CUSTOMER STORIES

MedTech - From Data Chaos to Product Insights

Background

A leading MedTech manufacturer with global operations was experiencing strong top‑line growth but lacked a clear, unified view of product‑level (SKU) profitability. Rising costs, tightening MDR/IVDR and Swissmedic regulations, and an increasingly complex product portfolio made decision‑making harder. To address these pressures, the executive team launched a strategic initiative to integrate fragmented data, gain end‑to‑end visibility across operations, and create a trusted single source of truth. The goal was to accelerate innovation, strengthen regulatory alignment, and guide smarter investment decisions in competitive global markets.

Challenges of the Customer

Lack of SKU‑level insights to assess product viability and profitability, limiting the ability to prioritize high‑performing products
Regulatory uncertainty around certified supply partners and in‑house manufacturing choices, particularly related to CE/MDR certification requirements.
Operational misalignment between business, finance, and technology teams — slowing execution and increasing project costs.
Security and compliance risks stemming from siloed data and manual reporting workflows, reducing audit readiness and slowing response to regulatory demands.

Our Recommendations

Regulatory Understanding & Compliance

We clarified product-level certification needs (e.g., MDR, ISO 13485) and aligned decisions with both internal capabilities and external certified suppliers. This avoided costly missteps in product lifecycle planning.

Supply Chain & Portfolio Optimization

We developed SKU-based KPIs to guide product and build-vs-buy decisions—balancing profitability with compliance feasibility.

Secure, Collaborative Execution

A secure analytics framework was implemented, enabling real-time tracking of SKU performance and collaboration across finance, regulatory, and product teams.

Agile Methodology & Stakeholder Governance

We restructured the project workflow with agile delivery sprints, a finance-aligned governance model, and rigorous project tracking to prevent delays and overrun.

Client Results

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Faster Execution

By introducing agile delivery methods and establishing clear cross-functional governance, we accelerated project execution across teams. This enabled faster business decisions, improved responsiveness, and eliminated typical bottlenecks from siloed collaboration.

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On-Budget Delivery

Through accurate resource forecasting and early alignment with finance, tech, and regulatory stakeholders, we ensured every phase stayed financially controlled. Not a single cost deviation occurred—giving leadership full confidence in ROI from day one.

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Reduction in Manual Audit Preparation Time

We proactively identified certification gaps tied to MDR and ISO 13485 and embedded regulatory validation into every product and supplier decision. This reduced compliance risk exposure by over 80%, ensuring product changes didn’t trigger costly re-certifications or audit failures.

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SKUs Analyzed

By evaluating over 100 SKUs with profitability, certification, and supply chain risk in mind, we enabled the leadership team to confidently underperforming products. This unlocked millions in potential savings while aligning investments with regulatory-ready, high-impact innovations.

"We were in trouble, 60% of our budget was gone with only 40% of the project done. Bringing in a senior project manager from this team made all the difference. With improved focus and teamwork, we finished the full scope on time and within budget. Their expertise turned our project around, I highly recommend their services for any project challenge."

Christoph I.

Manager - MedTech - Morges, CH

Ready to start Unlocking Insights?

Unlock the full potential of your MedTech data with expert guidance tailored to your business goals. In this no-obligation session, we’ll assess your current data landscape, identify opportunities for improvement, and outline a clear roadmap to drive smarter decisions and growth.