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The ultimate prize promised by Theory U is the kind of transformational improvement that self-perpetuates. While even the most dynamic systems will eventually succumb to entropy, the Theory U approach is one possibility of creating an organisational shift that embeds a deep culture of learning and continuous improvement.
Change demands a step into the unknown. The fear of how things might turn out often trumps the sure knowledge that those very same things cannot continue as they are—regardless of how compelling the case. The image of a strong steel spring being held in the open position comes to mind.
[Listen to audio version, read by David Hodes]
This is Part 8 of our series on The U Journey: Part 1 | Part 2 | Part 3 | Part 4 | Part 5 | Part 6 | Part 7 | Part 8
It has a natural memory of being coiled, and unless held open, or permanently bent into a new shape, will revert to its original form as soon as the countervailing force is removed. So too with any attempt at introducing new ways of working. The memory of how work has been led and managed is like that strong spring. Often, it has taken many years to give it form and you cannot readily expect that the new ways will be sustainable without significant effort.
The dance of change
In his classic book The Fifth Discipline, Peter Senge promoted his theory about how to develop a ‘learning organisation’. Ten years later, in The Dance of Change, he reviewed how his ideas had fared in practice across a range of organisations. He identified some of the limits to scaling change from the laboratory of the initiators to the organisation at large:
• There’s not enough time
• There’s not enough money
• There’s not enough help, and we don’t know what we’re doing
• It’s irrelevant
• The leadership is not walking the talk, so why should I?
• I’m not sure if I’m able
• Can these people be trusted?
• Can I trust myself?
• Why is it taking so long?
• I don’t want to be part of a new religion
• What they’re doing is a complete mystery to me, and I’m anxious about showing my ignorance
• Who’s in charge?
• The old guard won’t give up the power
• We’ve seen all this before
• Where is all this heading?
Whilst I do keep looking, I’m yet to find an organisation with a leadership capable of voluntarily undertaking deep transformational change because they want to go from good to great. Far more often, they only seek change from a place of deep trouble where the anxiety associated with having to learn new ways of working has been outweighed by the anxiety associated with going out of business altogether. Nothing quite focuses the mind on overcoming Senge’s list than the prospect of bankruptcy. In cases where the case for systemic change isn’t immediately evident, it therefore takes real courage to put a safe job at risk and call to attention what most colleagues do not want to hear. Not if it means having to learn new rhythms and routines, relate to old colleagues in new ways, and embrace new colleagues with different and often competing ideas to yours.
If the people you seek to influence were not part of your initial phases of the U Journey—the Generative Interviews, Foundation Workshop, Learning Journeys, Retreat, and Crystallising Intent—there is a strong chance they’ll see you as, at best, misguided in your understanding of their issues and, at worst, as a self-serving promoter of the shiny new thing, arguing that your motive is tainted because of how heavily invested you are in understanding and communicating the benefits of your ideas to others.
The Innovation Workshop
Your opportunity to address, head on, all of these issues has now arrived. The Innovation Workshop is similar to the Foundation Workshop but larger in scale. It is designed to give a ‘whole system in the room’ experience to all the participants and has a mini-U architecture. The participants must include the upper ranks of the organisation, including executives and senior managers. The purpose is to give those who have been leading the transformation journey thus far the opportunity to share their learnings, have them tested by the expertise assembled in the room and gain acceptance on a formal program of work required to standardise and scale the most valuable insights gained during the U Journey to date.
By design, the workshop should ideally run over two days in a relaxed and inspiring venue close to nature. As with the Foundation Workshop, establish the workshop’s social field in such a way that deep dialogue can take place. Allow time for walks in the woods and make extensive use of social processes such as Appreciative Inquiry and the World Café.
The people who have been running the learning-journey phase as stream leads are asked to prepare an immersive experience for those they are looking to influence into adopting the best of what they have discovered. Whilst it is important to present facts and figures, nowhere is it mandated that this should be in the ditchwater-dull tones of an endless PowerPoint presentation. It is worth investing in professional help in the arts of communication to provide compelling visual design, graphics, video, writing and storytelling. Pay as much attention to selling your best ideas as you would if you were about to launch an important new product or service into the market.
“It takes real courage to put a safe job at risk and call to attention what most colleagues do not want to hear.”
Over the last few years, I have had the pleasure of working with people who have deep roots in branding. I am now convinced that the approach that masters in branding take to build trust and belief in their client’s product or service is perfectly suited to delivering large-scale change within organisations. Good brand work always asks questions about vision, mission and values and is able to communicate the resulting purpose in aesthetically and cognitively arresting ways that engage the organisation.
Up the capability ladder
So, what is it we’re actually trying to achieve? In the diagram below is a representation of an ascent up the ladder of capability maturity. By committing to the hard work of building process capability within a structured framework of the development of organisational maturity you develop a better way to do better work.

Note how the delivery time initially pushes the target deadline back [1-2]; reality bites as you account for what’s actually going on with your current processes. As you proceed up the capability ladder [3-5], the way of working changes winding in the target date with it. It all adds up to more successful projects, on time, in less time—every time.
As the saying goes, ‘you campaign in poetry but govern in prose’. For us, the left-hand (downward) side of the U Journey is the poetry and the rising right-hand side the prose. It is advisable to check in on who will form the core team and hence lead the streams of work associated with the newly envisioned organisational future. There’s a definite shift towards leadership by the competent and conscientious administrators rather than the creative innovative dreamers. They have the skills and temperament to bring order, repeatability and scale to the new way of thinking. The more open creative types need to remain deeply engaged in the process, if for no other reason (and there’s always another reason) than to be the jealous guardians of the spirit of change dreamed of in the earlier phases of the journey.
It is essential to convene all decision-makers for the Innovation Workshop. Its power and magic lie in the fact that the hard work of developing and testing prototypes has been done. The wheat has been sorted from the chaff and it’s time to decide which initiatives are going to be given the nod and in what order. Decisions on matters such as the process of governance, the allocation of resources, which products, services and markets will be pursued, which technology platforms will be used, how the organisational hierarchy will be designed, what the learning curricula will comprise and what methods are used to run operations. Having all decision-makers in the room means that anyone can mount their case for their point of view, debate its merits with their colleagues and understand, and hence accept, why any given decision went the way it did.
The important point coming out of the Innovation Workshop is not that everyone agrees on every decision, but rather that there is strong alignment behind the decisions taken. The energy and momentum that’s built around a leadership team aligned around a mighty purpose is inspiring to the troops and serves to strengthen the relationships and bonds of trust within the leadership. The Innovation Workshop works best when people empowered by the crystal clarity of their intention feel inspired to do meaningful work with people with whom they share a vision. They know in their bones that the world would be a poorer place if they and their colleagues had not committed to making this contribution.
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This article is Part 8 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
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What’s next?
The change from standard thinking to Theory of Constraints (TOC) is both profound and exhilarating. To make it both fun and memorable, we use a business simulation we call The Right Stuff Workshop.
We’d love to run it with you. To learn more:
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[Background photo by William Ander ]
“Design is not just what it looks like and feels like.
Design is how it works.”—Steve Jobs
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Healthcare professionals are central to the patient’s progress from awareness of a therapy to successful long-term use. They identify risk, interpret evidence, diagnose conditions, discuss options, perform procedures, provide training and monitor outcomes.
Yet many medical device development programs treat healthcare professionals primarily as users to be trained or customers to be persuaded.
HCP-Centered Design takes a wider view. It examines the work healthcare professionals must perform, the system in which they perform it and the constraints that limit their ability to move suitable patients through the care pathway.
“If patient flow depends on a healthcare professional, that professional’s available capacity may determine how many patients ultimately receive the therapy.”
A medical device patient journey commonly depends on several healthcare professionals:
Each professional governs a transition in the flow of patients.
If one transition lacks sufficient capacity, information or clarity, the whole pathway slows. More marketing, sales activity or production capacity will not compensate for a shortage of specialist time or a burdensome diagnostic process.
This is why HCP-Centered Design is not simply about making an interface easier to use. It is about enabling the system of care to perform.
A healthcare professional’s work depends on information and actions supplied by others. They may rely on referrals, patient histories, pathology, imaging, electronic records, clinical guidelines and the availability of equipment or trained colleagues.
After reaching a decision, they may need to explain it, document it, arrange authorization, coordinate treatment and prepare the next person in the pathway.
A technically strong solution can still create difficulty if it:
The relevant design question is not merely, “Can the HCP use this product?”
It is, “Does this solution improve the HCP’s ability to complete important clinical work within the conditions in which care is actually delivered?”
“HCP” is not one persona.
A general practitioner, specialist, interventional physician, nurse, technician and clinical administrator encounter different stages of the pathway. Each has different responsibilities, authority, expertise and exposure to risk.
Even within a profession, context matters. An experienced specialist in a major hospital may approach the same task differently from a professional who encounters the condition infrequently or works without immediate specialist support.
Useful HCP personas distinguish factors that influence work:
These personas clarify who performs each job and what support each person requires.
The HCP journey often begins before the visible clinical procedure.
It may include receiving a referral, gathering information, forming an initial view, ordering investigations, interpreting results, deciding whether the patient is eligible, discussing treatment, obtaining authorization, preparing for the procedure, delivering care and arranging follow-up.
At each stage, ask:
The resulting journey map should distinguish processing time from waiting time. A decision may require only minutes of specialist attention while patients wait weeks to access that attention.
This reveals the practical relationship between HCP capacity and patient flow.
The Theory of Constraints directs attention to the factor limiting the performance of the entire system.
In some pathways, the constraint may be the number of qualified interventional specialists. In others, it may be diagnostic capacity, physician confidence, authorization effort, operating room access or the time required to train patients.
The constraint may also be hidden inside the HCP’s working day.
A specialist supporting a therapy must still manage other clinical duties, administration, meetings, documentation and urgent cases. The question is not simply how many specialists exist. It is how much of their usable capacity is available for the activities upon which patient flow depends.
“The scarcest resource may not be the healthcare professional. It may be the few hours of focused capacity available for the critical work.”
Improvement away from this constraint can make performance worse. Sending more referrals to an already overloaded specialist increases the queue. Adding information may increase cognitive burden. Creating another approval may consume the capacity required to treat patients.
HCP-Centered Design seeks to protect and expand the capacity that governs flow.
Policies and procedures describe how clinical work should happen. Observation reveals how it actually happens.
Healthcare professionals routinely compensate for missing information, awkward interfaces and unreliable handovers. These workarounds may become so familiar that nobody reports them as problems.
Gemba research should examine:
The purpose is not to judge the healthcare professional. It is to understand the system surrounding the work.
“A workaround is often evidence that the system has failed to support the person doing the work.”
Healthcare professionals do not simply use devices. They use them to make progress in clinical work.
An HCP may need to identify risk, reach a confident diagnosis, select an intervention, perform a procedure safely, explain options, monitor progress or recognize deterioration.
A structured job map divides this work into eight stages:
This wider view prevents the product team from concentrating exclusively on the procedure.
The greatest value may come from reducing preparation, improving decision confidence, clarifying an exception, simplifying documentation or improving the handover to follow-up care.
Comments such as “the interface is difficult” or “we need better information” indicate dissatisfaction, but do not provide sufficient direction for design.
They should be translated into measurable outcome statements, such as:
“Minimize the time required to identify which clinical information is missing before making a treatment decision.”
Or:
“Reduce the likelihood that a clinically significant change goes unrecognized between scheduled reviews.”
A broader population of healthcare professionals can then assess the importance of each outcome and their satisfaction with their current ability to achieve it.
Highly important and poorly satisfied outcomes provide a rational basis for prioritizing innovation.
“Adoption follows when a solution makes important clinical work safer, clearer or easier to complete.”
The five-step FOCUS process creates a practical improvement cycle.
Find the constraint. Determine which HCP activity or resource currently limits patient flow.
Optimise for it. Protect the constraint from avoidable work, missing information, interruptions and rework.
Collaborate around it. Align upstream and downstream teams so patients, information and resources arrive when required.
Uplift it. Add capacity, redesign responsibilities, improve technology or remove restrictive policies.
Start Again. Identify the new constraint once flow improves.
This approach allows the organization to distinguish activity from value. It also turns HCP engagement into an ongoing management discipline.
HCP-Centered Design must connect clinical reality with patient needs, technology, regulation and business strategy.
A Value Management Office can help coordinate these perspectives across the product lifecycle. Its role is to ensure that projects, resources and stage-gate decisions remain connected to patient flow and business value.
The organization should be able to show:
The goal is not simply a device that healthcare professionals can operate. It is a solution they can confidently incorporate into care and a delivery system capable of getting that solution to more patients.
Use the HCP-Centered Design assessment to determine how well your organization understands clinical work, HCP capacity and the constraints governing patient flow.
The resulting evidence should guide product design, process improvement and investment toward better products, delivered faster, with more lives changed for good.
Medical device companies devote enormous skill and investment to developing safe, effective products. Yet a technically successful device changes no lives while suitable patients remain unable to reach it.
Between a patient becoming aware of a therapy and receiving its intended benefit lies a pathway of referrals, consultations, diagnostics, approvals, procedures, training and follow-up. Every step consumes time. Between the steps, patients wait. At some points, they become confused, discouraged, ineligible or lost to the process.
Patient Centered Design must therefore address more than the design of the device. It must improve the performance of the entire system through which patients reach, receive and live successfully with the solution.
“A life-changing therapy changes no lives while patients remain trapped in the pathway leading to it.”
A typical medical device journey may include:
Companies often manage these stages as separate functions. Marketing works on awareness. Medical affairs supports clinicians. Market access addresses reimbursement. Sales works with specialists. Clinical teams gather evidence. Training teams support adoption.
The patient, however, experiences one journey.
From the patient’s perspective, a delay between two organizational functions remains a delay. A repeated test remains repeated work. An unclear handover creates uncertainty regardless of which department owns it.
Patient Centered Design begins when the organization sees and manages this journey as a connected system.
Every step contains some necessary processing time. A consultation takes time. A diagnostic test takes time. An authorization must be assessed. A procedure must be performed.
The patient’s total lead time, however, also includes the waiting between these activities.
A consultation may take 30 minutes, but the patient could wait six weeks for it. A diagnostic test may take an hour, followed by another delay before a specialist reviews the result. Prior authorization may require little actual work while adding weeks to the pathway.
This distinction matters because organizations often improve processing time while leaving the larger queues untouched. Saving five minutes during an appointment produces little benefit if the patient waits months to reach it.
Patient Centered Design therefore asks:
The answers reveal the true performance of the patient system.
Theory of Constraints teaches that the performance of any system is limited by a constraint. Improving a part of the system that is not constraining flow may create more activity without increasing results.
If diagnostic capacity is the constraint, generating more awareness may simply produce a longer queue for diagnosis. If specialist capacity is the constraint, accelerating authorization may move patients more quickly into another wait. If training after first use is inadequate, increasing procedures may produce poor experiences and avoidable follow-up demand.
“More activity at a non-constraint creates work in process. More capability at the constraint improves the system.”
The constraint is not always a physical resource. It may be a policy, an eligibility rule, missing evidence, a fragmented handover, an information delay or the cognitive burden placed on the patient.
The most important question is therefore not, “How do we improve every step?”
It is, “What currently limits the flow of suitable patients to successful use of the therapy?”
Numbers show where patients are lost. Patient research helps explain why.
Two patients with the same diagnosis may respond very differently. One may actively seek new treatment options. Another may delay action until symptoms become severe. A third may want help but lack confidence in navigating the healthcare system.
Meaningful patient segmentation considers characteristics that influence behavior:
These differences affect whether patients enter the pathway, remain engaged and successfully adopt the solution.
The Gemba is the place where work actually happens. For patients, this includes the home, clinic, hospital and all the places where they manage their condition between formal encounters.
Interviews alone may miss important evidence. People normalize inconvenience, forget workarounds and simplify their past decisions. Observation allows the development team to see what patients actually do.
Good research combines three activities.
Observe. Watch how patients obtain information, prepare, use the solution and respond when something goes wrong.
Immerse. Understand the physical, emotional and practical conditions surrounding the experience.
Engage. Ask open questions that allow patients to describe their goals, fears and frustrations in their own language.
The purpose is to discover the patient’s reality before asking them to evaluate the organization’s preferred answer.
Patients rarely want a medical device for its own sake. They want the progress it may enable.
They may want to recognize deterioration earlier, preserve independence, reduce pain, avoid repeated visits, return to work or prevent a disease from controlling daily life.
A useful job map examines eight recurring stages:
This reveals opportunities beyond the immediate use of the device. The most valuable improvement may involve helping patients prepare, confirm readiness, recognize an exception or understand what happens next.
Stories create understanding, but investment decisions require structured evidence.
Patient observations and comments should be converted into outcome statements that identify:
For example:
“Minimize the time required to recognize that my condition has changed sufficiently to require clinical help.”
Patients can then assess the importance of each outcome and their satisfaction with their current ability to achieve it.
Highly important and poorly satisfied outcomes represent genuine opportunities. This prevents teams from prioritizing attractive features that do not materially improve the patient’s life or progress through the pathway.
“Innovation becomes valuable when it improves an outcome that matters and remains poorly served.”
The Patient Centered Design pathway can be improved through a repeating discipline:
Find the constraint. Identify what currently limits patient flow or successful use.
Optimise for it. Make the best possible use of existing constraint capacity.
Collaborate around it. Align functions and partners so their actions support the constraint.
Uplift it. Add capability, remove restrictive policies or redesign the pathway.
Start Again. Once the constraint moves, identify and address the next limiting factor.
This prevents improvement from becoming a collection of disconnected initiatives. It directs scarce resources toward the factor that most strongly governs the result.
Patient insight should influence more than early product design. It should shape clinical evidence, regulatory strategy, reimbursement, manufacturing, education, market development and post-market support.
The organization should be able to show:
The goal is not simply to place the patient at the center of a diagram. It is to organize the enterprise around delivering better products faster, so that more lives can be changed for good.
Use the Patient Centered Design assessment to determine how well your organization understands its patient journeys, priority outcomes and constraints to patient flow.
The result should be more than another collection of patient opinions. It should provide evidence that directs strategy, investment and execution toward the changes that matter most.
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We’ll only use your email address for this newsletter. No sales calls