#351: The State of AI & Clinical Investigations

Global Medical Device Podcast · 11 Jan 2024 · 39m · Episode 351

What this episode covers

Dr. Maria Nyakern, founder of Acre Scientific Consulting (acquired by NAMSA), discusses the integration of AI in medical devices and the implications of the European AI Act. She explains how the regulation's focus on 'trustworthy' systems parallels existing medical device frameworks, emphasizing the need for robust data integrity and bias mitigation in clinical investigations. Nyakern highlights that AI can lower the cost of generating diverse patient datasets, potentially reducing the number of required clinical trials, while stressing the importance of maintaining human-centric oversight and addressing data privacy vulnerabilities.

Mentioned

Companies
Greenlight Guru, Acre Scientific Consulting, NAMSA
Products
ChatGPT, Google Gemini
Also
European AI Act, FDA, MDR

Other shows on the same ground, closest first.

  • Let's Combinate · 32m

    107 - Distilling Decades of MedTech Data, Generative AI, and Doing Without Tribal Knowledge with Michelle Wu

    Michelle Wu, CEO and Founder of NyquistData, explains how her company uses generative AI to distill decades of MedTech data, removing the 'tribal knowledge' barrier for quality and regulatory professionals. She details the distinction between pre-trained models and fine-tuned algorithms, emphasizing that Nyquist’s data is validated and specific to FDA and global medical device regulations, unlike generic models like OpenAI. Wu discusses the challenge of changing organizational culture and overcoming skepticism in life sciences, highlighting features like the 'Device Explorer' and 'Data Writer' that democratize access to complex regulatory insights.

  • Let's Combinate · 31m

    206 - Will AI Decide Your Next Drug/Device Approval?

    Dominick Romano, founder of Drainpipe.io, explains how AI can be regulated in pharma and medtech by applying ICH guidelines and process validation to AI systems. He argues that pharmaceuticals are uniquely suited for AI because both deal with 'combinatorial problem sets' involving infinite inputs and outputs, requiring rigorous validation to prevent hallucinations in regulatory dossiers. Romano details how AI can accelerate dossier preparation by reducing millions of working hours in data acquisition and how regulators might use AI agents to speed up review processes, provided the technology is proven safe and accurate by the companies themselves.

  • Let's Combinate · 41m

    059 - Literature Review, EU MDR CER’s, and Being Problem Driven with Ethan Drower

    Ethan Drower, Co-Founder of CiteMed, explains how his company uses software to streamline the literature review process for EU MDR Clinical Evaluation Reports (CERs). He details the shift from ad-hoc searches to rigorous, reproducible protocols required by notified bodies, emphasizing the need to track search results and maintain continuous risk-benefit assessments. Drower discusses the operational challenges of managing large portfolios of devices and the importance of validating software tools to ensure compliance and efficiency in regulatory submissions.

  • Let's Combinate · 28m

    054 - "EUDAMED" with Richard Houlihan

    Richard Houlihan, CEO of Eirmed, discusses the history, structure, and compliance requirements of EUDAMED, the European Commission's medical device database. He details the system's six modules, highlighting the complexity of the clinical investigations module and the shift from private competent authority access to public transparency for device data. Houlihan explains the legal obligations for economic operators, including manufacturers, authorized representatives, and importers, emphasizing that EUDAMED is a mandatory cost of doing business in Europe with strict data validation rules.

  • Being an Engineer · 51m

    S5E29 Steve Gompertz | Medical Device Quality Control & Regulatory Requirements

    Steve Gompertz, a partner at QRx Partners with prior leadership roles at Medtronic, Boston Scientific, St. Jude Medical, and Pelican Biothermal, explains how to build scalable quality management systems for medical device companies. He details the evolution of regulatory frameworks, noting the shift toward stricter EU standards and the integration of AI and cybersecurity into device compliance. Gompertz emphasizes tailoring quality systems to company size, using a case study of a client who reduced FDA findings from dozens to zero by implementing a holistic, process-connected system rather than a checklist approach. He also advocates for concurrent engineering and cross-functional teams to accelerate development while maintaining rigorous safety standards.

The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Global Medical Device Podcast. The episode itself belongs to its publisher.