Nasal sprays cause complications including nasal mucosa irritation, dryness, temporary burning, and runny noses.
This is because nasal sprays have a chemical to shrink blood vessels. Thus, continuous use may render the vessels to be less responsive to medication.
Overuse can cause addiction and lead to serious long-term conditions such as chronic sinusitis.
According to the U.S. Department of Health & Human Services, in 2014, there were 29.4 million adults (12.3% of pop.) diagnosed with sinusitis in the U.S. Doctors typically are unable to control dosages, leading to decongestion and other chronic problems.
Are you aware of upcoming innovations in the space?
Any recommendations for a great CRO with ENT device experience who understand the unique challenges associated with a small surgical device company? Would prefer they have their own EDC system and also work in Germany.
Thanks in advance,
I seek a cleanroom facility (full body suit) that is sterile individually packed / triple-pack in sterile Pasteur pipettes (1-2 ml) and ship in a Cryovial. The drug is manufactured for a major multi-national firm. Who can you recommend, thank you?
A Chief Technology Officer writes about Spectre and Meltdown cyber threats on medical device and clinical assets. Have you been hit by this?
A group member seeks an FDA and GMP facility to fill high viscosity gel (500,000 CP) into ABL tubes. Suggestions?
Hi all. If my EC representative is presently based in the UK, do I have to change him? If so, by what date?
What is the BREXIT on non-EU manufacturers with UK-based representation?
Did you know Texas Medical Center in Houston is the largest medical center in the world?
And they spend millions annually with medical device startups and innovators?
Do you know how to qualify for some of it?
No? Well, read on, my good friend!
Meet Dr. Lance Black, our 10x keynote speaker
Meet or watch him, your choice.
As Medical Device Innovation Lead, Lance focuses on the resident companies of TMCx by supporting their efforts in developing innovative health care technologies.
His video begins, "So, because we don't take equity, we don't charge, we've had companies come through who are your typical accelerator companies all the way to companies who are 30, 50 strong, who've raised their Series A, Series B, who want to use Houston as either their US launching pad or a new sales channel, or just a new market they can evaluate.
When you have 10 million patient visits per year, [we're our] own market!
Which of five TMCx programs is right for you?
From Dr. Black: "We have five different programs, and you can think of these programs really just at from a stage of supporting start-up companies at different stages within their life cycle. So, we focus primarily on medical device and digital health. Our partners focus on therapeutics, and diagnostics, and we'll walk you through what each of these programs mean, and how they affect innovation."
If that's relevant for you, listen to Lance's presentation. He is very engaging!
Next up: Our May 2019 keynote speaker will be...
Former Proove Biosciences' CEO Brian Meskin, and I applaud him for his brave keynote topic: What the F**k Happened at Proove Biosciences?!
"Proove Biosciences, which sold dubious DNA tests to predict addiction risk, sells off assets as CEO departs amid criminal probe" read the August 31, 2017 headline in Stat News.
The article was filled with false allegations, says our keynote speaker, but the damage was done.
According to a website called The Truth About Proove Biosciences, disgruntled ex-employees created false allegations against Proove in 2015 and filed a whistle-blower lawsuit in 2015 (which was rejected by the government in 2016).
Brian explains, "The former employees STAT News to publish the misinformation, grouping Proove in a governmental inquiry involving giants Myriad Genetics, Genomic Health, Natera, and Invitae.
In June 2017, the FBI delivered a subpoena for documents, and by August 2017, Proove Biosciences was placed into court-ordered receivership."
As our May 14 keynote in San Diego (details), Brian will answer publicly the question he gets so often, "What the F**k happened at Proove Biosciences?"
He's committed to setting the record straight and helping others not fall victim to "post-truth," "fake news," and "misinformation." If you're a business executive, business owner, or entrepreneur, you'll value this riveting keynote presentation, followed immediately by our two-hour food and drink reception. (Two drink tickets included with your registration.)
Hey, what are you doing today?
This 2012 throwback photo with Beth, Lucas (center), and Zachary might give you a smile.
Not playing basketball?
Then, if you have time and you ever reference FDA's databases, have I got a 🎁 for you!
I'm sitting with Rachel Benway today (Tuesday, December 11 at 2 p.m. EDT) for a live demo of the Navigator platform from Reed Tech. It's the first time I've shared a live demo with you. I believe it's going to be very interesting and relevant for many of you.
Joining is as easy as clicking the button below. If you miss the live event, the button will *magically* take you to the replay and slides.
Hey, throw us a frickin' bone here!
If you know the answers to any of these questions, would you help your medical device neighbors?
- Cheryl is looking for a PLM system. She said she's already looked at Arena Solutions, Propel, Oracle Agile, and Upchain.
- General Surgeon Ikenna Brown asks, "What factors, if any, increase your likelihood of getting something reimbursed?" Ikenna, see Beth Brooks' workshop for a 2016 for a start.
- Whitney Lewis got a few answers about investigational use labels. Learn from the replies.
- Kevin reminds you to write Congress about the medical device tax. It's not dead yet.
- What do you think about genetic DNA manipulation? I think it's inevitable.
- Danny needs to know about regulatory requirements for selling first aid kits in the US.
Thank you for being part of our Medical Devices Group community!
If you're looking for work, check out the newly posted jobs here!
Make it a great week.
Medical Devices Group Leader
Are these going to help or hurt the medical device industry?
Are they adding fuel to the fire by rehashing known issues or helping advance patient safety through public awareness?
Do the MDR and the newly announced FDA 510(k) program changes address these concerns?
Is the public getting the full picture?
Would like to hear your thoughts on this - whether you are in the medical device industry or not!
This really makes me nervous. Can people be trusted to only use this for good? And we won’t know for years what the side effects of the surgery will be.
MDMA, the Medical Device Manufacturers Association, created this easy-to-join outreach to contact your member of Congress to include repeal of the medical device tax in ANY legislative packages enacted by Congress this year.
Editor's note: Hey, it's Joe. The above image resulted from simply entering my name, email, address, and phone. The form routed the email, without my having to look up anything.
I wish there were a way to adequately convey what's going on right now at Singularity University's annual event Exponential Medicine.
I know. It sounds like a commercial. Like I'm being paid to say this.
I'm not. Event founder and chairperson Daniel Kraft doesn't even know I'm writing this.
His sold-out event is "an intensive four-day experience that gathers world-class faculty, innovators and organizations from across the biomedical and technology spectrum to explore and leverage the convergence of fast moving technologies in the reinvention of health and medicine.
It was live-streamed and available for you right now.
Here's the four-day agenda. Look it over and decide which presentations you want to watch.
Each video is roughly 10 hours long. You'll have to be selective.
Thank you, Singularity University!
For the inspiration, the leadership, and so much more to improve the world's healthcare.
Your biggest fan
HORIBA Instruments: Regulatory Manager - Medical
Encision: Director/VP RA/QA
GeneCoda: Regulatory and Quality Consultant
Hiring managers, promote your jobs for only $49 at https://medgroup.biz/jobs (promo code NOVEMBER) and candidates, search medical device jobs and sign up for job alerts!
Discussions You May Have Missed
Emily Saba, Research and Development Intern at NCGrowth, asks for input on an "ER Vital Wristband"
Tom Bowen, President at Bowen Medical, asks if you need to "sacrifice accuracy of blood pressure cuffs to low cost disposables?"
Thank you for being part of our Medical Devices Group community.
Make it a great week.
Medical Devices Group Leader
P.S. Check out those Exponential Medicine videos when you have a chance.
YAY! I finally figured out how to conduct polls for you here on MedicalDevicesGroup.net!
To create your own poll for our community, ask your question here.
YAY! Let's do this thing!
Live event: October 25 at noon New York timeThe live event will be Thursday, October 25 at noon, New York time. As always, if you can't make the live event, no prob. We record it and give you the slides afterward. And when you click here to register, I send you to his 2015 presentation, since watched thousands of times. Coincidentally, Rob is in Amsterdam today, teaching this exact same content – for $600, I might add. So, seriously, come. It's a gift. Rob writes, "FDA made a lot of changes to the 510(k) process since our last webinar together, Joe. I can cover some imminent changes and assemble a completely updated presentation, with new tips and tricks I learned from doing dozens of pre-subs since then. See you on the 25th? +++
When it rains, it pours!Here's another freebie for you, courtesy of greenlight.guru, another name you probably recognize by now. FDA invited us(!) to an FDA live announcement on Thursday, October 18, starting at 11:45 a.m. New York time, for an hour. FDA will discuss new draft guidance, entitled "Computer Software Assurance for Manufacturing, Operations, and Quality System Software." +++
Hiring managers and recruiters, you can list your opportunities at https://medgroup.biz/jobs anytime this month for just $39 using code OCTOBER. Candidates, visit https://medgroup.biz/jobs to create a profile, upload your resume, search by keyword and location (city/state or ZIP), and sign up for job alerts (available at this time only in the US, Canada, UK, and Australia). Good luck! +++
Discussions You May Have MissedGot a question? This is a free resource for all members. Ask yours at medicaldevicesgroup.net/question/add. Clément Vallois, Project leader at Fresenius Kabi, has a question about "Finished good article codes" Saurabh Dubey, Regulatory Affairs & Quality System at Syngene International Limited, asks for "Help with 510(k), GTIN, and GUDID" Tom Bowen, President at Bowen Medical, wonders if you have to "Sacrifice accuracy of blood pressure cuffs to low cost disposables" +++
Thank you for being part of our Medical Devices Group community!Make it a great week. Joe Hage Medical Devices Group Leader P.S. If you can't afford the time to attend the entire 10x for ENGINEERS conference – no problem! Come only for Dr. Black's talk on Wednesday night. Stay for the reception! Register now.
“Let's forget about how many of you have invested in Bitcoin. How many have just heard of Bitcoin or blockchain?” began Jad Mubaslat, founder of Bitquick, and Industrial and Human Factors engineer.
“How many of you understand it?” he continued. (Not so many hands went up and – I won't lie – I had to watch his presentation more than once to "get it.")
“Blockchain is not going to completely revolutionize how you build medical devices, but it is going to revolutionize how that data flows in the background, and how effective your medical devices can be, and how they can take advantage of the data going around.”
Jad explained what a blockchain is, how it fits into healthcare, and answered the question, "Do you need one?"
If you have an interest in blockchain and how it may affect your business, give a listen.
I made the video and slides free for everyone – even had it transcribed for your download. 😊
This time next week I'm boarding a plane to San Diego to spend quality time with group members eager to make new connections and keep abreast of the latest thinking in medical device design, development, manufacturing, and commercialization.
I got a lot of positive reviews on the agenda.
We can accommodate another dozen or so folks – so please reply to this email if there's even a chance you might attend. (I have to finalize food and beverage numbers with the Hyatt by Friday.)
The event is geared equally for senior and junior levels. If you're senior, you'll return with ideas the team can use. If junior, you'll return with specifics lessons, materials, and action items to do your job better.
Our keynote speaker is Lance Black, Medical Device Innovation Lead at Texas Medical Center
He served in the U.S. Air Force, where he completed a residency in family medicine with additional training in aerospace medicine. He had the opportunity to deploy twice during his service, first as Chief of the Medical Staff at Manas Transit Base in Kyrgyzstan, and then as a Squadron Flight Surgeon in Okinawa, Japan.
During his time in Manas, Lance helped to create a mobile modular medical facility aimed to uplift the surrounding defunct healthcare system. In Japan, he responded to in-flight emergencies and orchestrated protocols ensuring the safety of F-22 pilots and their crew.
His work with wounded warrior amputees during his military career and his background in biological engineering prompted him to refocus his efforts from patient care to the design and development of medical devices.
Following the completion of his commitment to the military, Lance attended Georgia Tech’s Masters of Biomedical Innovation and Development program to include one year in their Masters of Industrial Design program.
Now as Medical Device Innovation Lead, Lance focuses on the resident companies of TMCx by supporting their efforts in developing innovative health care technologies.
His Keynote Topic:
How the world’s largest medical center invests in medical device innovation (and how you can benefit!)
Did you know Texas Medical Center is the world’s largest? And did you know they spend millions annually on medical device innovation with players ranging from industry titans to the smallest start-ups?
Then come listen to Dr. Black and learn how TMC – potentially one of your biggest customers – looks at innovation and how it fosters it among companies like yours!
P.P.S. Special thanks to RTI - The Industrial Internet of Things Connectivity Company. Their 10x sponsorship made it possible for us to make some seating available for students and those in transition. Thank you!
See something you like? Click away!
Hiring managers and recruiters, let's get these nice people some jobs!
List your opportunities at https://medgroup.biz/jobs anytime this month for just $39 using code OCTOBER.
Candidates, make yourselves at home. You can:
- Create a profile;
- Upload your resume;
- Run searches by keyword and location (city/state or ZIP); and,
- Sign up for job alerts (available at this time only in the US, Canada, UK, and Australia).
Discussions You May Have Missed
Got a question? This is a free resource for all members. Ask yours at medicaldevicesgroup.net/question/add.
Valeria Fast Wouterlood, Training and Development Manager at Venn Life Sciences, asks for "A question about annual safety reporting medical devices (pre-marketing)."
Kasper Friis, Head of UX & Design at Technolution A/S, asks, "How do you make sure that people will love your product?"
Thank you for being part of our Medical Devices Group community!
Make it a great week.
Medical Devices Group Leader
P.S. If you can't afford the time to attend the entire 10x for ENGINEERS conference – no problem! Come only for Dr. Black's talk on Wednesday night. Stay for the reception! Register now.
IS BLOOD PRESSURE READING JUST A NUMBER?
One of the most critical factors in patient assessment is the blood pressure reading. If the accuracy of the blood pressure reading is compromised then the ability for accurate assessment of the patient is also compromised.
For many years we were exposed to cross contamination due to microbe laden blood pressure cuffs. The medical industry has solved this dilemma through the use of cheap disposable blood pressure cuffs. New research questioning the accuracy of these cuffs is now available.
A major teaching hospital was concerned about the cross-contamination of their manufacturer-validated cuffs. They substituted a washable cuff. In their hypertensive unit they documented that 33% of their patients with poorly controlled hypertension were wrongly diagnosed as normotensive due to lack of accuracy of the washable cuffs. One third of the entire patients in this hypertensive unit would not be given the proper medication to control their hypertension had they not discovered the compromise in accuracy.1
The most comprehensive research to date on accuracy of various types of cuffs compared eight different types of cuffs made of coated woven and non-woven fabrics. There were variations of up to 27mmHg for systolic readings and 17mmHg for diastolic reading.2
Using the American Heart standards for blood pressure- a person with an accurate blood pressure reading of 113 systolic that had an erroneous 27mmHg systolic cuff could be diagnosed as Stage 2 hypertensive at 140.
This lack of accuracy should alarm every health care worker. The blood pressure measurement should be focused on accuracy, not the lowest cost of a cuff.
There is remedy for the compromise of accuracy by using a reliable well-made reusable cuff such as the W.A.Baum company makes and a low cost cover to protect the cuff, like Bowen Medical Cuff-Guard to prevent cross -contamination. Cleaning of the reusable cuffs between each patient is also an option-if it is thorough and documented.
The most basic of healthcare are the accurate evaluations of vital signs. The blood pressure reading should always be the most accurate we can strive to obtain.
“Since hypertension is a major world-wide problem affecting millions of people, its accurate estimation is imperative and needs further attention. The methods of measurement, equipment and the size of the cuffs have already been standardized but the cuff fabric construction and the material of the cuffs which are the cornerstone of accurate BP measurement have been neglected.”2.
1. Unsafe health and safety: sphygmomanometer cuffs are not interchangeable. By Shaw KC, McEniery CM, Wilkinson and Brown. Published in Journal of Hypertension 2013 July,27(7):434-36 2. Variation in BP values for different cuff types by Naqvi, Potluri, Mandal and Lewis published in Journal of Industrial Textiles 2018, Vol.47(7) 1478-1495.
- The rise of wearables and EHRs make precision medicine concepts possible.
- If medical device manufacturers are going to be successful with precision medicine, they’ll need to figure out how to navigate outcome-based compensation models for these therapies.
- Pharmaceutical companies work alongside medical device manufacturers for precision medicine. Pharma creates the targeted therapeutic; manufacturers design the diagnostics. There are 40,000+ different in vitro diagnostics (IVDs). The 2022 IVD market projection is $81.3 billion (a CAGR of 4.9%).
- 93% of drugs currently in phase III clinical trials are diagnostic-dependent.
- Multiple studies have shown that most traditional therapies in the US today are effective in fewer than 60 percent of treated patients, costing the healthcare system billions of unnecessary dollars.
- According to a National Academy of Medicine report, a precision-medicine innovation – one that more accurately identifies people who are at risk for a disease and is coupled to an intervention that reduces incidence even by as little as 10% – could generate hundreds of billions of dollars in value in the form of longer, healthier lives enjoyed by the US population.
FDA webinar in two days.Click here for the FDA content, courtesy of Jon Speer and Greenlight Guru. They will cover: • 'Critical To Quality' pilot program; • 'Manufacturing and Product Quality' pilot program; and, • Issues and concerns FDA is hearing from constituents. And you'll get access to the first FDA in the series where they covered what CfQ is and how FDA is engaging; summary detail on CDRH pilot programs; and, how FDA is rethinking regulations.
Members with questionsIf you've got the answers, please share with our community. Tautvydas Kazlauskas has a question on how to classify a fibrin-glue like medical device. Antonia Trevisan asks, "Are custom-made devices exempt from CE marking?" And I could really use help on Irina's question. So far no one has answered, "How to estimate safety BSE requirements?"
A whole new worldAs you can see, with our new home here in WordPress, I can add images and video each week. But even better, I have enough room to express myself and to highlight questions and contributions from group members like you! So here's your chance to ask a question and get a crowd-sourced answer from our members. Just go to https://medicaldevicesgroup.net/question/add/ to ask it. The page will look like this and there's even a way for you to get notified with each comment (just like the very old days):: I look forward to your participation!
Thank you for being part of our Medical Devices Group community.Make it a great week. Joe Hage Medical Devices Group Leader P.S. Meet me at ConX (Sep 17, South Carolina), the MedTech Regulatory Awards at RAPS (Oct 2, Vancouver, BC), and our group's 10x for Engineers (Oct 10-12, San Diego) – especially that last one! 😊
I'm curious to hear what other industry professionals feel about the Netflix documentary "The Bleeding Edge" that recently debuted offering a scathing exposé of our industry. My thoughts: For sure there are companies that have not always held patients' best interests, as illustrated by the alarming number of adverse events reported with the Essure device in the film. That said, we rely on FDA to initiate investigations and recalls as a result of such reporting, and regulatory agencies SHOULD employ what is necessary to keep patients safe. Lastly, the argument that clinical trials are too short is unrealistic. For implants, post-market surveillance is key, and it appears FDA needs to do a better job.
First, where are other Healthcare Technology industry related discussions occurring in your life? I know some professional organizations may have forums on their websites, or during conferences, but I am asking to make sure I am aware of all resources.
Second, do you have any recommendations for transitioning into this industry? (medical device OEMs, contract medical device engineering firms, medical device consulting firms, etc.)
I have a Biomedical Engineering degree and an MBA, with much of my experience in clinical engineering within hospitals. While I have enjoyed my hospital time and may continue in that direction, I am exploring transitioning from the clinical setting towards industry to expand my experiences. There are many areas that peak my interest such as R&D, Quality, Manufacturing, Testing, Consulting, Auditing, Regulatory, etc., and I may be looking for a technical / hands-on role as an individual contributor. I’m pretty flexible on U.S. locations, and whether the roles are temporary or permanent, etc. (I have thought of performing or managing service for an OEM as a way to get my foot in the door, but I haven’t pursued that yet because it seems pretty close to what I’ve been involved in already.)
Difficulty seems to be convincing people my transferable skills allow me to take on new types of roles, kind of a chicken and egg scenario. I understand it is easiest in hiring to match jobs with candidates who perfectly match the stated position requirements. Have you ever had success in pivoting to new types of roles in this industry? If you have hired employees in this industry, have you been able to effectively source candidates with highly transferrable skills?
Thank you in advance for your insight!
I can’t disclose fully yet, but this is a registered Class I med device, designed for disposable one-use treatment in the outer ear. Let’s assume IP, packaging, production (overseas), inventory are all complete and take a price of ~$10. It can be covered by reimbursement and is going to first be targeted to MDs (ENT, FP, GP, audiologists) and then later direct to ‘patients’ for home use via retail (mass market, pharmacy). So, pre-launch work is done, so how would we develop the channels and marketing of this product?
Thanks for your advice and comments. Shall we begin?!
Does anyone know what is the meaning of "no additional cost" in COMMISSION REGULATION (EU) No 207/2012?
Is it including phone bill which make manufacturer should have free-toll number in each country?
can someone share how you deal with electronic IFU?
Medical devices can be purely hardware based (eg stethoscopes), be composed of hardware and software (eg patient monitor) or purely software (eg mobile medical apps).
In both the US and the EU, standalone software, such as a mobile app, can be a medical device in its own right if it has a medical purpose. This software may operate on a general purpose platform such as a smartphone and typically falls under the jurisdiction of a medical device regulatory authority. Such software is generally called Software as a Medical Device or SaMD.
1. What is Software as a Medical Device (SaMD)?
Software as a medical device (SaMD) is software that’s intended to be used for a medical purpose and that performs this function without being part of a hardware medical device, i.e. it runs on general purpose (non-medical purpose) computing platforms. For example, mobile apps that meet this definition are considered SaMD.
2. How do you determine if your software is a medical device?
This can vary depending on the country of sale, but in most jurisdictions (US, EU), the software is a medical device if the manufacturer (the person who legally markets the product) intends it to be used for a medically related purpose.
In other words, your software is a medical device when its intended use falls under the definition of a medical device.
The intended use is reflected in the specifications, instructions and information provided by the device (software) manufacturer.
With the changing face of education in many sectors to online education courses I wonder how many people or companies are changing or are thinking of changing to this form of education.
In 2015 online education was a 105 billion dollar market which is predicted to grow to 244 billion dollars by 2022.
What are the advantages of online education?
- You determine when and where to study the courses. No travelling to training centres or paying for trainers to come to you.
- Immediate results and feedback throughout the course.
- In many cases, this results in a more effective learning experience.
- Courses usually come a lot cheaper than standard classroom delivered courses.
- Courses can be tailored to specific industry needs.
But are the courses which you require available?
Yes, there are many providers of this type of education, certainly for regulatory affairs and ISO standards. However, when it comes to education for those medical device manufacturers using ERP systems I do not see ERP courses readily available. They are provided by either external or internal generic courses in most cases.
This where I would like to ask for your help.
I would like to see what the demand for this type of course would be in the medical industry for manufacturers using Oracle eBusiness Suite (EBS) R12, in particular, but not limited to, quality results data collection using the Quality module.
Could I please ask you to answer three simple questions, yes or no. Obviously any other comments you may care to offer would be welcome.
1. Does your company use Oracle EBS R12?
2. If yes, do they use the Quality module or would they consider using it?
3. If an online education for "Quality Data Collection using Oracle EBS R12 Specifcally for the Medical Devices Industry" was available, would you be interested in taking the course?
Thanks in advance for your assistance in this short survey.
Can Cannabis Cure Epilepsy in Children? 5 Year Old Child Seizure Free Du...
http://smokersguide.com - Uncle Stoner talks to Peter Starostecki, father of Stefan Starostecki; a 5 yeaar old medical marijuana patient who uses cannabis to control his seizures. Subscribe for more videos like this - http://tv.smokersguide.com...
For this second case, the medical device, if classified on its own, would be a Class I, 510(k) exempt product. I understand that kitting it or making it combination product would throw it into a different regulatory category. However, the client is wondering if there is a way to “submit” the medical device separately (ahead of the combination submission) to receive FDA clearance for the medical device as a standalone product, and then just reference the clearance (510(k) number) in the drug application. Specifically, the client would like FDA to view documentation and data about the device ahead of the drug submission because they do not want the same thing to happen as before where questions about the device cause issues. The challenge in this case is the device being a 510(k) exempt product code as a standalone device.
Because this device would be 510(k) exempt, I have the following questions.
1. Would FDA accept a 510(k) submission for a product code that doesn’t require a 510(k), or would they just reject it because it goes beyond what is required?
2. I’ve been told that if you submit a Device Master File to FDA, they will not review it until it is reference in a submission. Is this true? This could be another path; but if FDA would not review it head of the drug submission, it does not meet the client’s desires.
3. Are there any other regulatory options that you are aware of for this case?
What are your views on the topic of e cigarettes will they be classed as a medical device?
I keen to hear thoughts.
I hope sales of these drugs was already going down before these new rules.
The US government is finally telling people that homeopathy is a sham
Companies that make homeopathic products will be required to spell out that their products are not based on science.
Least favorite was the 360 wheeled car (not actually an invention because they have not reduced it to practice, and was probably in Popular Mechanics 50 years ago).
Haven't these guys heard of CRISPR?
The 25 Best Inventions of 2016
Every year, TIME selects the best inventions that are making the world better, smarter and-in some cases-a little more fun. In the past, we've featured everything from the real-life hoverboard to the desktop DNA lab. Here's which ones made this year's...
Periodontal inflammation (Periodontitis or gum disease) and chronic diseases such as diabetes and cardiovascular disease are thought to have a strong connection. (Ref: American Academy of Periodontology www.Perio.org).
So diagnosis via an oral swab test at the dentist could help to alert the patient and their doctor to preventative possibilities early enough to slow or stop serious systemic disease progression.
Do you think that we (consumers of healthcare ) are ready for genetic testing and all that comes with it? Am I alone in wondering why the dentist and the Medical Doctor do not work more in an interdisciplinary manner to improve preventative care?
In the US, the medical device industry heavily relies on a sales force covering territory to introduce a new device. Is the same true for developing nations?
Is the cost of the sales and distribution in developing nations prohibitively expensive even for devices with known demand? Excluding development costs, do major device OEMs have a business motivation to produce these products if the lower COGS targets could be achieved?
I would love to hear from anyone with experience around sales/distribution in developing nations!
Is there a standard that answers to this (does 10993 say? - I don't think so.).
Grateful for a pointer where to study.
/Sven Milton; Sweden
I conduct a two day workshop on acceptance sampling, which I update regularly. As I work on the update I would like to know the issues that device manufacturers face with attribute sampling and what topics and methods you would expect to see covered in a comprehensive workshop.
- What did the CRO(s) seem to do well/not so well?
- What kinds of studies did the CRO manage? Feasibility, safety, pivotal, usability?
- What was your take-away in terms of how to select a CRO and/or work productively with a CRO?
- Has anyone seen any advantages/disadvantages in working with a CRO that evolved out of pharma trials versus a device-trials-only CRO? A CRO specializing in a particular therapeutic area? A small versus large CRO?
Wound Dressing Manufacturers – FDA will be reclassifying your devices. Speak now before October 20, 2016 or forever hold your peace (at least until the proposed rule making)
If your company manufacturers wound dressings containing drugs under the FRO unclassified, product code, do not miss this opportunity to participate in conversations with the FDA that will affect y…
Quite a while ago, right after the suspension, I stated that things early on really didn't look too good, and that the Industry "Leaders" needed to focus on producing new products right away to gain and retain employees. In other words, don't squander the gift you were handed! Well, things are looking worse, I'm afraid. Throughout the year, we have all seen the notifications of layoffs on QMed and FierceMedical Devices, among other sites. Here is a recent one: http://www.qmed.com/news/alphatec-laying-dozens-workers?cid=nl.x.qmed02.edt.aud.qmed.20161011
In addition, we've seen a number of significant plant closures. And, where are all the new, exciting medical devices to treat unmet medical needs?
As I've said before, and I'll say it again, those in Congress, in that pesky Congressional Budget Office, are keeping score. You can be very certain that, very shortly, it will be firmly decided by those in Washington that layoffs are completely unrelated to the tax. When the suspension lapses, new wolf cries will absolutely fall on deaf ears. It's time you "Leaders" step up, because, right now, you're failing us all.