MD+DI Managing Editor’s Must-Attend List for BIOMEDevice Silicon Valley

As the managing editor for MD+DI with an avid interest in the supplier and manufacturing side of medtech, innovation, and the importance of regulatory compliance, here are just a few of the sessions I’m particularly excited about at the Nov. 15-16 BIOMEDevice Silicon Valley conference.

ISO 10993-1 Committee Draft and FDA Guidance Update: Key Biocompatibility Changes and Regulatory Status

Taking place at the Center Stage on Wednesday, Nov. 15 from 10:30am to 11:15am, Thor Rollins, VP global market segment leader - medical device at Nelson Laboratories, will delve into the evolving concepts within the Committee Draft of ISO 10993-1 and Guidance on Biocompatibility, with a keen focus on their relevance to next-gen design and emerging technologies, and provide insights into their current regulatory acceptance. Furthermore, he will address the latest comments on the draft and resolutions arising from the ISO committee meeting.

Fundamentals of X-ray Sterilization

Taking place at the Tech Theater on Wednesday Nov. 15 from 11:30am to 12:15pm, Betty Howard, senior radiation sterilization manager at Steris, will compare gamma to X-ray, describe similarities and differences, showcase the benefits of adding X-ray sterilization plans, and discuss considerations in validation and transfers from one radiation technology to another. This presentation will also outline why X-ray is a viable alternative to gamma processing, assuring long-term processing capacity while providing the same level of product assurance.

Keynote: The Story of nVision: From Patient to Impatient Entrepreneur

Taking place at the Center Stage on Wednesday, Nov. 15 from 1pm to 2pm, Surbhi Sarna, author and partner at Y-Combinator, will discuss how she went from patient to an impatient entrepreneur, hiring a best-in-class team, winning two FDA clearances, and completing several clinical trials. The team's work culminated in a blockbuster sale of the company, nVision, to Boston Scientific for $275M.

How to Achieve Lean & Smart Processes in Medical Device Manufacturing

Taking place at the Center Stage on Wednesday, Nov. 15 from 2:15pm to 3pm, Faycal Benayad-Cherif, global strategic account manager at FOBA, and Tyler Kim, sales manager at FOBA Marking + Engraving, will share the common challenges faced by the medical manufacturing industry, how different technologies and solutions have changed process flow, and cover the lessons learned from the manufacturing of medical implants to reusable instruments in the fields of orthopedics, cardio, spine and dental.

What Every Startup Should Know Before Applying for FDA Approval

Taking place at the Great America Meeting Room 2 on Thursday, Nov. 16 from 9am to 9:45am, Farid Farahmand, CEO at Tidal Medical Technology, will provide a concise overview of his startup's journey in submitting an FDA application for a Class II device. He will delve into the obstacles The company faced throughout the design and development stages, along with preparations for FDA submission.

Keynote: The Next Frontier for Innovation: Biomedical Manufacturing in Space

Taking place at the Center Stage on Thursday, Nov. 16 from 1pm to 2pm, Pearly Pandya, in-space manufacturing – biomedical at Axiom Space, will highlight biomedical products being developed by Axiom Space that have the potential to change the paradigm of the medtech industry.