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!
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
- 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?
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.
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.
Second Wave – Extended Clinical Trial Exemption List published by China FDA
On 30th September 2016, China FDA published its updated “Exemption list of Class II & Class III devices for local clinical study”. Following release of the the draft exemption list for manufacturer’s comments in May 2016, CFDA published the...
With the industry poised for a tidal wave of software devices to emerge in the coming years, I'm seeing a lot of software device start-ups with the same type of management team and investors...heavy on software, little to no medical device expertise.
I would be interested to hear your thoughts on whether or not a company developing a software device (either primarily driven by or standalone) is likely to fair without medical device experience on its management team. When we look back 10-20 years from now, is this going to be a major candidate of for "most likely cause of a Theranos II" Or are there other causes that you think are more likely to prove out?
Attacking the stodgy standard of care is oftentimes the loftiest of goals. One recognizes that the status quo is truly not in the best interest of the patient. Well, "it" was fine, say ten or twenty years ago. Patients are dying because physicians have resigned themselves to a certain percentage lost simply because that's the way it is. I'm sorry, this just isn't right. There must be a better way. Unfortunately, the medical device developer has practice comfort or educational drift, it-was-always-done-this-way or that's-the-way-I-learned-it, to contend with. That physician acceptance of the new, at the early, critical stages of a device's life cycle, is oftentimes much tougher to deal with than any little U.S. FDA.
Finding something to treat a completely unmet medical need is becoming trickier and trickier since medical devices have already done so very well, become ubiquitous throughout the body. Trying to break into medical devices with 510k's is increasingly harsh as one must try to scrape slivers of market share from entrenched big names at hyper-tight commodity prices. This leaves the most room for real meaningful success in the most difficult middle. So, I wish all of you the best of luck towards focusing on the patient, to fight the best fight for truly better care and treatment.
I am looking for HIPAA safe harbor requirements guidance . How can we implement process for compliance in an organization? What are the compliance requirements? What documentation needed for audit?
GE Plans to Invest $1.4B to Acquire Additive Manufacturing Companies Arcam and SLM; Accelerates Efforts in Important Digital Industrial Space
BOSTON, MA (USA) – September 6, 2016 – GE (NYSE: GE), the world’s leading digital industrial company, today announced plans to acquire two suppliers of additive manufacturing equipment, Arcam AB and SLM Solutions Group AG for $1.4 billion. Both...