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The Medical Device Development Process: Goddard’s Guide

Human factors engineering is a critical part of the product development process. And for medical device development, this work is mandated thanks to the medical device regulationsput forth … See more

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URL: https://www.goddardtech.com/medical-technology/medical-device-development-process-goddards-guide/

How U.S. MedTech Industry Has Shaped Medical Device Innovation

The purpose of medical device technologies is that of safety, efficiency, and health improvement. Medical device development companies drive the production of …

Category:  Medical Go Health

Human Factors in Healthcare – Building Useful Medical Devices

And, perhaps most importantly, how does the device fit into a patient’s experience of health technology? Take, for instance, a glucose meter designed to help someone manage …

Category:  Health Go Health

510(k) Submission: Clearance & Selecting a Predicate Device

When it comes to a 510 (k) submission, selecting a predicate device is one of the most consequential decisions a medical device developer will make. The predicate device is …

Category:  Medical Go Health

Design Outputs for Medical Devices: Truly Control Your Design

As defined by the FDA ¹, design controls are procedures that control the design process to ensure that your product meets user needs, intended uses, and specified …

Category:  Health Go Health

5 Lessons in MedTech Leadership: Insulet CEO Shacey Petrovic

Shacey Petrovic is the CEO of Insulet – a device company based in Massachusetts that pioneered the development of wearable, tubeless insulin delivery systems. …

Category:  Health Go Health

MD&M West 2020: Industrial Design & Human Factors Engineering

MD&M West 2020 takeaways: Leveraging data in medical device development, human factors engineering for user-centered industrial design, & more

Category:  Medical Go Health

MD&M West 2020 Robotics, User-Centered Design & Nurturing

The panel features Lori Jordon from Microsoft, Richard Leparmentier from Auris Health, Hari Nayar from the Nasa Jet Propulsion Lab and Brian Schmitz from Stryker. Also on …

Category:  Health Go Health