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Risk Management Leader | Problem Solver

🏰A castle with a moat, or 🚢A container ship out on the open ocean? ❗Randy Horton uses these metaphors to explain why the traditional approach to medical devices needs a reboot in the age of connected devices. ================================== 👍Like this clip? ♻️Repost and share. #letstalkrisk #medicaldevices #riskmanagement

Ritam Priya

Founder & Principal @ Novarum MDRQ Consulting | Expert in MedTech Innovation & Healthcare Compliance | Driving Regulatory Excellence |

1mo

Naveen Agarwal, Ph.D. & Randy Horton The castle and moat analogy perfectly captures the traditional medical device industry. In the traditional medical device world, companies build these "moats" to defend their products from competitors and to ensure compliance with stringent regulatory frameworks. This model worked well for physical devices with long development cycles and high production costs.However, with the rise of digital health, SaMD, and AI-driven innovations, the “moat” is definitely shrinking. Thanks for sharing this insight!

Neil Di Spirito

I have more than two decades experience helping pharmaceutical, medical device, biologics and life science clients comply with US drug, biological and medical device law.

1mo

Naveen Agarwal, Ph.D. Interesting topic and good conversation on your podcast.

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