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If we want positive cultural change in our organisation, we’ll need more than a simple redesign of surface artefacts. More even than challenging espoused beliefs and values. We must courageously explore the basic underlying assumptions that determine behaviour, perception, thoughts, and feelings.
Part 1: Cultivating Culture
Part 2: Digging below the surface
Part 3: The Anxieties of Changing Culture
[ Read online | Listen to the audio version, read by David Hodes]
Just as the nick in the sapling remains with the tree into maturity, the founder’s influence remains embedded in an organisation’s culture throughout its life. However, the way an organisation, during its founding and early growth, establishes internal coherence and adapts to its markets is unlikely to serve its midlife, maturity, decline and rejuvenation.
Ed Schein, Emeritus Professor at MIT, identified two anxieties at play when thinking about organisational change—the anxiety of learning and the anxiety of survival. Any change requires new knowledge; and, by definition, that means learning afresh. However, learning afresh means having to confess ignorance. And with that confession comes the fear that the new learning will demonstrate, at least temporarily, a level of incompetence. Along with the loss of mastery that arises as we abandon the old way in favour of the new, we experience fear that we could lose the power and status associated with our current way of doing things.
Further, what if we think we’ll be punished for our incompetence? Learning always demands a temporary fall in productivity as we gain mastery in the new ways of working. Will we be given the necessary time and instruction required to gain competence in the latest methods and tools? We also need to understand that often we wrap our identity into our jobs and the relationships they foster. Suppose the change we contemplate is structural in its nature. We might find we become so alienated from our group or the organisation at large that we either live in misery or feel compelled to leave.
“Learning always demands a temporary fall in productivity as we gain mastery in the new ways of working”
We are not automatons and are endowed by our creator with free will. Along with free will comes its flip side—free won’t—more typically called ‘resistance to change’. This is a rational response to the anxieties of learning and can take the form of denial, scapegoating or manoeuvring. When we deny, we convince ourselves that things aren’t as bad as we’re told and that the change can therefore be avoided. Scapegoating makes the case that our function or department is not the cause of underperformance and that it is others who need to change. Manoeuvring is the behaviour we adopt when we seek out special compensation for our engagement in the change. We need belaboured convincing that it’s in our interest for the change to happen, and undue persuasion that it’s in the long-term interest of the organisation at large.
So how do we overcome this real anxiety of learning and resistance to change? The big idea is to create psychological safety. In recent years, Professor Amy Edmondson of Harvard Business School has popularised the term. But it’s been around a long time. In his book, Leadership & Culture, Schein incorporates the concept in eight mutually reinforcing activities, which I quote below:
1. A compelling positive vision: The targets of change must believe that the organisation will be better off if they learn the new way of thinking and working. Such a vision must be articulated and widely held by senior management and must spell out in clear behavioural terms what ‘the new way of working’ will be. It must also be recognised that this new way of working is non-negotiable.
2. Formal training: If the new way of working requires new knowledge and skill, members must be provided with the necessary formal and informal training. For example, if the new way of working requires teamwork, then formal training on team building and maintenance must be provided. This is especially relevant in multicultural groups.
3. Involvement of the learner: If the formal training is to take hold, the learners must have a sense that they can manage their own informal learning process. Each learner will learn in a slightly different way, so it is essential to involve learners in designing their own optimal learning process. The goals of learning are non-negotiable, but the method of learning can be highly individualised.
4. Informal training of relevant ‘family’ groups, and teams: Because cultural assumptions are embedded in groups, informal training and practice must be provided to whole groups so that new norms and new assumptions can be jointly built. Learners should not feel like deviants if they decide to engage in the new learning.
5. Practice fields, coaches, and feedback: Learners cannot learn something fundamentally new if they don’t have the time, the resources, the coaching, and valid feedback on how they are doing. Practice fields are particularly important so that learners can make mistakes without disrupting the organisation.
6. Positive role models: The new way of thinking and behaving may be so different from what learners are used to that they may need to be able to see what it looks like before they can imagine themselves doing it. They must be able to see the new behaviour and attitudes in others with whom they can identify.
7. Support groups in which learning problems can be aired and discussed: Learners need to be able to talk about their frustrations and difficulties in learning with others who are experiencing similar difficulties so that they can support each other and jointly learn new ways of dealing with the difficulties.
8. Systems and structures that are consistent with the new way of thinking and working: For example, if the goal of the change program is to learn how to be more of a team player, the reward system must be group-oriented, the discipline system must punish individually aggressive selfish behaviour, and the organisational structures must make it possible to work as a team.
These activities are underpinned by his five principles, each of which should make us sit up and pay attention:
Principle 1: Survival anxiety or guilt must be greater than learning anxiety.
Principle 2: Learning anxiety must be reduced rather than increasing survival anxiety.
Principle 3: The change goal must be defined concretely in terms of the specific problem you are trying to fix, not as ‘culture change’.
Principle 4: Old cultural elements can be destroyed by eliminating the people who ‘carry’ those elements, but new cultural elements can only be learned if the new behaviour leads to success and satisfaction.
Principle 5: Cultural change is always transformative change that requires a period of unlearning that is psychologically painful.
Principle 1 tells us that, usually, learning takes place when survival anxiety exceeds learning anxiety. In other words, I will not learn if something I really value, such as my job, or position in the hierarchy, is not at stake. But, in accordance with principle 2, rather than amp up the survival anxiety, the more productive way to go is to decrease the anxiety associated with learning. For example, embody the idea that failure is a necessary condition of learning and that we should ‘fail often to succeed sooner’. Could we even go so far as to embrace our fondest memories of learning as a child and make it playful?
Principle 3 is fundamental. If we bring in the culture change consultants to tell our teams that we are embarking on an initiative to change our culture, then, after the eyes have rolled, the teams will know that the initiative is doomed. Culture doesn’t sit outside of our striving to bring greater integration to how we work together to solve the problems of adapting to our market. We need to explicitly articulate our goal and frame the initiative in terms that show how the intervention is going to get us closer to its accomplishment.
“All change requires unlearning as well as learning”
Principle 4 means we cannot be afraid to remove people who are unwilling to contribute to the learning. Notwithstanding that all should be given a fair go, the sooner these toxic elements are removed, the less the risk that their negative assessments will infuse the rest of the change team in cynical resistance to change. The effect is often salutary, as it sends a message about the mandate for change. To achieve enduring success though, the change team need to see the success from their new ways of working and reap the satisfaction that comes from doing good work well.
Principle 5 is a reminder that all change requires unlearning as well as learning. We come to understand that our mental models were flawed and that, by embracing change, the future is not going to be what we had hitherto invested so much of our energy in imagining. We need to let go of our old selves to allow the new ones to enter the arena. Thus, the first activity when creating transformative change is to create a compelling and aligning vision. For, as Nietzsche put it: ‘He who has a why to live can bear almost any how’.
To close, let’s see what Schein has to say about what a learning culture could look like:
1.Proactivity
2.Commitment to learning to learn
3.Positive assumptions about human nature (Theory Y)
4.Belief that the environment can be managed
5.Commitment to truth through pragmatism and inquiry
6.Positive orientation toward the future
7.Commitment to full and open task-relevant communication
8.Commitment to cultural diversity
9.Commitment to systemic thinking
10.Belief that cultural analysis is a valid set of lenses for understanding and improving the world.
Changing culture is not easy, but neither is it impossible. As per one of our enduring mantras, ‘to change the way you work, you have to change the way you work’. But perhaps we’ll give the final words of our exploration of culture to Deming: ‘survival is not mandatory’.
Part 1: Cultivating Culture
Part 2: 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.
[Background image: Guy walking the tightrope., on Shutterstock]
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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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