I provide comprehensive, 360-degree lifecycle advisory for medical devices and IVDs - guiding innovations end-to-end from unmet clinical need identification through R&D, prototyping, design verification, preclinical and clinical validation, regulatory certification, commercialization, procurement, and market entry in India.
My Differentiators
Serial MedTech Innovator: Granted patents across medical devices and pharmaceutical/drug technologies, offering firsthand insight into bench-to-market translation.
Multidisciplinary Expertise: Doctoral-level scientific research foundation combined with portfolio management, innovation management, business strategy, and deep working insight into government ecosystems.
End-to-End Execution: One advisor connecting need identification, technical R&D, prototyping, laboratory/design validation, statutory compliance, and commercial scale-up - not a fragmented handoff between consultants.
Full Lifecycle Coverage
Need Identification & Concept Validation: clinical gap analysis, unmet-need scoping, early feasibility, innovation de-risking
R&D & Prototyping: TRL progression, design inputs/outputs, proof-of-concept to functional prototype
Design Verification & Preclinical: design V&V planning, essential principles checklists, biocompatibility/preclinical strategy
Regulatory Certification: CDSCO pathways plus EU MDR/IVDR awareness for dual-market strategy
Clinical Validation: clinical investigation protocols, CPE/PER reports, ethics compliance
Commercialization, Procurement & Market Entry: HTA, public tender strategy, go-to-market for private and public-sector adoption
Services Offered
CDSCO Regulatory & Licensing:
Risk Classification (Class A–D) under MDR 2017
Intended Use & Technical Documentation: DMF, PMF, essential principles checklists
Test License Facilitation: dossier prep for MD-12/MD-13
Clinical Validation & Performance Evaluation: protocols, CPE/PER reports, ethical strategy
Manufacturing & Loan Licenses: MD-3/MD-5 (State) or MD-7/MD-9 (Central)
Procurement & Market Entry:
HTA: cost-effectiveness analyses, value propositions for public uptake
Translational Strategy: feasibility analyses, TRL progression, indigenous manufacturing roadmaps
Key Skills & Tags: CDSCO, Medical Device Rules (MDR), IVD, Risk Classification, Intended Use Drafting, Test License (MD-12/13), Manufacturing License (MD-5/MD-9), Design Verification & Validation, Preclinical Testing, Clinical Validation, Performance Evaluation, TRL Progression, Government Procurement, Public Tenders, Health Technology Assessment (HTA), Technical Dossiers, Bioengineering, Prototyping, Product Development Lifecycle, Innovation de-risking