You’ve probably heard about managing your work using the Pareto Principle, or the ‘80/20 rule’. The idea being that 80% of outcomes derive from 20% of the causes. The causes may be clear in retrospect. But how do you know what to focus on in advance?
Organisations are complex and interdependent in nature. What one person believes will improve the organisation is usually limited to their domain expertise. Many times, individuals can’t see the global impact of their localised perspectives. Compounding the issue, management rewards behaviours using metrics and accounting systems that optimise local priorities at the expense of the business as a whole.
Such conflicts jeopardise the organisation’s performance and hold back enormous potential because they encourage people to work against each other. This unintended consequence is a big problem in large companies where the common goal is obvious—make a profit—but where competing interests often lead to misalignment. In our age of disruption, it’s akin to people carefully tending their patch of trees while a wildfire is ripping through the forest.
‘Focus on those things that count’ is a good mantra and excellent advice. The problem, of course, is that what you imagine might count, may not be what actually counts. And worse, what ‘counts’, in large organisations, is determined by politics—with clashing egos and personal agendas setting priorities and determining what is deemed ‘urgent’. It becomes a matter of opinion. Or who shouts loudest.
So, is there something to help organisations cut through the noise? Is there a way to align behaviours across the enterprise and hone in on what will objectively contribute to the goal of any business? Namely, making more money now and in the future?
We think so. And it’s called the Theory of Constraints (TOC). The founder of TOC, Eli Goldratt, was once asked to summarise it in one word. His answer? ‘Focus.’
Focusing a lens on your organisation
TOC is a powerful lens that helps organisations get beyond the insular illusions of organisational silos and focus objectively on doing those few things that will contribute positively to the bottom line. TOC poses three simple yet powerful questions of the organisation:
What to change? What to change to? How to make the change?
Goldratt analysed the persistent problems that arise in managing business operations and asked these three questions in order to find out how they could be irrefutably solved. A physicist by academic training, Goldratt was inclined to elegant and logically articulated solutions to complex situations. TOC is a true theory in the sense that it is a falsifiable hypothesis.
Goldratt’s solution proceeds from the hypothesis that all systems, in business or otherwise, have constraints or bottlenecks. If that weren’t the case, the output of the system would tend to infinity. Or the time a project takes would collapse to zero. Since no business produces an infinite return on investment—or completes projects instantly—it is therefore proven that constraints exist and that they govern the rate at which value is created.
We all know anecdotally that a chain is only as strong as its weakest link. TOC acknowledges the reality of these weak links, or constraints, in business and provides a framework for how to manage them—instead of having them manage us.
Not satisfied with conventional management practices and incremental improvements, Goldratt sought a means of identifying the deepest sources or leverage within an enterprise and how to take advantage of them. TOC is not chiefly about things like process improvement, waste reduction or quality control. It’s about making money.
TOC is designed to identify and maximise the value of activity performed at or by a company’s most scarce resources. These resources (constraints) are what determine the level of financial performance the business is able to achieve as a whole.
“The constraint governs the rate at which value is created.”
Even so, in most organisations, the three questions (What to change? What to change to? How to change?) usually elicit a multitude of opinions but few objective answers in relation to achieving the goal of the company of making a profit.
So Goldratt developed a process he called the ‘Logical Thinking Process’ to painstakingly validate the robustness of his solutions. In taking a deep dive into the conflicts that plagued production, project management and distribution operations, Goldratt uncovered a common factor contributing to the deterioration of quality, due-date performance and lead time, all of which have a substantial impact on the bottom line.
Underperformance for the most part, he discovered, is caused by management’s lack of knowledge about how to successfully manage a company’s constraints and the inherent variation or ‘uncertainty’ that disrupts the flow of value produced by those constraints, by over- or under-loading them. This observation is applicable for any given operational environment.
To remedy this gap in managerial knowledge, Goldratt consolidated the solutions into a five step continuous improvement process, called The Five Focusing Steps.
Goldratt’s steps included words like ‘subordinate’ and ‘exploit’. Over many years of delivering TOC in our consulting practice, we’ve found we start off in defensive mode justifying these rather unfriendly words. After all, do people really want to ‘subordinate’ themselves or be exploited? Of course, Goldratt didn’t mean it like that. But since systems are run by people, if we want to change the way they think about their work, we need to consider our language. So we reworded his phrases to be more inspiring. It’s no coincidence that the first letters of these phrases create an acrostic: FOCUS.

1. FIND the constraint
Which resource is the most overloaded? Is it a process? Or a person? It could even be the market itself. And a company can also determine where to place its constraint by design to control the process of value creation.
2. OPTIMISE it
Is the constraint ever idle? The constraint should do ‘only’ that which ‘only’ the constraint can do. (We call this the ‘double only’ mantra—you need the word twice to capture the whole meaning.) As far as possible, a company’s constraint needs to be 100% utilised, since it’s the constraint’s activity that determines total business performance. Its needs should be prioritised over the needs of other resources (non-constraints) which become free to support the constrained resource.
3. COLLABORATE around it
All other resources are not constrained and therefore have capacity relative to the constraint. When required, they must assist the constraint, ensuring it is 100% utilised in performing value added work. Non-constraints not only don’t have to run at capacity—they shouldn’t, as their extra output is wasted and even creates more stress at the bottleneck. This is an eye-opener for those managers bred to aim for 90% utilisation across all resources.
The first three steps prioritise activity based on value contribution, focusing only on those things which deliver bottom line results. Applying them correctly typically yields a 25% improvement in performance that was latent in the system.
4. UPLIFT system performance
Add additional capacity to the constraint. This usually means investment. In other words increase the amount of value the constraint can produce.
5. START AGAIN
After elevation, the constraint will shift to another location in the value chain. To avoid the inevitable inertia when the system settles down you must go back to step one. This is why it’s called continuous improvement.
In later posts, we’ll look at more of what Goldratt called the ‘proven solutions’, which cover Project Management, Production, Distribution and even accounting. They are the bedrock on which the Ensemble Way is built.
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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