The channel to support the medical device community with expert presentations on a range of topics relevant for medical device professionals. A secondary emphasis on medical device marketing best practices.
My wife is going through the same thing she just had her 4th surgery. If you have found out anything more or any update on any new info on the disease if you could please share. Thanks
Please response me this tube benefit for man or not? My brother accident happened doctor say tomorrow fix the tracheotomy tube and my brother foot can't working fast time no any feeling now feeling ok but working not ?
Evn i got tracheostomy after 1 month it closed completely no issues but it looks like some dent or small hole n got that scar doctor said it wll heal in 1-1.5 years
I can breath also through my mouth and nose and last time they took a scope in my throat they punctured my vocal cord. It's been four years since my throat cancer. I wonder if it will ever close and if they can remove some scar tissue
I have idiopathic subglottic stenosis. I am 23. I am mixed white and asian. I need to know why I am like this. I'm having a third surgery next month because my narrowing keeps coming back. It is debilitating and I am miserable and I always sound like I just ran 10 laps. I am FUCKING 23. I am a healthy, ordinary weight. I already was born with asthma and I didn't know what was wrong for the longest time. I am so scared all the time. I want my life back. No one should have to experience this.
i have been struggling with this for nearly 8 years, I was 15 when I first had subglottic stenosis( because of 1-week mouth air ventilation), now stenosis is over but I had 3rd surgery for closing tracheotomy. I think if you are not HAVING tracheotomy after widening your windpipe(airway) it keeps coming back, there is a tube called T SHAPED made out of silicone(rubber), after tracheal tube you should have to have this t shaped tube, You should have to talk to your doctor about it. if you need any help regarding the tube get in touch with me !
I’m 21 and was born with subglottic stenosis but I had it fixed a year ago ( with a tracheal resectioning ) so now I can breathe just fine but my voice still hasn’t fully came back
@@nauadev it hasn't closed. Been four years. It's small but it still leaks like when I drink. I think they messed up putting my trach in.. of you find anything out could you let me know? Please and thank you. The last time I went to the rest nose throat doctor he shoved a scope down my throat with the largest scope he could find and pinned me to the chair. My husband watched and said it was a nightmare. They want my vocal cords removed and that really made them mad. I speak and breath so I'm at a lost what to do. If you have any ideas please tell me. Thank you. This hole in my throat makes it harder to breath. I must want it out. Let me know what you do and you may ask if they can cut out some scar tissue in it
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?
My voice is messed up due to my doctors. My voice was so raspy and I could barely talk after I got my trach out. After a while I started to be able to talk and then over the years I’ve started to be able to talk louder and more clearly. But to this day my voice is not as it should be. While they were working on my neck they messed my vocal cords up. I have a noticeable scar on my neck and a dent in my chest where they took a rib, but I think they took a few more ribs because it is a big indent. I’ve lived with this all my life and I feel they didn’t do as good of a good as they could have because everyone always said I was going to die and they thought I would too. I’m 16 and I have bad body dysmorphia as a result of all of this and I’ve tried taking to my doctor but he refuses to do anything until I’m 18. He said that the surgery is not major but he wants to be “safe.” I’m so sick of this bs lol
Yeah same that messed up my voice too and probably why I have tracheal stenosis where I could barely catch a breathe while coming up the stairs or even while talking, 😫it’s so annoying with my raspy horse voice, people always think I’m sick 💀 they wanna do a balloon dilation thing to widen my airways so I could breathe but it’s only temporary idk what to do and if it’s even worth it if it lasts 3-6 months, I’ve dealt with this my whole 20 years of life so idk I don’t know if it gets worse later on? Probably not 🤔
@@carrieobrien5624 same they thought I had asmtha too & gave me inhalers that I barely used & the doctor even threatened me with an oxygen tank lol even tho the problem was with my windpipe not my lungs, I’m surprised they thought it was asmtha since I got covid in November and that didn’t do anything with my breathing, sooo clearly it would of ruined my lungs even more if I did have asmtha
@@nicolebowland I was misdiagnosed too, I had this(tracheal sub-glottic stenosis) after 1 week of through-mouth ventilation, I don't know but you have to talk to professionals and have tracheal surgery, they will burn the airway with so called laser cutter(using HO2, I really cant remember) and widen it. after several months they will take out tube!
This is q1, q2: the lecture was mostly a promo for his company and the claim that the learnings can be used even if you want to apply for a job is not very accurate.
Hi Joe, Thank you for everything you do. Quick question. Do patient-specif class II devices require 510K clearance when they aren't sold in batches or lots? I am aware of hospitals and universities that make their own implantables such as bone replacement with PEEK (which is FDA approved). I know they don't have 510K clearances on these single products. Of course, hospitals and universities make these under specialized conditions and I am sure they know what they are doing, but I was wondering if anything that is considered a permanent implantable class II needs to be 510K cleared or only production devices? Thank you
For PEEK, the material is not FDA approved. The FDA doesn't approve materials. In fact, they also don't refer to the 510(k) as approval. Technical a 510(k) is pre-market notification, and a PMA is pre-market approval. PMAs are required for high-risk implants, and 510(k) submissions are required for moderate risk devices with similar "predicate" devices that are already on the market. In this case, you have described, a 510(k) is required for patient-matched implants. You generally do your validation using a worst-case example of the smallest or largest possible implant (e.g. 120% of someone my size - 2 meters tall and 135 kg). Hospitals that are making implants are typically doing this as part of research. The only big difference between the production of a patient-matched implant and batches of implants, is the lot size is 1 instead of many and the labeling includes a patient ID #. Both batches and patient-matched implants can have serial numbers, but only a patient-matched implant will have a patient ID # on the label. I have also seen a few companies make a spare implant for patient-matched implants, because if the original is dropped they need a spare
Hello Joe! For a 510k, must you do biocompatibility tests on the primary material used in your device; material that has already been approved by the FDA on other predicates? Is the ASTM certification of your material not enough? Take PEEK or UHMWPE as an example.
The FDA guidance for biocompatibility covers this topic in detail: www.fda.gov/media/85865/download. Material certifications are never enough by themselves, because you need to consider the impact of all the manufacturing processes on the finished device. The reason for this is that there may be residuals or contaminants from the manufacturing process that could negatively affect biocompatibility. For example, if you are currently making a molded part at one facility, you need to do additional biocompatibility testing if you change to a different molding facility. If you can show that there are no new residuals or contaminants from the new molding process, then you might be able to provide a biocompatibility risk assessment with limited testing data. Differences in raw materials are important, because plastics will include plasticizers and additives that may not be obvious but the same is true for metals that have different cleaning and passivation processes. Unless you have a raw material specification that a competitor used AND you know exactly what the manufacturing process was, your justification for not doing testing will not be adequate.
"Why do people that live in the Sout Pole age just as fast as people that live in the Equator?" What a stupid thing for Bill Andrews to say. Because when we talk about "environmental" causes of ageing, we are talking about things like cigarette smoking, diet, exposure to pollution, and not to temperature!! And BTW, Bill, people that live in the Equator do have higher incidence of skin cancer and which contributes to ageing.
120 calendar days, and lately that is increasing due to an increase in RTA Holds. The Covid-19 pandemic is certainly stretching the FDA's resources for reviewing 510(k) submissions.
I enjoyed this presentation even though it was from almost seven years ago. The information still holds true. I have two products that can be marketed through DME suppliers and I was inspired by Mr. Sperduti.
Thanks for your Question. I think the answers are different for a pure developer like us or a manufacturer. Manufacturers will need full Erp systems while we exist fine without. I can't really recommend anything.
