GuideWire

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

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:

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

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

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...