A leading MedTech manufacturer with global operations had strong top-line growth, but lacked visibility into the profitability of its individual products (SKUs). With rising costs, tightening regulations, and an increasingly complex product portfolio, their executive team launched a strategic project to review product performance, improve regulatory alignment, and inform smarter investment decisions across global markets.
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.
We developed SKU-based KPIs to guide product and build-vs-buy decisions—balancing profitability with compliance feasibility.
A secure analytics framework was implemented, enabling real-time tracking of SKU performance and collaboration across finance, regulatory, and product teams.
We restructured the project workflow with agile delivery sprints, a finance-aligned governance model, and rigorous project tracking to prevent delays and overrun.
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.
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.
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.
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.
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.
