The FDA MedTech Regulatory Forum is one of the most anticipated and popular events within Ohio’s medical device community. Presented annually by BioOhio and Green & Associates, this year’s forum once again featured educational sessions led by FDA Investigators and a myriad of industry experts from throughout Ohio. Attendees were given the most up to date information regarding state and federal regulations and upcoming changes to consider when applying for FDA approval.

This year’s forum was held in Akron at the newly renovated Bounce Innovation Hub. Our group christened Bounce’s brand-new, state of the art conference space, The Signal Tree. Guests were immediately impressed and quickly surmised that Bounce, with its forward-thinking design esthetic and thoughtful touches, is Akron’s home for creativity and innovation.

The first floor is set up perfectly for entrepreneurs with plentiful individual work stations, and plenty of private meeting spaces accommodating up to 250 people. Most impressive were the ‘phonebooth’ inspired spaces allowing for private conversations and impromptu meetings of 1-6 guests. Having these booths just outside The Signal Tree allowed attendees the chance to step away from the conference to take a call, or to engage with our educators privately, while still being a part of the forum.

This year’s FDA MedTech Regulatory Forum was blessed to have amazing speakers, each of whom are the industry’s foremost experts in their fields. The morning sessions covered a host of topics including the 510(k) premarket approval process, best practices for compliance, and more. The highlight of the morning had to be FDA investigators Laureen Geniusz and Ben Dastoli, long time colleagues working in the Ohio area. Their unique presentation sytle and ability to share amusing anecdotal stories lifted the conversation up and put everyone at ease while discussing intensely complicated procedures and pathways. BioOhio is fortunate to have had Laureen and Ben as participants in the FDA MedTech Regulatory Forum for many years, and hopefully many more to come.

BioOhio is committed to providing educational programming rich with content covering the most relevant topics within the industry. To that end, this year’s FDA MedTech Regulatory Forum included an afternoon devoted to cybersecurity and in the medical device sector. Sessions covered medical device design, risk management considerations, legal issues present and future, compliance, and a discussion of the cybersecurity threat landscape.

We are already looking ahead to next year’s FDA MedTech Regulatory Forum. Are you interested in joining next year’s planning committee? Do you want to be one of next year’s panel of experts? Do you have a topic you’d like to see added to the next year’s agenda? Have suggestions on other ways we can improve attendee experiences for next year’s forum? Please contact us directly at