STAY CONNECTED AND SIGNUP TO RECEIVE INSIGHT updates
Not long before I did my solo retreat in nature, I took part in a visioning exercise. The facilitator invited us to sit in our chairs, close our eyes and forget the rest of the group. He asked us to transport ourselves—alone in our chair—to a beautiful meadow, surrounded by mountains and forests, with a stream running through it.
As we heard the burbling stream and inhaled the crisp mountain air, he described a boundary on one side—a dry-stone wall with a country gate leading out of the meadow. When our scene was vivid enough, he asked us in our mind’s eye to rise from the chair and walk slowly but confidently through the gate. We were told we’d now crossed a threshold and were our future selves looking back on the person sitting in that chair. What did we see? What did we have to say to that person? What was our intent as we crossed the threshold?
[Listen to audio version, read by David Hodes]
This is Part 7 of our series on The U Journey: Part 1 | Part 2 | Part 3 | Part 4 | Part 5 | Part 6 | Part 7 | Part 8
When you engage deeply with the U Journey process, you emerge from that time alone revitalised, strong and confident. You have a powerful vision which pulls you forward and you’ve let the old self die for the birth of the new. The alone time in nature is an exercise in scattering seeds across a fertile field, and though you don’t know what will germinate when, you feel confident in the deep knowing you have of the future you’re ready to will into being.
You’ve had the opportunity to think and feel deeply about your learning journeys and have synthesised their lessons into a more complete picture of how you will act to create meaningful change in the world. The natural anxiety you feel about having to lead yourself and others into a brave new future is tempered by the sense of mission you have about your life. In the words of Zig Ziglar, you have found your way to become a meaningful specific rather than a wondering generality.
“You’ve let the old self die for the birth of the new”
It’s a wonderful time to bring your whole being into the world, confident that you have explored yourself more deeply than you might ever have thought possible. From your learning journeys—including your visits to other organisations—you have come to really understand what it takes to be your best and to inspire your team to do likewise. There’s a particular potency that emanates from anyone who is being fair dinkum about what they are trying to bring into the world, and you become that kind of attractor to your boss, peers and subordinates. As you access the silent stillness you explored when alone, you can instantly bring that state of being into whatever it is you’re doing. You are forthright without being dogmatic, committed without being attached. You have stored in your way of being a key to a calmer, more deliberative and compassionate sense of self.
The journey so far
There are many lessons you have learned in the months prior to your journey to the bottom of the U. How important it is to have all the resources necessary to do the job: human, material, financial and informational. You understand the fundamental need for effective communications and an operational cadence suited to the nature of the work at hand. You feel more acutely the need to build effective, high-performing teams who develop trust through integrity, shared intent, the development of specific capabilities and the reinforcing virtue of stellar results.
You know that people work better when they have a sound structure, predicated on an aligned vision and a clear understanding not only of roles and responsibilities but, importantly, how work is to be effectively conducted across the functional silos. You know what it takes to build this requisite accountability hierarchy and the importance of matching what you are asking others to do with the authority you give them over the resources they require to deliver the desired outcome. You know of the importance of developing camaraderie and the capacity we all have to put aside our egos and work for each other to achieve something much bigger than any of us could achieve on our own.
You’ve heard the mantra ‘plan the work then work the plan’ many times, but you feel connected to the idea in a new way. It is the means by which you bring your vision into the world. It’s the way you get to answer the question: ‘What does the world call on me to do?’ You want to develop a stable team so your vision has the best chance of being developed, extended and strengthened through the participation of others. Yours is the spirit that transforms the cynics and the tyrants—or at least holds them at bay whilst you create an opening in which those committed to more visionary action have the chance to exercise their will.
“You no longer see yourself as a cog in the wheel of the mechanical construct…but understand in a profound way what it means to be part of a more deeply connected whole”
You know that measurement drives behaviour and you move confidently to articulate systems-based metrics which look to optimise the whole rather than strangling progress on the false promise of local efficiencies. Measurement is there to help you understand where you are and not to provide a reason to persecute those trying to deliver an outcome. You and your team have skin in the game, not because there is a financial reward for what you are doing but because you’re so deeply committed to being the change you want to see in the world. That you may get rewarded anyway is just an added and sweet bonus, not your primary motivator.
Ready to commit to change
More than anything, you understand how the organisation as a whole needs to understand and be engaged in what you are setting out to change. You no longer see yourself as a cog in the wheel of the mechanical construct of a project but understand in a profound way what it means to be part of a more deeply connected whole. In the words of the cognitive psychologist, Eleanor Rosch, as quoted in the book Presence:
In the ‘analytic picture offered by the cognitive sciences, the world consists of separate objects and states of affairs, the human mind is a determinate machine which, in order to know, isolates and identifies those objects and events, finds the simplest possible predictive contingencies between them, stores the results through time in memory, relates the items in memory to each other such that they form a coherent but indirect representation of the world and oneself, and retrieves those representations in order to fulfil the only originating value, which is to survive and reproduce in an evolutionary successful manner’.
By contrast, ‘primary knowing’ arises by means of ‘interconnected wholes, rather than isolated contingent parts and by means of timeless, direct, presentation’ rather than through stored ‘re-presentation’. Such knowing is open rather than determinate, and a sense of unconditional value, rather than conditional usefulness, is an inherent part of the act of knowing itself. Acting from such awareness is spontaneous, rather than the result of decision making, and it is compassionate…since it is based on wholes larger than the self.
The visioning exercise that began this article was one of the few occasions I found myself in a lucid dream that I remember to this day. When I saw myself sitting in that chair, I was wearing a cape. The cape was made of a kind of thick black linen and had stitched onto it pieces of earth-coloured ceramics in the shape of inch-long, two-dimensional diamonds. They were the most exquisite rustic colours, with a depth of texture I had never seen in reality. These were the living, earthy colours of the valley I sat in. But there was something missing. The pattern on the cape was incomplete—only something like a third of it was covered in the ceramic diamonds. I have no idea how I intuited what that dream was telling me, but I instantly knew the story.
It was talking about me and my incompleteness. I had until then always looked outside myself for those virtues best described as deeply humanist. As an engineer, I thought I could make powerful connections through the use of reason—those were the pieces already on the cape—and it would be up to others trained in the world of sentiment to complete the garment for me. However, I realised only I could make myself whole. I would have to let go of that safe engineer’s place and venture into the unknown. I, and no other, would have to risk looking stupid in my quest to find the missing pieces and make the cape complete.
My immersion in nature gave me the will to find those qualities within myself to be the whole person—just as I was on the day I was born. My intent was crystallised, and I knew that I could no longer dodge my destiny. The world, it now appeared, was made up of indissoluble wholes and I could step courageously into being the person wearing the completed cape. That sense of purpose inspires me to this day.
____________________________
This article is Part 7 of our series on The U Journey.
Part 1: How to change: Introducing Theory U
Part 2: Preparing for the Foundation Workshop
Part 3: Running the Foundation Workshop
Part 4: Stepping into Design
Part 5: Wisdom from outside your domain
Part 6: Retreat and Reflect
Part 7: Crystallise Intent
Part 8: Deliver
____________________________
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:
____________________________

“Whether you believe you can do a thing or not,
you are right.”—Henry Ford
____________________________
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.
Discover better ways to do better work.
We alternate our own actionable articles with three relevant links from other authorities.
We’ll only use your email address for this newsletter. No sales callsDiscover better ways to do better work.
We alternate our own actionable articles with three relevant links from other authorities.
We’ll only use your email address for this newsletter. No sales calls