DCB Standards, AI Regulation and the Real Risk in Healthcare, with Rudi Hennessy Co-Founder of Orthon

Tue, 08 Sep 2026 10:00:00 +0100

Rudi Hennessy, co-founder of clinical safety organisation ORTHON, joins Health Tech Social to talk about the difference between having a clinical safety officer and actually building a culture that manages clinical risk.

We get into DCB 0129 and 0160 in practice, the MHRA's recent move to declassify some ambient voice technology as a medical device, and why "human in the loop" gets treated as an automatic safety mitigation when it often isn't one. Rudi also shares a candid account of what happens when supplier hazard logs treat training as a fix, delivered months before go-live, and reality doesn't cooperate.

What we cover:

What to do if you're a health tech founder without a clinical safety officer
Why co-designing with the people who'll actually use a product is a stronger mitigation than guessing on their behalf
DCB 0129 and 0160, and where AI-driven products complicate the standards
The MHRA's new guidance and what it means for ambient voice technology
Why "human in the loop" is often a weaker mitigation than manufacturers assume
Getting buy-in from stakeholders and founders for a clinical risk management plan

Timestamps:
00:00 Introduction to Orthon and Its Founders
00:53 What should you do if you don't have a clinical safety officer?
03:43 The Benefits of User Research
07:54 Navigating DCB Standards and Medical Device Regulations
10:30 The MHRA's New Guidance on Ambient Voice Technology
11:00 AI in Healthcare: Risks and Regulatory Challenges
13:15 Designing AI Systems with Human Factors in Mind
17:52 The System of Systems Approach in Clinical Safety
19:26 Engaging Stakeholders in Clinical Safety
21:07 Empowering Organisations for Clinical Risk Management
23:03 Trends and Misconceptions in Health Tech
27:05 Are wearables worth it?
28:26 Connecting with Rudi Hennessy and Orthon
29:36 Outro: Subscribe & Get Featured on HTS

About Rudi Hennessy: Rudi co-founded ORTHON with Mike Anderson. Between them they've spent 30-plus years in national clinical safety roles. Find ORTHON at orthon.co.uk

This episode is a disclosed collaboration between Health Tech Social and ORTHON.

Book a clinical safety session with ORTHON here. This is a referral link - Health Tech Social receives a commission for bookings made through it.

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