Have you heard about this amazing form of personal transport? In a city, it’s often faster than a car; in the country, it connects you to nature. It’s cheap, green and keeps you fit. The bicycle may not be the jetpack we hoped for as children, but it does all as advertised. So why aren’t we all on our bikes?
It’s a profound paradox that something as simple, powerful and unique as Eli Goldratt’s Theory of Constraints can be so difficult to implement in an organisation. So what’s the constraint? The reasoning behind the theory is rock solid:
All systems have a constraint. If this were not the case,
the output would be infinite, or would collapse to zero.
Do you know of any business making an infinite return on investment? Do you know of any project whose critical path is over before it begins? Can you think of a supply chain where an item of physical stock is replaced the very minute it is sold? Of course not. And until you find data to disprove it, you too must accept the idea that the rate at which systems deliver value is governed by their constraints. So simple, and yet so elusive.
It’s not only theoretical, either. The empirical evidence around the results achieved by applying TOC methods to production, projects and replenishment is overwhelming. A PhD written on the comparison in results showed, across a sample size of twenty electronic plants, that when TOC was applied in combination with Lean and Six Sigma, the tangible dollar and cents results were an order of magnitude more than when only Lean or Six Sigma were applied. An academic study out of Victoria University in Wellington, New Zealand, showed average increases in throughput (revenue) of 68%, reductions in inventory of 50%, improvement in due-date performance of 60% and lead-time reductions of 69%.
The evidence is in
These are incredible results supported by empirical evidence. So why isn’t this just the way work is done? Why do people who know about it, whether expert or amateur, end up scratching their heads when asked the question: ‘If it’s so good, why isn’t everyone doing it?’ I’ve been using TOC for the last twenty years so I’ve heard pretty much every response you could imagine–from the instant evangelists to the diehard cynics. Only a very few have gone on to realise the full benefit available to them from this remarkably simple idea, but many more have stumbled and fallen.
I remember the first time I went to my boss and asked him if I could give TOC a go. I was the managing director of a national commercial refrigeration company serving a leading chain of supermarkets as they transformed their customer value proposition. After a period of being starved for work and living on the crumbs from servicing installed fridges, we were hit by a tsunami for which we were ill prepared. My research led me to The Goal. As soon as I finished it, I knew there was something profoundly different about this way of thinking. Yet when I told my boss what I’d discovered and how I would be able to better manage my bottlenecks through the application of its associated Critical Chain Project Management methodology, he told me he didn’t believe in constraints. ‘I may not believe in the theory of gravity,’ came my response, ‘but that doesn’t mean my arse doesn’t point to the ground.’
“Non-constraints have capacity available”
So, there are two clues about the adoption of TOC. You need to be convinced of your argument and you need courage to take on conventional wisdom with all of its associated inertia. This, however, is what you would ordinarily expect from the adoption of the likes of Lean, Six Sigma, Agile, PRINCE2 and the assortment of other methods you can name. But, TOC has a particular burden, unlike any of the others. You see, all of the rest can comfortably get away residing in the reductionist world of our management and accounting systems. But TOC and its associated methods cannot. Why? The more profound implication of the Theory of Constraints is not that systems have constraints—everyone knows that intuitively. What matters is that non-constraints have capacity available relative to the constraint. And that’s where the real trouble begins as you go to war with the custodians of the accounting systems.
Of course, even the most modest business is a complex web of people, process and technology in constant motion. They are divided into the functional specialities of sales, marketing, manufacturing, distribution, R&D, IT, finance and so on. How else, you ask yourself, could you tame the complexity other than by dividing it up into more manageable parts? Just do what you can to keep those parts functioning efficiently and live comfortably in the delusion that the sum of the parts delivers what’s best for the whole. Throw into this mix that you don’t have to be excellent—just that bit better than your competitors—and you’ll earn enough to keep playing the game.
There’s another big obstacle to moving to constraint-based management. We have what Daniel Kahneman, Nobel-winning author of Thinking, Fast and Slow talks of as ‘loss aversion’ where we count our losses at twice the value we give to our gains. We would prefer not to lose a dollar than make two. Effectively, we treat our bird in the hand as worth the two you offer me from the bush. Even if our bird clearly has a broken wing.
“You need to be convinced of your argument and
you need courage to take on conventional wisdom.”
It has certainly been my experience that whenever I’m called in it’s not because of an aspiration for greatness; rather there’s a terrible fear of loss. Fortunately, that fear can be a powerful stimulus to adopting new methods. For, as MIT’s Edgar Schein put it, learning probably isn’t going to happen until ‘the anxiety of survival outweighs the anxiety of learning’. The leader is now ready, as economic buyer, to engage. The competitor is eating his lunch and there is real fear about personal survival, and in extreme cases for survival of the organisation at large. He or she is ready to take on the deep transformation required to bring in something—anything—that will make a difference. Now the conditions are ripe for making the reasoned argument, backed up by the comforting empirical data.
But that’s only the external sales job done—the journey has barely started. A central tenet of the Theory of Constraints is the 5-Step FOCUS. If a constraint exists—a real one, a systemic one which prevents you getting more of your goal—then the first order of business is to find the damn thing. In fact, I’ve found that the first order of business is to get really clear about the boundary of the system you are dealing with and to clearly articulate the goal in terms of ‘at least x by no later than y’. But, that’s a story for another day.

Let’s assume you know the boundary of your system and its goal. Finding the real constraint is no simple matter. And even when you know it, the process of managing it by stepping through the 5-Step FOCUS (see illustration) is a real challenge. For starters, we have to be clear about our time horizon. Are we thinking ‘day of operations’, the tactical look-ahead or the big strategic horizon? Where would we design the constraint into our system if we had the choice and how might we keep it there? Supply? Our ability to make? The market’s ability to buy what we make? And once we have chosen, what method are we going to use to make the most of our constraint? The theory of Constraints clearly has the most to offer (the clue is in the name).
Are you ready for real collaboration?
By far the greatest obstacle to adopting TOC, though, is not the theory itself—it’s the collaboration part. If non-constraints have capacity relative to the constraint, which by definition they must, then their job is not to maximise their own production, but rather to support getting the most out of the constraint. This demands that people get moved around; that having multiple skills to bring to bear on whatever-the-problem-is defines a person’s value; and that you may have one supervisor today and another you’re not so keen on tomorrow. In short, what sounds like a process problem is really an organisational one. There is a basic instability in the social fabric of an organisation being managed on this principle. Indeed, to paraphrase Churchill, it’s the worst system of management possible, besides all others. That’s why people come to TOC last—when all else has failed. The belief that you can learn a better way of working ultimately demands a ‘growth mindset’.
To return to our cycling analogy, if you live twenty miles from your office, it may not make sense to ride in each day. Many people who discover TOC think it’s great in principle but, like a bike, has a rather specialist application. Wrong. If you work in any kind of production or supply chain—or projects, which these days covers most everything else—TOC is not only your friend, it’s the best chance you have of realising the bold vision you need to stay competitive. And, like riding a bike, once you learn how, you’ll never forget.
* * *
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:

‘If you change the way you look at things,
the things you look at change’—Wayne Dyer
____________________________
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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