Webinar: EU MDR Compliant Stainless Steels for Medical Devices

Company Events

Carpenter Technology's, Global Strategic Business & Applications Development Lead - Medical, Gaurav Lalwani, PhD, and Ray DeFrain, Regional Metallurgist, Medical SME, are hosting a webinar on 'EU MDR Compliant Stainless Steels for Medical Devices', July 26th 2023 at 11am (ET). 

The webinar aims to provide attendees with a comprehensive understanding of metal allergies, regulatory changes, material advancements and alternative alloys for manufacturing EU MDR-compliant stainless steels for medical devices.

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Webinar Overview

Metal allergies are a growing cause of concern for the Medical Device industry. The Center for Devices and Radiological Health (CDRH) estimates that ~15% of general population is sensitive to elements such as Nickel and Cobalt. Exposure to metal ions released from the normal wear of medical implants can lead to adverse side effects such as hypersensitivity, implant loosening and premature device failure leading to life threatening outcomes. The European Union has implemented regulatory changes (EUMDR) to limit the Cobalt content in medical devices without a definitive solution creating a wide-disconnect between the device manufacturers and material suppliers. Commonly used stainless steel alloys such as 300 series, 400 series, custom 455, custom 465 etc. typically contain 0.5-0.40 wt% Cobalt attributed to impurities during the melting process making them non-compliant with new EUMDR regulations. In this webinar, Carpenter Technology will present recent material advances implemented to produce EUMDR compliant Low-Cobalt stainless steel alloys. We will also introduce BioDur 734 (Cobalt-free stainless) and BioDur 108 (Cobalt and Nickle free stainless) alloys for the medical device industry.

Meet the Speakers 

Gaurav LalwaniGaurav Lalwani, PhD, Global Strategic Business & Applications Development Lead - Medical

Dr. Gaurav Lalwani is the Global Applications Engineering lead at Carpenter Technology Corporation for Medical markets. He received his MS and PhD in Biomedical Engineering from Stony Brook University with a focus on materials science, tissue engineering and regenerative medicine. Dr. Lalwani manages the overall technology portfolio and new product development strategy for Carpenter's Medical business unit and is currently engaged in the development of novel wrought and additive solutions for the medical device industry.

Prior to joining Carpenter Technology, Dr. Lalwani was the co-founder of Millennial Material & Devices and VP of Research for Theragnostic Technologies Inc. - seed stage biomedical startups focused on commercializing carbon based nanomaterials for regenerative medicine, bioimaging and high-fidelity purification applications.

Dr. Lalwani is the winner of Stony Brook Entrepreneurs Challenge, ‘DARE-to-RISK’ regional business plan competition and a New York Business Plan Competition 2015 finalist. Dr. Lalwani has also authored >25 peer-reviewed publications in top scientific journals, 4 book chapters and holds 3 US patent awards. Dr. Lalwani holds a keen interest in promoting inclusive education and food safety by supporting & advising organizations focused on social entrepreneurship.

headshot raydefrainRay DeFrain, Regional Metallurgist, Medical SME

Ray DeFrain is a highly accomplished and versatile professional with a proven track record of excellence as a metallurgist and alloy expert in the medical market. With 16 years of experience, he has consistently demonstrated exceptional skills in product and process development, project management, and “boots-on-the-ground” customer support. Ray DeFrain's dedication to continuous learning and adaptability has allowed him to stay at the forefront of industry trends and technologies, delivering innovative solutions to OEMs, contract manufacturers, and tiered suppliers.

Throughout his career, Ray has held leadership roles at Carpenter where he has successfully led multimillion dollar development projects and exceeded organizational goals for both internal and external customers. Known for his exceptional communication and interpersonal skills, Ray has built lasting relationships with clients, stakeholders, and colleagues, fostering a collaborative and productive work environment.

An avid problem solver and critical thinker, Ray is passionate about making a positive impact in the medical market. He remains committed to pushing boundaries and seeking new opportunities for growth and advancement with application, regulatory compliance, and design criteria in mind. Whether it's leading complex projects, implementing strategic initiatives, or providing expert consultation, Ray DeFrain consistently delivers excellence and demonstrates a relentless pursuit of working together with customers to improve patient outcomes.

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Carpenter Technology