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Think of a production system and you’ll probably conjure up some kind of assembly line. Whether you imagine humans or machines doing the work, this mental model feels wedded to manufacturing. It needn’t be—production principles are universal.
An airline’s check-in desk is part of a production line. So is the hospital’s procedure for admitting patients. Running scripts in software development is production. As is the sales pipeline that gets software to market. Insurance claims and loan applications? Production systems. And the barista in the café offers a vivid everyday production system—so obvious we almost don’t see it as such.
Perhaps we don’t naturally think of these examples as production environments because they don’t result in physical products that would hurt if you dropped it on your toe. But even the kind of heavy industrial environments we at Ensemble operate in offer plenty of counterintuitive examples, including:

All these examples are production systems that benefit from a systemic approach. Let’s examine a simple process made up of four steps, each of which is linked to the other. And let’s say the capacity to do work for each step is as shown in the diagram. It doesn’t really matter what the process is, but let’s use technical notifications as an example.
Let’s say that the person at the first work-centre, an inspector, generates 20 notifications per day. The person at the second work-centre has the capacity to assess 14 of those notifications per day. The highly skilled planner can only manage to plan 10 notifications per day and, at the end of the process, back office has capacity to close out 20 notifications per day.
On the demand side, the manager of the process has been told to allow for a regular demand of 10 notifications per day. In the majority of cases, the manager would be looking very closely at costs and would wonder:
Why do I have all this extra capacity? The planner can only handle 10 units per day, so she’s the bottleneck. Yet this capacity perfectly meets demand.
So I’ll scale back the capacity of all the work-centres to 10. This will balance the system to match the demand while reducing costs by removing unneeded extra capacity.
The manager who thinks this way, trying to perfectly balance supply and demand across a connected sequence of steps is in for a nasty surprise. With the newly ‘balanced system’ (all work-centres at 10 capacity), production consistently falls short. Why? The manager discovers that common cause variation means that each of the steps in the process has only a 90% chance of processing their full quota of 10 notifications per day.
By the laws of statistics, the cumulative probability of getting ten completed is reduced to 90% to the power of 4—that is, 90% x 90% x90% x90%—or a cumulative 65%. In other words, almost one in three notifications would not be completed on time. The name of this statistical fact is covariance—when there are individual fluctuations between dependent events.
And of course, over in the real world of the plant, what if equipment failure increases and demand changes? If it’s lower than forecast, we end up with people standing round idle. While if it’s higher than forecast, we delay return to service.
First, find your constraint
If, as per the Theory of Constraints, systems are governed by their constraints, the first thing we must do, is to find the constraint. What’s yours? Do you know? Is it where it is because you’ve designed your value-creation engine to take advantage of the laws of physics? Or are you forever its victim, watching it turn up, unannounced, in a different place every day…like whack-a-mole?
Once we find our constraint, if we want to optimise its performance for value creation. How can we go about doing that?
The TOC approach to managing production systems is called Drum Buffer Rope (DBR). Let’s take a closer look at how Dr Eli Goldratt, the physicist founder of the method came up with such a name.

The constraint in our example is the planner, who can only plan 10 jobs per day. We call this bottleneck resource the drum, because it beats the rhythm of value creation. The power of the solution lies in the fact that a 10% gain at the drum is a 10% gain for the system as a whole. That is, 10% more capacity for the planner means 10% more production for the whole maintenance system. 10% more production for the maintenance system means less downtime, more reliable performance and more throughput. By the same logic, increasing the capacity of a non-constraint by 10% has no positive effect on the system and, in fact, may produce a negative effect by increasing the backlog and stress at the bottleneck.
“A 10% gain at the drum is a 10%
gain for the system as a whole”
In most cases, the value of that gain in throughput dwarfs whatever gain there might be in micromanaging the operating expense of each component part. Moreover, designing your production around your drum lets you use it as a synchronisation tool for the whole—everyone marches to the same drum beat. And, it bears repeating, because by definition everyone has more capacity than the drum, 10% gained at the drum is 10% gained for the system as a whole.
Understanding this requires a mindset shift. Everyone has to play as one band. If the drum is starved because the upstream process was goofing off or produced the wrong component, the whole system loses out. So how do we ensure that the drum never runs out of work? Well, we place a buffer in front of it. This buffer is in effect the stored capacity of the upstream functions. We want to size the buffer so that it’s not so big as to flood the engine with work in progress, but not so small that the drum misses a beat because it’s starved. This is why everyone on the team has to understand the idea of supporting the constraint—their colleagues working at the drum.
To keep the size of the buffer right, we tie a rope to the release of inputs at the entry point to our engine. The buffer is sized to be big enough to accommodate the time it takes from the input step until it is ready to be processed by the drum. As soon as the drum has begun work on the buffer, it gives a tug on the rope to release the next work packet, such that it arrives in good time to keep the whole value-creation engine running smoothly.
And, yes, the rope means that occasionally those working in non-constrained work-centres will be asked to slow down, or even stop work, so as not to flood the engine. This is profoundly counter-intuitive to our natural assumption of what it means to be ‘productive’.
With our drum-buffer-rope system in place, we give our system its best chance of 10 out of 10 performance. At this point, there is no way to squeeze more juice out of the system in its current configuration. If we want to uplift the system now, we need to invest in additional resources. Most organisations jump straight to this step long before they need to—and often with unintended consequences.

Adding another planner at the drum takes the combined uplifted capacity to 20 jobs, which is at first glance more than the plant demands. The internal constraint of the production system has become external. It’s time to find new tasks to which we can put this hitherto hidden capacity. Could we encourage the team to be more proactive in bringing innovation to their work? How might they use the time dividend released to contribute to ensuring that ever shorter turn-times deliver ever more throughput—reliably, on time and at the requisite quality?
Let’s recap the steps to implementing DBR—one of the twentieth century’s least known, but most effective, innovations in productivity:
One final note. It is a tragic truth that most managerial leaders are all too keen to use the productivity gain of DBR to fire people who they believe are now surplus to their requirements. This mindset completely misunderstands the ‘systems thinking’ approach to improving production. Firing people may provide a short-term cost-saving, but is foolish in the medium- and long-term if you want to develop a culture of continuous improvement which, after all, is the only way you can sustainably compete. Why would employees wish to improve production if they knew that in doing so, they would be putting their own jobs at risk?
To accomplish the principles of Just Work—in which everyone has the right to be well-managed—we must rather tap into aspiration and imagination. Do the hard yards of gaining the trust of your workforce to co-create better ways to do better work.
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The Theory of Constraints offers a new operating system fit for our complex world of change. To learn what that operating system might look like, we invite you to download our Executive Guide to Critical Chain Project Management [PDF].
The change of mindset 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. Just as astronauts need a few zero-gravity rides in a special aircraft before they experience the real thing in space, the game simulates the effects of TOC. We call it The Right Stuff workshop and we’d love to run it with you.
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[Background photo: ‘Coffee smarts’ by Nathan Dumlao on Unsplash]
“Every situation, no matter how complex
it initially looks, is exceedingly simple”
—Eliyahu Goldratt
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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We’ll only use your email address for this newsletter. No sales calls