MKA Insights

About Vidur

Vidur Sahney leads MKA’s Operations Consulting Practice and supports clients in medical devices, clinical diagnostics, and life sciences. With over 20 years of experience in medical device operations, he helps executives improve efficiency, scalability, and regulatory compliance in highly regulated environments. His work spans validations, manufacturing operations strategy, sourcing and supply chain, contract manufacturing, logistics and warehousing, and quality systems (ISO 13485, CFR 820). He is known for taking difficult-to-manufacture products and transforming them into scalable, repeatable processes—often in quick-turnaround, high-pressure situations where the stakes are high and the margin for error is small.

Vidur’s career has been defined by his ability to solve manufacturing challenges that others can’t—whether that means scaling production from 20 units per week to 5,000 units per week without leveraging contract manufacturers, increasing yields for a Class III/PMA device from the 12th percentile to the upper 80th percentile within 8 months, or leading FDA site clearance for a Class III device by developing comprehensive validation strategies in collaboration with cross-functional teams. These accomplishments reflect his deep understanding of manufacturing processes, quality systems, and regulatory requirements—and his ability to execute under pressure while maintaining the rigor required in regulated environments.

One of Vidur’s core strengths is his expertise in Design for Manufacturability (DFM). He has trained and indoctrinated R&D teams at multiple startups on DFM principles—fundamentally changing how innovation, design, sourcing, and manufacturing are managed and executed. This work is critical because many early-stage medical device companies develop products that are technically brilliant but operationally impractical—leading to manufacturing bottlenecks, quality issues, and commercial delays. Vidur’s ability to bridge the gap between R&D and manufacturing ensures that products are designed not just to work in the lab, but to scale in production environments where repeatability, consistency, and cost efficiency matter.

Vidur’s sourcing and supply chain expertise has been instrumental in helping companies identify and manage critical manufacturing partnerships. He has led sourcing of injection molding partners, developed lot history records, created manufacturing guidance documents, and deployed effective Root Cause Analysis (RCA) for troubleshooting. His strategic approach to sourcing goes beyond finding the lowest-cost supplier—it’s about identifying partners who can deliver consistent quality, scale with the business, and navigate the regulatory complexities that come with medical device manufacturing. This disciplined approach to supplier management has helped clients avoid costly manufacturing failures and ensure continuity of supply during critical growth periods.

Throughout his career, Vidur has successfully managed complex teams—including 20 direct reports and 300+ indirect reports—demonstrating his ability to lead large-scale operations while maintaining focus on quality, compliance, and performance. He has led numerous successful audits with the FDA and Notified Bodies, ensuring that manufacturing operations meet the stringent regulatory requirements necessary for market approval and commercialization. His experience navigating regulatory inspections gives him a practical understanding of what auditors look for—and how to build quality systems that can withstand scrutiny.

At MKA Insights, Vidur works with medical device and diagnostics companies on operations strategy, scale-up planning, contract manufacturing partner selection, quality system design, yield improvement initiatives, and Design for Manufacturability training. His deep operational expertise, combined with his regulatory knowledge and hands-on manufacturing experience, makes him uniquely qualified to help companies navigate the challenges of bringing complex medical devices from prototype to commercial production. Whether he’s helping a Series A medtech startup prepare for its first manufacturing scale-up or advising a growth-stage diagnostics company on FDA readiness, Vidur brings a disciplined, execution-focused approach that reflects his two decades of experience solving manufacturing problems in regulated environments.