Sandy Wright, Head of Devices at Scarlet, the first notified body built specifically around software as a medical device. A former doctor who moved from clinical practice into digital health. Sandy now sits on the assessment side of the table, reviewing the very submissions most manufacturers dread putting together.
In this episode, we start with the question that trips up so many companies. What actually turns a piece of software into a medical device and why is the wellness boundary still so blurry that entire businesses are straddling the divide without realising it. Sandy shares some of the more unusual examples out there, including AI ambient scribes and augmented reality tools that let surgeons revisit patient scans mid-operation.
We then go inside Scarlet itself. Sandy explains why they see themselves as a technology company first and a notified body second, how a combination of expertise, redesigned process and their own internal tooling means customers are not sitting at the back of a queue for months and what genuinely drives faster conformity assessment.
The most valuable part for anyone in this space is Sandy's breakdown of where nonconformities actually come from. Clinical evaluation, post-market clinical follow up treated as an afterthought, incomplete software requirements and risk analyses that are too narrow. We also cover the EU AI Act and how it may or may not intersect with MDR, what makes a genuinely good PCCP and Sandy's parting advice on the underrated power of narrative in a regulatory submission.
Timestamps
[00:01:00] What Actually Turns Software Into a Medical Device
[00:03:39] AI Scribes and AR Headsets: SaMD You Might Not Expect
[00:06:10] Why Scarlet Sees Itself as a Technology Company First
[00:08:43] How Scarlet Cut Assessment Timelines Without Cutting Corners
[00:12:12] Clinical Evaluation: The Most Common Source of Findings
[00:13:18] Why Post-Market Clinical Follow Up Is Treated as an Afterthought
[00:16:20] Risk Management and Why a Narrow Lens Causes Problems
[00:16:55] The EU AI Act and How It May Intersect With MDR
[00:19:56] From Foundation Doctor to Babylon Health and Beyond
[00:22:42] What Separates a Good PCCP From a Box-Ticking One
Connect with Sandy - https://www.linkedin.com/in/wrightsandy/
Learn more about Scarlet - https://www.scarlet.cc/
Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/
Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal
Medical device training courses delivered by Karandeep through Bywater - https://www.bywater.co.uk/
