Director, Regulatory Affairs, Hologic
Ashley Miller
Bridging the Gap: SaMD Strategy for Teams Built on Hardware
Software as a Medical Device (SaMD) is a medical device. It is regulated, reimbursed, and expected to deliver clinical impact just like its physical counterparts. But anyone who’s tried to navigate both knows that they have different traits that lead to different development processes.
That difference, the “delta,” can slow down even seasoned device makers. Whether you’re extending a hardware product with connected software or building a pure-play digital solution, misunderstanding that delta can slow development, regulatory strategy, and delay your path to market. At the same time, your competitors are likely moving full steam ahead.
Join Orthogonal and a panel of experts who’ve brought both physical medical devices and SaMD products to market. We’ll unpack what’s shared and diverges and how to recalibrate your thinking to avoid common pitfalls and capitalize on software’s unique acceleration potential.
What You’ll Learn:
- What makes SaMD similar to and different from traditional physical devices
- Why connected devices blur the lines and how to manage complexity across cloud, mobile, and embedded software
- How to shift your regulatory, clinical, and business strategies to match the nuances of SaMD
- How teams familiar with physical devices can adapt confidently to software-led development
Who Should Attend?
- Engineering and Product Teams working across cloud, mobile, and embedded software and navigating hybrid systems
- Regulatory and Quality Leaders looking for clarity on how SaMD requirements compare to physical devices
- R&D and Innovation Teams aiming to accelerate digital product development without regulatory missteps
If you’re used to working with devices you can see and touch, but software still feels like a black box, this session will help you close that gap. Gain practical insights from leaders who’ve navigated both sides and can help you avoid the slowdowns that come from treating SaMD like just another device.
Director, Digital Quality, Lilly
Carl Washburn
Chief Solutions Officer, Orthogonal
Randy Horton
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