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Health Tech Social

Amrit Bance

Business & Entrepreneuriat

Forme & Santé

Technologie

Fréquence : 1 épisode/0j. Total Éps: 1

Health Tech Social is the digital media platform for health tech, hosted by a Clinical Safety Officer with experience across pharmacy, primary care, and national digital health programmes.

Straight-talking conversations and sharp breakdowns on AI, wearables, and digital health, for:

Founders & scale-ups: what actually scales, and what falls apart at procurement
Clinicians & healthcare decision-makers: trusted, responsible coverage of the technology changing real-world care
Investors: the products, signals, and founders worth backing
Health tech enthusiasts: all things health tech, from wearables to AI & more

💡 Founder interviews, clinical tech breakdowns, & market insights

📩 Sponsorship and partnership enquiries: info@healthtechsocial.com

📬 Subscribe to the Health Tech Social newsletter on LinkedIn

🌐 Find us @healthtechsocial on TikTok, Instagram and LinkedIn

🎥 Watch the full video interview on YouTube @healthtechsocials

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

Saison 1 · Épisode 1

mardi 8 septembre 2026 • Durée 29:57

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.

Health Tech Social brings clinical breakdowns, industry insights and product features, covering everything from wearables and AI to healthcare products and clinical safety.

Subscribe to the newsletter and follow along on LinkedIn, Instagram, TikTok and YouTube.

Working on something in health tech and want to be featured?

Get in touch via LinkedIn or healthtechsocial.com

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