It pays to stand on the shoulders of giants, those who have come before and exposed eternal truths. You get to see further, you have a reference point to test your own understanding and insight and it gives you the confidence to continue, even when you are not sure of the ground you’re standing on. Their work is the compass you pull from your pocket when you’re not sure which direction to take.
Dr W Edwards Deming was a giant amongst the giants. He studied electrical engineering at undergraduate level, and mathematics and physics as a postgraduate. He worked as a statistician in the US Department of Agriculture and was a leader in the post-war reindustrialisation of Japan. Lean, Six Sigma and TOC all owe Dr Deming an enormous debt.
[Listen to audio version, read by David Hodes]
He managed to distil his life’s work into his System of Profound Knowledge, which incorporated in it his famous 14 points:
When I look at these fourteen points, I can’t think of a single organisation I have worked with which has successfully implemented all fourteen. I wonder what kind of workplaces we would create if we understood better what Deming was driving at. So long ago Deming articulated a path that encouraged me to pursue my ideal of Just Work. A way to frame the transformation that the 14 points calls for is Deming’s system of profound knowledge:
Let’s take each in their turn and recognise how such a seemingly simple construct can provide a pathway to transformation.

Appreciation for a system
Systems, by their nature, are complex. They are made up of parts but have a quality that makes them function in a way that none of the parts can on their own. Take a car, for example. You could lay out all the parts of a car on a workshop floor and not one of the pieces can get you from where you are to your destination—only the car can do that. A fundamental characteristic of a system is that the sum of the parts is never equal to the whole. And yet, when we examine systems, we will often get overwhelmed by the complexity and resort to trying to understand the whole by breaking it up and then looking at the parts. This is the reductionist approach to making sense of and trying to influence the world we live in.
We make an additional fundamental error when we consider our systems—be they of education, business, government, health or any number of others. We have emerged from the mechanical age and tend to ignore the distinction between living and non-living systems. How often do executives and managers talk about driving change? As if the system they are looking to influence were a machine. When non-living systems, such as software programs, bicycles and steam turbines are broken, we fix them. Bugs are reprogrammed, chains are fixed and bearings are replaced. Living systems, though, are complex and adaptive. In our free society, if your boss is tyrannical, you can leave; if I lose my sight, my other senses will attenuate to mitigate the effect; if a meteor hits the earth and the dinosaurs disappear, the conditions arise for the human experiment.
‘Systems are perfectly designed to give the results we get’
With our anthropocentric view of life, we often forget that we are a part of that ecosystem of nature which made it possible for us to be here in the first place. We’ll tend to think that we have an existence which dwells in independent, disembodied thought and forget that we are bound by the same time and space in which all of this good earth dwells. We should constantly practice lifting our awareness of the axiom that systems are perfectly designed to give the results we get. Such awareness should encourage us to take a humbler stance towards the challenges we face, acknowledge the progress we have accomplished so far and understand that if ever we are going to solve our most pressing problems it cannot be other than through a profound appreciation for and primacy of the whole.
Knowledge of variation
Our very existence depends on variation. No random mutation of genes, no evolution and no human beings. But, we needn’t go so far. Deming was referring to the context of business and the economy. How can we hope to get better and better quality if we don’t know how to understand variation? In Deming’s world, he talked of two different types of variation: common cause and special cause.
Common cause variation occurs as an intrinsic part of the system being examined. If I have a jig which saws steel at a tolerance of 1mm, then I can expect that all the measurements of my cut pieces of steel will be within 1mm. He and his thinking partner from Bell Telephone Labs, Walter Shewhart, developed and popularised the idea of statistical process control and taught the world how to use control charts to routinely improve quality. He was quite adamant that poor quality could not be ‘inspected out’ but could only truly be remedied through improving the system responsible for the outputs.
Special cause variation is that which cannot be accounted for by the system’s daily operations. If my production target is 1,000 steel bars, each to a tolerance of 1mm, but the bearings on my saw seize because someone forgot to lubricate them, I cannot say that the production loss for the day was a part of common cause variation.
Goldratt, with his Theory of Constraints, built on the work of Deming and Shewhart, among others, when creating his production system Drum Buffer Rope and his project management system, Critical Chain. Common to both methods is a profound understanding of statistical phenomena such as covariance (the effect of fluctuations on dependent events) and the central limit theorem (the law of large numbers and the power of aggregation).
Theory of knowledge (epistemology)
How do we know what we know? The simple beauty of a sunset is in fact the earth rotating. If you mix the two deadly elements of sodium and chlorine, you get the indispensable condiment of salt. And if the foetus you carry has x and y chromosomes, congratulations! You’re having a boy. Galileo, often referred to as the first scientist, presaged the enlightenment and its adoption of reason as the basis of expanding our knowledge. The scientific method tells us to ask a question, do background research, construct a hypothesis, test our hypothesis by doing an experiment, analyse the data and draw a conclusion and then share our results.
Deming and Shewhart distilled this scientific method down further with their Plan-Do-Study- Act (often misrepresented as Plan-Do-Check-Act). You plan what you are going to do, you do it, you study the results against what your hypothesis said would be the outcome, and then you act according to that new knowledge. This is the heart of the empirical method of advancing knowledge and stimulating progress. As evidence of progress, how vastly superior are even our least expensive cars today in terms of comfort, safety and economy than those Deming was helping perfect in the fabled Toyota production lines?
‘Having a theory of knowledge allows us
to make predictions of the world around us’
What are other ways of knowing what we know? We can apply our powers of reason: think deductively and you take a known fact and, through the application of logic, arrive at another known fact. This is what we do when, for example, we apply our minds to the puzzles of algebra. Alternatively, we can think inductively: we see a pattern of observable phenomena and create a model for how we think the pattern might evolve. Complex modelling of the effects on climate of putting ever increasing amounts of carbon into the air is one such example. Deming argued that having a theory of knowledge allows us to make predictions of the world around us and actively shape our future rather than merely reacting to events.
But reason and logic alone are not the only ways we come to know what we know. The psychologist Jonathan Haidt uses the metaphor of an elephant and its rider to understand how we make decisions. The rider is our conscious mind, with which we make sense of the world around us and use our reasoning faculties to do everything from knowing when to cross the road to developing a business strategy. The elephant however is the unconscious mind. ‘Like the rider on the back of the elephant,’ writes Haidt, ‘the conscious, reasoning part of the mind has only limited control of what the elephant does.’
The unconscious mind is the home of emotion, justice, courage and love. How do we know those virtues? How do the poet and the artist come to share their knowing with the rest of us? What theory of knowledge will prise open those secrets? Can musicology ever trump music?
Of course, you could argue we’ve already crossed over from epistemology to psychology. Which is entirely appropriate as Deming insisted these four parts were indivisible.
The psychology of people, society and change
According to the Cambridge English dictionary, psyche means the mind, or the deepest thoughts, feelings or beliefs of a person or group. You cannot hope to transform a system such as a business without a deep appreciation of how the human mind works. Since the pioneering days of Freud, Jung and Alfred Adler, we have come an incredibly long way in understanding intellect, temperament, behaviour and motivation. Deming implores us to drive out fear and remove barriers that rob people of pride of workmanship and eliminate the annual rating or merit system. I find it difficult not to be moved by Deming’s unswerving belief in the worker’s desire, given the opportunity, to do what is noble and dignified. Driving out fear is the precondition of learning, experimenting and ultimately of innovation.
And if we talk about society, what kind of society offers the best chance of increasing prosperity? We ignore the hard-won freedoms of our civilisation at our peril. Freedoms that include free speech, free enterprise, and freedom of association, all under a rule of law that prevents the arbitrary exercise of state power. If you think the business of free speech isn’t an issue for business, have a look at the world’s most successful hedge fund run by Ray Dalio and the way how, as he describes in his book Principles, he has inculcated into everything he does at Bridgewater the propelling question ‘How do I know I’m right?’ Or read in the book One Mission about the radical transparency that General Stanley McChrystal brought to his victorious fight against Al Qaeda in Iraq.
Then there is the perplexing issue of change. Most of us are at our best when we find ourselves surfing the boundary between what is old, known and ordered and what is new, unknown and chaotic (or at least unstructured). Too much order and we become sclerotic. Lots of rules and regulations, but no clean, fresh air to breathe. At best, it’s soporific; at worst, tyrannical. Without discipline, however, life becomes chaotic—at best merely a dream, and at worst a nihilistic nightmare. To live our most fully expressed life, we must search within for the seat of the dynamo – that place which perfectly couples the power of intention with the discipline of the will.
Deming allows us to stand on his shoulders. His insights remind me of eternal truths which talk across all ages in the same way that philosophers since Socrates have done for these thousands of years. It pays to pause from time to time and enjoy the view. Then let’s get back to work inspired by what’s possible.
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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 Elena Taranenko on Unsplash]
“Learning is not compulsory…
neither is survival.”—Dr W Edwards Deming
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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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