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MedTech Crossroads
United States
เข้าร่วมเมื่อ 6 มี.ค. 2019
For the medical startup community and those focused on investing in and delivering better health to our world.
Brought to you by in2being, your medical product development partner.
Brought to you by in2being, your medical product development partner.
Medical Device Development Simplified with This ONE Simple Concept
It turns out that understanding the idea of medical device development convergence puts a powerful tool in your hands, enabling you to become the master of inputs, outputs, as well as verification and validation - allowing changes to all aspects in a way that shortens development time.
What if there was one concept you could use to optimize your medical device development process for FDA approval? Turns out there is... it's the concept of "convergence". Many teams struggle to understand how requirements, product design, and testing relate to their readiness to submit a 510(K) to FDA. And the idea that development iterations are needed is at once obvious, and also confusing. How many iterations? How long until you're "done"? The much vaunted "design freeze" seems always out of reach... and is "design freeze" even the goal?
What if there was one concept you could use to optimize your medical device development process for FDA approval? Turns out there is... it's the concept of "convergence". Many teams struggle to understand how requirements, product design, and testing relate to their readiness to submit a 510(K) to FDA. And the idea that development iterations are needed is at once obvious, and also confusing. How many iterations? How long until you're "done"? The much vaunted "design freeze" seems always out of reach... and is "design freeze" even the goal?
มุมมอง: 66
วีดีโอ
Why Cybersecurity is Critical for Medical Devices
มุมมอง 1192 หลายเดือนก่อน
Stay ahead of the curve in 2024 by sidestepping critical FDA cybersecurity pitfalls that could put your medical device company at risk. In this video, we'll dive into the latest FDA guidelines and regulatory updates, highlighting potential threats and vulnerabilities that could compromise more than just medical device safety and efficacy. From understanding the FDA cybersecurity framework to im...
Examining the Unexamined Data: How digging deeper could revolutionize healthcare
มุมมอง 475 หลายเดือนก่อน
What if we could immediately tell who was at a higher risk of certain diseases? How would it change the way we prevent, diagnose, and treat illness? Dr. Ram Peruvemba of HSR.Health joins us at the MedHealth Summit to answer these questions and more. Each week we bring you fresh FDA news and commentary, in-depth regulatory and development education, interviews with MedTech community members, and...
Training the Doctors of the Future: The Role of Virtual Reality in MedTech
มุมมอง 797 หลายเดือนก่อน
In this interview episode straight from the MedHealth summit in Detroit, MI, we met with Kim Hanke, founder and CEO of Elm Park Labs, to discuss her work and the role of virtual reality in training doctors for the future. Each week we bring you fresh FDA news and commentary, in-depth regulatory and development education, interviews with MedTech community members, and announcements of relevant e...
Clearing Electronic Health Records and AI: MedHealth interview with Dr. Micky Tripathi
มุมมอง 747 หลายเดือนก่อน
We take a break from our in-studio shows to meet with Dr. Micky Tripathi from the U.S. Department of Health and Human Services at the MedHealth Summit in Detroit, MI. Dr. Tripathi provides expert answers to two questions on the topics of AI, software, electronic health records, and more. Each week we bring you fresh FDA news and commentary, in-depth regulatory and development education, intervi...
Philips Consent Decree: Nightmare for Respironics Company
มุมมอง 1517 หลายเดือนก่อน
It’s well known at this point that inhalation of degraded foam in Philips CPAP masks was involved in the deaths of at least 561 people. Philips knew what was going on, and the former CEO lost his job over it. But with the recent announcement of a consent decree between Philips, FDA, and the department of justice, what really is the fallout? How much trouble is Philips really in? All this and mo...
Quality Systems: GMP, GLP, GCP, and more
มุมมอง 2558 หลายเดือนก่อน
Good manufacturing practice... good laboratory practice... good clinical practice... oh my! And what's all this about quality? In today's episode of MedTech Crossroads, we'll give you a quick, informative, birds' eye view of GMP, GLP, GCP, and more. Each week we bring you fresh FDA news and commentary, in-depth regulatory and development education, interviews with MedTech community members, and...
Complying with FDA Guidance Documents
มุมมอง 2209 หลายเดือนก่อน
What are FDA guidance documents? How are they different from standards? And which ones do you need to pay attention to? Each week we bring you fresh FDA news and commentary, in-depth regulatory and development education, interviews with MedTech community members, and announcements of relevant events - all curated by your medical product development team at in2being, LLC. Find FDA Guidance Docum...
Complying with FDA Standards
มุมมอง 909 หลายเดือนก่อน
FDA standards can be confusing. Which ones do you need to follow? Do they ever expire? All of this and more on today's episode on MedTech Crossroads. Each week we bring you fresh FDA news and commentary, in-depth regulatory and development education, interviews with MedTech community members, and announcements of relevant events - all curated by your medical product development team at in2being...
How presbyopia lenses are changing the vision landscape
มุมมอง 15810 หลายเดือนก่อน
How presbyopia lenses are changing the vision landscape
How to avoid submitting for clearance AGAIN
มุมมอง 26ปีที่แล้ว
How to avoid submitting for clearance AGAIN
Revolutionizing Healthcare: Can ChatGPT Be Trusted?
มุมมอง 30ปีที่แล้ว
Revolutionizing Healthcare: Can ChatGPT Be Trusted?
Making Informed Decisions: Exploring Clinical Trials for Children
มุมมอง 24ปีที่แล้ว
Making Informed Decisions: Exploring Clinical Trials for Children
How to Navigate Angel Investors and Syndication: Investment Size and Board Seats Demystified
มุมมอง 63ปีที่แล้ว
How to Navigate Angel Investors and Syndication: Investment Size and Board Seats Demystified
Is FDA involved in the 3m earplugs lawsuit?
มุมมอง 604ปีที่แล้ว
Is FDA involved in the 3m earplugs lawsuit?
New biologic treatment for multiple sclerosis FDA approved
มุมมอง 1.1Kปีที่แล้ว
New biologic treatment for multiple sclerosis FDA approved
Revealing the future of medical device sterilization
มุมมอง 45ปีที่แล้ว
Revealing the future of medical device sterilization
FDA's stance on Off The Shelf vs Custom Software: What you need to know
มุมมอง 243ปีที่แล้ว
FDA's stance on Off The Shelf vs Custom Software: What you need to know
FDA Grants Approval to Groundbreaking Diabetes Therapy
มุมมอง 416ปีที่แล้ว
FDA Grants Approval to Groundbreaking Diabetes Therapy
Accelerate 510k Software Submissions with FDA Guidance
มุมมอง 202ปีที่แล้ว
Accelerate 510k Software Submissions with FDA Guidance
What's up with FDA meeting timelines in 2023?
มุมมอง 18ปีที่แล้ว
What's up with FDA meeting timelines in 2023?
From bootstrap to big league: Is VC funding right for you?
มุมมอง 17ปีที่แล้ว
From bootstrap to big league: Is VC funding right for you?
Unlocking Growth: Making the Right Call on Venture Capital Money
มุมมอง 98ปีที่แล้ว
Unlocking Growth: Making the Right Call on Venture Capital Money
Why Your Voice Matters: FDA's Call for Patient Feedback
มุมมอง 22ปีที่แล้ว
Why Your Voice Matters: FDA's Call for Patient Feedback
Saying Goodbye to CPAP: Meet the Implantable Treatment for Sleep Apnea
มุมมอง 77ปีที่แล้ว
Saying Goodbye to CPAP: Meet the Implantable Treatment for Sleep Apnea
How to Qualify for FDA's Breakthrough Devices Program 2023
มุมมอง 226ปีที่แล้ว
How to Qualify for FDA's Breakthrough Devices Program 2023
I still can’t wrap my mind around that this machine exists and actually works!!! You would think people would be getting sepsis left and right at the very least! It’s honestly amaaaazing!!! We don’t talk about it enough as humans, that it exists! It’s like putting someone on the moon but harder!
How to do work in fda sir I have experience in pharma industry but my education qualification is btech mechanical engineering
Does it effect the body negatively?!!! My loved one has MS and he just got diagnosed. some people say that biological treatments increase the risk of catching a brain virus that kills patients Is this true?!?!!!!
Diane M Welsh is the snake who let Philips off the hook with Zero Apology and horrible excuse for settlement. If you get Diane M welsh to sell her soul again your company too can commit mass murder and increase your revenue simultaneously!
Looking forward to the grassroots innovation and partnership PPP with MEDHealth!!!
Nonsense
Wouldn't you want a clinical AI to have good discrimination?
Interesting and informative content. Thanks Gene and team! Keep up the great work!
Thanks for your video. I am starting to be involved in all of those process as software engineer, and you gave me the basics that I needed.
Thousands of children each year undergo life saving surgeries that require anesthesia. However, the FDA states that, while anesthesia has been tested on adults, not much study has actually been done on the effects of anesthesia in children. Furthermore, in young animals, anesthesia has been shown to have severe negative side effects, including brain damage. So, FDA has collaborated with the International Anesthesia Research Society to create SmartTots, a Public Private Partnership, to coordinate and fund anesthesia research with the goal of making healthcare even safer for adults and children alike. Watch the full video or visit smarttots.org for more information.
Thousands of children each year undergo life saving surgeries that require anesthesia. However, the FDA states that, while anesthesia has been tested on adults, not much study has actually been done on the effects of anesthesia in children. Furthermore, in young animals, anesthesia has been shown to have severe negative side effects, including brain damage. So, FDA has collaborated with the International Anesthesia Research Society to create SmartTots, a Public Private Partnership, to coordinate and fund anesthesia research with the goal of making healthcare even safer for adults and children alike. Watch the full video or visit smarttots.org for more information.
Conservatives when they find out every drug has some level of side effects in which we have balanced out the positives to the negatives: 😱😱😱😱😱
How many of those are dental procedures?
That’s why a risk benefit analysis is done. It’s why a gall bladder surgery for a 16 year old may be called elective but open heart surgery on an infant is an emergency. It also depends on how long they’re under. What do you propose? We stop performing life saving surgeries on young people? Let them die?
wtf
It's not like we are putting them under because we want to. Along with all the other risks, it's a measure of benefit vs risk. Duh. We don't exactly have a huge arsenal of other more acceptable options, so what exactly is the point here? Either show us the solution to the issue or stop crying about the risk, I hate when people just perpetuate negativity without a positive solution. Jeez.😒
Yes the Question like how does it affect animals in general? What animals are they testing it on do they have a similar weight to humans? How does their body expel the chemical compared to ours? What source did you get this from? What was the purpose of the study? Is it a negligible risk? Who is this guy?
1. Source? 2. If your child needs open heart surgery, are you gonna let them be awake for that shit?
What is your point? Any chance some of these surgeries may have saved lives? And for little ones, if they are not knocked out, they won't hold still long enough for the procedure. Speaking from personal experience. You want to scar them for life - tie them down and pump them full of pain killers.
Solution: Ban Children
Soo? What’s the point of this video…
So?
Aaaaannnnnd? 🤨
They made so much money selling it to the military over the years and they can only pay out 6 billion dollars 🤔
wtf is this
That’s what I’m sayin
Gene - thank you for the chance to be on your podcast! Really enjoyed getting a chance to share with you.
Excellent presentation - thanks!
A well deserved 9.5k views
Your content is captivating. Let's collab and weave more stories!
*PromoSM*
『p』『r』『o』『m』『o』『s』『m』 🏃
Are there legal limitations on marketing an FDA cleared device? For example, if the device is approved for treating specific diagnoses, what happens if the device is used for treating more diagnoses?
Melinna, good questions. Feel free to reach out through our website contact form at in2being.com for more information, but in short, the intended use of the device and the indications for use as cleared by FDA determine what how the device can be legally marketed. While doctors and patients may decide to use a device "off-label", the marketing company's statements are limited to what claims the device is actually cleared for.
We found our N95 respirator can be registered as FDA product code MSH in FDA database with no 510(k) is needed. Once we got the establishment number issued by FDA, we can only use FDA registered for our N95 respirator. However, why we cannot declare our N95 respirators as FDA cleared? How should we do if we want to be FDA cleared eventually?
Emergency Auth?
here are 2 stories 1) Typical client payout for product liability is 8% 2) not a single lawyer would ever stand up in congress and try to stop any of these products being produced because these injuries produces millions of dollars for this industry every year.
FDA help American company and push down other , is it normal ???.