Expert Profile
Ravi ***** is the founder of ***** LLC, a consulting company located in Indianapolis, Indiana. He is innovative, talented and accomplished technology and business management professional with more than 16+ years of experience with IVD manufacturer specially in product design, product manufacturing, operations improvements, supplier quality, FDA compliance, intellectual property, device complaint handling process, failure & non-conformance root-cause analysis, IVD competitive market analysis and project management. He has proven to facilitate corporate growth through the effective leadership of business and technology initiatives. He is adept at strategy development, best practices, process improvement, organizational change management, and streamlining. He is an author and inventor who have consistent record of success in delivering innovative new products and intellectual property for employers, with over 115 patent applications and 30 patents granted. He possesses excellent leadership, communication, and problem-solving skills. He has BSME from University of Southern California (USC), an MBA from Purdue University (PU), executive certification in Technology, Operations and Value-Chain Management from Massachusetts Institute of Technology (MIT) and executive certification in Technology and Innovation Management from California Institute of Technology (Caltech).
*****, LLC
Independent consultant to medical device and pharmaceutical companies.
ROCHE DIAGNOSTICS, Indianapolis, IN 1992 – 30 Jan 2009
Manager, Strategic Business Initiatives (***** Jan 2009)
Internal consultant at $4B+ medical diagnostics manufacturer, reporting directly to President. Charged with evaluating existing supply chain processes and industry supply chain trends and leaders. Member of Supply Chain Transformation team responsible for developing & delivering best practices, associated technologies, including lean supply chain roadmap.
• Saved $600,000 per year in shipping of products manufactured in Puerto Rico by eliminating shipping to, and storage at, US warehouse. Migrated process to direct shipping from manufacturing site to customers, to manage finished goods inventory without additional touches or movements.
• Delivered recommendation projected to save >$3.1M in less than 2 years by implementing centralized transportation planning function for domestic and international shipping.
Tasked to deliver FDA complaint, most cost effective, end-to-end device complaint handling business process.
• Led and created “to-be Future State” end-to-end device complaint handling process introducing RFID in cross-functional team.
Tasked to co-ordinate and transfer a novel technology base low cost blood analyzer from a start-up company in Finland to well established Roche Instrumentation group in Rotkreuz, Switzerland.
• Led a multi-disciplinary executive team of Finish and Swiss expert to delivered (tech transfer) product platform plan on novel technology to launch low cost, decentralized blood analyzer with the goal to expand revenue stream and market share.
Manager, Supplier Quality & Development (Supply Chain) (*****)
Promoted to oversee resolution of supplier quality issues and obtain FDA compliance for purchasing controls (21 CFR 820.50) , including procurement, supplier section, and supplier quality & Corrective And Preventive Action (CAPA) management. Managed procurement process, procurement and supplier quality records management, supplier audits, and Lean & 6 Sigma initiatives. Supervised 5 source development engineers and 3 source compliance consultants across 2 teams.
• Led successful supplier remediation project that eliminated pre-existing 483 FDA citations and remediated 80% of all supplier records, including 100% of high-risk records. Supervised 8-person team.
• Directed project to create electronic database of all supplier records. Coordinated file location, scanning, and labeling effort that saved company $80,000 per year in costs caused by delays in finding files.
• Reduced time required for purchase requisition approval from 1 week to 2 days, and eliminated backlog of approvals, by migrating Purchasing requisition categorization process to centralized team.
• Assumed control of Supplier Quality Board and implemented changes that resulted in shorter times required for company to make decisions regarding ongoing supplier issues.
• Improved productivity and performance levels by initiating group evaluations of new hires. Also increased productivity and quality by implementing cross-training of personnel.
Principal Engineer, Discovery, Process R&D (*****)
Coordinated multi-disciplinary, international teams in developing, discovering, and enabling innovative technologies to improve company’s competitive edge. Investigated and resolved issues for scientists. Performed physical and structural analyses of competitors’ products. Developed new process technologies. Worked closely with technical and scientific partners in academia, industry, and institutions worldwide. Administered $250,000 - $1.2M in annual R&D budgets. Created significant intellectual property. Supported cGMP regulation 21 CFR 820.30 for Design Controls.
• Directed team of US and German scientists and engineers (tech development & transfer) in revolutionizing company’s manufacturing platform for diabetes test strips by introducing patented laser ablation manufacturing technology. Product launched with 6 Sigma Quality internationally in 2005 and has facilitated over $1B in sales.
• Provided company with potential to save up to $20M per year by replacing adhesive based sealing with patent-pending laser sealing technology.
• Delivered patented organic light emitting diode-based biosensor, giving Roche competitive edge.
• Filed numerous patents and assisted patent attorneys in patent prosecutions.
• Recommended building prototype pilot facility to rapidly test biosensors, eliminating months of testing.
Principal Engineer, Product & Manufacturing Process Design & Development (*****)
Coordinated multi-disciplinary teams in conceiving, developing, and enabling innovative production technologies to fulfill company’s new product commercial launch criterion. Worked closely with technical and scientific partners in academia, industry, and institutions worldwide to understand & solve manufacturing problems. Administered $10 M in project budgets.
• Directed team of internal and external resources to design, develop, test and qualify various production technologies (converting) for successful commercial launch of disposable bio-sensor. For example:
o Hot melt adhesive dispensing, coating and slitting (Lean & 6 Sigma Project)
o High speed sensor punch and packing (6 Sigma Project)
o High speed labeling technology (Lean & 6 Sigma Project)
o High speed mesh slitting technology (Lean & 6 Sigma Project)
o High speed dispensing technology (6 Sigma Project)
CAREER NOTES: Previous positions with Roche include Principal Engineer, Product & Process Design and Development (*****) and Machine Design Engineer, Production System Design and Development (*****). Led internal and external (global) teams to design and develop numerous innovative products, along with production systems that led to major costs savings and process improvements while meeting launch criterion.
• Masters of Business Administration (MBA), Purdue University (PU), West Lafayette, IN
• BS in Mechanical Engineering (BSME), University of Southern California (USC), Los Angeles, CA
• Executive Certificate in Technology & Innovation Management,
California Institute of Technology (Caltech), Pasadena, CA
• Executive Certificate in Technology, Operations & Value Chain Management,
Massachusetts Institute of Technology (MIT), Cambridge, MA
I provide consulting in the following areas:
1. Process Improvement (business & technical)
2. Kaizen (continuous improvement) & Lean Project design & implementation
3. FDA compliant medical device complaint handling business process
4. FDA compliant global supplier management, purchasing controls & quality assurance
5. Supply chain improvements (diagnostic, analysis and recommendations)
6. Biosensor (strip) technology development & transfer
7. Manufacturing technology development & transfer
8. Due-diligence (product, process & supply chain)