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This is Part 1 in the series on Change Management | Read Part 2
To change the way you work, you have to change the way you work. As obvious as that may sound, achieving change that delivers the value promised by a new way of working is no simple matter.
[Listen to audio version, read by David Hodes]
Change requires what Deming characterised as ‘constancy of purpose’ in addressing a real need, inspired by an attractive vision for the future, and executed with a relentless focus on a credible plan to get there.
Large-scale change—such as the implementation of the Theory of Constraints and its associated Systems Thinking suite of methods and tools—requires a comprehensive, focused and structured approach to ensure the workforce is effectively transitioned from the current ways of working to the desired future state, whether technically, organisationally or personally.
Of primary importance is an understanding of the value contained in the business case for the change initiative. The realisation of this value becomes the focus of communications designed to stimulate awareness of what’s at stake and inspire all stakeholders to play their part.
By definition, people follow leaders. Thus, for the success of an organisational change, people with authority, power and influence must visibly lead the change by engaging with as many stakeholders as possible. It is for them to communicate the importance the initiative has for the enduring success of the business, and thus encourage a high level of adoption.
“To change the way you work,
you have to change the way you work.”
But what and how are leaders supposed to communicate? How do we create an aligning narrative that has irresistible sway? What is going to be most effective? Telling the story, selling it, consulting on it, or working with two-way communication to co-create it? Different parts of the organisation will be operating from their context, and any program of change must take account of the readiness of a division, function or department to embrace the call for change.
It is a big deal for all levels of a workforce to transition to a new way of working. Thus, any organisational change-management program needs to understand the impacts and develop formal plans to address them. These impacts can range from changes to reporting lines and accountability hierarchies to new KPIs, processes and technology along with their associated rhythms and routines.
Learning new ways of working induces anxiety but can also provide the stimulus for personal growth. To reduce the anxiety and increase the chances of making organisational change stick, you must invest in supporting learning and performance management programs. The performance management work can be enhanced through formalised coaching and mentoring. These programs need to be designed to aid with both the transition to the new ways of working and with sustaining them over the long haul.
Let’s take a closer look at the processes and tools that we could use to bring about large-scale organisational change. In the first instance, leaders must lead the way. This leadership means sponsoring the change initiative. It’s no good holding anyone accountable to perform a piece of work if you don’t provide them with the resources necessary to acquit that accountability. Those resources will come in the form of people, materials, information and money, all of which are likely to be constrained, and therefore the subject of fierce debate over their use. The leader’s job, then, is to tangibly demonstrate that they are willing to dedicate the necessary time to sort through these competing demands. They have to model the behaviour they wish to see, develop a charter for their initiative, and take a meaningful stand for the benefits they want to realise.
The next step is to create a shared need. This need involves both a positive and negative aspect. It is necessary but not sufficient to talk only of the benefits. We must also make a case for what would transpire if we didn’t make the change. We should support both the positive and negative points with data and be transparent about the assumptions underlying the reason for the choice of the solution. Too often, the parsimonious will emphasise cost without examining opportunity cost, and it is thus the role of the leader to articulate both. If we are confident in the business case, we can proceed to sharpen our focus and more vividly render our vision. If not, it’s back to the sponsor for a rethink. We should never get so infatuated with our idea that it trumps the need for sound reasoning supporting a compelling business case.
A valuable way to provide focus and vision is to define the future state from a behavioural point of view. In other words, we can develop the suite of behaviours we want to see more of and which we’d like to retire. Next, we must develop creative and effective ways of communicating these behavioural changes and then embody them in everything we do. It’s of the essence to create a compelling ‘elevator pitch’ which powerfully captures in as few words as possible the raison d’etre for the project. This articulation is often the ultimate statement at the top of the Goal Tree.
With clarity of vision and a focus on the goal, we need to step into a process of coalition building. Coalitions of the willing are what make organisation-wide change occur. We need to determine who the key stakeholders are and what level of support they are likely to give the initiative. If we sense resistance, it is no good to simply moan about it. Instead, we must use our listening skills to not only understand where they are coming from but to feel with them—to empathise. Seeing and feeling others’ points of view allows us to develop more effective influencing strategies designed to address their sources of resistance to what we are trying to change. Deploying a sound influencing strategy can remove a lot of the undesired friction you may encounter on the way to achieving the goal. There will always be laggards and recalcitrants, but if we can work well with the early adopters to build out an early majority, the late majority will follow, and the laggards will either comply or leave.
When undergoing organisational change, people can keep their anxiety in check if they have a good sense that there is a plan, with a beginning, middle and end. Developing a roadmap for the transition from current to future state allows people the opportunity to gain comfort from the order such a roadmap produces from the tendency of change to create chaos. Everyone gets a sense of where we are and what remains to be done. Along the road are milestones and tollgates, allowing for reflection, recalibration and renewal.
“Seek out the champions and recognise their courage and skill”
As mentioned above, organisational change inevitably means changes to reporting lines and accountability hierarchies, as well as the instituting of new KPIs, processes and technology. Therefore, a good plan will incorporate an understanding of how we can leverage existing structures and systems to support the transition to the new ways of working. It is doubtful you can move from an extant set of systems and structures to something entirely new without going through one or more transitional arrangements. Therefore, we must think through these interim systems and structures and effectively communicate why they are necessary waypoints on the road to the desired future state.
Finally, to sustain momentum, we must always be on the lookout to ensure that our teams have the resources necessary to manage their day jobs and the demands of building out the new. We can and should develop fora to share learning, rapidly adopt what works and abandon what doesn’t. It is essential to continuously connect what we do to the overall business strategy and ask if it is getting us closer or further from our goal. It’s not easy to overcome your fear of failure, and very few are willing to be the first to cross the chasm, so seek out the champions and recognise their courage and skill. And be sure to celebrate success whenever possible and use those small wins as occasions to reinforce the idea of progress toward a goal worthy of the team’s energy and talent.
This is Part 1 in the series on Change Management | Read Part 2
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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: Butterfly cocoons, Hakon Grimstad on Unsplash]____________________________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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