Bits in Bio 26.01 :: Agile in a regulated world
Hello Bits in Bio Belgium! 👋
Time for another Meetup, with the exciting topic that's been on our minds for a couple of years now: "Agile in a Regulated World". Or, in slightly spicier terms: move fast and don't kill anyone.
During this event, we'll explore what it really takes to build and ship software fast when that software lives in a regulated environment. From notified bodies (ever heard of these?) and regulatory perspectives to day-to-day software delivery in medtech and embedded systems, this evening is about one central question: how do you move fast without cutting corners on compliance, quality, and patient safety?
We will also make sure to properly introduce the topic and frame the discussion well, so both tech and biotech people can plug into the conversation, even if this is not their daily terrain.
Big thanks to Wintercircus & Collective for hosting us again at this iconic location in Ghent. 🙏
You can make the difference by spreading the word. 📣 Our mission is to bring together the brightest minds in tech and biotech, so bring your peers and acquaintances from either world. As always, we carefully pick speakers with genuinely different perspectives, backgrounds, and lenses on the topic. Let the ideas collide, and find novel paths forward. Hope to see many of you again!
Agility and velocity are deeply valued in startups and software teams. But what happens when your software lands in a hospital, a pharmaceutical company, a clinical workflow, or a medical device context?
Key challenges:
How do teams keep shipping quickly in a highly regulated environment?
Where do software and AI regulatory submissions tend to break down?
How do regulatory frameworks shape day to-day product and engineering decisions?
What does agile development actually look like in medical device software?
Speaker Line-up
Talk #1 - Jan Smolders (Comate) - How Comate develops and ships medical device software, Jan is leading SW Engineering at Comate and is drawing on 20+ years in software development in strictly regulated domains like financial services and medical devices.
(Talk #2 Regulatory lense - Name to be announced soon) - Speaker form medical device regulation for AI/software: practical pitfalls and the 510(k) pathway, drawing on previous experience at SGS as IVDR Product Manager and at VITO
(Talk #3 Agile lense - Name to be announced soon**)** - Agile Hero. Drawing on experience as a Tribe Lead, Scrum Master, and Analyst at In The Pocket, NGDATA, and DPG Media - and hands-on experience in medical device development in a regulated context.
(Talk #4 Hospital lense - Name to be announced soon) - Doctors are where compliance meets reality: they use these systems directly in patient-facing care.
Location:
On-site: Wintercircus, Ghent
Practicalities for the evening on Wednesday, April 29:
18:30: Doors open, drinks and networking
19:00: Welcome and intro
19:10: Speaker talks
20:50: Q&A and open discussion
21:10: Drinks and networking
22:00: Doors close