#353: How Artificial Intelligence is Impacting the MedTech Industry

Global Medical Device Podcast · 30 Jan 2024 · 45m · Episode 353

What this episode covers

Ashkon Rasooli, a biomedical engineer and quality management expert at Engenius Solutions, discusses the integration of AI in the MedTech industry, highlighting its statistical nature versus deterministic software. He details current applications in radiology, cardiology, and neurology, as well as wellness wearables like January AI and Whoop, while emphasizing the critical need to mitigate data bias in AI models. Rasooli also outlines a staged adoption strategy for validating AI tools within Quality Management Systems to manage inherent uncertainty, and touches on regulatory efforts by the AFDO/RAPS Working Group.

Mentioned

Companies
Greenlight Guru, Engenius Solutions
Products
January AI, Whoop, 8 sleep, Unique, ChatGPT, GPT 4
Also
AFDO/RAPS Working Group, FDA

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.

  • 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.

  • Let's Combinate · 1h 03m

    021 - "Options" with Karandeep Singh Badwal

    Karandeep Singh Badwal, a QA/RA consultant and host of The MedTech Podcast, explains how defining 'intended use' determines whether a product is a regulated medical device or unregulated software, a critical distinction for startups. He details the specific regulatory challenges of Software as a Medical Device (SaMD), including cybersecurity, GDPR compliance, and the impact of the EU MDR on software classification. Badwal also discusses the strategic advantages for UK software companies post-Brexit, where they can still self-certify as Class 1 devices while EU counterparts face stricter notified body audits.

  • Being an Engineer · 41m

    Ajay Panwar | Statistical Control Processes, Regression Analysis, and Philanthropy

    Ajay Panwar, Senior Engineering Manager at Medtronic, discusses statistical process control, regression analysis, and inventory strategies like JIT. He explains the regulatory differences between Class 1 and Class 3 medical devices and shares insights on ISO 13485 auditing gaps. Panwar also covers his philanthropic work and angel investing in the healthcare startup ecosystem.

  • Being an Engineer · 47m

    S5E44 Geoff Gaw | Nitinol, R&D, and How to Learn About New Technologies

    Geoff Gaw, a Senior Principal Engineer at Edwards Lifesciences with prior leadership roles at Medtronic and Applied Medical, discusses the unique challenges of working with Nitinol and managing teams in highly regulated medical device environments. He explains how he aligns product development with process development by waiting for clinical viability signals before committing to mass production strategies, and details his approach to scaling engineering teams by leveraging high performers rather than micromanaging. Gaw also shares his perspective on staying current with emerging technologies through job mobility and predicts the integration of AI in medical procedures, noting the associated risks of opacity in decision-making.

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.