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The FDA Group’s Nick Capman sat down with Sean Gallimore, an executive consultant at AJS Consulting Company who has led product, commercial, and cross-functional teams in medtech and industrial tech, for a wide-ranging conversation on how leaders actually build high-performance teams in heavily regulated markets.
Sean’s lens is pragmatic: blend clinical, operational, strategic, and commercial rigor while navigating regulation, market dynamics, and a tough talent environment—and do it in a way that inspires people to follow you.
Whether you lead R&D, operations, product, or the P&L, this episode breaks leadership down into four levers—Strategic Clarity, Capabilities, Compliance, Connectedness—and shows how to deploy them so strategy turns into execution.
It also includes practical tooling like X-matrix goal deployment, RACI-style accountability, and “gemba” walks to keep leaders deeply connected to work.
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Sean’s key takeaways and recommendations
If you’re short on time, here are standout insights from this episode, especially useful for medtech leaders across R&D, operations, quality, and commercial.
Leadership is the 4 Cs, underpinned by trust. Sean’s framework: Strategic Clarity, Capabilities, Compliance, and Connectedness. If any one is “out of whack,” address it directly. Trust drives followership: humanity, competence, reliability, and communication.
Start with strategic clarity: pick a hill you can actually take. Pressure-test where you have a real “right to win” using feasibility questions (market, technical, systems, value proposition). Sean cites a “play to win” construct and emphasizes rigorous leadership team debate and data.
Make strategy executable with disciplined deployment. Translate the plan into an X-matrix of 1/3/5-year targets. Tie SMART one-year objectives to incentives and make ownership explicit (RACI-style). “That creates a really robust connection between strategy and execution.”
Prioritize like an owner: ROI first, then enabling and defensive work. Avoid “neat” features that don’t move the needle. Leaders often choose between good vs. good options—use clear decision rules and resource constraints to focus. “The tougher ones are the dilemmas where you’ve got good choices.”
Capabilities must match the strategy—or the strategy must change. If the plan demands muscles you don’t have, decide early to build, buy, or partner. Use an objective vetting (ask for data, timelines, pathway to performance) and be willing to pivot if options to close the gap aren’t viable.
Create a culture that surfaces the truth. Encourage rank-less debate, humility (“admit when you’re wrong”), and diversity of perspectives so teams can be candid about capability limits and risks—all without political reprisals.
Compliance = measuring the doing, not just the planning. Use KPIs/OKRs to see if people are actually executing the strategy. When there’s a gap, diagnose root causes: org design, process, resources, market dynamics, or lack of buy-in—then fix the cause, not the symptom.
Connectedness is the lever leaders control most. Make connection habitual and multi-channel (not just memos or meetings). Sean adapts “gemba” walks (spelled out on-air) beyond the factory floor—walking meetings across all functions to listen, learn, and build trust, including with hybrid teams.
Proof it works: the ultrasound launch story. Using walking meetings to surface team trepidation and then pairing connection + strategy + investment + execution flipped a historically underperforming launch into a success—with largely the same team a decade later!
Shift cultures from “play not to lose” to “play to win.” Combine clear vision, contextual data, and small-group conversations (beyond town halls) to move mindsets and accelerate adoption—especially in hybrid settings with intentional onboarding and right-sized face-to-face time.
One thing to bring back to your team
Sean’s framework isn’t just theory. You can put it into action with a quick “4 Cs health check” in your next leadership meeting. Here’s how:
Clarity: Write down your top one to three strategic goals. Ask: Do we really have a right to win here? Pressure-test with data, not just conviction. If the strategy can’t pass that test, revisit it before you deploy.
Capabilities: For each goal, check: Do we have the muscles to deliver this? If not, decide deliberately whether to build, buy, partner, or pivot. Avoid optimism bias by requiring evidence and realistic pathways to performance.
Compliance: Look at your KPIs and OKRs. If execution isn’t matching the plan, run a root-cause check: is the issue process, resources, market dynamics, or buy-in? Fix the system, not just the people.
Connectedness: Block regular time for gemba-style walks—in person or virtual. Sean emphasizes making this a habit across all functions, not just operations. Being visible and accessible surfaces reality, builds trust, and helps hybrid teams feel connected.
“If any of those four Cs are out of whack, I think leaders have to really address those in earnest.” — Sean Gallimore
Running this short exercise exposes whether clarity, capabilities, compliance, or connectedness is slipping, and gives leaders an immediate way to course-correct before small gaps turn into major failures.
Books mentioned include:
Never Split the Difference by Chris Voss
Supercommunicators by Charles Duhigg
Atomic Habits by James Clear
Sean Gallimore, MBA is an executive consultant who helps medtech and industrial technology companies scale through clear strategy, disciplined execution, and operational excellence. He brings 30 years of leadership across Fortune 500, mid-cap, and PE-backed firms with specialization in medical devices, life sciences, and industrial manufacturing.
Sean served as President/CEO of Dynisco LLC, where he led a strategic and operational turnaround that delivered consecutive double-digit revenue growth and meaningful EBITDA expansion through site consolidation, cost discipline, and capability building. As SVP & GM at PDI Healthcare, he drove growth in core and acquired businesses, exceeded profitability goals, and reduced attrition. Earlier executive P&L roles at Medtronic, Smith & Nephew, and Philips sharpened his commercial and general management toolkit. As Chief Marketing Officer at Parexel, he built a high-performance marketing organization, strengthened brand management, and drove cross-functional demand generation and new sales.
His healthcare experience spans clinical trials, cardiovascular, diabetes, orthopedics, diagnostics, informatics, and imaging. His industrial background includes manufacturing, plastics, oil and gas, automotive, and food production. Core strengths include full P&L and turnaround leadership, financial acumen, M&A, building high-performing teams, driving innovation, operational and commercial excellence, and cultivating growth cultures.
Sean holds an American Chemical Society–accredited BA in Chemistry and an MBA in Marketing from Rutgers University. He completed executive education in strategy, general management, financial management, and product management and innovation at Wharton, Notre Dame, the University of Chicago, and Northwestern.
Connect with him on LinkedIn here.
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