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Somewhere over the rainbow

David Hodes, Founder

Despite the disruption brought about by the pandemic, we already know some aspects of our future. Regardless of when and how we reboot our economy, it will no longer be in our national interest to rely on China for the manufacture of products critical to our lives and livelihoods.

[Listen to audio version, read by David Hodes]

This fact presents us with a fundamental choice—do we erect high tariff barriers to protect our industry against lower-cost providers? Or is there a case to be made for a competitive, growth-oriented manufacturing sector? Some think that manufacturing in Australia is a thing of the past. According to the Australian Bureau of Statistics, in the year to end June 2016, manufacturing represented 6.1 per cent of Australia’s GDP and 7.4 per cent of employment at some 886,800 direct and 331,000 indirect jobs. In the 2015-2016 financial year, manufacturing generated $100bn in export income, second only to mining’s $117bn.

In isolation, I have sometimes found my mind drifting to a dark vision. We have spent an unprecedented amount of our children’s money on keeping our economy afloat. What hospitals and schools will not get built as a result? How will we defend ourselves against the rise of an expansionist totalitarian regime? How will we fund the interest payments on all that debt and how will we ever pay it back? The Reserve Bank has been working overtime to manufacture a fistful of money, but it’s our work that’ll be required to pay it back in the form of higher taxes and lower levels of government services. In my darkest moments, I wonder if, through the provision of our equivalent of the universal basic income, we will ultimately lose the will to get up and have a go at competing.

Manufacturing the future

We have some fundamental decisions to make before thinking about our post-pandemic future. Are we going to take on personal responsibility, or will we surrender our liberty to a collective? Are we for a free enterprise system or will we succumb to the siren song of high tariff barriers to insulate our industries from the competition? Will we have the will to rein in the administrative state, or will we allow our burgeoning bureaucracy to perpetuate itself into eternity? Do we want to be free, democratic and subject to just laws? Or shackled by either real tyrannies or those made from low expectations?

As we all sit in our homes and maintain social distance, it is apposite to remember the words of Robert Menzies in his famous Forgotten People speech of May 1942—in the middle of the Second World War:

‘My home is where my wife and children are. The instinct to be with them is the great instinct of civilised man; the instinct to give them a chance in life—to make them not leaners but lifters—is a noble instinct.’

Whether it was Menzies, Hawke and Keating, or Howard and Costello, Australians have always been at their best when the orientation is toward aspiration. We are the people of the ‘fair go’ and ‘having a go’. It has served us well in the past and will do so again in the future. We routinely box above our weight and are keen competitors in all fields of human endeavour. Indeed, as I write, Australia is not in the top twenty in the world in both absolute and relative terms for confirmed cases and deaths. It’s not luck.

The Advanced Manufacturing Growth Centre (AMGC) developed the sector competitiveness plan after members of the AMGC team met with small and large manufacturers from around the country. Their goal was to understand not only these manufacturers’ unique sources of competitiveness and their aspirations for growth but also their challenges. They consulted with other members of Australia’s manufacturing ecosystem, including international customers, entrepreneurs, academics, researchers and representatives at all levels of government. In their study, they summarised the three sources of competitiveness thus:

Reduce Cost

  • Manufacturers can reduce their costs by reducing the cost of their inputs, such as transport, energy and materials
  • More advanced production techniques that enable greater output with existing resources can improve efficiency and reduce costs per unit
  • Manufacturers can reduce their costs per unit by increasing their scale and fractionalising overheads and other fixed costs

 Improve Value

  • Manufacturers can focus on innovation and technological improvements that give their products a distinctive value proposition
  • Manufacturers can increase the value of their products by providing value-adding services that improve their function, utility and longevity

Shift Market Focus

  • Manufacturers can identify and enter high-growth or high-value product segments
  • Manufacturers can identify and enter underserved geographies and participate in global value chains

 

The managing director of the AMGC made the point in bold, on a single page of the 166-page report:

“It is essential that any analysis of competitiveness looks beyond product cost.”

The report offered this vignette, which neatly illustrates how an already competitive export sector in Australian manufacturing could do better:

‘In the medical devices industry, management and professional wages are 38% lower in Australia than in the United States (US). However, this often doesn’t flow through to lower overall labour costs because Australia’s high-skill workers have a more limited mix of skills (e.g. only 17% of Australian aerospace workers have bachelor’s degrees compared with 44% in the US). Second, Australia has an opportunity to lift its competitiveness in capital efficiency and overheads. It can do this by improving management quality in areas where Australia lags significantly behind other nations, and by collaborating more to overcome the challenges of scale.’

Before proceeding, it is worth pausing for a moment to consider what the AMGC defines as manufacturing. The illustration below shows that when considering the end-to-end lifecycle of manufactured products and their associated services, the pure production component has reduced significantly since the 1970s. High value-added comes with the intangibles of preproduction R&D and Design and the postproduction activities of Sales and Services. The tangible activities of logistics, production and distribution are far more likely to be commoditised and thus demand a focus on low cost and highly efficient execution.

Value added curve

The roots of Theory of Constraints (TOC) lie in Systems Thinking and stem from the seminal book The Goal, first published in 1984. It was a response from its inventor, Eli Goldratt, to the crisis in American industry and its lack of competitiveness against the rising Japanese behemoth. There was a deep irony in the fact that rising manufacturing giants such as Toyota had drunk deeply from the well of American legend W Edwards Deming’s total quality management and used his system of profound knowledge to devastating effect. Thirty-six years on from the publication of The Goal and an entire body of knowledge has been developed to take advantage of the theory’s fundamental insight: a system’s constraint governs the rate at which value is created.

TOC sits in the realm of the hard sciences, with its falsifiable hypothesis promoting the idea that no system can produce infinite output for a finite input. Since its invention, many leaders in the field of manufacturing have contributed to the TOC Body of Knowledge. Thus, TOC has a robust set of methods for strategy formation, project, production and distribution management, and an innovative approach to management accounting. The empirical evidence demonstrates an abundance of proof as to its validity as a significant contribution to the struggle to continuously improve production.

“A system’s constraint governs the rate at which value is created”

Thus, I believe it behoves all those in the manufacturing sector in Australia to learn about its methods and tools systematically and on a grand scale. By way of precedent, in 1995, a team commissioned by Paul Keating’s minister for Employment, Education and Training, Simon Crean, reported on a three-year round of consultations, research, study missions and analysis. The report was boldly titled Enterprising Nation – Renewing Australia’s Managers to Meet the Challenges of the Asia Pacific Century.

Without the fundamental insights of TOC, I wonder how a second wave of renewing Australia’s managers in manufacturing will ‘…improv[e] management quality in areas where Australia lags significantly behind other nations, and by collaborating more to overcome the challenges of scale’. At every step in the value chain described in the illustration above, there is a robust and, for all intents and purposes, an infinitely scalable solution to the problem of competing based on a differentiated product and service offering rather than product cost alone.

In a study conducted at Victoria University in Wellington, Balderstone and Mabin wrote in 1998 their Review of Goldratt’s Theory of Constraints (TOC) – lessons from the International Literature which summarised the results thus:

TOC results table

Balderstone and Mabin wrote this paper in 1997. However, still, we have not grasped the truth of their conclusions to anything approaching the degree required to ensure a unique competitive advantage for the future of advanced manufacturing in Australia and the contribution it will make to sustaining our prosperity.

Of interest when reviewing this report is the fact that the authors note a trend which is true to this day: ‘TOC is still perceived by many, unfamiliar with the approach, as an operations management technique instead of a systems management philosophy’. I have written previously on the topic ‘If TOC is so bloody great, why isn’t everyone doing it?’ Perhaps, at last, the time has come, when necessity births invention, to consider the contribution to be made to Advanced Manufacturing by:

  • The 5-Step FOCUS to continually and systemically improve throughput
  • The Thinking Process to make sure you’re doing the right things
  • Drum Buffer Rope to improve production
  • Critical Chain Project Management to do projects faster
  • The replenishment solution to make supply chains more effective
  • Constraint Accounting to make sure you’re measuring the right things

These are the associated methods and tools for a coherent and unified operating philosophy for any enterprise—regardless of its size or complexity. We can map these proven solutions to all the stages in the manufacturing lifecycle: R&D, Design, Logistics, Production, Distribution, Sales and Service. Every person operating within the entirety of the value chain can learn how to speak in a common language, measure performance in a way that delivers what is best for the whole and focus together on the task of continuously improving the competitive advantage of our vital manufacturing sector.

If we are not for ourselves, who will be? If we are only for ourselves, what are we? And if not now, when?

____________________________

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:

  • download the brochure (no email required)
  • schedule a call
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    “Think ‘can if…’ rather than ‘can’t because’.”

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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.

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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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