How structured is your thinking? No less a figure than W Edwards Deming made the theory of knowledge one of four pillars in his System of Profound Knowledge. And yet, in my experience, very little structured thinking goes on in our modern workplaces.
[Listen to audio version, read by David Hodes]
This is Part 1 of our series on the Logical Thinking Process: Part 1 | Part 2 | Part 3 | Part 4 | Part 5
Without a doubt, there is an enormous and ever-increasing amount of analytics performed in our digitising business environments. But how do we come to know what questions to ask of our immense sets of data? And, even if we knew all the powerful questions, not all knowledge is reducible to bits and bytes. For that knowledge which we cannot contain in a computer program, how do we construct our arguments, test them for logical coherence and then communicate the results?
Having a means of thinking in a logical and structured way is not to say that all decisions can be made based on reason alone. Difficult choices often don’t lend themselves to binary answers derived from cause and effect logic. We cannot possibly know everything about a given situation. Additionally, we all have our prejudices, often based on an emotional response to a given situation. Further, it is not always clear that parties to an argument share the same goal. Therefore, what appears to me to be sound reasoning may be intolerable to you.
Notwithstanding these caveats, neglecting to develop a substantial capability in critical thinking seems to me to be one of the root causes of the difficulty we all encounter when advocating for change. Imagine for a moment that you or one of your team was well versed in the available means of persuasion. How much more could you accomplish? How many more rounds of innovation could you achieve while your competitors get lost in incoherent argument? How much more glide and how reduced the friction if you take the science and art of critical thinking seriously?
The Logical Thinking Process from the Theory of Constraints (TOC) provides a logically structured means of developing rhetorical muscle. It endeavours to do for TOC what Hoshin planning does for the Toyota Production System (Lean). The logic trees from the Thinking Process were designed initially to comprehensively answer the three critical questions of any change initiative: What to change? What to change to? How to change? There is a suite of five logic trees used to examine each of those questions: the goal tree, current reality tree, evaporating cloud, future reality tree and transition tree. But, before diving into the use of the trees, we would be better served by first studying Goldratt’s rules of rhetoric, which he calls The Categories of Legitimate Reservation, but which I prefer to simplify and call ‘logic checks’.
“Is what’s being said true, and what data
backs up the truth of its existence?”
Goldratt’s rhetorical test kit provides six logic checks: clarity, causality existence, additional cause, concurrent cause, missing intermediate effect and predicted effect. Getting to know these checks well is a little like learning a new language, but it can pay big dividends once mastered. With practice, you can start to pick out the logic flaws in your colleagues’ arguments as they speak. When constructing an argument of your own, you can ensure you have covered all that is necessary and sufficient to make it watertight. Let’s take each in their turn, with an example.
Clarity. Are the logical statements about reality clear in what they are saying? Can anyone involved in the system understand and readily share what is being said?
Example: ‘Johnny is upset because of sales’. We don’t know if Johnny is upset because sales are up and he has no more inventory, market prices are down, along with profits, and he thus won’t get his bonus, or logistics has screwed up and failed to get the product to the customer on time and in full, meaning the revenue can’t be brought to book.
Entity existence. Is what’s being said true, and what data backs up the truth of its existence?
Example: ‘The pump is broken’. If we incorrectly connected the wiring for the motor that drives the pump, it might be that the pump is in good working order, but it is unable to perform its function of circulating fluids because of the faulty wiring of the motor.
Causality existence. When connecting a chain of cause and effect, what are the assumptions underpinning the linkage? Can these assumptions be altered without the logic breaking down?
Example: ‘The project failed because we were over budget and behind schedule’. Being over budget and behind schedule were the effects of poor project management and not the actual cause of project failure. Improve project management and the cost and schedule outcomes will improve.
Additional cause. Is there another entity, which on its own would have the same effect and which, when combined with other causes, may have an amplifying effect. Alternatively, if we remove the original cause, the additional cause will still play its part in keeping the undesirable effect in place.
Example: ‘I can’t believe I failed to qualify as a coded welder when I got such a good grade for the exam’. To qualify, there were two necessary conditions: complete a supervised workplace assessment and pass the exam. A failure to satisfactorily do either, even when the other is done exceptionally well, results in an inability to qualify.
Concurrent cause. Is there a cause that needs to combine with another before it’s sufficient to create the observed effect?
Example: ‘We wouldn’t have been so late if the supervisor had given us a better estimate of how long his tasks would take’. To get a better estimate, you would need input from the supervisor, the specialist and the tradie performing the work. Leave out any of the three of them, and it becomes more likely that estimates miss their mark.
Missing intermediate cause. The proverbial ‘long arrow’ statement in which the distance between cause and effect is so great that one can intuit a connection, but to provide clarity, must be articulated as a full chain of cause and effect.
Example: ‘We failed to deliver on time and budget because we had a poor plan’. What had to happen after we developed the plan for us to succeed in achieving our goal? For example, how was the plan communicated? How was that communication connected to the organisational goal? What measures were put in place to help everyone know how they were travelling relative to the goal? How did we go about making any needed course corrections?
Predicted effect. This check is the tool of the diagnostician, who says if we deem the cause to be something in particular, then it could have multiple effects. The absence of any predicted effect eliminates the possibility of the hypothesised cause.
Example: ‘Because of the tight control we had on our contract labour, production costs for the month ran at a record low’. For the claim to be valid, we would predict that the variable costs of material inputs and all other operating expense beside contract labour remained the same.
I have found that one of the most significant benefits of using a structured approach to critical thinking is how it creates a possibility to avoid either ad hominem attacks or a singular claim for all the credit. It demands that the person who develops the logic has a degree of empathy for the subjects who are part of the analysis and understands the difference between blame, credit and cause. Having a grammar for the application of logic allows the team to share a safe way of examining assumptions and exploring, through dialogue, better ways to do better work.
Given these essential building blocks for the development of compelling logical argument, how can they be used? In my next article, I will start with some tips on how to develop the Goal Tree.
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This is Part 1 of our series on the Logical Thinking Process.
Part 1: Intro to the Logical Thinking Process
Part 2: Setting your goal
Part 3: Mapping your current reality
Part 4: Deciding with the evaporating cloud
Part 5: Realising the future
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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 image: Wooden human sculpture, Daniel Ionn on Unsplash]
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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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