Hardware Podcasts

Challenges related to Home Use Devices

Global Medical Device Podcast · 10 Sept 2020 · 30m · Episode 163

What this episode covers

Mike Drues, founder of Vascular Sciences, discusses the unique safety, risk, and usability challenges of medical devices used in non-traditional, home-like environments by laypeople rather than trained professionals. He highlights the difficulty of defining user subgroups for human factors testing, noting that engineers often fail to represent patients with physical or cognitive limitations. Drues argues that risk mitigation should rely on intelligent design rather than labeling, as users rarely read manuals, and emphasizes the need to decouple regulated and consumer functions when assessing combined system risks.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Vascular Sciences, Green Light Guru
Also
FDA, ISO, NASA

Related episodes from other shows

Other shows on the same ground, closest first.

  • Let's Combinate · 53m

    072 - OXO PFS, Drug/Device Usability, Toothbrushes for Children, Epicurious Series and Baseball with Dan Formosa

    Dan Formosa, founder of ThinkActHuman and former Smart Design partner, discusses his philosophy of designing for the full spectrum of human ability, from arthritis patients to children. He details his work on OXO Good Grips kitchen tools, a children's toothbrush for Johnson & Johnson, and a pre-filled syringe for UCB that empowers patients with rheumatoid arthritis. Formosa also explains his approach to usability in drug/device combination products, emphasizing the elimination of instructions through intuitive design, and shares insights from his Epicurious series 'Well Equipped' and his book on baseball rules.

    Industrial & consumer product designMedical & health devices
    7 chapters

  • Let's Combinate · 1h 16m

    012 - "Asking then Seeing" with Sara Waxberg Mcnew

    Sara Waxberg McNew, Chief Scientific Officer at Design Science, explains the human factors process for medical devices, emphasizing the distinction between formative studies and summative validation. She details how to interpret ANSI/AAMI HE75 and IEC 62366-1 standards, manage risk for combination products, and handle regulatory submissions with the FDA. The discussion covers specific challenges like testing rare patient populations, using surrogates, and conducting threshold analyses for generics.

    Medical & health devicesValidation & product-market fit
    12 chapters

  • Let's Combinate · 46m

    049 - "What Does the Data Say?" with Shannon Hoste

    Shannon Hoste, President of Agilis Consulting and former FDA reviewer, explains the regulatory framework for combination products, detailing the distinct roles of CDRH, CDER, and DMEPA in human factors reviews. She clarifies the critical distinction between design validation and human factors validation, emphasizing that the latter focuses specifically on safe and effective use rather than all user needs. Hoste also discusses the methodology for summative evaluations, including the rationale for the N=15 sample size per user group and strategies for recruiting representative participants to identify use errors.

    Medical & health devicesCertification & compliance
    8 chapters

  • Let's Combinate · 50m

    055 - "Critical Tasks and Knowledge Tasks" with Alexandra Benbadis

    Alexandra Benbadis, Usability Leader at Sanofi and former Senior Human Factors Consultant at Emergo by UL, explains the regulatory distinctions between critical and knowledge tasks in combination product human factors studies. She details how the FDA's CDRH and CDR definitions of 'harm' expand the scope of critical tasks to include compromised medical care, such as underdoses in maintenance medications, requiring rigorous residual risk commentary. Benbadis also describes the evolution of knowledge task protocols, specifically the two-part approach to evaluate Instructions for Use (IFU) findability and comprehension without requiring their use during initial open-ended questioning.

    Medical & health devicesQuality & yield
    7 chapters

  • Being an Engineer · 45m

    S2E33 Custom Medical Device Manufacturing, Durability, & the Future of Med Device Tech | Mark A. Farber, MD

    Dr. Mark Farber, a vascular surgeon at the University of North Carolina and medical device consultant, discusses the challenges of developing custom medical devices for aneurysm treatment. He highlights the difficulty of predicting long-term durability in the harsh mechanical environment of the human body, noting that off-the-shelf devices only fit 25% of patients, necessitating custom manufacturing that can take months. Dr. Farber emphasizes the critical need for engineers to observe clinical procedures to understand the complex, dynamic variables of in vivo testing that lab simulations often miss.

    Medical & health devicesMaterials & manufacturing processes
    9 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.