Bringing about deep change in an organisation is hard. Legendary management consultant W Edwards Deming claimed that transformation was simply not possible without profound knowledge: appreciation for a system, knowledge of variation, theory of knowledge and the psychology of people society and change.
With my engineering background, I appreciate the systems view, understand variation, and work within a methodology to come to know what I know. But perhaps the greatest hurdle preventing change is the people part of Deming’s framework. We’re the real challenge. Deming, who died in 1993, was prescient. The last twenty years has brought a revolution in the study of behaviour and motivation and increasingly we’re using hard science to come to understand why we do what we do. But that’s a subject for a whole book. So for now let’s consider the need for change. Is it real? Is it urgent?
[Listen to audio version, read by David Hodes]
This is Part 1 of our series on The U Journey: Part 1 | Part 2 | Part 3 | Part 4 | Part 5 | Part 6 | Part 7 | Part 8
Start with the fact that of the 500 companies comprising the Fortune 500 in 1955, only 60 remained in 2017. And that while heavyweights used to spend 33 years in the S&P500, that is forecast to drop to 14 years, according to Inc Magazine. As Deming noted, ‘Survival isn’t mandatory’. It’s a sobering thought. In our digitised world of AI, AR and IoT, any organisation looking to make the transition from today into tomorrow must surely consider the idea that the ends themselves are going to be different, not simply the means of getting there. Wherever we look, there is an ever louder call to reimagine every industry. Is it true? At first glance it certainly seems so.
For example, the core job of an airline is to transport you and your luggage safely from A to B, departing and arriving on time, every time. Yet increasingly we also expect the airline to seamlessly offer us everything associated with the experience of travel—from web-based bookings of the flight and hotels, to transfers and in-flight entertainment. Soon we’ll think it normal to be geo-tracked at the airport, with a text telling us when we should head to the gate. And more.
Even something as mundane as a mine producing the basic inputs to the front end of a supply chain must reimagine its operations if it wants to avoid the depredations of the bust years and the indulgences of the boom ones. And how will we address the real issues of ecological footprint, social obligation, ‘just work’ and customer satisfaction while at the same time keeping the shareholders rewarded for their investment?
People, not machines
An engineer by temperament and habit, I like the application of reason to problem identification and solution. The industrial revolution gave us the machine as both an innovation in productivity and a metaphor for human endeavour. Surely, we just needed to think hard enough about the causes of a problem and we could find a solution? The cogs and gears of a machine create a deterministic system. There’s no randomness, for example, in a Swiss watch.
More recently, our metaphor has become the computer. Yet, despite all the advances, it’s still a deterministic device—a machine. IBM’s Watson may win Jeopardy and Google’s text-to-voice assistant can convincingly book a hair appointment, its naturalistic ‘mm-hmms’ helping it pass for human. But that’s not quite what Alan Turing’s test had in mind. And while AI can decide when an aircraft should come in for maintenance, or identify the elemental composition of a sample of minerals—even help robots assemble an IKEA chair—it cannot (yet) solve a general set of problems when the future is fuzzy and there are no instructions.
We have evolved to divide the world into two fundamental parts—the known and the unknown. The taxonomic engine of our minds is in a constant dance of perceiving what is ‘out there’ on the frontier of our experience and codifying it into models of ever increasing complexity. These models serve us well for a time—until they don’t. Then we do what machines cannot. We become afraid.
Legendary systems thinker, Russell Ackoff—not coincidentally a friend and collaborator of Deming—talked of reformation and transformation. He defined the former as the change of the means to accomplish the same ends, whereas the latter occurs when the end itself is changed. Either approach may be valid, but regardless, you have to look within and ask the two big existential questions: “Who am I?” and “Why am I here?”
Overcoming our fears
A life lived fully demands that we regularly see the world afresh. So how do we overcome the real dread of not knowing what’s beyond the frontier of our own experience? How do we surrender to what is beyond the walls of our fortress—that dark forest which before you venture within, is unknowable and untamed? This exploration is not only for ourselves, but for our teams and organisations, individually and collectively embarking on the kind of transformational change needed to do both the minimum—survive—and also to thrive?
How do we overcome the real dread of not knowing
what’s beyond the frontier of our own experience?
We hope the leaders of our multinational enterprises will be brave and eschew the temptation to take the low road of short-term profits, rent seeking or even corrupt practices. But why do so few take up that option? And if they do, why do so many grand initiatives fail spectacularly? The major flops get splashed across the front pages for a day or two. But how well do we really learn their lessons? And what of the failures that didn’t make the headlines? Are we even learning the right lessons from success? We lionise successful companies, but too often take their leaders’ memoirs at face value without acknowledging the ‘right place, right time’ luck of it all. Survivor bias makes us blind.
I have found Theory U to be a useful framework to help leaders better understand what comprises the necessary and sufficient conditions to create a transformation—at first individually, but ultimately, collectively. I am attracted to the theoretical underpinning Otto Scharmer of MIT has given to Theory U, but have also found much of value from other practitioners such as Adam Kahane, Joe Jaworski, Peter Senge and Brian Arthur. In many ways, the ‘U’ journey describes the archetypal Hero’s Journey, a story familiar to every culture in every age, told most lucidly by Joseph Campbell in his very popular series The Power of Myth.
At some point in our life, we are invited into an adventure. We cannot simply move from where we are now, in the comfort of our every day to the new world of bounty by calculating our way there through our powers of reason alone. If transformation is to occur, there is a necessary descent into the metaphorical underworld. The butterfly does not come into being until the caterpillar has dissolved into a seemingly formless chrysalis. We must be willing to confront our psychological shadow and sacrifice our limited view of how the world works for something to emerge which is much deeper and richer. The butterfly is not apparent within the cocoon. But its final form, mysterious as it is, is encoded in the DNA of the chrysalis.
It’s no wonder that transformation is the road less travelled. There is pain associated with letting go of what once you may have held dear. The past, after all, may have brought you riches, status and authority. And, even if it didn’t, there’s truth in the cliché ‘better the devil you know’. It takes genuine courage to summon the new you from the practised routines of your life lived so far. Most folk don’t embark on this kind of adventure unless what they are leaving behind has become intolerable. It’s easier to remain a caterpillar chewing on a leaf than to surrender to the unknown, break down the walls and submit to the adventure that lies beyond.
Eventually, though, you have to answer the call. If you don’t pick up your share of the load and turn the virtue of your aspiration into responsibility for creating a better world, then the risk gets higher and higher that you will become stale, increasingly bored and ultimately cynical or nihilistic. When you call on your brave heart, deep down, you know you must rise to the challenge.
But how to change?
As Yogi Berra said: ‘the future ain’t what it used to be’. Clearly, if our organisations are to survive—and we as individuals are to thrive—we all have to get better at overcoming the inertia bestowed on us from past successes—and failures! We must build a better way of running transformational processes which hold out the possibility of reducing the high anxiety associated with the speed and scope of the changes being rung in by our age. But while technology plays a large role in defining the future of our organisations, in my engagements I hear, again and again, that what’s holding people back from realising the potential of their best ideas is an engaging and disciplined approach. It comes down to envisioning the future we want, then aligning around what needs to be done—and doing it with a shared consciousness.
Where the computer analogy holds is that we need to upgrade the whole managerial leadership operating system which acknowledges that the way we work is in constant renewal. Our organisations are not Swiss watches. In truth, they never were. Even Adam Smith’s pin factory had to deal with variation. The difference today is the depth and scope of what needs to be changed. Because the ecosystem in which we exist—whether you call that your value chain or the whole natural world—is changing around us, moment by moment. Like Alice’s Red Queen, we have to run just to stay in place.
Journeying down and back up
At the start, I said the psychology of people within the system is the biggest hurdle to transformational change. This invariably means that in order to incite change, you are best served by bringing in expertise from outside. That’s what Deming did in Japan and what I try, in my own small way, to do, too. In doing so, I call on a valuable framework based on Theory U, that has worked not only for me, but in many other contexts.
As articulated by Brian Arthur of the Santa Fe Institute, Theory U provides an approach to learning new ways of being and acting in the world, involving three fundamental movements:

1. Observe, observe, observe
2. Retreat and Reflect
3. Act in an instant
Over the years, I have adapted this idea into the Ensemble Way, with three distinct phases, each of which has sub-phases making up the whole. I’ve already written, in ‘Shut Up and Listen’, about the generative interviews, a critical step of the ‘Explore’ phase and precursor to the Foundation Workshop. Over the coming weeks I’ll be writing more about how Theory U gives you a process to follow for personal liberation and organisational transformation.

What excites me about the U process is how it taps into the collective wisdom at all levels of work, facilitating each contributor’s ability to come alive to the possibility of what the future of their aspirations represents. It’s a process, when run well, which engages with the collective intelligence of the overall ecosystem engaged in the work of its own renewal. Like the chrysalis, we already have the DNA to become the butterfly, despite how things might appear!
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This article is Part 1 of our series on The U Journey.
Part 1: How to change: Introducing Theory U
Part 2: Preparing for the Foundation Workshop
Part 3: Running the Foundation Workshop
Part 4: Stepping into Design
Part 5: Wisdom from outside your domain
Part 6: Retreat and Reflect
Part 7: Crystallise Intent
Part 8: Deliver
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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:
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[Background photo by Samuel Zeller on Unsplash]
“You’ve got to be very careful if you don’t know where
you are going, because you might not get there.”—Yogi Berra
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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.”
A medical device patient journey commonly depends on several healthcare professionals:
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.
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:
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?”
“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:
These personas clarify who performs each job and what support each person requires.
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:
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.
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.
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:
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.”
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:
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.
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.”
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.
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:
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.
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.
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.”
A typical medical device journey may include:
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.
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:
The answers reveal the true performance of the patient system.
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?”
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:
These differences affect whether patients enter the pathway, remain engaged and successfully adopt the solution.
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.
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:
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.
Stories create understanding, but investment decisions require structured evidence.
Patient observations and comments should be converted into outcome statements that identify:
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.”
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 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:
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.
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.
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