Siddharth Jain is CEO and Chief Regulatory Advisor of Symbiorph Clinical Trialogy. He is based in Ahmedabad and has extensive experience in Medical Device Clinical Evaluation Report Preparation, Post Market Clinical Follow-up (PMCF), Risk Management, CE Certification and Global Product Registration in Latin America, GCC, MENA, South East Asia and US FDA. He has total 04 years of experience in Medical Device Regulatory Affair Compliance and currently advising many Orthopaedic Implant Manufacturers, Disposable Manufacture and Laparoscopic Instrument & Equipment Manufacturer across India. He has done Post Graduate in Microbiology from the B.R Doshi School of Bioscience, Sardar Patel University, Vallabh Vidyanagar and further did Post Graduate Diploma in Clinical Research from Xcellon Institute, a sister concern company of Claris Pharmaceuticals affiliate to Ganpath University. He has also published his research paper on Naphthalene Degradation by Bacteria Consortium (DV-AL) developed from Alang-Sosiya Ship breakage yard, Gujarat in Science Direct Journal.

Mr. Tim Galekop
(TiGaMed Consulting, Belgium)

Mr. Tim is regarded as a Global Expert in the field of Infection Prevention and Sterilization In his last role Tim was Responsible for Global Technical Support and Regulatory affairs and has been working in the medical field for more than 30 years.

He is a member of the Dutch Norm group from the day of foundation in 1980 and has participated in the German DIN, and the French AFNOR.

Since 1988 he is convener of TC 102 WG 4 Packaging Materials, Tim is as well a participant in ISO TC 198 WG 7 Medical Packaging and CEN TC 205 WG 14 Surgical drapes and gowns.

Over the years he has visited many hospitals globally and spoke on numerous international conferences. During his stay in India he has spoken in various conventions and visited several hospitals and surgeons in Delhi, Chennai, Bangalore, Kolkata, Hyderabad and Mumbai among other cities.

Tim is committed as well to several medical education programs and has published several publications.

Tim is attending the INDA, EDANA and SBA (Sterile Barrier Association as a board member) meetings. Tim led EDANA’s Task Force infection prevention conference – “ IN CONTROL” in the role of Chairman.

Tim now consults with some of the most respected companies worldwide.

Mr. Sumit Marwah
CEO & Director,
Dispoline Healthcare Private Limited,
I2i Consulting,
Deccan Crest,
Management Consultant & Entrepreneur.

In the field of Single Use Medical Devices And Infection Prevention for the past 17 years, as a Manufacturer, Consultant & Trainer.

Committed to Medical Education Programmes and have taken programmes at various International Conferences, Forums and Hospitals across the globe. Special focus on Education through Creative Learning Programmes. These are done uner the aegis of THE INPREV FOUNDATION.

Interests in OT, CSSD and Sterilization with specific reference to Infection Prevention.

Pioneered Customised Pre Sterile OT / Procedure Kits in India, and developed a low cost model of Design, Manufacturing and Distribution for the same.

Active Member of various Medical Device - industry and regulatory bodies, with a vision to form a Comprehensive Medical Device Regulation for India and assist the medical device industry to produce products with adequate and appropriate controls and systems for ensuring patient and staff safety.

Mr. Manoj Bhardwaj
(Managing Director,
SMC Medical Manufacturing, Bangalore)

Manoj Bhardwaj is the Managing Director of SMC Medical Manufacturing headquartered at Bangalore, India.

SMC Medical Manufacturing is a fully owned subsidiary of SMC Ltd headquartered in Somerset, Wisconsin US. The core competencies of SMC Ltd spans across medical device design, tool design and build, molding, manufacture and assembly of medical devices as well as industrial automation and robotics.

Manoj is a polymer engineer with over three decades experience in Manufacturing, Consulting and IT sectors. Manoj has hands on experience in compounding of polymers, alloys and blends as well as downstream polymer processing operations like extrusion, injection molding, welding, machining, printing, decoration, etc. He also has experience in manufacture of extrusion and injection molding machines, product design, mold design and mold making.

Besides polymer science, Manoj’s background includes business strategy consulting, business process consulting, supply chain and logistics, new product introduction, lean manufacturing, program management as well as IT/ ITeS consulting,  infrastructure and services.

Mr. Dhiren Mehta
(Managing Director,
Surgimedik Healthcare India Pvt. Ltd. Mumbai & Surat)

Mr. Dhiren Mehta is a B.Chem Engineering with 27 years in Medical Device industry.

Currently he is the Managing Director of Surgimedik Healthcare India Pvt Ltd (Mumbai & Surat.)

Dr. Pallavi Kulkarni
(Technical Manager Lubrizol Life Sciences,
Lubrizol Advanced Materials, USA)

Dr. Pallavi Kulkarni is Technical Manager at Lubrizol Advanced Materials Life Sciences division. Her area of expertise is in developing thermoplastic polyurethanes for medical applications.

Pallavi obtained her PhD in Chemical Engineering from University of Toledo, Ohio, USA followed by a 2 year post-doctoral fellowship at University of Massachusetts, USA. Over the past decade she has gained knowledge and experience in polymer chemistry, processing and structure-property relationship. She is the author on several research articles as well as inventor on several patents.

Pallavi has contributed to the commercialization of several products at Lubrizol, and is a subject matter expert in thermoplastic polyurethanes and their applications specifically for medical devices. As a senior scientist, her role is to develop novel polyurethanes for un-met market needs and to explore new areas of application for existing polymers. She is also actively involved in Lubrizol’s regulatory efforts in manufacturing excipient GMP grade materials and preparing DMF files. The medical device market in India is growing with an evolving regulatory landscape, requiring component manufacturing using engineered polymers versus commodity plastics. Pallavi is working extensively with Indian medical devices manufacturers and assisting them in introducing complex technology to manufacture specialized medical devices. She is helping customers adopt TPU based manufacturing and critical components sourcing through Vesta Inc.

Dr. Manasi Nath
(Technical Application Engineer,
Kraton Polymers International Ltd. Mumbai)

Dr. Manasi Nath is currently working as Technical Application Engineer– with Kraton Polymer International Limited, India. In her present role, she is actively involved in Application & Product Development with key focus on new Business Opportunities for Kraton Polymer.

Dr. Manasi Nath is M. Tech and Ph. D in Polymer Technology from renowned University of Chemical Technology (U.I.C.T.), Mumbai. She had varied experience of Research & Development to Technocommercial Activities. Her research interests are in Specialty Polymer, Polymer Modification, Polymer processing and Polymers in Healthcare sector. She has a diverse Techno- Commercial experience in the field of Polymers.

Prior to the current portfolio, she worked as a Senior Technical Manager – Application Development with Fine Organics, Mumbai for four years. She also worked as a project co-coordinator of an innovative highly reputed World Bank Project at IRMRA through National Agricultural Innovation Project of Govt. of India for few years.

Earlier, she worked as a Research Scientist with “Baerlocher” Research Centre, Mumbai.

She has presented papers in various International symposia as an invited speaker.

Mr. Sanjay Chotalia
(Manager – Technical Sales & Marketing,
Covestro (India) Private Limited)

Sanjay Chotalia is MBA in Marketing, Bachelors in Polymer Engineering from Pune university and Diploma in Plastics Engineering from Mumbai university.

He has total 8 years of experience in Technical Sales and Application Development of Engineering Plastics like Polycarbonate, Nylons, PBT, Polyacetal etc.

He has been working with Covestro India Pvt. Ltd., for more than 3 years as Manager – Technical Sales & Marketing for west India region, Handling Polycarbonate resin with the Major focus on Medical & Electrical segments.

Mr. Shinto Joseph
(Director,
LDRA, Bangalore)

Mr. Shinto Joseph is Operations and Sales Director at LDRA Technology Pvt. Ltd, Bangalore. He holds a B.Tech from Kerala University and MBA from Christ University, Bangalore. With over 18 years of experience in supporting and implementing  embedded software lifecycle solutions, Shinto has built a solid reputation at the forefront of embedded systems working with cross border delivery teams, technology partners and industry regulators within the defence, aerospace, nuclear, rail and automotive sectors. Today he concentrates on creating a healthy ecosystem in the embedded, mission and safety critical domains in India.

Mr. Mekala Rao
(Founder & President,
Atachi Systems, Hyderabad)

Mekala Rao is the Founder and President of Atachi Systems. Mekala has more than 20 years of expertise in designing and deploying the shop floor systems for the world’s leading medical devices and diagnostics companies in US, Canada and Europe. Mekala’s expertise comes from streamlining the manufacturing operations by reducing the wastage on the floor, product recalls and ensuring the FDA compliance for the medical devices and diagnostics and Pharmaceuticals. Atachi has an innovative MES software NGIMES (Next Generation Manufacturing Execution System) that is built on the cloud using the latest In-Memory computing technologies that brings traceability, compliance, faster NPI (new product introduction), with IT simplification and cost-effectiveness to the manufacturing floors.

Mr. Jayavanth Kamath
(Founder & Principal Consultant
Caliber Assurance Services, Bangalore)

Mr. Jayavanth Kamath (Jay), Sr. Principal Consultant, Medical Devices Practice, currently provides Engineering, R&D, Quality and Regulatory compliance consultative services to global medical device manufacturers, and also has an accomplished record with more than 24 years of experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Systems Engineering, Quality Assurance, Regulatory Affairs and Compliance. He currently runs Caliber Assurance Services (CALIBER), a consulting firm focused on R&D, Engineering, Quality, and Regulatory Assurance Services.

He has been previously employed, with increasing responsibilities by medical device manufacturers and services, such as Wipro Technologies, GE Healthcare and L&T Medicals.

He has worked in Medical Devices such as Patient Monitoring Devices, Ultrasound / CT scanners, Drug delivery systems, Implantable pacemakers, leads, defibrillators, Mobile c-arms, endoscopes, energy based devices, Home monitoring devices etc.

He has handled over 100 projects for Medical Devices Manufacturers, Pharmaceutical, CRO and IVD manufacturers.