Welcome, MedTech Professionals.
W3 Edition of The MedTech AI Monitor
Hey there,
Welcome to another edition of the MedTech Monitor, where I break down what happened the past week in the world of AI. CES wrapped up and gave a taste of what's expected in the next few years in the consumer electronics space, many are health wearables and devices.
The Biden-Harris Administration introduced an AI chips regulatory framework with a strong focus on U.S. national security. J&J is hiring like mad for robotics & AI-enabled med device jobs! Let's get into it.
Have a great rest of your week!
-Greg
tl;dr
New US AI framework = export controls, licensing, safeguards
Rise of the Cobot. An R2D2 for every employee!
Metaverse is back from the dead
1. CES 2025: MedTech Recap
At CES 2025, neurotech leaders highlighted advancements in AI-driven brain health technologies, such as EEG headphones and neural earbuds, discussing their potential to revolutionize diagnosis and treatment by 2030. Key themes included improving noninvasive brain sensing, seamless AI integration, and ethical data use. Experts also explored future applications, including tailored brain-computer interfaces, consumer-grade devices, and drug-free solutions for neurological conditions. [Link]
2. Clinical Trial Trends in 2025: Headwinds & Wearables
In 2025, clinical trials face investment challenges but are increasingly leveraging wearables, AI, and rare disease research to optimize outcomes. Wearables improve patient data collection, while AI’s targeted use enhances efficiency. Sponsors prioritize functional service provider models and digital platforms to streamline costs. Rare disease trials remain key, requiring advanced data management to maximize limited resources and deliver impactful results. [Link]
3. The Impact of AI Regulation on Europe’s Medical Device Trials
The Outsourcing in Clinical Trials: Medical Devices Europe 2025 conference in Munich (Jan 28–29) will address the EU's Medical Device Regulation (MDR) and AI Act's impact on MedTech. Key discussions include MDR compliance, AI’s role in clinical trials, and streamlining certification for AI-driven devices. Panels will also explore CRO-MedTech collaboration challenges and strategies to balance innovation with regulatory demands. [Link]
📌 Job Board
Founding Product Engineer, Medbill AI, $150,000/yr to $230,000/yr
Senior Regulatory Affairs Program Lead (Robotics & Digital Solutions) - MedTech Surgery, Johnson & Johnson, $104,000/yr to $166,750/yr
Manager, AI for Medical Engagement, Johnson & Johnson, $113,000/yr to $170,000/yr
Staff Product Development Engineer, Jupiter Endovascular, $140,000/yr to $200,000/yr
🗞️ In Other News
🎟️ Upcoming Event Streams
- Leveraging Advanced Manufacturing Technologies to Drive Sustainability, Jim Beretta, January 16, 2025 | 12-1 PM ET [Event Link]
- Cobots and AI Vision for Smarter Manufacturing, Universal Robotics, January 23, 2025 | 2 PM - 3 PM ET [Event Link]
📄 Doc Control
Bureau of Industry and Security: 'Framework for Artificial Intelligence Diffusion'
Yesterday, the Biden-Harris Administration introduced a regulatory framework for advanced AI technologies, focusing on balancing innovation with U.S. national security. Key measures include export controls on AI chips and model weights, enhanced licensing exceptions, and secure AI storage requirements. The framework ensures responsible AI diffusion globally while safeguarding against misuse by adversaries. [Doc Link]
Key Points
- AI Regulation: Balances innovation and national security priorities.
- Chip Controls: Restrictions on exports with exceptions for allies.
- Model Weight Limits: Applies to advanced closed-weight AI models.
- License Exceptions: Support allies, supply chains, and limited transactions.
- Data Center Rules: Streamlines global operations with security measures.
- Dual-Use Focus: Prevents AI misuse in weapons and surveillance.
- Global Collaboration: Encourages partnerships with trusted nations.
- Legal Basis: Governed under Export Control Reform Act and EAR.
The views and opinions expressed in this email are for informational purposes only. They do not constitute legal advice. Readers are encouraged to consult with their own legal counsel regarding any specific legal questions or issues related to the topics discussed.
