REAL WORK. REAL BARRIERS. REAL RESULTS.

Every engagement starts the same way: we go to the Gemba, find what's blocking the team, and remove it. Here's what that looks like in practice.

The plant that had 'always been this way'

THE SITUATION

A manufacturing division of a global corporation had a problem that everyone knew about and nobody had been able to fix: the gap between what leadership believed was happening on the floor and what was actually happening. Strategy wasn't connecting to execution. Cultural dynamics varied wildly between the plant and corporate teams. Improvement efforts kept stalling. The phrase leadership kept using — almost as a resignation — was that things had 'always been this way.'

Twenty-seven people across senior and plant leadership teams were interviewed. What emerged wasn't a skills problem. It was a systems problem — unclear priorities cascading into confusion, siloed decisions, and a leadership team that had never been given the tools to solve problems together. The people were capable. The system wasn't letting them move.

WHAT WE DID

We went on-site for three days — not to present recommendations, but to see. We attended meetings, walked the floor, observed how decisions actually got made. Then we worked with leadership to build a strategic roadmap grounded in what we'd seen together, not in what anyone assumed was true. The roadmap included immediate quick wins alongside longer-term alignment work, and was presented back to stakeholders in a way that created shared ownership rather than top-down instruction.

WHAT CHANGED

✓ Leadership left with a clear, actionable roadmap tied to their actual mission and values — not a generic framework

✓ Prioritized next steps gave the plant team immediate momentum rather than another planning cycle

✓ Senior and plant leadership began practicing the collaborative skills needed for sustained transformation — during the engagement, not after it

✓ The organization moved from 'this is just how it is' to a practical foundation for building a lean, high-performing culture

A leadership team that needed to learn to trust each other — fast

THE SITUATION

A global supply chain executive team at a healthcare company was going through a difficult transition: new leader, recent team member changes, shifting strategic priorities, and the urgent need to collaborate across functions that had historically operated independently. The team recognized the opportunity — and the risk. If they couldn't build real trust and alignment quickly, the next phase of strategic execution would stall before it started.

The challenge wasn't competence. Every person on that team was highly capable. The problem was that they hadn't yet built the shared language, relational trust, or collaborative habits to function as a unit under pressure. And in a global supply chain role, pressure is constant.

WHAT WE DID

We started with diagnostics — a Team Values Assessment and an Interdisciplinary Team Questionnaire — to surface the real gaps before designing anything. What we found shaped a four-day off-site workshop in France built around the team's live strategic challenges, not hypothetical exercises. They worked through real business problems together, designed their own collaboration processes, and established clear rules of engagement. On the third evening, a drumming workshop gave the team a completely different experience of what it feels like to create something together.

WHAT CHANGED

✓ Trust and communication improved measurably within the group

✓ The team built shared ownership of strategic priorities — not just awareness of them

✓ Cross-functional problem-solving became a practiced skill, not an aspiration

✓ Roles, responsibilities, and decision-making became clear

✓ The team left with the norms and processes to keep collaborating effectively — without needing another intervention

Zero late reports to the FDA — achieved in four days

THE SITUATION

A global MedTech company was submitting Medical Device Reports to the FDA late. Not occasionally — consistently. In a regulated industry where late MDR submissions carry real compliance risk, this was serious. Leadership knew it needed to change but previous efforts hadn't stuck. The process was fragmented, roles were unclear, and the team had never had a clear shared view of how work actually flowed from trigger to submission.

The deeper problem, as it often is, wasn't the people. It was that nobody had ever mapped the real process — what actually happened versus what was supposed to happen — with everyone in the room at the same time.

WHAT WE DID

We ran a four-day Lean Six Sigma Blitz with a cross-functional team: process users, subject matter experts, and representatives from connected departments. Day one was about seeing reality clearly — mapping what was actually happening and finding exactly where submissions were getting stuck. Day two the team redesigned the process together, with full accountability for what they were creating. Day three turned the redesign into a concrete action plan with named owners. Day four was a stakeholder presentation where leadership committed — publicly, in the room — to driving post-blitz actions to completion. We stayed on remotely after the engagement to monitor progress and help the team hold the gains.

WHAT CHANGED

✓ Zero late MDR reports — the target was met and sustained

✓ A global To-Be process was documented and implemented, covering both FDA and CAPA requirements

✓ The cross-functional team had clear roles and responsibilities for the first time

✓ Leadership was aligned and accountable — not just informed

✓ The team built the capability to prevent future lapses independently

Complaint handling transformed across a global organization — 30% faster resolution

A global organization with complaint handling processes that varied by business unit — creating inconsistent response times, unclear accountability, and elevated costs.

Top result: Response times reduced by 30%. Handoff points cut by 40%. A centralized complaints function with a standardized process and clear accountability.

Complaint handling transformed across a global organization — 30% faster resolution

THE SITUATION

A global organization recognized that its customer complaint handling was broken — but in a way that was hard to fix from the inside. Response times were too long. Communication was inconsistent between business units. Costs were elevated. And because each unit had developed its own approach over time, there was no shared standard to build from. Leadership needed a transformation, not a tweak — one that would work across all business units simultaneously.

The core challenge was that the problem existed at multiple levels: the process itself, the organizational structure, and the systems needed to support both. Fixing one without the others would just shift the bottleneck somewhere else.

WHAT WE DID

We ran a four-phase transformation program designed to address all three levels in sequence. Phase one assessed the current state across all business units and benchmarked against industry best practices. Phase two brought 16 leadership representatives together for a two-day working session to align on strategic direction — what to keep in-house, what to consider outsourcing, and what the target looked like. Phase three was a three-day working session with 16 subject matter experts who mapped the new standardized process in detail, built a RACI matrix, and designed the unified approach to be piloted across all units. Phase four defined the organizational structure and systems requirements to support the new process — including data visibility, performance measurement, and reporting capabilities.

WHAT CHANGED

✓ Response times reduced by 30% through a standardized, unified complaint handling process

✓ Handoff points reduced by 40% through the elimination of redundant steps and clear RACI accountability

✓ A centralized complaints management unit was established with clear reporting lines and standardized roles

✓ Projected cost reduction of 20% through process efficiency and targeted outsourcing opportunities

✓ Leadership gained actionable data visibility into complaint handling performance for the first time

Recall process mapped — findings presented directly to the FDA

A consortium of healthcare providers and suppliers with fragmented, inconsistent recall processes and increasing regulatory scrutiny from the FDA.

Top result: Comprehensive process maps across both provider and supplier workflows. A prioritized improvement plan. A structured presentation delivered to the FDA.

Recall process mapped — findings presented directly to the FDA

THE SITUATION

A consortium of healthcare providers and suppliers had a recall process problem that was both operational and regulatory. The process was fragmented between organizations, inconsistencies were creating delays and compliance risks, and the FDA was paying attention. Leadership recognized they needed to do two things simultaneously: fix the process and present a credible plan to regulators. Neither could wait for the other.

The challenge was that the consortium spanned multiple organizations with different processes, different terminology, and different perspectives on where the problems actually lived. Bringing them to a shared view of reality — let alone a shared plan — required a structured facilitation approach that could work across organizational boundaries.

WHAT WE DID

We facilitated a four-day process mapping exercise in Chicago with a hand-picked team of 12 participants spanning both providers and suppliers. The first day aligned the group on expectations and outcomes and finalized the mapping agenda. Two-and-a-half days of intensive cross-functional mapping followed — giving both sides of the consortium a complete, shared view of each other's processes for the first time. Facilitated sessions identified the inefficiencies, communication breakdowns, and bottlenecks driving compliance risk, and prioritized them for immediate, mid-term, and long-term action. The final half-day was devoted to drafting unified recommendations for FDA presentation — structured, evidence-based, and ready for the upcoming regulatory forum.

WHAT CHANGED

✓ Comprehensive current-state process maps created for both provider and supplier recall workflows

✓ Critical pain points identified and prioritized — giving the consortium a clear, shared view of what needed to change

✓ A structured communication plan developed for the FDA presentation at the Spring Forum

✓ The mapping process itself built cross-organizational alignment that hadn't existed before

A standards organization finds its path forward on antimicrobial resistance

Fifteen subject matter experts needed to align on a unified strategy for breakpoints determination in a rapidly shifting regulatory landscape.

Top result: A prioritized action plan and FDA engagement strategy — built in a single day, with full expert consensus.

A standards organization finds its path forward on antimicrobial resistance

THE SITUATION

A leading clinical standards organization recognized it needed to reassess its strategy for breakpoints determination in antimicrobial susceptibility testing. Emerging testing methods, increasing regulatory scrutiny, and the growing complexity of antimicrobial resistance were all shifting simultaneously. Leadership needed to bring 15 subject matter experts — each with strong and sometimes divergent views — to a unified strategic position.

The challenge wasn't expertise. The room was full of it. The challenge was that without a structured process, expert discussions tend to generate debate rather than decisions. The organization needed clarity on where it stood, where it was going, and what it needed from the FDA — and it needed that clarity fast.

WHAT WE DID

We designed and facilitated a one-day strategic planning session structured to move the group from current state to future state to action plan in a single intensive day. Pre-work included gathering existing documentation, AMR position papers, and emerging methodology research so participants arrived informed rather than getting up to speed in the room. The session moved through current state assessment, future state mapping, gap analysis, and FDA engagement strategy development — using brown paper, flip charts, and structured facilitation tools to keep 15 experts moving in the same direction. The day ended with consensus on a prioritized action plan and a draft proposal for FDA recognition of the organization's breakpoints determination approach.

WHAT CHANGED

✓ Fifteen subject matter experts left with a shared understanding of the current AMR landscape and its regulatory implications

✓ A clear roadmap was developed covering process changes, funding needs, and targeted FDA engagement strategies

✓ The session produced a repeatable strategic planning format the organization could use as the landscape continued to evolve

✓ Leadership was aligned on a path forward — not just informed of options

A new Operational Excellence team gets aligned — and stays that way

A recently restructured OE team with ambitious goals, varied backgrounds, and low relational trust — and a mandate they couldn't deliver on alone.

Top result: Shared strategic priorities, clear collaboration structures, and a team ready to drive results across the business.

A new Operational Excellence team gets aligned — and stays that way

THE SITUATION

A recently restructured Operational Excellence team within a global healthcare company had been tasked with delivering on ambitious strategic objectives. But the team had grown quickly, bringing together members with varied backgrounds and limited shared experience. Priorities were unclear. Collaboration practices were inconsistent. Relational trust was low. Without addressing these fundamentals, the team couldn't deliver on its mandate — regardless of how capable its individual members were.

This is a pattern we see often with newly formed or restructured teams: strong people, unclear system. The individuals know what they're supposed to do. They just haven't yet built the shared language and habits to do it together.

WHAT WE DID

We designed and delivered a two-and-a-half-day off-site workshop built around the team's real strategic challenges — not hypothetical scenarios. The workshop combined trust-building sessions with a structured review of the team's A3 projects, Annual Strategic Review, and individual improvement goals. We facilitated project prioritization discussions, identified cross-functional dependencies, and helped the team design its own collaboration matrix with clear accountability. We also built in a team experience on the second evening to reinforce the connection the group was building. Meeting standards, template protocols, and communication norms were developed by the team itself — so they owned the structures from day one.

WHAT CHANGED

✓ The team built foundational trust and rapport — during the engagement, not after it

✓ Strategic priorities were agreed and owned collectively, not assigned from above

✓ Top-priority cross-functional projects were organized and ready for immediate execution

✓ Clear processes for ongoing collaboration and communication were established

✓ The team left with a shared sense of ownership for both strategic delivery and team culture

Document development cycle time cut by 60% across 64 committees

A clinical standards organization with a document development process that had resisted previous improvement efforts — running across 64 committees.

Top result: 60% reduction in document development cycle time. A standardized process rolled out across all 64 Document Development Committees.

Document development cycle time cut by 60% across 64 committees

THE SITUATION

A clinical standards organization had tried to fix its document development process before. Turnaround times were still too long, and the problem ran across 64 Document Development Committees — meaning any solution had to work at scale, not just in a pilot group. Leadership set an ambitious target: 60% reduction in cycle time. That required understanding not just what was slow, but why different committees performed so differently from each other.

The root cause wasn't motivation or effort. It was process design — inconsistent meeting structures, unclear consensus guidelines, and documentation practices that created delays rather than prevented them. The people running the committees were capable. The process they were working within wasn't.

WHAT WE DID

We started by observing six DDC meetings and running focus groups with committees across the performance spectrum — fast producers, middle performers, and slower ones — to understand what was actually driving the difference. That diagnostic work shaped a redesign process with a cross-functional team of 12 DDC representatives. The team mapped the current state, identified quick wins and longer-term changes, and developed a standardized future state process. A single pilot committee tested the new process end-to-end, surfacing issues before the wider rollout. We refined the design based on pilot feedback, then supported the organization through a full rollout to all 64 DDCs with ongoing remote support throughout.

WHAT CHANGED

✓ Document development cycle time reduced by 60% — the target was met

✓ Meeting duration reduced by 30% through redesigned templates and documentation protocols

✓ Standardized consensus guidelines eliminated decision-making delays and unnecessary revisions

✓ The pilot-first approach ensured a smoother rollout across all 64 committees

✓ The team built the capability and discipline for ongoing process improvement independently

Global escalation process streamlined — 30% faster resolution

A global contact lens manufacturer with an escalation process causing delays, communication breakdowns, and compliance risk.

Top result: Escalation cycle time reduced by 30%. Leadership equipped and aligned to sustain the improvement.

Global escalation process streamlined — 30% faster resolution

THE SITUATION

A global contact lens manufacturer had an escalation process that wasn't working. Delays were building up, communication was breaking down at handoff points, and resolution timelines were inconsistent enough to create both operational and compliance risk. Leadership could see the problem clearly. What they didn't have was a shared view of where exactly things were going wrong — and a team aligned on how to fix it.

The escalation process touched multiple functions and geographies, which meant the problem couldn't be solved in one room without the right people in it. It also meant any solution needed leadership buy-in from the start, not just at the end.

WHAT WE DID

We started by training site leadership on Lean and continuous improvement principles — not as a prerequisite, but so they could actively support the blitz rather than just attend the closing presentation. The four-day Lean Process Blitz that followed brought together 12 participants from across the escalation process: operators, coordinators, and data analysts. Day one mapped the current state in full, surfacing exactly where submissions were getting stuck. Days two and three moved through root cause analysis and immediate corrective actions. Day four produced a comprehensive action plan with named owners and new KPIs to track escalation performance going forward.

WHAT CHANGED

✓ Escalation cycle time reduced by 30% through process mapping and standardization

✓ New KPIs gave leadership clear benchmarks for tracking ongoing performance

✓ Standardized escalation templates and communication protocols delivered immediate operational gains

✓ Leadership left equipped — and motivated — to champion continuous improvement beyond the engagement

North American operations harmonized across Planning, Customer Service and Logistics

Three functions working independently with inconsistent processes, leading to inefficiencies and a lack of cohesion across a North American division.

Top result: Lead times reduced by 20%. Order accuracy improved by 15%. A cross-functional team now measuring and improving their own process.

North American operations harmonized across Planning, Customer Service and Logistics

THE SITUATION

A North American division of a global MedTech company had a cohesion problem that showed up in the numbers: lead times were variable, order accuracy was inconsistent, and Planning, Customer Service, and Logistics were essentially operating as separate organizations. The teams weren't in conflict — they just hadn't been given the tools, the shared language, or the collaborative structure to work as a unit.

Leadership knew the opportunity was there. What they needed was a structured way to see the full picture across all three functions simultaneously — and a process that would build genuine alignment rather than just surface-level coordination.

WHAT WE DID

We ran a three-month engagement structured in three phases. The first established a baseline — reviewing existing documentation, analyzing KPIs, and running an initial workshop to align the team on the scope of the problem. The second phase used Value Stream Mapping workshops to give the cross-functional team a shared view of end-to-end processes across all three functions — surfacing redundant approval steps, information flow delays, and inconsistent handoffs. The third phase moved from diagnosis to action: implementing standardized workflows for order processing and inventory management, running targeted coaching sessions to bridge cultural differences between the teams, and following up to track progress and refine what wasn't working.

WHAT CHANGED

✓ Lead times reduced by 20% through streamlined cross-functional workflows

✓ Order accuracy improved by 15%

✓ The three functions developed genuine cohesion — not just coordination

✓ The team built the capability to identify and address process inefficiencies independently after the engagement ended

Operational Excellence training standardized across multiple global sites

A global medical device company with four critical OE tools being applied inconsistently across sites — the gap wasn't awareness, it was standardized capability.

Top result: Consistent application of four OE tools across sites. 40% reduction in unplanned equipment breakdowns. Internal trainers equipped to sustain delivery independently.

Operational Excellence training standardized across multiple global sites

THE SITUATION

A global medical device company had identified four critical operational excellence tools it wanted embedded across its sites: Making Improvements, Team Maintenance, Planned and Preventative Maintenance, and 5S. The tools were known. The problem was that how they were understood and applied varied significantly from site to site — creating inconsistency in outcomes and making it impossible to build on progress from one location to another.

The gap wasn't motivation or intent. Teams wanted to improve. What was missing was standardized training that could be delivered consistently, adapted to local context, and sustained by internal trainers after the external engagement ended.

WHAT WE DID

We designed and delivered a four-module training program, one module per tool — each structured as three half-day sessions for up to 12 participants per wave. Every module was customized to the client's operational environment, incorporating site-specific examples and practical exercises rather than generic content. Critically, we co-delivered each module with a designated internal trainer, building their capability to run future sessions independently. Materials were developed iteratively with multiple review cycles to ensure alignment with the client's existing frameworks.

WHAT CHANGED

✓ Standardized training content ensured consistent application of all four OE tools across sites

✓ 25% reduction in non-value-added activities in pilot areas following Making Improvements training

✓ 30% reduction in equipment downtime and 15% improvement in maintenance task completion rates from Team Maintenance training

✓ 40% reduction in unplanned equipment breakdowns through Planned and Preventative Maintenance training

✓ 50% reduction in workplace clutter and 20% improvement in workspace organization from 5S training

✓ Internal trainers left equipped to sustain delivery — the capability stayed in the organization

Product data management harmonized across a global MedTech organization

Fragmented product data processes creating data silos, inconsistent documentation, and workflow inefficiency across multiple functions.

Top result: 35% reduction in data entry errors. Cycle time reduced by 25%. A comprehensive process playbook to sustain the gains.

Product data management harmonized across a global MedTech organization

THE SITUATION

A global medical technology company had a product data problem that was showing up everywhere: inconsistent documentation practices, workflow inefficiencies, data silos between functions, and redundancies that nobody had a complete view of. As part of a broader strategic initiative, leadership needed to harmonize and streamline how product data was managed across multiple functions — and do it in a way that would hold.

The challenge with data management problems is that they're rarely visible in their entirety from any single function's perspective. Each team sees its own piece. The inefficiencies live in the handoffs. Fixing it required getting all the right people in the same virtual room at the same time.

WHAT WE DID

We facilitated a five-day virtual Kaizen event — intensive, structured, and built around the real work rather than abstractions. Day one established a shared view of the current state and surfaced the pain points no single function had seen in full. Day two mapped the data flows and pinpointed redundancies and gaps. Day three developed the To-Be process and identified quick wins for immediate implementation. Day four turned the redesign into a concrete action plan with named owners and clear responsibilities. Day five was a stakeholder presentation where executive leadership aligned on next steps and committed publicly to driving the plan to completion. We integrated the outputs into a strategy playbook and stayed on to support implementation remotely.

WHAT CHANGED

✓ Unified data management workflows reduced inconsistencies and streamlined documentation across departments

✓ 35% reduction in data entry errors through improved data architecture

✓ Cycle time reduced by 25% through cross-functional alignment and clearer accountability

✓ A comprehensive playbook was developed to guide ongoing process management and sustain the gains

Environmental monitoring standardized across two medical sites

Inconsistencies in Environmental Monitoring workflows causing data collection delays, inefficiencies, and potential compliance risks across two locations.

Top result: Monitoring accuracy improved by 30%. Process cycle time reduced by 25%. A unified process across both sites.

Environmental monitoring standardized across two medical sites

THE SITUATION

A medical organization operating across two sites had an Environmental Monitoring problem that was creating compliance risk. Data collection was inconsistent, workflows varied between locations, and the delays building up in the process were starting to affect reporting accuracy. Leadership knew the situation needed to change — but the fix had to work across both sites simultaneously, not just in one location.

The root cause wasn't negligence. It was a lack of standardization. Each site had developed its own approach over time, and without a unified process map that both teams had built together, any solution imposed from above would likely produce the same variability in practice.

WHAT WE DID

We ran a three-and-a-half-day Lean Blitz across both sites, bringing together a cross-functional team of 10 participants including process operators, data analysts, and QA representatives. Day one established a shared view of the current process across both locations and identified where workflows were diverging and where bottlenecks were building up. Days two and three focused on eliminating waste, implementing immediate improvements, and standardizing data collection protocols that would work consistently across both sites. Day four produced a comprehensive action plan with clear owners for both immediate actions and longer-term improvements. Leadership was present at the opening and closing sessions — not just to show support, but to commit publicly to the changes the team had designed.

WHAT CHANGED

✓ A unified process map aligned EM workflows across both sites — eliminating the variability that was creating risk

✓ Monitoring accuracy improved by 30% through standardized data collection protocols

✓ Process cycle time reduced by 25%, accelerating data processing and reporting

✓ Leadership commitment at the closing session ensured post-blitz actions were driven to completion

See yourself in any of these stories?

The details change — the industry, the team size, the specific process. But the pattern is almost always the same: capable people blocked by systems that weren't designed to let them succeed. If that sounds familiar, let's talk.

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REAL WORK. REAL BARRIERS. REAL RESULTS.

The plant that had 'always been this way'

A leadership team that needed to learn to trust each other — fast

Zero late reports to the FDA — achieved in four days

See yourself in any of these stories?

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