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‘Avoid inertia. Start again.’ Those were Goldratt’s exact words for the final focusing step. Once you’ve made an investment of money, time and effort, the constraint will move. Ideally, you’ll find it where you intended.
[ Listen to audio version, read by David Hodes]
This is Part 7 of our series on The 5-Step FOCUS:
Part 1 | Part 2 | Part 3 | Part 4 | Part 5 | Part 6 | Part 7
Let’s say you applied the 5-Step FOCUS and the constraint was in supply. If your ‘uplift’ step was to invest in new sources, the constraint may then move to production. If you’ve invested in production resources, you may now be seeking additional markets for your goods and services. And, if your uplift step was to invest in your marketing and sales, you may find you now have to effectively marshall your resources to accommodate the step-change increase in demand.
But there’s something vital missing if all we consider when contemplating the final step (‘S’ for ‘start again’) is to think about the logic of load and capacity as applied to the buying, making or selling functions. People are not widgets, and they need renewal as much as any process might need modernising. It’s exhausting bringing a significant investment to the finish line. But, in truth, that line is only the starting point for the new business dynamics.
You may have considered all the major elements of organisational change management carefully. You may have acted on the job readiness reviews and completed both structural change and system and process training. You may have aligned the workforce within an effective accountability hierarchy and developed their competency to manage the new technology and processes. You may even have developed a communications plan and some expertise in change leadership.
These are all important and necessary steps. But do they create a sufficiency for the sustained success of your enterprise? There is no guarantee that the uplift investment will work. How can we give it as good a chance of doing so as reasonable and possible? What else might mitigate the risk associated with transforming an idea into an innovation capable of delivering a return commensurate with the resources marshalled to make that transformation happen?
A fundamental part of the ‘start again’ step is to think about renewal. Once, while watching a lecture by Joseph Campbell, I was taken by a metaphor he used. He told us that life is a force that is in and of itself regenerative—you cut the lawn, and it doesn’t fall over and say ‘enough is enough’. I agree with Campbell that we humans are similarly inclined. Like the lawn, we need nourishment from the ground of our being. The more cycles we go through of the 5-Step FOCUS, the more depleted the soil becomes, and the greater the need for renewal. It fits the system archetype of limits to growth. For every growth cycle, we must pay attention to what forces are limiting that growth.
Fundamental to the process of renewal is the story we tell ourselves about why we do what we do. Every religion, country and organisation has a founding story, or myth. We know of Adam and Eve and the expulsion from the Garden of Eden, Captain Cook and his voyages to the Antipodes, and the Queensland and Northern Territory Aerial Service as the beginnings of QANTAS.
It may be the case, as in Proverbs 29:18, that ‘without vision, the people perish’. But it is equally true that if we have no narrative about where we came from, no tales of the derring-do of our founders and heroes, no accounting of the epic battles we joined to grow and prosper, then all the technology investment and process improvement in the world will be unable to inspire people beyond perfunctory performance.
“You cut the lawn, and it doesn’t
fall over and say ‘enough is enough’.”
Since all improvement requires change, but not all change is an improvement, you can be sure that within your organisation, many will be sceptical of your ‘uplift’ initiative. Some will be outright cynical. A powerful antidote to cynicism is a compelling story that inspires people to act with a sense of purpose transcendent of the locus of self. The narrative should invite them to dwell in the profundity of the questions: ‘How can I serve the greater whole? What does the universe call on me to do? If not me, who? If not now, when?’
If we are to live a life filled with meaning, we must fully embrace the responsibility of lifting our full share of the burden of bringing into being the future in which we wish to live. The implication is that if the story is good, beautiful and true, we will have the means to sustain ourselves through the inevitable dips associated with bringing something new into the world.
In his book The Dance of Change, a ten-year retrospective on his endeavours to introduce into the world of business ideas about Learning Organisations, Peter Senge noted the following factors limiting the adoption of the principles contained in his seminal book The Fifth Discipline.
• There’s not enough time.
• There’s not enough money.
• There’s not enough help, and we don’t know what we’re doing.
• It’s irrelevant.
• The leadership is not walking the talk, so why should I?
• I’m not sure if I’m able.
• Can these people be trusted?
• Can I trust myself?
• Why is it taking so long?
• I don’t want to be part of a new religion.
• What they’re doing is a complete mystery to me, and I’m anxious about showing my ignorance.
• Who’s in charge?
How do you overcome these limiting factors? How do you sustainably embed and develop mastery of the new technology and processes in your organisation? Through the power of the story you tell, which itself is amplified by the grandeur of your vision. Fail here and your efforts will likely produce ‘just a transaction system’. It is doubtful there will be any motivation towards process discipline, which in turn will result in poor data quality. The limitations on the data will hinder the ability to make sense of the local and global situation, resulting in customised fixes and symptomatic workarounds. Generating sustained outcomes is achieved through the plaiting together of grand vision and remarkable operating discipline.
In Built to Last, Jerry Porras and Jim Collins characterise ‘truly great companies’ as those that ‘understand the difference between what should never change and what should be open for change; between what is genuinely sacred and what is not’. This idea gets to the heart of what a genuine culture is all about. The balancing act of managing this change while maintaining continuity takes, they say, a rare ability ‘requiring a consciously practised discipline—closely linked to the ability to develop a vision’.
We have now reached the end of our deeper exploration through the 5-Step FOCUS. In thinking through this cornerstone component of the Theory of Constraints, I hope that I leave you with the sentiment of ‘Start Again’ best expressed by TS Eliot: ‘We shall not cease from exploration, and the end of all our exploring will be to arrive where we started and know the place for the first time’.
This is Part 7 of our series on The 5-Step FOCUS.
Part 1: Identifying the System
Part 2: Setting the Goal
Part 3: Find the constraint
Part 4: Optimise the Constraint
Part 5 : Collaborate Around the Constraint
Part 6 : Uplift System Performance
Part 7 : Start Again
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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: Boy at stairs, Jukan Tateisi 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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