The Future of MedTech: Innovations in Molecular Wearables and Regulatory Transitions

The MedTech Podcast shares the journey behind the path of the people shaping the MedTech industry and its future. Join me as I connect with industry leaders, thought providers and innovators. Hosted by Karandeep Singh Badwal, Karandeep is a Quality & Regulatory Consultant specialising in the MedTech Industry.

Reinventing Continuous Glucose Monitoring with SAVA

Renato (Ren) Circi, co-founder of SAVA, a London based MedTech company building a new generation of minimally invasive continuous glucose monitors and molecular wearables. In this episode we rewind to the underground labs at Imperial College London where Ren and his co-founder Raph first immersed themselves in biosensors and began questioning the status quo of health monitoring. Ren explains how their shared obsession with measuring the body more effortlessly led to SAVA’s founding and what it really looks like to push through years of scientific failure in order to build a complex medical device platform.

We dive into why SAVA manufactures everything in-house, how their micro sensor architecture differs from traditional filament based CGMs and why controlling every layer from chemistry to algorithms is essential if you want to iterate fast on performance. Ren sets out SAVA’s long term vision of continuous molecular tracking for everyone, not just people with diabetes, and what could be unlocked once you can monitor many molecules in real time from a single patch. Furthermore, we discuss regulatory expectations for CGMs, the reality of one way product decisions in medical devices and the difficulty of fundraising for a consumer facing yet highly regulated deep tech company.

How QMSR Is Reshaping U.S. MedTech Regulation

Dr. Yuan Li, Director of Medical Business at DQS and a former medical device auditor with deep expertise across orthopaedic manufacturing and regulatory systems. In this episode, we discuss the sweeping regulatory transition coming to the U.S. with the introduction of the Quality Management System Regulation (QMSR), which formally aligns 21 CFR Part 820 with ISO 13485. Yuan unpacks what this shift means for U.S.-based manufacturers, why FDA is phasing out the QSR audit model and why contract manufacturers and software-based device firms are particularly vulnerable if they delay planning.

We also explore the growing use of AI in QMS platforms, the pitfalls of template-driven compliance, and why “regulatory fatigue” is no excuse when patients’ lives are at stake. From post-market surveillance strategies to paperless QMS migrations and the validation grey zone, Yuan offers pragmatic, deeply informed advice for those navigating FDA audits, ISO certification and international expansion.

MedTech Insights Comparison Table

• Topic: Continuous Glucose Monitoring (CGM) | Expert: Renato Circi (SAVA) | Focus: Molecular Wearables, Micro Sensors, and in-house manufacturing.
• Topic: Regulatory Quality Systems (QMSR) | Expert: Dr. Yuan Li (DQS) | Focus: ISO 13485 alignment, FDA Inspections, and AI in Auditing.
• Key Challenges: Fundraising for deep tech and scientific failure | Key Challenges: Regulatory fatigue and paperless QMS migrations.

Key Discussion Timestamps

• [00:00:21] Origins at Imperial and discovering biosensors
• [00:02:36] Why QMSR is a Big Deal for U.S. Manufacturers
• [00:06:46] How SAVA’s micro sensor CGM platform actually works
• [00:10:18] AI-Generated QMS Systems: Useful or Risky?
• [00:13:43] When CGMs become cheaper than finger-pricks
• [00:17:21] Why building CGMs is one of the hardest engineering challenges