Vivek Shimpi
Vivek Shimpi is CTO at VivaLogic, the company behind CLIP. He designed and built the platform’s technical architecture end to end: the websites, the calculators and simulators, the back-end services and the API that individual users, financial advisors and CLIP’s distribution partners run on, and the cloud infrastructure, deployment pipelines and software validation underneath them. He built the financial simulator, in C# and Avalonia, that models CLIP’s full mechanics at population scale, and he evaluates CLIP’s development and implementation partners on technical fit. He has led CLIP’s technology for seven years.
At Avanos Medical he is Manager of Quality Systems and Continuous Improvement, accountable for the global enterprise application that serves as the company’s system of record for quality and compliance: more than 2,000 users across four manufacturing sites, a global team of seven, and enterprise approval authority over the validation of the software the company runs on. That accountability covers encryption, handling of personal and health information, uptime and monitoring, configuration management, and recordkeeping with complete audit trails. He has been the company’s lead host for external certification audits, which closed with no major findings, and second chair during FDA inspections, and the measurement program he built took quality nonconformities down 58% year over year.
He builds the data and machine learning layer himself: pipelines over up to 200,000 records per process, executive reporting in SQL and Power BI, and a machine learning model that classifies incoming complaint data against an international standard taxonomy, agreeing with the company’s specialists 95% of the time. His governing principle for AI is that assurance scales to the criticality of what the model touches rather than being applied uniformly. A model informing a regulated decision is validated, its outputs are auditable and a human reviews them; lower-risk tooling is not made to carry weight it does not need. He is the AI governance owner for CLIP, and at Avanos owns AI and machine learning within the quality system.
The foundation is a decade in medical devices, beginning at Abbott in January 2016, where he spent seven years in R&D on an implanted cardiac device: every design decision documented, reviewed and auditable, and the software held to the same standard as the hardware. He wrote code the whole way, from Python test and equipment automation to the instrument drivers an agile team he led built for real-time testing of the implant, and he coordinated the engineering documentation remediation behind the closure of an FDA warning letter. He holds a B.S. in Biomedical Engineering from the Georgia Institute of Technology and is a certified Project Management Professional and Six Sigma Green Belt. What he brings to CLIP is an engineer who has shipped and defended software in an environment where electronic records, signatures and audit trails are regulated, audited and inspected.