Workshop On Medical Device
Development, Testing, Regulations & Market Access
Medical Device: Development, Testing, Regulation & Market Access
In pursuit of realising this hope, CPDMed TBI, IISc in collaboration with Incense TBI, IISc and Tata Trusts PATH Impact Labs is organizing a two-day workshop on
“Medical Device: Development, Testing, Regulation & Market Access”
Aim:
To help MedTech start-ups in different stages of product engineering , testing for compliance and certification to anticipate preparatory requirements to face the challenges in bringing the PoC Ready state through to the Market Ready State
Coverage :
1. Safety and Performance testing | 5. Vendor management |
2. Quality management | 6. Clinical study design |
3. Sensor technologies in MedTech | 7. Avenues of funding for scale in MedTech innovation ecosystem. |
4. Regulatory requirements – CDSCO & FDA, manufacturing readiness, certification and global market access. |
For Whom: | Highly relevant for MedTech product innovators and startups. |
Jointly organised by: | CPDMed, Tata Trusts PATH Impact lab, InCeNSE |
Dates and Days: | Thursday 5th September & Friday 6th September 2019 |
Registration Last Date: | 3rd September, 5PM |
Seats Available: | 65 Only (Reservation Only On Payment) |
Venue: | Cense Auditorium, IISc Bengaluru |
Registration: | Click on Register to register yourself to the event |
Registration Fee : | 1000/- |
Bank A/c details :
SB A/c No | 0683101018843 |
Name | Society for Innovation and Development (SID) |
Bank Address | Canara Bank, IISc Campus, Bangalore 560012 |
Branch Code | 0683 |
IFSC Code | CNRB0000683 |
MICR No | 560015023 |
Agenda :
DAY 1: Thursday, 5th September
Sessions | Speakers list with designation and company |
09:30 AM – 10:00 AM Registration and Tea | |
10:00 AM – 10:10 AM Welcome & Setting the Scene | Dr Satya Dash, Impact Lab, PATH |
Session 1: | |
10:10 AM – 10:20 AM Medical Device Development and Translation of Medical Research | Dr Navakant Bhat, Chairperson, CeNSE, IISc |
10:20 AM – 11:30 AM Plenary Lecture(s): Medical Device Design, Testing and Development Processes | Shyam Vasudevarao Founder & Director, Forus Health, Renalyx, Rx DHP Chandrashekhar Nair Director, Bigtec |
11:30 AM – 12:00 PM Tea & Networking | |
Session 2: | |
12:00 PM – 01:30 PM Risk Management, Compliance to Quality and Safety Standards in Medical Device Design & Manufacturing | Nachiket Deval Co-founder, Coeo Labs Manoj Jain Site Head of Quality (APAC R&D), Boston Scientific Guruprasad HC Lead Auditor, TÜV Rheinland |
01:30 PM – 02:15 PM Lunch & Networking | |
Session 3 | |
02:15 PM – 03:30 PM Sensors and (Bio)MEMS Technology in Medical Device, Calibration, Measurement Technique & Communication Standards | Vinay Kumar CEO, PathShod Healthcare Jayadeep Unni Founder, Sensivision Health Technologies Dhananjaya Dendukuri CEO & Co-founder, Achira Labs |
03:30 PM – 04:00 PM Tea & Networking | |
Session 4 | |
04:00 PM – 05:30 PM Challenges in Vendor Engagement, Material Selection, Design for Manufacturing & Assembly (DFM, DFA) | Malathi Lakshmikumaran Executive Director and Practice, Head of Patents, Lakshmikumaran & Sridharan |
05:30 PM – 06:00 PM Open Forum | |
06:00 PM – 06:30 PM Day 1 Close & Networking Tea |
DAY 2: Friday, 6th September
Sessions | Speakers list with designation and company |
09:00 AM – 09:30 AM Day 2 Registrations | |
09:30 AM – 10:00 AM Welcome & Recap of Day 1 | Dr Satya Dash, Impact Lab, PATH |
Session 5: | |
10:00 AM – 10:45 AM Medical Device Regulations, Pathways and Securing Regulatory Approvals | Sukanta Bhatt Head of University/ Clinical Programs, Philips Healthcare Innovation Centre (HIC) Vinayak Nandalike Founder, Yostra Labs Deepak Raj Founder & Director, Osteo3D |
10:45 AM – 11:15 AM Tea & Networking | |
Session 6: | |
11:15 AM – 12:15 PM Certification for National and Global Market Access | Neena Sonavane Senior Manager – Regulatory Affairs, Philips India Ltd. Yogesh Patil Co-founder & Director, Biosense |
Session 7: | |
12:15 PM – 01:30 PM Funding for Scaleup | Yogesh Patil Co-founder & Director, Biosense Radha Kizhanattam Investment Director, Unitus Venutres Satya P Dash (Moderator) Director Global Innovations, PATH Premnath Venugopalan Director, Venture Center Mukesh Sharma Co-founder & Managing Director, Menterra Venture Advisors |
01:30 PM – 02:30 PM Lunch & Networking | |
Session 8: | |
02:30 PM – 03:30 PM Study Design, Planning, Ethics Committee Approval | Anant Bhan Adjunct Visiting Professor, Yenepoya University |
03:30 PM – 04:15 PM Open Session (All Speakers) and Management of Device Clinical Validation | |
04:15 PM – 05:00 PM Close & Networking Tea |