BIOME Device Silicon Valley Digital Speakers for Health, IVD and Automation - Gadgets Price
Wed. Dec 8th, 2021
BIOME Device Silicon Valley Digital Speakers for Health, IVD and Automation

BIOMEDevice returns to Silicon Valley from December 8-9 with BIOMEDevice Silicon Valley, an event about advancing medical technology, digital health and the development of personal diagnostics at the San Jose McEnery Convention Center. Organized by Informa Markets – Engineering, publisher of MD+DI, the event will feature an exhibit along with keynote presentations, panels and sessions at Center Stage. In addition, some sessions will launch online early every Wednesday ahead of the event, with Google Health launching this week. All sessions will be accessible online four weeks after the event.

The educational content of BIOMEDevice Silicon Valley examines the ongoing maturation of advanced technologies within the software as a medical device (SaMD) and adjacent sectors, as venture capitalists inject billions to support the growth in the development of digital health and diagnostic products, areas that the third in the 2021 quarter alone, Informa reports.

“The healthcare system is undergoing massive disruption as technology leaders continue to introduce smart solutions that improve patient outcomes and save lives, but these rapid advances require industry connection and ongoing education to scale the adoption of these technologies,” said Adrienne. Zepeda, Group Event Director, BIOMEDevice Silicon Valley, in a press release. “Many of this year’s speakers are responsible for the advanced tools and technologies available on the market and are eager to connect with their peers to explore the challenges and opportunities that remain untapped.”

Zepeda continued: “While Silicon Valley is the largest biotech hub in the country and we are so excited to hold the in-person event at the epicenter of technological innovation, we understand the importance of connecting the entire industry regardless The introduction of the Smart Event format will give visitors unfettered access to the biotech speakers and content through an online platform that will be accessible next week on November 8.”

A selection of BIOMEDevice Silicon Valley 2021 expert content

Wednesday December 8

Panel: The Gamble of Overseas Manufacturing – Understanding the Opportunities

Moderator: Noreen King, President & CEO Evolve Manufacturing

Panelists: Arnold Cabuang, CEO, Peridot; and Kevin O’Brien, Vice President, Operations, Triple Ring Technologies

It is widely believed that going abroad is much cheaper than producing domestically. Is that really so? Hear from expert panelists on these issues as they explore whether the added risk of producing overseas is worth the risk. You may feel like you’re betting on the successful launch of your dream product, not to mention your investors’ money, so it’s important to understand the factors to consider when deciding where to produce. How can customers, suppliers and manufacturers learn and protect themselves from future disruptions?

Panel: Tales from the Trenches – Overcoming the development and manufacturing challenges facing all IVD companies

Moderator: , Michael Robards, Vice President, Business Development, Planet Innovation

Panelists: Anthony Favaloro, Director, Strategic Partnerships, Lumos Diagnostics; and Geoff Facer, VP Engineering, Levitas Bio

The pandemic has brought about a lot of change, both good and bad. While rapid diagnostic testing was a major challenge for the first time in 2020, there are many lingering obstacles, including supply chain disruptions and scaling-up issues such as quality control. Getting a product from concept development and testing to product development and then to production is filled with many questions and challenges. Join our panel of experts as we discuss what you need to know to bring your next IVD product to market. They will share their success stories and give you insights on how to avoid the problem areas.

Thursday 9 December

Not so fast: is that software really still a medical device?

Speaker: Michelle Jump, Vice President of Security Services, MedSec

The US passed the 21st Century Cures Act in 2016, which made many significant changes to our regulation of health products. One of these changes was in the definition of a medical device, specifically what types of software products are regulated medical devices. The FDA later issued guidelines for products such as MDDS, Clinical Decision Support Software, Mobile Medical Apps, and Multiple Function Device Products, and clarified which software is no longer under FDA supervision as a medical device. This guideline also identified software that falls under ‘enforcement discretion’. Join industry expert Michelle Jump as she reviews the changes to the medical device definition and subsequent FDA guidelines.

Panel: is there an app for that? The rise of digital prescription therapy (PDTs)

Moderator: Scott Thielman, CTO & Co-Founder, Product Creation Studio

Panelists: Gordon Kass, Vice President of Engineering, Pear Therapeutics; Jessica Lake, Chief Science Officer, Limbix; and Mike Rosenbluth, Ph.D., CEO and Founder, Swing Therapeutics

A growing number of companies are sticking to the label for digital therapies. The main difference between digital therapies and other digital healthcare sectors is that digital therapies are generally expected to be evidence-based, regulated technologies designed to bring about changes in patient behavior. Digital health products are not necessarily evidence-based or regulated. Clear FDA guidelines around software-based therapies and defined reimbursement pathways drive better outcomes for patients and smarter engagement and tracking tools for clinicians.

To access the full BIOMEDevice Silicon Valley Center Stage content schedule and tune in to sessions of interest, register here. The online platform opened on November 8 and gives all early registrants exclusive access to an online-only presentation of senior leaders at Google, plus much more.

Follow BIOMEDevice Silicon Valley on social #BIOMEDevicesSmartEvent

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