CULTURE: Cultivate a winning culture
When you understand, codify and develop the shared assumptions and behaviours of your team, your people will learn to better adapt to the external world and to work together energetically towards a common goal.

3. LANGUAGE: Engage purposeful language
People are meaning-making machines, basing action on verbal, written, visual, aural and bodily cues. How you communicate plans and possibilities makes all the difference in the world.

4. ORGANISATION: Cleave to a requisite organisation
When you match accountability with authority at each level of work, your people can take empowered ownership of their roles, with inspired results for the whole team.

5. RESOURCES: Mindfully manage resources
How will you turn intention into reality, every time—on time and budget? Here we define the human, material, information and financial resources required to do the work.

6. OPERATIONS: Design systematic operations
We apply the Theory of Constraints to the way you work with your resources in and across time and place to achieve your organisational goal.

7. PEOPLE: Develop the amazing in people
When you empower your people by building their sense of autonomy, mastery and purpose, you increase the rate at which they energetically perform value-adding work.

8. PROCESS: Engineer seamless processes
What can you standardise and repeat? Who does it? When? With what aim?

9. TECHNOLOGY: Profoundly transform with technology
Understand how to leverage technology to create value across your organisation, and you reap the rewards of our revolutionary digital age.

10. INNOVATION: Bring value into the world
Your idea only becomes an innovation when it starts creating value—for you, your team and your organisation. At that point, you unleash new power to start again and sustain the virtuous cycle.

The small module that’s about to dock is the VMO (Value Management Office) put in place to instrument and control the flow of value. Head office governs the rhythms and routines, while mission control ensures every part of the system functions with the sole objective of doing what’s best for the whole. It provides the operating system with the firepower to counter any disruption and seize every opportunity.

“The firepower to counter any disruption
and seize every opportunity”

In our figurative and generic system, you can imagine the complexity involved in managing it for high-performance outcomes. What choice do you have to apprehend the complexity, let alone control it if you don’t simplify it all by breaking it up into parts? In the absence of systems thinking, people give primacy to the elements and manage them to within an inch of their lives. Each function, sub-function and operation dwells in their silo, doing what they think is best for the whole. And every measure used is predicated on the idea that if all the parts are efficient, then that’s the most effective way to manage the whole.

But, that’s not how to get the best from the system. In fact, it’s counterproductive. A characteristic of a system is that it can do what none of the parts can do on their own. You may have every component needed to make a bicycle, but if it’s not correctly put together, it ain’t going nowhere. Tyres, chains, gears, saddles and handlebars cannot do anything until you assemble them into a bicycle. And then there’s the issue of intention: what is the system’s purpose? It’s one thing to have a bike, but what about the rider? What about the destination? What about the journey?

Living and non-living systems

These questions raise a thought about a fundamental divide in types of system: non-living and living. A non-living system, like our bicycle, needs repairs when it gets a puncture, greasing of the chain to keep it running smoothly and adjustments to the saddle to fit the cyclist. It’s the same with a piece of computer code or an asset like one of our rockets. By contrast, living systems are complex and adaptive. Our rider is always sensing traffic, the condition of the road, the direction he is riding and making adjustments. He imagines the destination and what he’ll be doing once he’s there, hoping he doesn’t get a puncture or get run over by a bus.

Our value-creation engines are fabulously complex combinations of people, equipped with a diverse range of capabilities, infused with personal and professional motivations, interacting with a wide array of technologies to accomplish individual and collective outcomes.

For example, take a moment to think about an organisation you’re a part of and have a go at answering these questions:

1. How many people do you interact with on a given day? Think of yesterday and put a name to every person with whom you had a conversation?

2. What systems were these people a part of? Your organisation? A vendor? A customer? A community organisation? A friend? A call centre?

3. In each of those conversations, what were you setting out to achieve? What were you thinking? What were you feeling? How did it move you to act?

4. What capabilities did each of them bring to the challenge your conversation was trying to address? What were they thinking? What did they feel? How did they act?

5. What means did you use to hold the conversation: Telephone? Video conference? Email? Face-to-face? What systems of people, process and technology provided the services you used?

6. If you met face-to-face, how did you get there: Did you fly? Go by rail? Drive? Who engineered, sold, financed, operated and maintained the ‘planes, trains and automobiles you may have used?

7. If you had a cup of coffee and a biscuit, how did you pay for it? Did you get cash from an ATM or pay for it with your credit card? What banking systems allowed you to lay your hands on your money or settle your payment with a swipe of your mobile?

I could go on, but you get the picture. The truth is we are immersed in so many living and non-living systems in our day-to-day lives that we barely notice them. Instead, we tend to look at the challenges we face in our organisations and our lives as if we were separated from the systems of which we are not only a part but in which we are deeply enmeshed.

The ripeness of the fruit

I was recently on an assignment with a leading global agribusiness firm. We were trying to think from a systems perspective of how they could improve the return they get from a substantial investment in a palm oil estate. We figured the plantation labourer cutting down oil palm fruit, paid by the kilogram, wouldn’t be much concerned about sorting his output by ripeness. Downstream, though, once the mill has crushed the fruit and shipped it to the customer, those overripe fruits included in the tally of the harvest have a material effect on the price the customer is willing to pay.

If you don’t understand the system and the time and effort required to go from forest clearing to planting, fertilising, harvesting, crushing, storing, shipping and converting, you’ll never be able to sustainably out-compete your rivals. And, if you don’t understand the living system that is the labourer responsible for the harvest, all your knowledge of the non-living systems and processes will come to naught. Importantly, all of this occurs in the much bigger system of our good earth’s ecology.

My client is acutely aware of the stigma associated with palm oil and its historical destruction of tropical forest—the habitat of the endangered and beloved orangutan. Our systems thinking must, therefore, embrace every aspect of the value chain—from the labourer in the field to the environmentally concerned consumer in the supermarket—each wanting to make their contribution to sustainable prosperity.

Whether building spaceships to conquer the new frontier or harvesting palm fruits on a tropical plantation, a profound understanding of systems thinking is a prerequisite of delivering on the potential of Asset Constraint Management.

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What’s next?

The change from standard thinking to Theory of Constraints (TOC) is both profound and exhilarating. To make it both fun and memorable, we use a business simulation we call The Right Stuff Workshop.

We’d love to run it with you. To learn more:

  • download the brochure (no email required)
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    [Background photo: Space walk]

    “Know the whole, focus on the constraint.”

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The healthcare professional: the hidden constraint in patient flow

Ensemble Administrator

Healthcare professionals are central to the patient’s progress from awareness of a therapy to successful long-term use. They identify risk, interpret evidence, diagnose conditions, discuss options, perform procedures, provide training and monitor outcomes.

Yet many medical device development programs treat healthcare professionals primarily as users to be trained or customers to be persuaded.

HCP-Centered Design takes a wider view. It examines the work healthcare professionals must perform, the system in which they perform it and the constraints that limit their ability to move suitable patients through the care pathway.

“If patient flow depends on a healthcare professional, that professional’s available capacity may determine how many patients ultimately receive the therapy.”

Healthcare professionals govern critical transitions

A medical device patient journey commonly depends on several healthcare professionals:

  • A primary care professional recognizes a problem or makes a referral.
  • A specialist assesses the patient and manages the disease pathway.
  • Diagnostic professionals generate and interpret evidence.
  • A managing physician supports authorization or reimbursement.
  • An interventional specialist confirms eligibility and performs a procedure.
  • Nurses, educators or allied health professionals help the patient adapt.
  • Follow-up teams monitor efficacy and coordinate adjustments.

Each professional governs a transition in the flow of patients.

If one transition lacks sufficient capacity, information or clarity, the whole pathway slows. More marketing, sales activity or production capacity will not compensate for a shortage of specialist time or a burdensome diagnostic process.

This is why HCP-Centered Design is not simply about making an interface easier to use. It is about enabling the system of care to perform.

The HCP works within a system

A healthcare professional’s work depends on information and actions supplied by others. They may rely on referrals, patient histories, pathology, imaging, electronic records, clinical guidelines and the availability of equipment or trained colleagues.

After reaching a decision, they may need to explain it, document it, arrange authorization, coordinate treatment and prepare the next person in the pathway.

A technically strong solution can still create difficulty if it:

  • Requires information that is hard to obtain
  • Interrupts established clinical workflows
  • Produces outputs that are difficult to interpret
  • Adds documentation without removing other work
  • Fails to connect with existing systems
  • Demands training that cannot be sustained
  • Transfers work or risk to another professional
  • Provides a result without clarifying the next action

The relevant design question is not merely, “Can the HCP use this product?”

It is, “Does this solution improve the HCP’s ability to complete important clinical work within the conditions in which care is actually delivered?”

Identify the real healthcare professional personas

“HCP” is not one persona.

A general practitioner, specialist, interventional physician, nurse, technician and clinical administrator encounter different stages of the pathway. Each has different responsibilities, authority, expertise and exposure to risk.

Even within a profession, context matters. An experienced specialist in a major hospital may approach the same task differently from a professional who encounters the condition infrequently or works without immediate specialist support.

Useful HCP personas distinguish factors that influence work:

  • Clinical responsibility and decision authority
  • Frequency of encountering the condition
  • Experience with the procedure or technology
  • Access to information and specialist support
  • Available time
  • Confidence in interpreting results
  • Responsibility for follow-up
  • Exposure to clinical, legal or financial risk

These personas clarify who performs each job and what support each person requires.

Map the HCP journey

The HCP journey often begins before the visible clinical procedure.

It may include receiving a referral, gathering information, forming an initial view, ordering investigations, interpreting results, deciding whether the patient is eligible, discussing treatment, obtaining authorization, preparing for the procedure, delivering care and arranging follow-up.

At each stage, ask:

  • What is the HCP trying to accomplish?
  • What information is required?
  • Where does the information come from?
  • What decision must be made?
  • What could cause delay or rework?
  • Who depends on this action?
  • What must happen before the patient can progress?

The resulting journey map should distinguish processing time from waiting time. A decision may require only minutes of specialist attention while patients wait weeks to access that attention.

This reveals the practical relationship between HCP capacity and patient flow.

Find the HCP constraint

The Theory of Constraints directs attention to the factor limiting the performance of the entire system.

In some pathways, the constraint may be the number of qualified interventional specialists. In others, it may be diagnostic capacity, physician confidence, authorization effort, operating room access or the time required to train patients.

The constraint may also be hidden inside the HCP’s working day.

A specialist supporting a therapy must still manage other clinical duties, administration, meetings, documentation and urgent cases. The question is not simply how many specialists exist. It is how much of their usable capacity is available for the activities upon which patient flow depends.

“The scarcest resource may not be the healthcare professional. It may be the few hours of focused capacity available for the critical work.”

Improvement away from this constraint can make performance worse. Sending more referrals to an already overloaded specialist increases the queue. Adding information may increase cognitive burden. Creating another approval may consume the capacity required to treat patients.

HCP-Centered Design seeks to protect and expand the capacity that governs flow.

Go to the clinical Gemba

Policies and procedures describe how clinical work should happen. Observation reveals how it actually happens.

Healthcare professionals routinely compensate for missing information, awkward interfaces and unreliable handovers. These workarounds may become so familiar that nobody reports them as problems.

Gemba research should examine:

  • How the HCP prepares
  • Which tools and information sources are used
  • What interrupts the work
  • Where the HCP waits or repeats activity
  • How uncertainty is communicated
  • What must be documented
  • How work passes to the next person
  • How the HCP recognizes that the job is complete

The purpose is not to judge the healthcare professional. It is to understand the system surrounding the work.

“A workaround is often evidence that the system has failed to support the person doing the work.”

Define the HCP’s job to be done

Healthcare professionals do not simply use devices. They use them to make progress in clinical work.

An HCP may need to identify risk, reach a confident diagnosis, select an intervention, perform a procedure safely, explain options, monitor progress or recognize deterioration.

A structured job map divides this work into eight stages:

  1. Define the intended clinical outcome.
  2. Locate the necessary information and resources.
  3. Prepare the patient, equipment and environment.
  4. Confirm readiness and choose between alternatives.
  5. Execute the clinical activity.
  6. Monitor its progress and results.
  7. Modify the approach when circumstances change.
  8. Conclude, document and prepare for subsequent care.

This wider view prevents the product team from concentrating exclusively on the procedure.

The greatest value may come from reducing preparation, improving decision confidence, clarifying an exception, simplifying documentation or improving the handover to follow-up care.

Convert experience into measurable outcomes

Comments such as “the interface is difficult” or “we need better information” indicate dissatisfaction, but do not provide sufficient direction for design.

They should be translated into measurable outcome statements, such as:

“Minimize the time required to identify which clinical information is missing before making a treatment decision.”

Or:

“Reduce the likelihood that a clinically significant change goes unrecognized between scheduled reviews.”

A broader population of healthcare professionals can then assess the importance of each outcome and their satisfaction with their current ability to achieve it.

Highly important and poorly satisfied outcomes provide a rational basis for prioritizing innovation.

“Adoption follows when a solution makes important clinical work safer, clearer or easier to complete.”

Apply FOCUS to HCP capacity

The five-step FOCUS process creates a practical improvement cycle.

Find the constraint. Determine which HCP activity or resource currently limits patient flow.

Optimise for it. Protect the constraint from avoidable work, missing information, interruptions and rework.

Collaborate around it. Align upstream and downstream teams so patients, information and resources arrive when required.

Uplift it. Add capacity, redesign responsibilities, improve technology or remove restrictive policies.

Start Again. Identify the new constraint once flow improves.

This approach allows the organization to distinguish activity from value. It also turns HCP engagement into an ongoing management discipline.

Connect HCP evidence with enterprise execution

HCP-Centered Design must connect clinical reality with patient needs, technology, regulation and business strategy.

A Value Management Office can help coordinate these perspectives across the product lifecycle. Its role is to ensure that projects, resources and stage-gate decisions remain connected to patient flow and business value.

The organization should be able to show:

  • Which HCP groups influence the pathway
  • What each group is trying to accomplish
  • How the work happens in practice
  • Which outcomes remain poorly served
  • Where HCP capacity constrains patient flow
  • How the proposed solution changes the wider care system
  • How improvement will be measured

The goal is not simply a device that healthcare professionals can operate. It is a solution they can confidently incorporate into care and a delivery system capable of getting that solution to more patients.


What’s next?

Use the HCP-Centered Design assessment to determine how well your organization understands clinical work, HCP capacity and the constraints governing patient flow.

The resulting evidence should guide product design, process improvement and investment toward better products, delivered faster, with more lives changed for good.

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Patient flow: the missing system in Patient Centered Design

Ensemble Administrator

Medical device companies devote enormous skill and investment to developing safe, effective products. Yet a technically successful device changes no lives while suitable patients remain unable to reach it.

Between a patient becoming aware of a therapy and receiving its intended benefit lies a pathway of referrals, consultations, diagnostics, approvals, procedures, training and follow-up. Every step consumes time. Between the steps, patients wait. At some points, they become confused, discouraged, ineligible or lost to the process.

Patient Centered Design must therefore address more than the design of the device. It must improve the performance of the entire system through which patients reach, receive and live successfully with the solution.

“A life-changing therapy changes no lives while patients remain trapped in the pathway leading to it.”

The patient journey is a flow system

A typical medical device journey may include:

  1. The patient becomes aware of a possible therapy.
  2. A primary care professional or specialist assesses the patient.
  3. Diagnostic work determines whether the therapy is appropriate.
  4. The patient secures authorization or reimbursement.
  5. An interventional specialist confirms and plans the procedure.
  6. The patient receives the device or therapy.
  7. The patient learns how to live with the solution.
  8. Follow-up identifies any necessary adjustments.
  9. Periodic reviews monitor longer-term efficacy.

Companies often manage these stages as separate functions. Marketing works on awareness. Medical affairs supports clinicians. Market access addresses reimbursement. Sales works with specialists. Clinical teams gather evidence. Training teams support adoption.

The patient, however, experiences one journey.

From the patient’s perspective, a delay between two organizational functions remains a delay. A repeated test remains repeated work. An unclear handover creates uncertainty regardless of which department owns it.

Patient Centered Design begins when the organization sees and manages this journey as a connected system.

Processing time tells only part of the story

Every step contains some necessary processing time. A consultation takes time. A diagnostic test takes time. An authorization must be assessed. A procedure must be performed.

The patient’s total lead time, however, also includes the waiting between these activities.

A consultation may take 30 minutes, but the patient could wait six weeks for it. A diagnostic test may take an hour, followed by another delay before a specialist reviews the result. Prior authorization may require little actual work while adding weeks to the pathway.

This distinction matters because organizations often improve processing time while leaving the larger queues untouched. Saving five minutes during an appointment produces little benefit if the patient waits months to reach it.

Patient Centered Design therefore asks:

  • How long does each activity take?
  • How long do patients wait between activities?
  • How many suitable patients enter each stage?
  • How many progress to the next stage?
  • Where and why do patients leave the pathway?
  • How much total time passes before the patient receives the solution?

The answers reveal the true performance of the patient system.

Find the constraint

Theory of Constraints teaches that the performance of any system is limited by a constraint. Improving a part of the system that is not constraining flow may create more activity without increasing results.

If diagnostic capacity is the constraint, generating more awareness may simply produce a longer queue for diagnosis. If specialist capacity is the constraint, accelerating authorization may move patients more quickly into another wait. If training after first use is inadequate, increasing procedures may produce poor experiences and avoidable follow-up demand.

“More activity at a non-constraint creates work in process. More capability at the constraint improves the system.”

The constraint is not always a physical resource. It may be a policy, an eligibility rule, missing evidence, a fragmented handover, an information delay or the cognitive burden placed on the patient.

The most important question is therefore not, “How do we improve every step?”

It is, “What currently limits the flow of suitable patients to successful use of the therapy?”

Understand why patients remain in or leave the flow

Numbers show where patients are lost. Patient research helps explain why.

Two patients with the same diagnosis may respond very differently. One may actively seek new treatment options. Another may delay action until symptoms become severe. A third may want help but lack confidence in navigating the healthcare system.

Meaningful patient segmentation considers characteristics that influence behavior:

  • The importance the person gives their health
  • Their confidence in dealing with healthcare professionals
  • Whether they act independently or need encouragement
  • Their comfort with technology
  • The pressures of work, family and daily life
  • Their ability to understand and act on clinical information
  • Their willingness and ability to pay
  • The outcomes they most want to achieve

These differences affect whether patients enter the pathway, remain engaged and successfully adopt the solution.

Go to the patient’s Gemba

The Gemba is the place where work actually happens. For patients, this includes the home, clinic, hospital and all the places where they manage their condition between formal encounters.

Interviews alone may miss important evidence. People normalize inconvenience, forget workarounds and simplify their past decisions. Observation allows the development team to see what patients actually do.

Good research combines three activities.

Observe. Watch how patients obtain information, prepare, use the solution and respond when something goes wrong.

Immerse. Understand the physical, emotional and practical conditions surrounding the experience.

Engage. Ask open questions that allow patients to describe their goals, fears and frustrations in their own language.

The purpose is to discover the patient’s reality before asking them to evaluate the organization’s preferred answer.

Understand the patient’s job to be done

Patients rarely want a medical device for its own sake. They want the progress it may enable.

They may want to recognize deterioration earlier, preserve independence, reduce pain, avoid repeated visits, return to work or prevent a disease from controlling daily life.

A useful job map examines eight recurring stages:

  1. Define what must be achieved.
  2. Locate the required information and resources.
  3. Prepare for the activity.
  4. Confirm readiness and choose between alternatives.
  5. Execute the activity.
  6. Monitor whether it is working.
  7. Modify the approach when circumstances change.
  8. Conclude or prepare for what follows.

This reveals opportunities beyond the immediate use of the device. The most valuable improvement may involve helping patients prepare, confirm readiness, recognize an exception or understand what happens next.

Turn patient experiences into evidence

Stories create understanding, but investment decisions require structured evidence.

Patient observations and comments should be converted into outcome statements that identify:

  • The desired direction of improvement
  • A measure of success
  • The object being controlled
  • The circumstances in which it matters

For example:

“Minimize the time required to recognize that my condition has changed sufficiently to require clinical help.”

Patients can then assess the importance of each outcome and their satisfaction with their current ability to achieve it.

Highly important and poorly satisfied outcomes represent genuine opportunities. This prevents teams from prioritizing attractive features that do not materially improve the patient’s life or progress through the pathway.

“Innovation becomes valuable when it improves an outcome that matters and remains poorly served.”

Apply the five-step FOCUS process

The Patient Centered Design pathway can be improved through a repeating discipline:

Find the constraint. Identify what currently limits patient flow or successful use.

Optimise for it. Make the best possible use of existing constraint capacity.

Collaborate around it. Align functions and partners so their actions support the constraint.

Uplift it. Add capability, remove restrictive policies or redesign the pathway.

Start Again. Once the constraint moves, identify and address the next limiting factor.

This prevents improvement from becoming a collection of disconnected initiatives. It directs scarce resources toward the factor that most strongly governs the result.

Patient Centered Design is an operating system

Patient insight should influence more than early product design. It should shape clinical evidence, regulatory strategy, reimbursement, manufacturing, education, market development and post-market support.

The organization should be able to show:

  • Which patients it intends to serve
  • What those patients are trying to accomplish
  • How the complete patient pathway operates
  • Where patients wait or leave the flow
  • Which outcomes remain poorly served
  • What currently constrains successful patient access
  • How the proposed solution improves the whole system

The goal is not simply to place the patient at the center of a diagram. It is to organize the enterprise around delivering better products faster, so that more lives can be changed for good.


What’s next?

Use the Patient Centered Design assessment to determine how well your organization understands its patient journeys, priority outcomes and constraints to patient flow.

The result should be more than another collection of patient opinions. It should provide evidence that directs strategy, investment and execution toward the changes that matter most.

READ MORE

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