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Imagine being the conductor of an orchestra and having to make your baton signal for every note of every musician, from beginning to end. Impossible, no? Now try and imagine the musicians playing without the guiding hand of the conductor to keep everyone sounding together—louder and softer, faster and slower, entrances and exits. This is the dilemma we face in our projects. We need to understand the ‘score’ in two tiers.
The top tier represents the fundamental shape of the project—the path from beginning to end—along with the resources for each task. In our orchestral analogy, the resources are the different parts of the orchestra—strings, woodwind, brass and percussion—while the conductor ‘assembles’ the musical phrases across the ensemble to create a mellifluous whole.
The second tier on the other hand is the detail each musician deals with. The second tier comprises the individual notes conceived of by the composer—each contributing to the effect on the listener—put together skilfully by each practitioner. We want our musicians to have mastered their instruments, and to use that skill to liberate themselves to turn the notes into phrases that stir the emotions.
It’s not enough to merely play out the algorithm of the notes on the stave—they must hold together, in both timing and harmony with all the other notes of the composition, to create a whole that is more than the sum of its parts. It’s really an extraordinary feat of human accomplishment to have perhaps a hundred musicians or more performing as one to achieve the intent of the composer.
The enigma of variation
In a project setting, Critical Chain 1.0 provided the means by which the top tier could be effectively managed. Goldratt captured the risk associated with what Deming characterised as ‘common cause variation’ and aggregated it in a buffer at the end of a resource-levelled chain of tasks. The work could then be monitored to check the rate at which the actual work was being completed against the rate at which the aggregate protection was being consumed.
In Goldratt’s original idea, he was there to solve the problem of finite capacity whilst labouring in the real world of uncertainty. You know that Murphy is always going to strike—you just don’t know where. The effect of a delay, using CCPM, can be effectively traced back to the specific task causing it. Focus the effort on that task, at the bottleneck, and it becomes possible to increase project throughput. This was a huge innovation in productivity. The benefits were shorter completions which realised the early receipt of benefits, incurred less project burn and allowed the organisation to deploy people to the next big idea sooner.
“You know that Murphy is always going to strike—
you just don’t know where”
However, when it came to the detail, matters tended to get too complex; different means (such as spreadsheet support) had to be used to articulate the detail. This was not particularly satisfactory, even though the results were a massive improvement on the critical path method which preceded it.
Thanks to pioneering work done by the likes of Sanjeev Gupta and Wolfram Muller we now have a robust framework for two-tier scheduling, extending the breakthroughs of Critical Chain Project Management for a whole new range of applications—and even better outcomes for those who have already started their CCPM journey.
Below is a brief explanation of the technical breakthrough of two-tier scheduling, with the assumption that you have read our executive guide to critical chain or know what it is through some other means. If you prefer to watch a video to get the basics of critical chain and buffer management, have a look at this video called Keeping Control in Real Time from our Science of Work playlist.

In the diagram, our project has three top-tier tasks, coloured in blue. Each represents a bucket of work which can be handed to a supervisor to complete. (We’ll assume you know typical task durations and are using the critical chain concept of pure touch-time, with no padding.) Within each bucket are four tasks, though there could be more. The different colours represent different resource types and their lengths represent their duration.
The nature of the tasks gathered under top-tier task 1 is such that they have to be done sequentially. Top-tier task 2 has enough resources available for two tasks to run at a time, so the red and yellow second-tier tasks can start together. But only once the first is complete can the next one start. Work-in-process (WIP) is therefore released in a controlled way. (WIP control doesn’t have to be restricted to two concurrent tasks; it depends on the available capacity.) Note also that the black task starts before the green in this case. We’ll come back to this a little later. The tasks in the last bucket (top-tier task 3) can all run in parallel, so its duration is determined by the task which takes the longest—in this case, the yellow one.
(Naturally, parallel work requires more resources, while the WIP-controlled mode lets you pace the work to your capacity. In many cases, logic will dictate when you must use the sequential mode but you might sequence work deliberately to use fewer resources. The work will take longer, but if the task isn’t on the critical path that may be fine.)
The overall duration of the schedule is thus a critical chain of 10 days and a buffer equal to half as much again (the standard calculation for a project buffer), making a total elapsed duration of 15 days. The project manager now has a plan resolved at the right level of resolution to execute the work. He or she is the equivalent of the conductor I talked about above. Their role is to monitor the progress of the top-tier tasks only, doing whatever is necessary to keep the work in flow towards the desired end-date.
Devolving authority to those doing the work
Beneath the top tier, so long as the participants keep within the bucket of activity and duration scheduled, they have the autonomy to organise their work as they judge to be in the best interests of the project as a whole. There are no hard dependencies between tasks within a top-tier bucket, as it is never so complex that the task manager in charge of the bucket cannot make a determination based on his or her own knowledge. The whole point of gathering second-tier tasks into a bucket is that they can be adjusted to take account of the situation in the moment.
Two situations can illustrate when this autonomy can be exercised. Let’s say that one of the tasks in the list is to overhaul a motor, and another is to isolate the electricity from the motor before starting the work. The task manager of any top-tier task would understand the work well enough to ensure the second-tier tasks were arranged in such a way as to ensure correct precedence was followed. If a sequential mode hadn’t been chosen, the task manager for, say, top-tier task 2 (the bottom bucket in our diagram) would arrange the second-tier tasks for safety, quality and speed, as part of the full kitting of the task.
“The dynamic shifts from ‘command and control’
to one of enrolled engagement.”

Look again at top-tier task 1 and top-tier task 2 which are themselves proceeding in parallel as work buckets. The order of the black and green tasks has been switched to remove the contention for the green resource. This is possible because the task manager for top-tier task 2 has the autonomy to determine which two tasks to put into WIP. On Day 4, we can see that yellow resources are required across two top-tier tasks. This might mean some levelling is required between those two top-tier tasks. It might also be possible to take resources from elsewhere in the system and apply them to that single overlapped day requiring yellow resources.
This is a simplified example. In real life, these kinds of calculations would quickly become cumbersome and complex beyond human brainpower. Fortunately, dedicated software is here to help. At Ensemble, we are proud to be associated with and represent Realization Technologies, pioneers in the art and science of execution management using the Theory of Constraints and Critical Chain Project Management (CCPM). With the Concerto tool (Realization’s CCPM software), you can input your workplan and then toggle between the different modes (sequential, parallel, WIP-controlled) to instantly see the tradeoffs between schedule and resource consumption (cost).
An ‘Agile Work’ manifesto
I should note that two-tier scheduling is absolutely not the same as the levels of a traditional work-breakdown structure (WBS) such as you might see in MS Project. There, work is organised much like a book’s table of contents, expanding from parts to chapters to sub-sections. But that’s just a way to collapse a Gantt chart. Two-tier planning, on the other hand, is a way of organising work such that you can maintain the shape of the network at the appropriate level of detail to ensure you navigate effectively to your goal. It also provides the people doing the work with all the detail they need in terms of work orders and operations.
A primary motivator for people at work is to have autonomy and be trusted to do the right thing by the team. The two-tier scheduling method gives those who manage the top-tier task high levels of autonomy to execute the second-tier tasks, but within the guardrails required to keep the overall project on track. They are encouraged to work with the people actually carrying out the tasks, to figure out what’s best for the whole. The dynamic shifts from ‘command and control’ to one of enrolled engagement.
It is not difficult to see how such a method can be used to powerfully combine the best of Agile and Waterfall methods. After all, what is contained in the top-tier task is really a series of Agile story points. And you could easily think of a top-tier task as a sprint. Two-tier scheduling therefore builds on what Wolfram Muller calls ‘Reliable Scrum’. In fact, we’d go so far as to tweak the original Agile Manifesto, overwriting some of the words with our own. Call it our ‘Agile Work’ manifesto—an invitation to a world of More Than Just Work.
Ensemble’s Agile Work manifesto

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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:
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[Background photo: ‘What path to take’
by Abraham Barrera on Unsplash]
“Nothing is more powerful than
an idea whose time has come”
—Victor Hugo
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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