Prachi Samarth
Healthcare Research and Insights professional with 6+ years of experience in medical device sector spanning research and development, regulatory affairs, Strategy and Insights
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About
Healthcare strategy and analytics professional with 6 years of experience across MedTech, healthcare research, and commercial strategy. Brings a cross-functional understanding of the healthcare value chain spanning product development, regulatory affairs, and market insights to support data-driven decision-making. Experienced in healthcare claims analysis, market entry strategy, and stakeholder mapping across cardiovascular, orthopaedic, and digital health segments.
Experienced in synthesizing clinical, regulatory, and commercial perspectives into clear, actionable insights for healthcare organizations.
Experience
Research Manager at TT Lifesciences (2024-09 – 2025-06)
- Shaped research-led thought leadership content for 5 international MedTech conferences (3 Europe-EUMDR, 2 US FDA), translating primary and secondary research into industry narratives for cardiologists, device manufacturers, and investors.
- Conducted 50+ expert interviews with scientists, device manufacturers, and industry leaders to identify emerging clinical and commercial trends shaping MedTech adoption.
- Performed competitive and market landscape analysis across MedTech segments to identify differentiation opportunities and emerging trends.
- Collaborated with sales and marketing teams to align research insights with outreach strategy and improve sponsor targeting.
- Synthesized insights from multiple sources into clear, structured narratives to improve content relevance and stakeholder engagement.
- Promoted within 9 months to Conference Producer; managed end-to-end event execution including timelines, stakeholder coordination, and delivery.
- Mentored junior researchers on analytical thinking, insight structuring, and presentation clarity.
Senior Engineer, Regulatory Affairs at Tata Elxsi (2022-12 – 2024-04)
- Drafted and reviewed EU MDR documentation for orthopedic devices including DoC, GSPR, and Technical Files, translating complex regulatory requirements into structured action plans.
- Conducted gap assessments and developed remediation roadmaps aligned to submission timelines, achieving zero major non-conformances across submission cycles.
- Improved documentation review timelines by ~25% through workflow optimisation across engineering and quality teams.
- Proposed an AI-based regulatory documentation solution, demonstrating application of automation in regulatory workflows.
Research Associate at Zydus Medtech (Nano Therapeutics Pvt. Ltd.) (2021-02 – 2022-11)
- Led development of an electromechanical Class III cardiovascular prototype from concept to proof-of-concept.
- Managed requirements gathering, risk analysis (ISO 14971), and validation protocols aligned with ISO 13485 standards.
- Coordinated with engineers, clinical advisors, and vendors to ensure technical and regulatory alignment.
- Conducted literature reviews and patent benchmarking to identify design opportunities and support product decisions.
Research Fellow at Vigyan Ashram (2016-06 – 2017-05)
- Designed and built a functional low-cost prosthetic hand prototype integrating mechanical and electronic systems.
Marketing Intern at Getinge India (2015-06 – 2015-08)
- Surveyed 60+ hospitals on infection control practices and translated findings into structured, evidence-based marketing insights.
Education
M.Tech in Biomedical Instrumentation – College of Engineering Pune (CoEP) (2020)
B.Tech in Biomedical Engineering – Bharati Vidyapeeth, Pune (2016)
