Where can I listen to this podcast?

This podcast is available on 4 platforms including Apple Podcasts, Spotify, and more. You can also use the RSS feed directly.

GuideWire

Claim This Podcast

by Devin Hubbard

5.0(4 reviews)

10 episodes

Updated Daily

Accepts GuestsHas Sponsors

Podcast Overview

Guidewire is a behind-the-scenes peek into the world of medical device innovation and problem discovery. Our team of medical device design engineers dive into the nuances, challenges and considerations that go into finding and solving high-impact unmet medical needs at a large university hospital. Hosted by Devin Hubbard of FastTraCS and the Joint Department of Biomedical Engineering at the University of North Carolina and North Carolina State University. The project described was supported by the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, through Grant Award Number UL1TR002489. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

Language

🇺🇲

Publishing Since

12/2/2020

Visit Website View on Apple Podcasts RSS Feed

1 verified contact email on file for GuideWire

Pitch yourself as a guest, propose sponsorships, or reach out directly to the host.

See contact details

Recent Episodes

June 8, 2022

Season 2 - Episode 8: Falls & Falls Prevention with Kim Young

What if you or a loved one goes into the hospital for a treatable condition only to end up with a completely unrelated health problem while admitted? It happens and is a perennial issue. Almost one-million Americans experience falls in the healthcare systems every year. In this episode of GuideWire, Devin Hubbard with FastTraCS talks to Kim Young, Clinical Senior Management Engineer in the Office of Quality Excellence and Performance Improvement at UNC Health, about falls and preventing them. Today’s Topics Include: Quality Coach: Why falls matter to Kim - it’s a really big, persistent problem Fiscal Year: Out of 850 falls, ~20% were injured and had to be treated because of fall Fall Defined: Anytime somebody hits the floor when assisted or not Financial Impact: Extending length of stay and who covers costs is a concern Who falls? Assessment is conducted for patient factors that predispose them to falls Where do patients fall in hospitals? All over, but mostly when going to the bathroom Why do patients fall then? Want to maintain independence, mobility, and privacy Ways to proactively prevent falls: Accompany and assess patient, use of alarms/aids Rounds/Telesitter: Ask, remind patients if they want help; time consuming and laborious What’s needed? Some type of technology or way patients don’t get injured due to falls Future of Falls: Improvement and innovation is needed for more elegant solutions Links and Resources: Devin Hubbard Kim Young - FastTraCS Clinical Advisory Group FastTraCS GuideWire Podcast on Twitter GuideWire Podcast U.S. Food and Drug Administration (FDA) National Database of Nursing Health Quality Indicators Telesitter Quotes:

February 2, 2022

Season 2 - Episode 7: The Effects of COVID-19 on Regulatory Affairs

In this episode of GuideWire, Devin Hubbard and Nabil Khan with FastTraCS talk to Jon Speer, founder of Greenlight Guru and host of the Global Medical Device Podcast. Jon discusses how the COVID-19 pandemic and shutdown affected the quality and regulatory affairs industry and specifically, Greenlight Guru as a company and quality management system (QMS). Today’s Topics Include: Greenlight Guru’s QMS: Needed now more than ever for to access documents, records Rules Change: Why Greenlight Guru decided to allow remote work to continue growing Greenlight Growth: Expected, forecasted, and planned for but faster because of COVID Industry Impact: Companies struggled, shut down, or shifted development efforts Clinical Trials/Investigations: COVID changed how these are being conducted New Types of Med Device Companies: Naive about requirements and regulations Positive Outcomes: In this together, so collaborate and share knowledge, feedback Emergency Use Authorization (EUA): FDA’s criteria for risk tolerance and assessment Side Effects: Longer lead times but faster standard practice to develop medical devices Links and Resources: Greenlight Guru Greenlight Guru Podcasts Greenlight Guru - Definitive Guide to ISO 14971:2019 Risk Management for Medical Devices Greenlight Guru - ISO 13485: Ultimate Guide to the Quality Management System (QMS) for Medical Devices Greenlight Guru - Ultimate Guide to 21 CFR Part 820 Greenlight Guru - The Ultimate Guide to Design Controls FDA - Guidance Document on Design Controls FDA - Emergency Use Authorization (EUA) FDA - 510(k) Submission Process FDA - Premarket Approval (PMA) FDA - Case for Quality Initiative National Institutes of Health (NIH) - Rapid Acceleration of Diagnostics (RADx Program) ASTM International F3502 Mask Standard IEC 60601 Standard

December 10, 2021

Season 2 - Episode 6: Electronic Quality Management Software with Jon Speer from Greenlight.Guru

In this episode of GuideWire, Devin Hubbard with FastTraCS talks to Jon Speer, founder of Greenlight Guru and host of the Global Medical Device Podcast. Jon discusses the origins of his company, electronic quality management software (QMS), and entrepreneurship experiences in the startup world. Today’s Topics Include: Greenlight Guru: Medical device success platform helps meet quality/regulatory needs Greenlight Guru provides workflows to navigate/manage design/development process Design Controls: Evidence demonstrates safe and effective products that actually work Why electronic quality systems are easier to manage, maintain than paper-based ones Primary Processes: Design controls, risk management, documentation, management Quality system intent is to describe how business is conducted w/ regulatory compliance Free Resources: How and where to learn about quality systems and regulatory affairs Entrepreneurial Experiences: Got a good idea? Be patient, wait for conditions to be right Guru: Story behind the business name, brand, and domain to be differentiator Trends: COVID-19 created choice to grow and hire talent without relocating Links and Resources: Jon Speer on LinkedIn Greenlight Guru Greenlight Guru Podcasts Greenlight Guru Medical Device Blog Greenlight Guru YouTube Channel Greenlight Guru - The Ultimate Guide to Design Controls Greenlight Guru - Definitive Guide to ISO 14971:2019 Risk Management for Medical Devices Greenlight Guru - ISO 13485: Ultimate Guide to the Quality Management System (QMS) for Medical Devices U.S. Food and Drug Administration (FDA) FDA - Guidance Document on Design Controls FDA - Emergency Use Authorization (EUA) HubSpot Devin Hubbard FastTraCS FastTraCS Clinical Advisory Group GuideWire Podcast on Twitter GuideWire Podcast Quotes/Tweets: “Prior to Green...

10 total episodes available

Deep-dive analytics for GuideWire

Frequently asked questions

Have a different question and can't find the answer you're looking for? Reach out to our support team by sending us an email and we'll get back to you as soon as we can.

What is GuideWire?: Guidewire is a behind-the-scenes peek into the world of medical device innovation and problem discovery. Our team of medical device design engineers dive into the nuances, challenges and considerations that go into finding and solving high-impact unmet medical needs at a large university hospital.

Hosted by Devin Hubbard of FastTraCS and the Joint Department of Biomedical Engineering at the University of North Carolina and North Carolina State University. The project described was supported by the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, through Grant Award Number UL1TR002489.

The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
How often does this podcast release new episodes?: This podcast updates daily.
Where can I listen to this podcast?: This podcast is available on 4 platforms including Apple Podcasts, Spotify, and more. You can also use the RSS feed directly.
Does this podcast accept guests?: Information about guest appearances is not available.

Legal Disclaimer

Pod Engine is not affiliated with, endorsed by, or officially connected with any of the podcasts displayed on this platform. We operate independently as a podcast discovery and analytics service.

All podcast artwork, thumbnails, and content displayed on this page are the property of their respective owners and are protected by applicable copyright laws. This includes, but is not limited to, podcast cover art, episode artwork, show descriptions, episode titles, transcripts, audio snippets, and any other content originating from the podcast creators or their licensors.

We display this content under fair use principles and/or implied license for the purpose of podcast discovery, information, and commentary. We make no claim of ownership over any podcast content, artwork, or related materials shown on this platform. All trademarks, service marks, and trade names are the property of their respective owners.

While we strive to ensure all content usage is properly authorized, if you are a rights holder and believe your content is being used inappropriately or without proper authorization, please contact us immediately at hey@podengine.ai for prompt review and appropriate action, which may include content removal or proper attribution.

By accessing and using this platform, you acknowledge and agree to respect all applicable copyright laws and intellectual property rights of content owners. Any unauthorized reproduction, distribution, or commercial use of the content displayed on this platform is strictly prohibited.