What does it take to design clinical evidence that satisfies regulators and earns investor confidence ? A promising medical device innovation may open doors, but credible clinical evidence often determines whether it advances toward regulatory approval and investment readiness.
As part of the Leap Global Bootcamp, Venture Center will host a featured online talk on :
Designing Clinical Evidence for Medical Devices: That Investors Actually Trust.
Organized by : Leap Global Accelerator and RIFC @ Venture Center
Supported by : DST NIDHI and Blockchain for Impact (BFI)
The session is designed for founders, researchers, and innovators navigating the complex journey from device development to regulatory approval and investment readiness.
Speaker Profiles :
Nikhil Khadabadi - Chief Medical Officer, Eclevar MedTech
- Orthopaedic medical professional with strong expertise in medical devices, clinical research, and healthcare innovation
- Leads global clinical research initiatives, regulatory strategies, and post-market clinical follow-up (PMCF) activities at Eclevar MedTech
- Former Clinical Reviewer at TÜV SÜD, with experience evaluating high-risk Class IIa, IIb, and III devices under EU MDD/MDR frameworks
- Orthopaedic specialist with expertise in clinical evaluation of prosthetic joints, spinal devices, and dental implants
- Clinical Lead at Milo AI Healthcare, advancing AI-enabled clinical trials and medical decision-making
Pierre Marie - Lead Medical Writer, Eclevar MedTech
- Medical writer with 10+ years of experience supporting medical device and pharmaceutical companies in clinical and regulatory strategy.
- Expertise in clinical evaluations, study design, and identifying regulatory gaps to strengthen market readiness.
- Develops scientific and regulatory documentation aligned with EU MDR and MDCG international standards.
- Focuses on building credible clinical evidence that supports both regulatory approvals and investor confidence.
- Experience across multiple therapeutic areas including oncology, dermatology, wound care, and dental health.
What the talk will cover :
- What investors look for in a medical device evidence strategy
- The difference between regulatory minimum requirements and commercially credible evidence
- How intended use, claims, and device classification shape study design
- When literature evidence may be sufficient and when prospective clinical data becomes necessary
- Common evidence pitfalls that weaken fundraising conversations
- Building a staged clinical evidence roadmap aligned with company maturity and resources
Event Details :
Date : 25th March, 2026
Time : 4.00 PM onwards
Mode : Online via Zoom
For Queries Please Contact :
Aishwarya Varpe | +91 9156465137 | rifc@web.venturecenter.co.in
