Legendary management guru Peter Drucker never actually said, ‘Culture eats strategy for breakfast’. But the epigram stuck. In fact, the two are entangled; an effective strategy requires an enabling culture.
This is Part 1 | Read Part 2 | Part 3
[Listen to audio version, read by David Hodes]
But what is culture? When asked this question, many provide the tautologous answer ‘the way we do things around here’. Such a response does not help answer the critical questions of a given organisation’s culture at a given time in its history, and how a productive and generative culture might be cultivated into the manageable horizon.
Much of my understanding of culture comes from the work of Emeritus Professor Ed Schein, who founded the Centre for Organisational Learning at the MIT Sloan School of Management. Schein’s model invites us to look at three levels of culture: artefacts, espoused beliefs and values, and basic underlying assumptions.
The iceberg metaphor is helpful here in that what we see at the top, above the waterline, is the manifestation of what is going on at a much deeper level. You may walk into an office or worksite and look at the general presentation of the work environment. Is it tidy, freshly painted, filled with light, or dark and dingy? Are the spaces intentionally set out like an Apple Store, or is it all rather more like the office of an inundated cohort of junior law clerks? How do people behave towards each other? Are they competitive or collaborative? Bureaucratic or in flow? Cynical or inspired? Family-like or formal? These are artefacts. But even with these, it’s not easy to know what’s really going on, based only on simple observations of what our senses feed to the meaning-making machine of our minds.
Dig a bit deeper, and we are in the realm of espoused beliefs and values. Espoused because they are what we read on the posters, see on the presentations, and hear from the functionaries when we ask questions about ideals, goals, values, and aspirations. When we notice a discrepancy between the espoused values and the actual behaviours, we’re likely to be fed some well-rehearsed rationalisations: ‘Mary’s behaviour is not congruent with our publicly stated value of inclusion, and we have had a lot of complaints about her abrasive and demeaning management style. Still, her personal story allows us to help her more fully activate the better angels of her nature, as, despite everything else, she delivers the results the business is looking for.’
Down at the deepest level, we are into the realm of the unconscious—the same domain that informs the myths we live by. In that domain, we answer the questions about the meaning and purpose of our lives, how we got here, and what we will do with the finite time we have left. In a productive culture, there is a deep congruence of value at all the levels within which we operate: the personal, the team, the organisation, and the society in which we live.
Arriving at such a state of harmony within an organisational setting is never easy. We have two significant challenges to overcome: external adaptation and internal integration. Before exploring these two challenges in more depth, it is worth quoting Schein’s definition of culture in full:
‘The culture of a group can be defined as a pattern of shared basic assumptions learned by a group as it solved its problems of external adaptation and internal integration, which has worked well enough to be considered valid and, therefore, to be taught to new members as the correct way to perceive, think, and feel in relation to those problems.’
In other words, what we learn about solving the problems of external adaptation and internal integration and how we examine the assumptions that inform that learning is of the essence to culture formation.
External adaptation includes understanding how we get to play our game within the markets in which we compete. We need to articulate our mission and strategy in a way that all critical stakeholders understand. We must embrace the question that asks what the fundamental problem is that we solve for those who consume our products or services? Given our mission, what is our goal? At least how much of what, by no later than when? How must the accountability hierarchy be constructed to best serve the processes which deliver on the mission? What means will we need to secure to accomplish our mission? How is the division of human, financial, material and information resources determined and allocated? What will we measure, and how could those measures be used to control progress towards our stated goal? How will we develop a consensus on the when and what of course corrections? What are the appropriate remedial or repair strategies to be used if goals are not being met?
Internal integration proves a more challenging arena for us to understand. It begins with the idea of creating a common language, where words and conceptual categories have shared meaning. As an example, think of the number of acronyms we demand a recruit learns before they come to readily understand the local dialects. The idea of internal integration begs the question of the extent to which the integration applies. What is the boundary for inclusion, and who, then, is in or out? By what criteria is membership determined?
Once we know the group’s boundary, each must work out its pecking order, criteria, and rules for how someone gets maintains and loses power and authority. Consensus in this area is crucial to help members manage feelings of aggression. If there are no rules around the exercise of power, we trigger that primal aggressive response associated with unfair authoritarianism.
Over time, every group must work out its ‘rules of the game’ for peer relationships, relationships between the sexes, and how openness and intimacy are handled in managing work. Consensus in this area is crucial to help us define trust and manage feelings of affection and love. How much damage has been done by the office affair? It’s not easy to navigate from the locker room to the board room. In brief, norms must be developed around trust, intimacy, friendship, and love.
Included in the theme of fairness at work, to develop a productive culture, we must come to share an understanding of what behaviour is heroic and what is unacceptable. Once we know these behaviours, we must achieve consensus on how we reward what is good and punish what is terrible.
And then there is the realm of the unexplainable—those events that fall outside the boundary of the day-to-day which challenges our well-worn nostrums of habit. How do we give meaning in a way in which group members can respond to them without excessive levels of anxiety?
Coming to meaningfully understand all these aspects of external adaptation and internal integration goes well beyond simply taking stock of the artefacts of culture, and even the deeper level of the espoused beliefs and values. To fully understand the culture of a group, we would need to equip ourselves with the competencies of a social anthropologist. Having said that, I have found the Competing Values framework offered by Cameron and Quinn helpful in getting an early read of the four archetypes they have in their model: Clan, Adhocracy, Hierarchy and Market. This model, illustrated in the diagram, looks at the competing values associated with an internal or external focus and whether stability and control are most essential or flexibility and discretion.
No organisation is at any given time any one of these archetypes, and there is always a natural tension between where the organisation is, compared to where the members would like it to be. There is an ongoing dynamic between the internal and external focus and whether the emphasis is on integration or differentiation. Many factors could influence the choices which value stability and control over flexibility and discretion or vice versa.
Even acknowledging that these competing values are forever in the dance of change, shifting the centre of gravity from one cultural archetype to another quadrant is far more challenging to accomplish than many in the field care to acknowledge. In the same way that a nick in a sapling is visible in the grown tree, so too does the influence of the founders run within the organisation’s DNA throughout its life.
It takes a very long time to learn to succeed in any given endeavour and the habits formed from learning how to succeed are not readily surrendered. We are far more ready to acknowledge when markets change, and our focus and comfort is found in what needs doing in the external competitiveness arena. It is far more challenging and takes much longer than we would ordinarily allow to co-create a new way of being in all the areas of internal integration outlined above.
In my next article, we’ll explore more deeply the subcultures present within most organisations as well as dig into the kinds of mental models we carry when assessing our place within a culture.
This is Part 1 of our series on Culture.
Part 1: Cultivating culture
Part 2: Culture – Digging below the surface
Part 3: The Anxieties of Changing Culture
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What’s next?
The change to using Theory of Constraints (TOC) as an underlying operating system is both profound and exhilarating. We’ve developed the Systems Thinker Course to bring the ideas into your organisation.
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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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