Biocom’s DeviceFest & Digital Health Conference will be held on Wednesday, August 28th, 2019 in Southern California. Since its inception in 2007, this conference has focused on supporting the medical device and diagnostics industries by giving our members access to key decision makers and thought leaders who have helped them expand their businesses and increase exposure for their products. Fast forward 12 years to the advancement of innovative technology, we are beginning to notice a fundamental shift within the healthcare industry.
With digital health and consumer-driven data now on the forefront of healthcare, there has been a convergence in the medtech and digital health industries. In order to better deliver on the needs of our members and conference attendees, the conference has been adapted to focus on medical device, diagnostic, and now, digital health.
Through a blend of panel discussions, keynote presentations and case studies, this conference is aimed at giving attendees a deeper look into the convergence of the medical device and digital health.
This year’s theme – The Product Life Cycle – aims to walk attendees through the process of creating a product all the way from creation to reimbursement. We will begin with sessions focused on creation where panelists discuss the importance and value of the value proposition. From there, we take you through the challenges of financing as we hear from panelists on raising funds for your medical device company and on forging strategic partnerships. From there, we walk you through reimbursement and regulatory strategy. Closing out the conference will be our popular ‘Hot Seat Challenge’ where theree innovative companies will have the opportunity to give their five minute pitches to a panel of judges and investors, while receiving on-the-spot critiques
Whether you’re looking to network, share insights, forge new connections with one another, or simply learn about new technologies coming out of Southern California, this conference is a must-attend event.
Halloran Chief Operating Officer, Greg Dombal, will be moderating the panel, "Regulatory Strategy Based on Novel Pathways."
Device and diagnostic companies map the path to market, usually seeking the fastest, least burdensome path to market. Several regulatory pathways exist for medical devices – each with their own challenges and each can present opportunities for managing the life cycle of your product. Please join our panelists as they discuss the development of a regulatory road map for your product and strategies companies use to mitigate regulatory risks. The fastest path may not be the best long term path. Companies have the opportunity to evaluate and use de novo, 510(k), DTC, or PMA (or a combination of these). Learn how these companies have considered and leverage different regulatory paths to enter the market. We will discuss current industry trends regarding this pathways, and discuss some of the key factors in determining which path is best for your product and organization.