12 épisodes

Medtech Mindset has been in hibernation the last couple of years. It's coming back! If you have suggestions on topics or speakers, please send email them to hello@archimedic.com.

MedTech Mindset brings together thought leaders, entrepreneurs, investors, clinicians, and other guests from the medical device and health technologies industries. We discuss:-Exciting new Medtech Projects, Companies, and Trends-Engineering, Design and Prototyping-Fundraising and Investor Pitching-Intellectual Property Issues-How to Collect, Evaluate and Present Clinical Data-Regulatory Pathway Approaches-Reimbursement and CMS CodesMedTech Mindset is a production of Archimedic, a medical device development firm with offices in Boston and Philadelphia. About Archimedic: Archimedic partners with innovators to transform novel concepts into market-ready medical devices that improve and save lives.From surgical instrumentation and point-of-care diagnostics to medical robotics, wearables,and drug delivery devices, Archimedic accelerates the development of breakthrough medicaltechnologies from napkin sketch through production.

MedTech Mindset Archimedic

    • Technologies

Medtech Mindset has been in hibernation the last couple of years. It's coming back! If you have suggestions on topics or speakers, please send email them to hello@archimedic.com.

MedTech Mindset brings together thought leaders, entrepreneurs, investors, clinicians, and other guests from the medical device and health technologies industries. We discuss:-Exciting new Medtech Projects, Companies, and Trends-Engineering, Design and Prototyping-Fundraising and Investor Pitching-Intellectual Property Issues-How to Collect, Evaluate and Present Clinical Data-Regulatory Pathway Approaches-Reimbursement and CMS CodesMedTech Mindset is a production of Archimedic, a medical device development firm with offices in Boston and Philadelphia. About Archimedic: Archimedic partners with innovators to transform novel concepts into market-ready medical devices that improve and save lives.From surgical instrumentation and point-of-care diagnostics to medical robotics, wearables,and drug delivery devices, Archimedic accelerates the development of breakthrough medicaltechnologies from napkin sketch through production.

    Maintaining Agility & Quality in Device Software Development with Rightley McConnell

    Maintaining Agility & Quality in Device Software Development with Rightley McConnell

    In this episode, Rightley McConnell, VP of Operations at Precision Systems, Inc., covers how to maintain quality and speed when developing medical device software. Rightley and Dan discuss:
    Challenges to device software development for complex systemsUse of AGILE methodology in a regulated environmentApplicable standards including 21 CFR 820, ISO 13485, ISO 14971How quality can remain central at each development phaseAnd more. Rightley can be reached at rmcconnell@psi-software.com.

    • 41 min
    Data Flow Medtech Innovation with Seth Goldenberg

    Data Flow Medtech Innovation with Seth Goldenberg

    In this episode, Seth Goldenberg, VP of Vault Medical Device & Diagnostics at Veeva Systems, cover data flow throughout the product lifecyle and how advanced data management can speed devices along the path to market.
    Seth and Dan discuss:
    How data management and access impact the product lifecycleWhat the device industry can learn from pharma's data practicesHow EU MDR is changing the data landscapeWhen in a device company's growth does a cloud system start to make sense?

    • 35 min
    Securing Funding with Adam Dakin, Part II

    Securing Funding with Adam Dakin, Part II

    In Part II of this two-part episode, Adam Dakin, Managing Director of Dreamit Health, covers funding trends in medtech and how to pitch to institutional investors. Adam and Dan discuss:
    Medtech funding trends and how they've changed in recent yearsInvestor perspectives on medtech vs. digital healthHow to build value to make your startup attractiveTips for success at the pitch table

    • 27 min
    Securing Funding with Adam Dakin, Part I

    Securing Funding with Adam Dakin, Part I

    In this episode, Adam Dakin, Managing Director of Dreamit Health, covers funding trends in medtech and how to pitch to institutional investors. (Part I of II)Adam and Dan discuss:
    Medtech funding trends and how they've changed in recent yearsInvestor perspectives on medtech vs. digital healthHow to build value to make your startup attractiveTips for success at the pitch table

    • 28 min
    Staking Your IP Claim with Gregory Bernabeo

    Staking Your IP Claim with Gregory Bernabeo

    In this episode, Gregory Bernabeo, Patent Attorney and Partner at FisherBroyles, covers intellectual property ground rules and special topics in the medtech space. Greg and Dan discuss:
    Why a patent isn't what (exactly) what you thought it wasIs my medtech innovation patentable?Are patents valuable if I can't afford to litigate?Can medtech innovators protect their IP rights and publish their research?What's important when selecting a patent attorney for my medtech project?

    • 40 min
    Overcoming Pediatric Device Innovation Challenges with Matthew Maltese

    Overcoming Pediatric Device Innovation Challenges with Matthew Maltese

    In this episode, Matt Maltese, Executive Director of the PA Pediatric Medical Device Consortium and Dan Henrich discuss:
    Current barrier to pediatric device innovationHow pediatric specialists operate without pediatric devicesRisk/Benefit rationale for small patient populationsCurrent industry and FDA initiatives to bring more devices to market for kids

    • 48 min

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