Our Team

Vidur Sahney is a Senior Partner at MKA Insights, located in San Francisco, CA.

Vidur is the leader of our Operations Consulting Practice. He supports clients in medical device, clinical diagnostics, life sciences and biopharmaceuticals.

With over 20 years of experience in medical device operations, Vidur helps clients employ better, smarter and faster operations strategies in the areas of Validations, Manufacturing Operations Strategy, Sourcing & Supply Chain, Contract Manufacturing Strategy, Logistics / Warehousing and Quality. He is experienced in ISO13485, CFR820 and regulatory and reimbursement strategies.

He helps executives improve efficiency across these areas while operating within highly regulated environments. Vidur’s work includes the following:

• Experienced in working with highly-regulated, difficult to manufacture products to improve manufacturability, scalability and ensure regulatory approval in quick turnaround situations.
• Operationally scaled production of a Class II Medical Device from 20 units per week to 5,000 units per week without leveraging contract manufacturing organizations (headcount, equipment, manufacturing and quality processes)
• Successfully led, trained and indoctrinated the principles of Design for Manufacturability (DFM) at startup organizations by focusing on how R&D groups approach innovation & design – changing the way design, sourcing and manufacturing are managed and executed
• Strategically planned and executed the increase in yields for a Class III / PMA Medical Device from 12th percentile to upper 80th percentile within eight months to demonstrate manufacturing process repeatability leading to a successful exit by the firm to a strategic buyer
• Successfully led FDA site clearance for Class III / PMA device by working closely with site managers, cross-functional engineers on validation strategy, execution and documentation
• Successfully managed complex teams and individuals including 20 direct reports and 300+ indirect reports
• Led the strategic sourcing of injection molded partners and developed lot history records, manufacturing guidance documents and deployed effective Root Cause Analysis (RCA) for troubleshooting where applicable
• Led numerous successful audits with the FDA and Notified Bodies