Hardware Podcasts

#443: Generative AI in MedTech: Quality, Risks, and the Autonomy Scale with Ashkon Rasooli

Global Medical Device Podcast · 26 Jan 2026 · 44m · Episode 443

What this episode covers

Ashkon Rasooli, founder of Ingenious Solutions and a specialist in Software as a Medical Device (SaMD), discusses the unique quality assurance challenges of generative AI in the medical device industry. He explains that unlike traditional machine learning, generative AI creates new data, introducing failure modes like 'hallucinations' where outputs appear plausible but are factually incorrect. Rasooli argues that because GenAI behavior is statistical rather than deterministic, traditional pre-market validation is insufficient, necessitating a shift toward continuous post-market surveillance and real-time independent monitoring to ensure safety.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Ingenious Solutions, OpenAI
Products
ChatGPT, Google Maps
Also
MD&M West, FDA, ISO 14971, ISO 13485

Related episodes from other shows

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.

    AI & machine learningQuality & yield
    10 chapters

  • 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.

    Medical & health devicesQuality & yield
    10 chapters

  • 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.

    Validation & product-market fitQuality & yield
    9 chapters

  • Let's Combinate · 22m

    210 - How AI Is Rewriting GMP: Smarter CAPA, PAT, DOE, and Continuous Yield

    Ben Locwin, a Healthcare Executive and Quality SME, joins host Subhi Saadeh to discuss integrating AI into Good Manufacturing Practices (GMP) within pharmaceutical and medical device manufacturing. They explore current applications like AI-assisted CAPA and deviation management, while highlighting the regulatory challenges of algorithmic opacity in Process Analytical Technology (PAT) and continuous manufacturing. The conversation emphasizes the critical role of Design of Experiments (DOE) in training AI models and using yield calculations as an early warning system for process discrepancies in combination products.

    Quality & yieldValidation & product-market fit
    6 chapters

  • Let's Combinate · 41m

    134 - ISO62304, Software Development Process, SaMD, Closed Loop Systems, Complexities with Cloud and Better Software in MedTech with Richard Koch

    Richard Koch, founder of KochSaMD, explains the complexities of developing cloud-based medical devices, using a closed-loop insulin pump system as a primary case study. He details how ISO 62304 governs software development within the broader ISO 13485 framework, emphasizing the shift from batch-based physical manufacturing to continuous, high-velocity software updates. Koch warns that tech giants like Apple and Google are disrupting the industry by leveraging their digital expertise to acquire or compete with traditional medtech firms, urging leaders to upskill in software development to survive.

    Embedded firmwareConnected products & IoT
    7 chapters

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.