074: Medical Device Product Development Best Practices

Product Startup · 5 May 2021 · 29m

What this episode covers

Rob Crowder, Head of Product at Nutromics, explains how his team uses user journey mapping to navigate the complexities of developing medical sensor devices, specifically the Neutromics wearable patch. He details the process of validating unmet needs in high-stakes areas like therapeutic drug monitoring for vancomycin, emphasizing the need to focus on specific indications like bacteremia to ensure clinical utility and commercial viability. Crowder contrasts this rigorous MedTech evidence bar with general product development, highlighting the importance of identifying all stakeholders—patients, clinicians, and payers—early in the design phase to avoid feature creep and resource burnout.

Other shows on the same ground, closest first.

  • Global Medical Device Podcast · 46m

    Best Practices for Clinical Evidence Management

    Keith and Kevin Kallmes, founders of Nested Knowledge, discuss the critical role of clinical evidence in medical device development, drawing on their experience building and selling a balloon catheter. They argue that entrepreneurs must validate unmet clinical needs through literature and clinician interviews before prototyping to avoid lack of product-market fit. The brothers detail their expensive early mistakes, including inadequate design history files and poor prioritization of navigability over robustness, which forced them to rebuild their device. They emphasize starting design controls at the concept stage and using pre-design validation to de-risk testing protocols before formal DV/DV.

  • Global Medical Device Podcast · 39m

    #469: Why Market Strategy Comes First in MedTech Development

    Shai Policker, Managing Partner at Edge Medical Ventures, explains how his firm reverses the traditional MedTech development paradigm by identifying validated clinical needs from multinational corporations before prototyping. He details how this approach allows for early mapping of reimbursement codes and regulatory pathways, citing examples like Urologic Health’s non-invasive urodynamics and Xero Medical’s smart surgical drains. Policker emphasizes that successful products must offer dramatic clinical improvements while maintaining familiar form factors to leverage existing 510(k) predicates and billing mechanisms.

  • Global Medical Device Podcast · 49m

    #347: Human-Centered Design in Medical Devices

    Morven Shearlaw, co-founder of the Glasgow-based design agency Fearsome, discusses the critical role of human-centered design in medical device development. She emphasizes defining the full ecosystem of users—including clinicians, patients, and cleaners—rather than just the end-user, and warns against jumping to solutions before understanding the core problem. Shearlaw shares anecdotes about how early user feedback can radically redirect product strategy and highlights the importance of integrating human factors early to manage risk and ensure commercial success.

  • Global Medical Device Podcast · 41m

    #425: The "Front End" of Medical Device Innovation: From Idea to Market

    Stuart Grant, founder of Archetype MedTech and former Johnson & Johnson executive, explains the 'front end of innovation' in medical device development, defining it as the critical phase between applied science and new product development where unmet clinical needs are identified. He details the Design Council's Double Diamond model for balancing divergent creativity and convergent analysis, emphasizing the need to validate viability, feasibility, and desirability. Grant shares ten specific behavioral insights from his doctoral research, such as observing workarounds and dissonance, to help teams uncover true user needs beyond what Key Opinion Leaders (KOLs) report.

  • Global Medical Device Podcast · 58m

    #392: Verification and Validation in MedTech: A Practical Guide with Devon Campbell

    Devon Campbell, a medical device consultant, explains the critical distinctions between verification (did we build the product right?) and validation (did we build the right product?) for early-stage medtech companies. He emphasizes that strong, testable user needs and design inputs are prerequisites for successful V&V, warning that weak requirements lead to validation failures. Campbell advocates for pre-verification testing to refine protocols and manage sample sizes, ensuring that design reviews and traceability are robust before formal regulatory submission.

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