Medical Device Connectivity: From Prototype to Market Readiness

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So you have a great prototype of a medical device connected via a USB cable to your PC where your algorithm runs. Now what? What does it take to create a market-ready IoMT (Internet of Medical Things) solution that is cleared by the FDA?
In this meetup we will cover the essentials of both the regulation and the technology required to create an IoMT solution.


Alisa Mesh Iliescu, MedTech:
Welcome and Introduction

Guy Vinograd, bio-T:
The Vectorious Case Study. An End-to-end Real-world Architecture of a
Connected Medical Device Solution

Vectorious is about remote monitoring and intervention for CHF patients using a heart implant (class III device). Such a vision can only be accomplished via IoMT (Internet of Medical Things).
However, designing a system of medical devices and a cloud presents a huge challenge because of the wide range of disciplines involved, and the tight regulation requirements for each of the disciplines.
In this session, using Vectorious as reference, I will review the requirements, main architectural dilemmas and the state-of-the-art tools for creating HIPAA/FDA/GDPR/MDR-compliant IoMT solutions.
Among the dilemmas discussed: firmware updates, device onboarding (BLE, wi-fi, cellular), security, standards for protocols and data models, and HIPAA-oriented UX.

Gai Anbar, Comply:
V&V in an Agile Medical Device Development

Time to market and short release cycles of products are key in an extremely competitive, technology-oriented market. Quality Assurance and regulatory requirements can easily become a limiting factor, negatively impacting a product’s release schedule.
In this session, I will talk about integrating Agile product development with Pharma level standards in Testing, Validation and Verification. Improving quality, reducing costs and optimizing efforts of an FDA approved Integrated Digital Medical Device.

Shosh Friedman, Promedoss:
FDA 21st Century Cures Act's implications on Digital Health

Wireless medical devices, mobile medical apps, medical device interoperability, health IT, telemedicine, medical device data systems, “software as a medical device” (SaMD), cybersecurity, and more – are all topics in the Digital Health field on which the FDA is working to modernize its policies and issue guidelines. The origin of this initiative is in the 21st Century Cures Act, signed into law on December 2016, which contains a dedicated section (Section 3060) to FDA’s regulation of digital health tools. This session will provide an overview of FDA’s activities to implement the digital health framework outlined by the new law.

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The meetup will take place at Raanana MedTech Innovation Center, in WOPA Building.
* Lots of parking is available in the surrounding streets.