Medical Device Start-up Partners With JALEX Medical and Achieves FDA Clearance 5 Months Early

We completed our FDA submission during a federal government shut down and still managed to get the clearance ahead of schedule. I’d estimate five months early.” Vikash Goel Cleveland Clinic Innovations, the commercialization arm of Cleveland Clinic, nurtures and spins off breakthrough inventions into stand-alone companies. Vikash Goel is the CTO and founder of one…

JALEX (Virtually) Presents: Successfully Navigating the Medical Device Development Process with CNY Biotech Accelerator

Developing a medical device is an extensive undertaking that requires expertise in engineering, manufacturing, regulatory affairs, and quality assurance, to name a few. Having a thorough understanding of the medical device development process and its key elements at the outset is essential to planning the development of an approvable product and can help anticipate timing and costs. This session will take attendees along the journey of creating a medical device from concept to market and provide high-level strategies to consider along the way. A few case studies will be presented to demonstrate the importance of all aspects of the process and how they yield a successful product launch and beyond.