Pratheep

About Pratheep

I\'m a Biomedical Engineer by training with class II & class NPI/NPD/ Sustenance experience. Navigated the ups & downs of launching and sustaining 15+ medical devices from concept to market. Executed the medical device programs in CFT environments vis-à-vis R&D, Manufacturing & Clinical sites.Experience Highlights : SYSTEMS ENGINEERING Rotational Atherectomy (Interventional Cardiology) • Patient Monitor (IBP, NIBP, SpO2, EtCO2, Temp, ECG,Wearable) • Ultrasound (Doppler | Greyscale | Portable) • Neonatal (Incubator,Radiant Warmer, Weighing Scale, Phototherapy) • Surgery (RF Generator | Catheter) • Resuscitation & CPAP Devices • Anesthesia & ICU Ventilator • Automated Slide Staining System (IHC/ISH) • Clinical Chemistry Analyser CLINICAL AREASInterventional Cardiology | Critical care (ICU,CCU & NICU)| Patient monitoring | Imaging (Ultrasound)| Neonatal care ( Thermoregulation, Respiratory, Jaundice )| Surgery ( Biopsy | Electrosurgery | Orthopedics | Image Guided)REGULATORY Class IIa, Class IIb & Class USFDA 510K: 4 filings, 2 inspections)| Safety Marking | EU-MDD (10 fillings)| SFDA (China 1 filing)| India (CDSCO : 2 filings)| JPAL(1 filing). Worked with reviewers & auditors of Notified Bodies ( BVQI, TUV, UL & GMED) & defended 15+ conformity assessments. Product Class Expertise : 21CFR87•••00 (MWI) 21CFR87•••25(MHX) 21CFR89•••50(IYN) 21CFR89•••70(ITX) 21CFR89•••60 (IYO) 21CFR87•••75(MCW)PRODUCT STRATEGYProduct Definition & Strategic NPI Tenders & Bids Benchmarking Product Refactoring & Sunset NPI ROADMAPPING Roadmap & NPD Plan Design & Development Product & Project Costing NRE Estimation Hiring & Onboarding V&V Clinicals & Usability Strategic Sourcing Design Transfer RMF DFSS (Blackbelt, Indian Statistical Institute) SUSTENANCE ENGINEERING Recalls & Non-Conformity CAPA Design Concessions VAVE Change Management Supplier Change Field Data Analysis Product Retirement Standards & QMS Upgrade Recall Management IP Credentials IP Strategy for product portfolio ( 50+ Granted Patents, 100+ applications ) IP landscaping. I’m Inventor/co-inventor of patents in Systems Engineering | Usability | Hardware | Mechanical | Clinical Applications ( 7 Patents : 1 International (PCT) & 6 India Patents ). Inventions filed are a mix of defensive & Invent-around patents. 15 filings with 60% granted, prosecution experience ranging 3 to 11 years. Patents : EU WO/2010/076808 IN 310484 IN 2084/CHE/2009 IN 251475 IN 251869 IN 257403IN 276335

Experience

1. Vertical Solutions Partner - Medical Device & Healthcare

   Quest Global

   Feb 2021 — Present · Bangalore, IN

   Solution development in NPD & Lifecycle Management for Medtech customers. Accountable for problem solving in NPD, LCM, Regulatory & Remediation : Radiology Imaging IVD Patient Monitoring Guided surgery Renal Care Respiratory Care

Education

• Madras Medical Mission

  Internship Training, Biomedical Engineering

• Cochin University of Science and Technology

  B.Tech, Biomedical Engineering

  1991 — 1995

Skills

• Iso 13485
• Iec 60601
• Critical Care
• Standards Compliance
• Risk Management
• Cross-Functional Team Leadership
• Iso 14971
• Npd
• Iec 62304
• Quality by Design
• Black Belt
• Management
• Part 820
• Ip
• Intellectual Property
• People Management
• Dfmea
• Iec 80001-1
• Product Development
• R&D
• Industrial Design
• Engineering
• Ce Marking
• Biomedical Device Design
• Mentoring
• Fda
• 21 Cfr Part 11
• Neonatology
• Regulatory Requirements
• Medical Imaging
• Engineering Design
• Patient Safety
• Product Design
• Innovation
• 510 K
• Six Sigma
• Value Engineering
• Patient Monitoring
• Medical Device Product Development
• Iec