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Producing production

David Hodes, Founder

Every dollar of the material prosperity we enjoy can find its roots in the industrial revolution and our ability to produce more for less. We came off the farms to work in the factories and delivered unprecedented growth in wealth for our toil.

This is Part 3 of our series on Asset constraint management: Part 1 | Part 2 | Part 3 | Part 4 | Part 5

Dickens gave us the literary view of what those early days were like and Marx had us thinking about how the means of production, distribution and exchange could be put to better effect if it were all owned and run centrally. Thankfully, I live in a country where Marx’s ideas carry little weight. Instead, our commercial and economic systems are deeply grounded in the concept of free enterprise, with unprecedented opportunity of wealth for toil.

People are at liberty to enter into a voluntary exchange between each other for the provision of goods and services that have the intention of delivering additional value and wealth to both parties. In the free market, it means that we have to compete against all comers in the global economy to both persuade and influence our existing customers to remain loyal and to win new ones.

If we have established that there are customers willing to pay us for products or services we wish to offer the market, then the question has to be how we go about producing them. Because we are thinking about production, we’ll ignore for now the work that goes into, in the first place, the marketing and engineering of the product or service—which is better suited to the domain of portfolio, program and project management.

Productive questions

My definition of production is simply the making of goods or services available for use. It is clear, then, that besides the desirability of the product or service itself, the critical factor is how we go about its production. How long will it take to get to the customer? What fixed and variable costs will I incur in doing so? What contribution will I make per unit, and what profit will the product or service add to my business? What penalties will I incur if I cannot deliver against my promise? What premium might I get if I can supply in shorter times than my competitors? How much do I need to invest in plant, equipment and inventory to be a reliable and agile supplier to my customers? How will I ensure that everything I supply is routinely of a quality that satisfies the needs of my client and minimises rework? What kind of learning program do I need to pursue with my team to continuously upgrade their ability to deliver ever better outcomes?

We owe an enormous debt to the pioneers of productivity, from the ‘scientific management’ of Frederick Taylor to Deming’s System of Profound Knowledge and from Taichi Ohno and the Toyota Production System onto the revolution wrought by Eliyahu Goldratt and his Theory of Constraints (TOC).

Ohno gave us the first fundamental principle of Lean in his famous quote: ‘All we are doing is looking at the timeline,’ he said, ‘from the moment the customer gives us an order to the point when we collect the cash. And we are reducing the timeline by reducing the non-value-adding wastes’. I always thought that the simplicity of Ohno’s injunction was akin to golf: get the ball in the hole in as few strokes as possible, or Goldratt’s injunction to make more money now and in the future. Compelling ideas because of their simplicity but requiring high levels of mastery to accomplish.

Below is a diagram of eight different types of waste identified by the Toyota Production System and subsequent development of Lean Manufacturing. In Goldratt’s words, he stood on the shoulder’s of giants to take what his predecessors had accomplished and use his insights from TOC to go further. While eliminating waste is a good start, it’s not the reason you run a business. What you’re there to do is, as mentioned a moment ago, ‘make more money now and in the future’.

Toyota Production System Wheel

There is a fascinating story told of the early days of TOC production software development. There were two significant challenges. First, most of the focus in those early days was in developing software for financial controls. Thus, access was granted to the ops analysts and programmers for minimal amounts of time in the dead of night when everyone else had gone home. Second, the memory available on the processors was tiny, so the pioneers had to enforce certain assumptions about fixed lead times and batch sizes, or else the computer couldn’t calculate the resulting production plan. This rule on batching and lead times became the norm in the development of materials requirements planning (MRP) software.

“Get the ball in the hole in as few strokes as possible”

The consequence of these fixes was an enormous impost on big manufacturing companies, in the form of the massive inventories the algorithms demanded. In a way, it suited them, as their management accounting systems were being run based on absorption costing principles. The more stock you made, the more of your cost base you ‘absorbed’ into it. Work in progress piled up on the shelves and the balance sheet showed them as assets. The only trouble was that much of the resultant product didn’t have a customer. All that production capacity, working capital and physical space were wasted.

All systems have constraints

Along comes Goldratt with his remarkable truth: all systems have constraints—if they didn’t, the output would be infinite. Since no system is capable of producing an infinite output, the theory holds as a valid falsifiable scientific hypothesis. A consequence of this insight was the development of the Five-step FOCUS, Drum Buffer Rope Scheduling and the TOC approach to management accounting called Constraint Accounting. These three innovations in productivity provided a platform to address the systemic issues associated with the complexity of the production environment.

Consultants and improvement practitioners around the world applied these methods and tools across an increasingly diverse array of industries. It turned out there were four basic production shapes—V, A, T, and I—each of which had their particular challenges. It is a testimony to the power of TOC’s approach to production planning and control that it can tailor the general principle to the specific use case. The four main production archetypes are recalled by the letters VATI because of the way the parts flow through the system. Each process looks like one of the letters, traced from bottom to top.

To quote from Eli Schragenheim’s paper in the TOC Handbook (p.201):

Material dependency, resource dependency, convergence points and divergence points are the fundamental elements of a product flow diagram (PFD). Production operations can be classified into families based on which element is the dominant element in the PFD of that particular operation. If divergence is the dominant element, then we have a V plant. If convergence is the dominant element, then we have an A plant. If both divergence and convergence exist (and exist at the same stage, then we have a T plant. If we have neither convergence or divergence, then we have a simple case of resource contention, and the plants are classified as I plants.

It’s essential to know what kind of product flow you are dealing with if you’re looking to optimise production. The way you implement Drum Buffer Rope (DBR) in each case is different. Some quick examples:

V – producing different electrical cables from separate windings and insulation of the same gauge copper wire.

A – the manufacture of an aero engine.

T – the production of a range of cars of the same model, but with different features such as a sunroof and mag wheels.

I – production of alumina in a refinery.

V and A – the overhaul of an aeroplane. The V pulls it apart to get to all the serviceable components, and the A puts it all back together again.

It is beyond the scope of this article to articulate the way you could use DBR in each environment. Still, there is more than enough evidence that this breakthrough in optimising production is, for all practical purposes, universally applicable. If you are in the market for systemic improvement, some further investigation will yield a handsome return.

A critical success factor for the delivery of excellence in production is the constraint accounting framework. At a speech given to an accounting conference, Goldratt once famously declared that ‘accounting is the number one enemy of productivity’. Accountants would like to know what a product costs so they can establish what profit it contributes when that cost is subtracted from the selling price.

To achieve this feat, they add together the material costs of the widget being produced to the product of the minutes and unit cost of the labour that went into making it. The problem is that not all minutes are equal. Saving a minute at the constraint saves a minute for the system as a whole, whereas saving a minute at a non-constraint is a mirage. Optimising production is a function of how the constraint performs, and not the efficiency of the parts.

Work your working capital

The ultimate in optimised production is that you are able to replace a sold product the instant it is bought by a customer. I go to the supermarket and scan my bar of chocolate across the till. Every gear should go into action to send it to replenish the shelf as if an attachment to an email. But most operations don’t do this. Instead, they wait until the retailer has assembled their sales report; they compare that against their own sales report; they wait to run a sales and operations planning meeting and finally they let a production order loose onto the shop floor. Then, they delude themselves about what makes up a minimum production order and what size batch they need to ship to make it economically viable.

Eventually they have a container load to ship and thousands more bars of chocolate have been sold. The system is stuffed with inventory to try and deal with the extended lead time it takes to replace a bar of chocolate.

They would like to avoid the risk of carrying inventory by doing everything they can on a make to order basis. Their customers won’t tolerate the time it would take to go from order to fulfilment, so they come up with very fancy forecasting algorithms to predict how much they should be making to stock. They always get it wrong and end up writing down or scrapping the excess.

The real task at hand is to understand what is reasonable and possible in terms of lead time to replenishment. By Little’s Law, the less lead time we take, the less inventory there will be in the system. Use the insights from TOC and DBR to reduce lead times, increase due date performance, increase throughput and reduce inventory.

Let me leave you with a few questions:

  • What shape does production take in your organisation?
  • Do you know where your bottleneck is?
  • Are you optimising your limited resources around that constraint?

As an executive in charge of production, you need to be a reliable and responsive supplier to your customers. Yet how do you really know what you can promise, by when? You don’t want to be a tyrant demanding impossible feats from your team. But, until you investigate the principles of TOC, you may not know what is reasonable and possible. In the next article in this series, we’ll look at how maintenance can move from a regret cost to a throughput enabler.

This is Part 3 of our series on Asset constraints management.
Part 1: Asset Constraints Management Capabilities
Part 2: Projecting Projects
Part 3: Producing production
Part 4: Maintaining production
Part 5: Controlling contractors

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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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    projecting projects

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The healthcare professional: the hidden constraint in patient flow

Ensemble Administrator

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.”

Healthcare professionals govern critical transitions

A medical device patient journey commonly depends on several healthcare professionals:

  • A primary care professional recognizes a problem or makes a referral.
  • A specialist assesses the patient and manages the disease pathway.
  • Diagnostic professionals generate and interpret evidence.
  • A managing physician supports authorization or reimbursement.
  • An interventional specialist confirms eligibility and performs a procedure.
  • Nurses, educators or allied health professionals help the patient adapt.
  • Follow-up teams monitor efficacy and coordinate adjustments.

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.

The HCP works within a system

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:

  • Requires information that is hard to obtain
  • Interrupts established clinical workflows
  • Produces outputs that are difficult to interpret
  • Adds documentation without removing other work
  • Fails to connect with existing systems
  • Demands training that cannot be sustained
  • Transfers work or risk to another professional
  • Provides a result without clarifying the next action

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?”

Identify the real healthcare professional personas

“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:

  • Clinical responsibility and decision authority
  • Frequency of encountering the condition
  • Experience with the procedure or technology
  • Access to information and specialist support
  • Available time
  • Confidence in interpreting results
  • Responsibility for follow-up
  • Exposure to clinical, legal or financial risk

These personas clarify who performs each job and what support each person requires.

Map the HCP journey

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:

  • What is the HCP trying to accomplish?
  • What information is required?
  • Where does the information come from?
  • What decision must be made?
  • What could cause delay or rework?
  • Who depends on this action?
  • What must happen before the patient can progress?

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.

Find the HCP constraint

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.

Go to the clinical Gemba

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:

  • How the HCP prepares
  • Which tools and information sources are used
  • What interrupts the work
  • Where the HCP waits or repeats activity
  • How uncertainty is communicated
  • What must be documented
  • How work passes to the next person
  • How the HCP recognizes that the job is complete

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.”

Define the HCP’s job to be done

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:

  1. Define the intended clinical outcome.
  2. Locate the necessary information and resources.
  3. Prepare the patient, equipment and environment.
  4. Confirm readiness and choose between alternatives.
  5. Execute the clinical activity.
  6. Monitor its progress and results.
  7. Modify the approach when circumstances change.
  8. Conclude, document and prepare for subsequent care.

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.

Convert experience into measurable outcomes

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.”

Apply FOCUS to HCP capacity

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.

Connect HCP evidence with enterprise execution

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:

  • Which HCP groups influence the pathway
  • What each group is trying to accomplish
  • How the work happens in practice
  • Which outcomes remain poorly served
  • Where HCP capacity constrains patient flow
  • How the proposed solution changes the wider care system
  • How improvement will be measured

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.


What’s next?

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.

READ MORE

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Patient flow: the missing system in Patient Centered Design

Ensemble Administrator

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.”

The patient journey is a flow system

A typical medical device journey may include:

  1. The patient becomes aware of a possible therapy.
  2. A primary care professional or specialist assesses the patient.
  3. Diagnostic work determines whether the therapy is appropriate.
  4. The patient secures authorization or reimbursement.
  5. An interventional specialist confirms and plans the procedure.
  6. The patient receives the device or therapy.
  7. The patient learns how to live with the solution.
  8. Follow-up identifies any necessary adjustments.
  9. Periodic reviews monitor longer-term efficacy.

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.

Processing time tells only part of the story

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:

  • How long does each activity take?
  • How long do patients wait between activities?
  • How many suitable patients enter each stage?
  • How many progress to the next stage?
  • Where and why do patients leave the pathway?
  • How much total time passes before the patient receives the solution?

The answers reveal the true performance of the patient system.

Find the constraint

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?”

Understand why patients remain in or leave the flow

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:

  • The importance the person gives their health
  • Their confidence in dealing with healthcare professionals
  • Whether they act independently or need encouragement
  • Their comfort with technology
  • The pressures of work, family and daily life
  • Their ability to understand and act on clinical information
  • Their willingness and ability to pay
  • The outcomes they most want to achieve

These differences affect whether patients enter the pathway, remain engaged and successfully adopt the solution.

Go to the patient’s Gemba

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.

Understand the patient’s job to be done

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:

  1. Define what must be achieved.
  2. Locate the required information and resources.
  3. Prepare for the activity.
  4. Confirm readiness and choose between alternatives.
  5. Execute the activity.
  6. Monitor whether it is working.
  7. Modify the approach when circumstances change.
  8. Conclude or prepare for what follows.

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.

Turn patient experiences into evidence

Stories create understanding, but investment decisions require structured evidence.

Patient observations and comments should be converted into outcome statements that identify:

  • The desired direction of improvement
  • A measure of success
  • The object being controlled
  • The circumstances in which it matters

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.”

Apply the five-step FOCUS process

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 Centered Design is an operating system

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:

  • Which patients it intends to serve
  • What those patients are trying to accomplish
  • How the complete patient pathway operates
  • Where patients wait or leave the flow
  • Which outcomes remain poorly served
  • What currently constrains successful patient access
  • How the proposed solution improves the whole system

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.


What’s next?

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.

READ MORE

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