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When I was in Year 3, I won a book prize for topping my class. The book, called How Things Work, had pictures of steam engines, telephone exchanges and aeroplanes; motor cars, power stations and printing presses. It fired my imagination and curiosity for how things work, which has never diminished.
Technical systems, like the ones described above, can be understood through the laws of physics and the axioms of mathematics. Social systems are another matter. Each of us is far more complex individually than any machine, and when you put us together in an organisation to accomplish a common goal, that complexity increases exponentially.
So, what means do we have at our disposal to understand how these complex organisations work? How do we get beyond the clichés of purely behavioural approaches to the challenges of managerial leadership and come to an understanding of what separates the great from the good and the indifferent from the failures?
Before we do, let me confess that when I first discovered the Theory of Constraints (TOC), fairly early on in my work career, it had immense appeal to my natural proclivities and the training I’d had in mechanical engineering. The ‘inherent simplicity’ Goldratt had discovered fitted in very well with my worldview, and I thought it simply a matter of time before everyone was doing their work using a constraint-based paradigm. I even left my secure job to start a consultancy in TOC as I didn’t want to miss the boat. More than two decades later, I have some better-formed ideas about why it is so difficult to bring this new way of working into the world, based on the principles of systems thinking.
What helped me on that journey of understanding was the work of Elliott Jaques, a pioneer in the field of Stratified Systems Theory and author of the seminal book Requisite Organisation. Jaques was born in Toronto in 1917 and died in 2003. He studied medicine and psychoanalysis. Through his work, which analysed tens of thousands of positions in a wide diversity of organisations, he empirically established a strong correlation between mental processing ability (cognitive capacity), time horizon of work and complexity.
“Different levels of work have as different a nature in terms of modes of thinking as, by analogy, water is different to steam”
Jaques made the point that there are strata of work in any substantial organisation, and that these strata are ‘as required by nature’. Thus, the requisite organisation is not seen as being optional, but rather, as he puts it, there are only requisite organisations and degrees of variance from the requisite order:
Misconceptions lead to inept people systems, which produce unfortunate behaviours, which lead to one-sided, negativistic view of people at work, which leads to new inept people system fads, which produce unfortunate behaviours, which…
He maintained that rather than the traditional 4D world of human life—three spatial and one time-based, there were in fact three spatial and two time dimensions. There is Chronos, which we are all familiar with as time measured by a clock. But there is also Kairos (also from the Greek), the axis perpendicular to the Chronos axis in the diagram below. At any given point in time, Kairos is informed by the memory of the past, perception of the present and intention for the future.
Cognitive ability is that quality of mind which defines the outer limit of the horizon of intention. That is, not some vague notion about a future vision, but the actual mental processing ability to apprehend the future, understand the complexity associated with bringing it into being and having the wherewithal to exercise judgement and discretion in overcoming obstacles on the way to that horizon.
Jaques discovered through his vast research that different levels of work have as different a nature in terms of modes of thinking as, by analogy, water is different to steam. He found that the time horizons of the levels of work were remarkably consistent—regardless of the specifics of the industry or organisation within it.

These levels of work, he called modes, and they break down as follows:
Mode 1 – 1 day to 3 months
Mode 2 – 3 months to 1 year
Mode 3 – 1 year to 2 years
Mode 4 – 2 years to five years
Mode 5 – 5 years to ten years
Mode 6 – 10 years to 20 years
Mode 7 – 20 years to 50 years
(For Mode 8 and beyond we’re talking about ideas that change the world, such as those of Galileo’s and Einstein’s, or Gandhi’s and Martin Luther King’s, which go beyond the realm of organisations.)
Interestingly, the cognitive classes of the strata repeat in a fractal way. Mode 1 is the frontline worker, Mode 2 the supervisor, Mode 3 the manager and Mode 4 the executive. So for the frontline worker at Mode 1, the object of the work is completion of the task at hand. At Mode 2, the work is supervising the tasks at Mode 1. And so on. At Mode 5 things start to repeat where, for the CEO of the strategic business unit, the object of the work is everything contained within that business unit. And the Group CEO at Mode 6 is accountable for the superordinate organisation comprised of multiple strategic business units. This stratified systems view is analogous to music where each note of a scale repeats at the octave. And in fact Jaques call the repetition of these four fundamental cognitive classes ‘quadraves’.
The work at the level of Modes 3, 4, 5 and 6 is as follows. Someone operating at Mode 3 will be running and improving an extant system of management. It’s what the Japanese Lean practitioners call kaizen—‘change for better’, or continuous improvement. Mode 4, however, is distinguished by the fact that the work involves the design of entirely new systems of managerial leadership—what the Japanese call kaikaku, ‘radical change’, or transformation. When operating at Mode 4, you are working on a hypothesis of what the future might be, two-to-five years from now, and reckoning on all that is necessary and sufficient to bring that future into being. Mode 5 would be asking strategic questions about new lines of business, geographies and markets. Mode 6 might be charged with fulfilling the intention to establish a worldwide chain of businesses, organised in regions within every continent.
“As long as the person acts within the socially accepted bounds of temperament, effectiveness is more important than likeability.”
There’s no getting away from the fact that most organisations have too many levels, and some have strata missing. No organisation can ascend beyond the level of work practised by the most senior person in the organisation. If that senior-most person cannot operate at the level required by the role, it will cause compression in the roles below, with competent people frustrated that they cannot be effective in exercising their discretion and judgement suited to their capability. Alternately, if a managerial leader occupies a role which is too big for him or her, then they will feel stressed, ineffective and unworthy of the trust placed in them when they took on the role in the first place. If a person is in the right-sized role for their cognitive ability, they operate in flow and have the opportunity to get great joy and reward from their work.
Having the right person in a role is thus not merely a function of their experience, knowledge or affability. One doesn’t have to be agreeable to be a fine managerial leader. As long as the person acts within the socially accepted bounds of temperament, effectiveness is more important than likeability.
What Jaques’s work promotes is the idea that in any managerial accountability hierarchy, success is predicated on there being a tight fit between accountability for getting the job done and authority over the resources required to do so. Understanding the nature of levels of work means there is a much richer set of conditions to overcome the all too frequent mismatch of accountability and authority.
In discovering the work of Jaques I felt I’d finally been given the key to understanding how organisational hierarchies work and how they can be designed to work better. It’s like being given a pair of X-ray specs to look at the organisation’s skeletal structure and noticing whether or not it is ‘requisite’. So often, in the early days of my enthusiasm for TOC I would hear vacuous statements such as ‘you have to have buy-in from the top’, or even more perniciously that hierarchy was in and of itself not a good thing and that the organisation should be ‘flat’. I now know that without a solid understanding of the pioneering work of Jaques I would always be running blind, dependent on dumb luck for results. A Requisite Organisation is a necessary condition of reliably and sustainably unleashing the power and promise of systems thinking.
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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:

[Background photo by Bernard Hermant on Unsplash]
“In a hierarchy, every employee tends to rise
to his level of incompetence”—Laurence J. Peter
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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