About our Virtual Round Table

Medical Devices industry is undergoing a transition with growth in technology solutions such as point of care and Software as Medical Device (SaMD) innovations. However, this is accompanied with several regulatory, quality and recall issues. This Virtual Round Table organized by Zinnov, in association with L&T Technology Services, focusses on use of new-age technology in innovation and key aspects for ensuring quality as well as regulatory compliance.

YOU CAN WATCH THE EVENT RECORDING HERE
Our Speakers

Nasir Desai, Director Stryker Technology Development, has worked on over 30 patents relating to product innovation and Ramakrishna Pidaparti, AVP L&T Technology Services, a widely recognized thought leader on quality, compliance and regulations in healthcare industry.

Key Takeaways

Session 1: Use of next-gen technologies (AI, ML) for driving innovation in medical devices

  • AI/ML has the potential to help healthcare professionals build more efficient and intelligent ecosystem for patient care and the industry is eager to capitalize on the benefits that AI can offer including improved quality of care and lower costs by handling the low yield administrative work
  • Key Adoption areas include:
    • Automation of EHR
    • Medical Imaging and Diagnostics
    • Patient Data and Risk Analytics
    • Patient Flow Optimization
  • Key Success Criteria
    • Productivity – Intelligent automations promises to boost operations efficiency by 10-15%
    • Precision – Including AI and Analytics in the workflow management can avoid all the human errors and result in reduction of medical errors
    • Actionable Insights – incorporating AI into the process can provide healthcare professionals with patient/ process insights which can be leveraged to increase through put

Session 2: COMPREHENSIVE COMPLIANCE FRAMEWORK FOR AI-ML-SaMD

  • With increasing prevalence of AI/ML SaMD there is a need for integrated compliance framework
  • Key factors to be considered when any medical product has IT (AI/ML/ SaMD)
    • NPI Considerations – It is very important to look at design controls, risk management and human factors
    • Traditional IT considerations include GDPR, HIPAA and the Qualified infrastructure etc.
    • Other Operational considerations include normal inhouse and post market QSR activities
  • Bake Cyber Security into product design as system requirements as it affects safety
  • AI/ML algorithm development involves learning from data and hence prompts unique considerations that embody GMLP
  • Few best practices and standards include - QSR, ISO-13485, ISO 14971, 21CFR Part 11, IEC 62304, IEC 2366, TIR 45, TIR 57, HL-7, ISO-27001
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