Every industrial workplace has safety rules you ignore at your peril. If you’re not wearing a hard hat and goggles at a refinery, or don’t have steel-capped boots in an aircraft hangar, you’ll be asked to leave. And not politely, either.
[Listen to audio version, read by David Hodes]
For five articles covering each of these rules in depth, start with Maintain True Data
These are binary metrics: yes or no. In or out. So why don’t we apply the same rigour to how we plan and perform our work?
Whilst working on the deployment of Critical Chain Project Management (CCPM), using advanced supporting software, I asked a colleague to share what he had learned about the core principles of making this step change in productivity work sustainably. After much reflection we concurred that, for success, you had to adhere to five core principles.

These are all phrased as an imperative for a reason. For the system to work, they are the five commandments. And if phrased as questions (‘Are you fully kitted for this task?’ or ‘Is this data true?’) there’s a yes/no answer. We have our binary metric.
Let’s take a deeper look at each principle.
Work fully kitted
‘Fully kitted’ means having everything you need before you start. You understand the work’s context and purpose, as well as the outcomes required in terms of quality and quantity. You also have the necessary human, material, financial and information resources to complete it. And you know when it should be finished by.
The Toyota management system famously allows anyone on the shop floor to stop the line when there is a defect. They would rather lose production and solve the root cause of the problem than perpetuate the flaw. Adopting this approach puts a premium on thorough and rigorous planning. Such a mindset demands behaviours which promote high-level coordination and enhanced collaboration across the system. People, parts, equipment, manuals, safety routines, operating procedures and the like must all be in place before the work can start.
If the full kit’s not there when the schedule calls for it, work should not start. Invest the necessary time to address the root cause of why the full kit’s not ready to go.
Act by priority
Theory of Constraints (TOC) is really quite simple. It says that for all systems, the rate at which value is created is governed by very few limiting factors. Often, just one. If our system had no constraints at all, we would have a magical machine that could produce infinite widgets instantly and our project critical paths would collapse to zero time. The laws of physics make the idea of limiting factors incontestable. But it’s easy to lose sight of what it means in reality. Often, a single constraint severely limits the throughput of a system.
There’s another profound—and counterintuitive—consequence that even fewer organisations consider. If we agree there is a constraint, then those people or machines that are not the constraint will, by definition, have capacity to spare. When you know where the constraint is at any given moment, you also know where you have reserve capacity. Every effort should be made to deploy non-constrained resources in a systemic and systematic way to focus on supporting and collaborating with the prime resource assigned to work on the rate-determining activity.
So, for example, if there are two tasks to complete on a project, and one of them is on the critical path and the other has some slack—and the one on the critical path could go faster if the person working on the one with the slack helped out—then deploying the latter to help out the former is being systemically responsive to resource constraints.
As Deming, the godfather of the quality revolution, put it, ‘The object of any component is to contribute its best to the system, not to maximise its own production… some components may operate at a loss themselves in order to optimise the whole system.’
Control work release
A necessary condition for high performance is to work in flow, when the challenge of the task matches the skill level of the person executing it. Similarly, you enable production flow by matching the release of work to the capacity of the system constraint—the bottleneck. In TOC, this bottleneck is called the ‘drum’ because its beat synchronises all component parts of the whole. Push work into the system faster than the drum can complete it and you create a logjam. Release work too slowly and the drum misses a beat. Flow stutters and production drops for minutes or hours, with the inevitable consequence of degraded performance.
When you know the capacity of the drum, you can release the appropriate amount of work to keep things flowing through the bottleneck at the optimum speed. The Theory of Constraints production and project management systems—Drum Buffer Rope and Critical Chain—were invented to solve the challenge of releasing work in the Goldilocks zone—not too much, not too little, but just right.
Resolve issues rapidly
Too often, time is squandered waiting for responses from management. In many cases, managers either ignore queries until the sound of the squeaking wheel can no longer be tolerated, or they tell their subordinates they’re onto it and will revert as soon as possible. When the subordinate asks why resolution of the issue has not yet been forthcoming, the obvious response of the manager is to say, ‘it hasn’t been possible’. We recommend a ‘two-hour rule’ for significant issues. What’s a significant issue? One which affects the system’s ability to meet the promises made to deliver on schedule.
The person who’s received such an escalation notice then has two choices:
In the latter case, the manager signs off on the full burden of the lost revenue, and/or the cost burn rate of the delay, until it has been satisfactorily resolved.
If neither of these two options is taken, the person who raised the issue is obliged to bypass their immediate boss and raise the issue with the boss one level higher. There are occasions when a manager is legitimately not available to respond with one of the two choices above. The idea of bypassing one’s line manager in favour of the next one up in the chain of command should not, therefore, be seen as ‘dobbing in’ one’s boss.
A colleague has a pithy phrase for this context: ‘You can’t push rope’. You cannot expect the person at the bottom of the rope to exert pressure on those above. By mandating all levels of management to follow the two-hour rule, the stigma of being a ‘dobber’ is removed and the tension in the rope is maintained with the pull of policy and behaviour set at the top.
Maintain true data
In one of Eli Goldratt’s lesser read books, The Haystack Syndrome, the fascinating introductory chapter talks about the difference between information and data. Specifically, how to find the needle of information in the haystack of data. Since its publication in 1990, the book’s subtitle, ‘sifting information out of the ocean of data’ has, besides mixing metaphors, become even more relevant in our age of big data and machine learning.
‘Information,’ wrote Goldratt, ‘is the answer to the question asked of the data.’ You have to ask good questions. Crucially, too, the data has to be reliable. From an operational perspective, I’ve found one need only ask about six measures:
Maintaining true data means having a reliable system of record that can provide timely answers to these questions. After all, the purpose of information is to assist in sense making within and across the system being examined. Having a reliable system of record ensures that the best possible sense-making information can be used to support effective decision-making.
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At Ensemble, we work with organisations where safety is part of the culture. To make the point, when onsite, my colleague is fond of innocently pointing out a possible breach: ‘What would happen if I went and stood beyond that barrier?’ The answer is always a variation on how the person would be obliged to warn him and, if he didn’t heed the warning, call for his removal from the facility.
He then explains how none of these five principles of high-performance execution can work without a robust system of binary metrics.
Is the work fully kitted? Yes or no? Are you acting by priority? Yes or no? Are you pacing to capacity? Do you resolve issues within two hours? Are you maintaining true data? Yes or no. Binary answers.
In organisations where people can get hurt, or worse, visitors may be surprised by signs exhorting them to hold the handrail when going up or down stairs, or not walk while using a mobile phone. In a different environment, say a tech startup, such rules would be ridiculed. But in an industrial context, it’s all part of the ‘safety first’ culture. If you want to maximise the throughput of your system, create a culture where the principles of work management are just as non-negotiable.
For the five articles covering each of these rules in depth, start with Maintain True Data
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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:

“Good is the enemy of great.”
—Jim Collins
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