End to End Process Journey to Introducing and Scaling New Materials for Medical Applications

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End to End Process Journey to Introducing and Scaling New Materials for Medical Applications
Sanjiv Bhatt and Saurin Shah

Several medical grade polymer materials have been developed; exhibiting unique characteristics that offer extraordinary benefits over non-polymeric materials in the modern healthcare system. Additionally, these materials comply with global regulatory requirements that ensure they maintain their integrity without causing secondary and/or long-term complications in the patient.

Not all medical grade polymers are created equal.  Poly-ether-ether ketone (PEEK) is one such material, originally developed for the US aerospace industry in the late ’70s, in the late ’90s was embraced by the medical device industry due in part to the anatomical compatibility of PEEK and inherent radiolucency of the polymer.  Now custom formulations of PEEK are enabling new potential applications for the polymer.

As PEEK continues to expand into new temporary and long-term implantable devices, the availability of custom formulations designed to enhance key properties will expand. At the forefront of consideration will be material and compound selection, characterization, qualification, validation, compliance to regulatory requirements, and supply chain management.   

We will be talking about the journey through the entire value stream and all things to consider in introducing new material and developing a product therefrom for medical applications i.e. from raw material to product and managing through the entire product development process.

BIOs

Sanjiv Bhatt
Operations Leader
Agile Technology

Sanjiv has 24 years of global experience developing and introducing new products, building end to end engineering and manufacturing operations, and business incubators for regulated (medical device, food and beverage, automotive, and aerospace) and unregulated (semiconductor, consumer electronics, and 3D printing) industries.
He is a chemical engineer, holds a Ph.D. in polymer science and engineering, and was an industrial fellow within Industrial Partnership for Interfacial Materials and Engineering at the University of MN.

Saurin Shah
Ex- Senior Director
Medtronic Monitoring Inc.
A subsidiary of Medtronic Inc
Cardiac Rhythm Disease Management

Saurin Shah was with Medtronic for 13 years and held various leadership roles in the Cardiac Rhythm business at Medtronic. Recently he was Sr. Director of Medtronic Monitoring Inc., a subsidiary of Medtronic Inc. In this role, he led the establishment of Monitoring centers and Customer Support function in the US and abroad. For diagnostics business. Prior to that, he was Senior Director of Global External Diagnostics responsible for working with the International Business leaders and their teams to understand barriers in their respective markets and lead development and commercialization of External Diagnostics products and solutions.
Saurin joined Medtronic in 2005 has held several R&D leadership roles in the CRDM Business, including leading the functional groups of Communication Systems Engineering, MRI Technology, Instruments Development and Operations, and Research and Feasibility Systems. Prior to Medtronic, Saurin was Executive Director of R&D at Imation Corp and had several leadership roles in R&D, Business Development and Manufacturing Operations during his 15-year career with 3M and Imation in the Data Storage industry.
Saurin has an MS in Plastics Engineering and an MS in Chemical Engineering from the University of Massachusetts, Lowell, and bachelors in Chemical Engineering from Gujarat University, India.

Event Information

Event Topic:
End to End Process Journey to Introducing and Scaling New Materials for Medical Applications

Event Description:

Date/Time:
Date(s) - 06/25/19
8:30 am - 10:30 am

Event Location:
NOVA - 505 West Olive Ave, Sunnyvale- Suite 799:

Speaker Information

Event Speaker:
Sanjiv Bhatt & Saurin Shah

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Event Details

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