Hardware Podcasts

Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

Global Medical Device Podcast · 2 Dec 2020 · 31m · Episode 170

What this episode covers

Andrew Frink, Regulatory Affairs Manager at Proxima Clinical Research, explains how Software as a Medical Device (SaMD) companies can leverage FDA Pre-Submissions to improve final submission outcomes. He details the specific documentation required for these early interactions, including a clear device description, intended use statement, user interface screenshots, and software architecture diagrams. Frink emphasizes that while full verification and validation plans are not needed upfront, companies must demonstrate a solid understanding of risk management, including FDA's 'level of concern' classification and cybersecurity considerations. The discussion clarifies that agile development is acceptable as long as the process is well-documented and supported by a robust V&V plan.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Proxima Clinical Research, Greenlight Guru, AWS
Also
FDA, 510 K, De Novo, ISO 14971, ISO TIR 24971, Linux, Docker

Related episodes from other shows

Other shows on the same ground, closest first.

  • 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

  • The Pragmatic Embedded Podcast · 33m

    How to Speed Up Safety Critical Processes

    Jeff Gable and Luca Njani discuss strategies to accelerate safety-critical development in medical devices, automotive, and aerospace without compromising quality. They argue that reducing scope for initial releases and automating documentation using modern tools like Jama and Matrix significantly shortens cycle times. The hosts emphasize that modern regulatory guidance, such as the FDA's Computer System Assurance, supports streamlined validation processes, allowing teams to iterate faster and uncover defects earlier.

    Medical & health devicesDesign for manufacturing & NPI
    7 chapters

  • The Pragmatic Embedded Podcast · 37m

    Agile Manifesto Pt. 1

    Hosts Jeff Gable and Luca Engineer discuss the first two principles of the Agile Manifesto, specifically 'Individuals and interactions over processes and tools' and 'Working software over comprehensive documentation,' with a focus on safety-critical industries like medical devices. They argue that while processes and documentation are necessary for regulatory compliance (FDA, MDR) and safety, they must be useful and not become 'cargo cult' rituals that hinder development. The conversation highlights the danger of overly granular specifications and emphasizes that code, infrastructure, and user interfaces can serve as valuable forms of documentation if they are clear and maintained.

    Careers & educationEmbedded firmware
    8 chapters

  • The Pragmatic Embedded Podcast · 37m

    Rapid Prototyping for Medical Devices with Ross Dehmoobed

    Ross Dehmoobed, VP of software and platforms at Veranex, explains how his company applies agile methodologies to medical device development. He details the use of 'Fusion Core' libraries and custom hardware modules to enable rapid prototyping, allowing teams to demonstrate functional breadboards and software features within the first two weeks. Dehmoobed emphasizes that while planning and regulatory pathway definition (such as 510(k) or de novo) require upfront waterfall-style rigor, the execution phase benefits from short sprints, off-target unit testing, and continuous customer feedback to maintain quality and speed.

    Prototyping & iterationEmbedded firmware
    7 chapters

  • The Pragmatic Embedded Podcast · 52m

    Living Documentation and Test Automation with Paul Massey

    Paul Massey, founder and CEO of Bluefruit Software, explains how to shorten release cycles for medical devices using living documentation and test automation. He discusses applying Agile principles to comply with standards like IEC 62304 and guidance document TIR 45, emphasizing the shift from efficiency to effectiveness. Massey details the use of Behavioral Driven Development (BDD) with Gherkin feature files to create executable specifications that serve as both tests and documentation, reducing the manual burden of compliance submissions.

    Embedded firmwareQuality & yield
    8 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.