There are many resources available on QSR, design controls and standards, etc; but there is a gap in understanding how these protocols should be designed to follow these regulations.
Let’s say I am designing a PCB and have to write a protocol to test it. I would include measuring voltages and current at different stages.
But there is much more to consider, even before I plug in the device (like shorts and loose solder connections). Many companies have a team to take care of this, but in a start-up that may not be practical.
My question: What's a good approach when just starting out in protocol design?
I just came across a legal manufacturer in EU with CE Certificate granted to their devices but without having ISO13485 certificate.
I ran through MDD 93/42/EEC and it seems there is no stated requirement that a legal manufacturer needs to obtain certification for their QMS. That is, as long as their QMS is in accordance to recognized harmonised standards, and subject to an NB assessment/audit.
Do you arrive at the same conclusion, that they'd be able to get CE certified in this situation?
Hello, is there a need to submit an annual safety reporting in medical devices, informing the progress of the investigation, in the pre-marketing phase?
If so, what´s it´s name? To whom should be submitted?
Polyolefins have been shown to be safe alternatives to PVC's widely reported risks.
However Polyolefin films make up only a small percentage of liquid tight medical bags in the US with shapes and fitments.
Is it because of the sizable investments already made, or not knowing how to make with Polyolefins in scale?
Group member Amy Baxter, MD, is furious.
"I just got back from #PAINWeek where supposedly doctors are learning about what works for their patients to manage pain. We brought our new DuoTherm low back pain thermal/vibration prototypes – almost all the doctors cared about was drugs!
Let me tell you a little about Dr. Baxter.
Amy Baxter MD is an inventor, innovator, and pediatric emergency physician. She made Buzzy, which, to date, has blocked pain from 31 million needle procedures.
And she's serious about drug-free pain relief. After Buzzy, she made VibraCool.
Then, in response to the repeated question, "When are you making one for the back?" she and her colleagues at PainCareLabs developed DuoTherm, now in the concept/prototyping stage and featured in an Indiegogo campaign through November 2018.
Why won't you believe me?
The history of devices is paved with skepticism. For your entertainment, a 1930 video entitled, "Fat Men Use Mueller Exerciser Belt." And, well, Theranos.
So you probably won't be shocked to learn, of the $60 billion spent on U.S. pain management each year, only two of it is on devices.
Devices are at such a disadvantage versus medication that – get this – the family behind OxyCotin is now looking to market a milder opioids to help wean addicts off, well, opioids.
Yet primary pain physicians aren't won over yet. "Only two of 126 #PAINWeek presentations were about consumer devices," Amy reported.
Turning the tide
"The first difficulty in turning the tide from pharma to device is, of course, reimbursement. Any prescription medication is fast tracked for coverage.
On the other hand, devices that work may not get paid for. Just last week, FDA announced a plan to give manufacturers clear guidance on what studies need to be done for payor reimbursement. This is extremely helpful, but underlies the huge hurdle of high quality studies."
"In general," Amy continued, "device research (especially for consumer devices) isn’t as rigorous as in pharma.
• Pharma has more cash to get top researchers;
• Evaluating drug studies is familiar to most physicians; and,
• Even "real-world" case studies can undermine the device industry."
Just one example, a device company study compared 800 compliant patients to 100 who self-selected out. They concluded those who stuck with the program, did better, evidence "the device works." Uh huh. 🙄
Audaciously, the QR code accompanying their "scientific poster" took you to a "Buy a Device" page. 😠
Fighting the good fight
Check out the IndieGogo campaign and, if you (or someone you love) is a back-pain sufferer, maybe get a unit at half price.
Thanks for reading and tell me what you think of this article, her concept, and the imbalance between device and pharma solutions in today's comments.
Jobs, Jobs, Medical Device Jobs!
Thank you for your warm response to the new Medical Devices Group Job Board last week.
Candidates can upload their resume and fill out a profile with links to sites of your choosing. And due to popular demand, medical device hiring managers can post a job for free through Thursday, September 13. Use code BETATEST at checkout.
I think it's gonna be big.
Also, we added a slick "Sharing" icon for each discussion. Use it to easily share items of interest over LinkedIn, Twitter, or email. I'm thrilled with the functionality.
Thank you for being part of our Medical Devices Group community.Make it a great week. Joe Hage Medical Devices Group Leader P.S. Four weeks to go, and the group rate at the beautiful Hyatt Regency Mission Bay Spa and Marina expires next week. So if you're flying in to San Diego for our 10x for ENGINEERS event, act today!
I'm based in India and would like to understand the overall regulatory workflow for medical device product development. What are the documents I need to create for entry into the US market?
I've started on our 510(k). Do I need to have GTIN and GUDID as well? How do I go about it?
Your assistance appreciated!
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.
Designing delightful and robust user experiences is not an art. It is science. And it is business.
These are the questions you should ask yourself - and the tools to get you started: http://bit.ly/product-love
Do you ask yourself these questions? If not, why? (I am genuinely interested in your perspective, so please comment)
All the best, Kasper
I've said for years, "The Medical Devices Group is the world's largest medical device community and the industry's only spam-free, curated forum for intelligent conversations with medical device thought leaders."
It was nice. But we've outgrown it.
We have an even bigger vision now.
and specifically MedicalDevicesGroup.net,
will be the most useful
medical device website in the world.
What do you think of our big, hairy, audacious goal?
I think we can do it. And it starts today!
Introducing the Medical Devices Group Job Board
I could tell you all about it. Or you could check it out now!
As of today, the job board lets:
- Candidates can post a resume.
- Candidates can create a profile.
- Candidates can search by keyword and location.
- Candidates can get job alerts.
- Employers can post jobs. (Today it's FREE! Ask me how.)
- Employers can highlight "urgent need" jobs and raise visibility with a "featured" job.
- Employers can sponsor a "featured employer" spot on the job portal.
I'm figuring it out as I go – today's job board is the minimally viable product – but I was too excited to wait another week to show you.
Please, try it out, and slam my inbox with feedback - good and bad (I can take it). I want to build the single most robust career platform available anywhere for the medical devices industry.
The Most Useful Medical Device Website:
What does that mean?
I know this is ambitious – it wouldn't be fun if it weren't. I'm setting a five-year horizon to build "every useful tool you can think of" to further your career and company success.
We have a strong head start, with:
• Years of completely searchable, archived questions and answers on the Community tab.
• 40+ archived webinars with replays, slides, and transcripts, all ready for your immediate download.
• The most comprehensive medical device events calendar available anywhere (also minimally viable, improvements underway).
• Legacy resources (we will build heavily here) and a blog (soon to be open for your contributions).
And with today's job board launch, we have the foundational elements in place.
SO WHAT ELSE?
My late mother-in-law would prompt me, “So what else?” right after I told her about something great that just happened.
So what else?
These are in the concept stage:
- Member reviews for events, books, content, etc.
- E-learning courses (for credit)
- Access to the Medical Devices Group Advisory Board
- Supplier directory
- Resources for distribution and inmport/export
- Research and tools you tell me you need
- Survey tools
And some nice-to-haves: Communication preferences (opt out of "this" but not "that"), a calendar of upcoming online events (webinars, etc.), nested comments, and more.
So what else? Well, that's up to you! What's on your wish list?
What do you wish "someone would just make because it would make your life so much easier?"
I may be that someone! Let's talk about it.
You can start by hitting the contact page today.
Big Things Ahead
I've never been more bullish on what our community can do together. Won't you tell your friends and colleagues about this site and our new job board?
I hope you will – and thank you in advance.
We're going to make something great together.
Thank you all so much!
Make it a great week.
Medical Devices Group Leader
P.S. Please come to 10x for ENGINEERS in San Diego if the agenda is remotely interesting for you. I want to meet (and serve) as many of you as I can. https://medgroup.biz/10x
We are an Italian medical device company promoting its products in the USA. Our products are related to post-op drain, chest tubes, and chest catheters. We seek an up-to-date information about prices, competitors' market share, SKUs and so on.
Which research companies provide that information? Recommendations welcomed.
PS: We seek local distributors too.
Group member Alma Denisse Martinez submitted a discussion that warrants a larger audience. She posted an article, "Mexico's new President-Elect Lopez Obrador and the future of NAFTA and Mexican Manufacturing."
Some excerpts (paraphrased for brevity):
- Leftist Andres Manuel Lopez Obrador (AMLO) won in a massive landslide... [in a] mandate to change the country. What does this mean for manufacturing in Mexico and the future of NAFTA?
- Rivals' propaganda and memes said AMLO would be disastrous for Mexican business.
- In his post-victory, AMLO said he'd sign NAFTA, affirmed practical economic policies, and the independence of the Bank of Mexico. (As former mayor, he had been a stauch NAFTA critic and has since adjusted his views, championing better wages and working conditions within existing trade agreements.)
- The US will resume NAFTA negotiations after the November elections, giving AMLO some time.
- Commentators suggest AMLO wants to put money into infrastructure, to be fiscally responsible, to gain investor confidence. They saw possible public-private investments, particularly in energy and power.
The unabridged article at https://medgroup.biz/AMLO.
For the group:
- Do you have experience manufacturing in Mexico?
- Do you believe NAFTA and/or the election will impact conditions materially?
- If you produce outside your country, was Mexico ever in your consideration set and rejected for some reason?
Agnitio’s take on an interesting BCG study at https://medgroup.biz/medtech-commercial-model. “Clinician-focused models generate revenues per sales rep 35% to 50% of those generated by companies targeting administrative decision makers.”
The demise of our LinkedIn group
The inside scuttlebutt among owners of big LinkedIn groups like mine say today (Tuesday, August 28, 2018) is the day LinkedIn starts the conversion to new groups.
This is the content of my last announcement to the group: "I SEE DEAD GROUPS."
And yes, I am quite pleased with my little meme here.
Thank you for being part of our Medical Devices Group community.Make it a great week. Joe Hage Medical Devices Group Leader
P.S. So you know how I say my 10x events are fun?
This is one of the between-session clips I played. Still makes me laugh.
I am doing a market study for a high performance coating and I seek your expert advice.
The technology allows the deposition of a very thin coating (between 200nm and 1,5 micron) on glass, stainless or ceramic. It brings anti-sticking, anti-corrosion, and hydrophobic properties to the surface. It can be deposited on and inside complex parts.
How often this type of problems are found in medical devices? Are they critical?
If they are, how are they generally solved?
I'm really interested by your feedback and advice on this topic. Many thanks in advance for your help.
Tanguy Van Regemorter
I am interested to learn about the fabric/textile products people are using in their medical related work. I am particularly interested to learn what problems could be helped with new or improved fabric/textile products. Thanks!
I am working with Live Life Personal Mobile Alarms in Canada to set up sales agents. Live life is a unique cell phone-based fall prevention alarm designed for seniors. Outstanding and innovative product with no monthly monitoring fees, extensive out of home coverage and a real benefit for seniors and their families. check it our and email me if you are interested. https://www.livelifealarms.ca
How gone are we?We're so gone that I changed the name of the LinkedIn group, From: Medical Devices Group To: MedicalDevicesGroup.net (we moved!)
Our progress so farI'm delighted with our first month of progress. We already have:
Full question-and-answer functionality along with the ability to be notified(!) when someone leaves a comment;
793 archived questions and 18,302 answers;
40 accessible webinars (replays, slides, transcripts);
Weekly announcements (opt-in required at https://medgroup.biz/stay); and,
NEW TODAY! A full calendar of 89 upcoming medical device events!
Coming attractionsVery soon, you'll also be able to:
Access our jobs board;
Search the entire database for questions and answers;
Share posts on LinkedIn, Twitter, and email;
Ask questions directly to our Medical Devices Group Advisors;
Consult a "promotions" tab for member offers;
Conduct a poll; and,
This is where you come inI grew up in Bay Ridge, Brooklyn, New York, where my 1978-1989 mayor Ed Koch asked his tagline, "How'm I doin'? If you have the time and inclination, tell me how I'm doin' with this group transition. I'm hosting an online "town hall" next week, Wednesday, August 29, where I can hear your real-time feedback and requests so we can build our new home into something really great. Here's the link to join us: Join the Town Hall.
Special Two-Day Offer: $250 offIn a cheeky farewell to the LinkedIn group, I'm running a 48-hour special on admission to 10x for ENGINEERS this October. Use promo code ByeLinkedIn to save $250 before Friday. It's the only time I'll have a promotion with this deep a discount. Take advantage of it today.
Thank you for being part of our Medical Devices Group community.Make it a great week. Joe Hage Medical Devices Group Leader P.S. Tick tock goes the clock! Just 48 hours to save $250 on your 10x for ENGINEERS admission.
- 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! 😊
How would you classify fibrin-glue like medical device? The intended purpose of the device is management of bleeding in traumas or surgical procedures (i.e endoscopy) IIb or III and why?
I have a question on MDR implementation: Is it confirmed that custom-made devices are exempt from CE marking?
According to MDR art.20 par.1, and art.52 par.8, I believe that custom-made devices are exempt from CE marking.
Are there any conflicting interpretations or guidelines?
Kessler's RegretI was going to discuss the much-discussed Netflix documentary, "The Bleeding Edge" today. (Here is a direct link to the documentary for Netflix subscribers.) But the group could not wait until Tuesday! Three submitted discussions this week about it. I finally published Amy DeWinter's commentary and it racked up two dozen comments in no time. There is so much to unpack in "The Bleeding Edge." I'll likely return to it in the future. But they covered something so interesting about our 510(k) path to FDA clearance in the first 20 minutes, I couldn't get past it.
Direct excerpts from "The Bleeding Edge"These are intended for context for our discussion. Dr. Michael Carome, Director, Public Citizen Health Research Group [Carome]: Most people probably believe, when they get a medical device implanted, be it a pacemaker or a joint, that those medical devices have undergone appropriate testing to demonstrate that they are safe and effective before they came on the market and doctors started using them. But for most moderate and high-risk devices, that is not the case. William K. Hubbard, Former FDA Associate Commissioner: Originally, Congress intended that almost all new devices go through pre-market approval (PMA). A PMA is similar to a new drug application, in that a manufacturer must test it first in humans, compile all this data, and then present that to FDA scientists, who will approve the device if in fact it is safe and effective. Industry argues, "We're innovating, we're changing products every year and that costs a lot of money, to test each of those iterations in humans.” So Congress established the 510(K) process. Carome: For the 510(k) pathway, all the manufacturer needs to demonstrate is that their device is substantially equivalent, is the regulatory term, to another device that's already on the market. Dr. David Kessler, FDA Commissioner, 1990-1997: Dr. Adriane Fugh-Berman, Professor of Pharmacology & Physiology, Georgetown University: This really can cause problems when one medical device is approved on the basis of being substantially equivalent to a previous medical device that was approved because it was substantially equivalent to an earlier medical device than that. Dr. Deborah Cohen, Associate Editor, British Medical Journal: You end up with what we call a daisy chain. And then, quite often what you found is that some of these predicate devices, as they call them... have been recalled from the market because they've been failing. Jeanne Lenzer, Author, The Danger Within Us: I called the FDA and asked them, "How can you clear something based on a predicate device that's already been shown to be dangerous? And they said, "We don't judge what the prior device is." Dr. Rita Redberg, Editor, JAMA Internal Medicine: So even if the device was recalled because it was dangerous, you can still use it as a predicate and get your device cleared 'cause it's substantially equivalent. So there's a lot of problems with that 510(k) system.
Your TurnSo there we are, folks. The current state of the 510(k) pathway. Does it make you feel safe... especially that part about basing your device on a failed predicate?! Yikes! "The Bleeding Edge" documents a number of devices gone terribly, terribly wrong. What say you? Is 510(k) a pathway to close? Markedly reform? Leave alone? I can't wait to read your robust comments – which(!) – you can receive as alerts(!!) – when subsequent members leave their comments.
Access to the first two of four FDA’s Case for Quality webinars.Part 1 covered: • What CfQ is and how FDA is engaging; • Summary detail on CDRH pilot programs; and, • How FDA is rethinking regulations. Part 2 will cover the: • 'Critical To Quality' pilot program; • 'Manufacturing and Product Quality' pilot program; and, • Issues and concerns FDA is hearing from constituents. Guys, it doesn't get much better than this. Cisco Vicenty works at FDA right now as the FDA Case for Quality program manager. And you can ask direct questions during the live event, August 16 at 11:45 New York time. Come if you do QA, RA, Clinical Affairs, R&D, or any kind of medical device engineering. Click here for the FDA content, courtesy of Jon Speer and Greenlight Guru.
Want to meet in person?As leader of our Medical Devices Group, I host a few events annually to meet and help members in person. Here are my upcoming events:
- September 17-18, 2018 for ConX, the 31st operational excellence event hosted by the Institute for Process Excellence, in South Carolina (as keynote speaker).
- October 2, 2018 at RAPS; I'll participate in the MedTech Regulatory Awards (as master of ceremonies).
- October 10-12, 2018 for the 10x Medical Device Conference event, "10x for Engineers," in San Diego (as host).
Fast RoundAnother new feature, I'll close most weeks with short stories, links of interest, sponsored ads, and more. Is there something our community should know about? Contact me and tell me all about it. I'll reply as quickly as I can.
- Your Feedback. I'm acutely interested in your feedback about this email and the new site.If you have the time and inclination, I'd be ever so grateful if you hit "reply" to this email. It will come directly to me.
Thank you for being part of our Medical Devices Group community.Make it a great week. Joe Hage Medical Devices Group Leader P.S. 10x for ENGINEERS is two months away. We have a "Buy Two, Get Three" promotion: Send any two employees at regular price and send the third one, free!
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.
It is extremely important for those involved to review and comment on the text, as this is the last chance for technical modifications to the project - if draft is accepted, technical requirements can no longer be modified until publication.
For each country, the availability of the document (which is copyrighted and not for open circulation) and means to comment depends on how the country deals with mirror groups to ISO TC 210 or ISO TC 210 JWG 1. Usually, there's a national mirror group that deals with the international work. Please inquiry at your National Committee organization.
In Brazil, the document is handled by WG 2 - Risk Management - from EC 26: 150.01 of ABNT CB 26. WG 2 members will receive and review the document.
The WG will also hold an open meeting for those interested to take note of the text and assist in creating the Brazilian comments. This meeting will be scheduled shortly.
Having no references to similar devices, I find it difficult to find the way to be able to license it when it is in the prototype phase.
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!
Anyone here have answers for, or maybe just some thoughts on, any of these questions?
FDA updates Pre-Cert program as it begins to grapple with ‘hard questions’
New updates to the FDA's Software Pre-Cert working model shows the program is making significant gains, but FDA attorney Bradley Merrill Thompson tells FierceHealthcare the agency is starting to bump up against difficult legal and regulatory...
One of the themes I come across regularly with my medical product manufacturing clients is uneven skills in investigation and determining root cause through a rigorous and adequate Root Cause Analysis (RCA). In some cases, it is newer team members who have not yet been mentored or (preferably) fully trained. In other cases, it flows all the way to the senior staff and process owner levels (including CAPA procedures that only describe a single RCA tool like 5 Whys).
The investigation analysis tools used in RCA are not intended to be used in isolation; they are intended to sequence from one to another until RCA is completed and a plan is formed.
Recently, I came across this linked article. I think it does a nice, concise job of describing a typical RCA tool flow and how to apply that to corrective and preventive actions. Definitely not the deep dive, but an easy to apply and brief start to the topic.
What do you think?
#RCA #CAPA #investigation #processengineering
Root Cause Analysis, Ishikawa Diagrams and the 5 Whys
Root cause analysis (RCA) may be limited to brainstorming and not fully thought-through ideas. Incorporate Ishikawa diagrams along with the 5 Whys in order to maximize your RCA efforts.
"HeartSciences’ MyoVista® Wavelet ECG Device is breakthrough technology in electrocardiography designed to assist in the early detection of heart disease*. MyoVista wavECG Technology is focused on closing the diagnostic gap related to identifying patients having an elevated risk of a cardiac adverse event. Patented signal processing methods using wavelet mathematics provide new information related to energy in the acquired ECG signal.
As for me and my family, I don't want to waste my -or taxpayer money. But a simple, inexpensive ECG or EKG that provides early diagnosis makes sense.
Doctors Told Not to Order ECG's for Low-Risk Patients
Doctors shouldn’t routinely perform electrocardiograms on patients at low risk for heart disease, an influential federal panel is recommending. While an ECG test of the heart’s electrical activity is safe and inexpensive, the benefits for patients at...
It blamed manufacturer risk management for a 2014 peak in recalls: The culture, the shallow industry-wide understanding, the inability to tie risk management into quality management systems.
The authors quoted Francisco Poliodoro, "Safety-related behaviors fade over time and other motivating forces come to the fore, gradually launching the seeds of the next error,” adding, medical device manufacturers have an “inability to disengage from the reactive cycle” and calling them “the main impediments to the reduction of adverse events.”
Last year there was another peak and with it a challenging article: http://bit.ly/epidemic-rages-in-2017
Do you agree with either of the findings? I welcome your comments or questions here and at email@example.com.
My team is helping 3 companies with this problem. One company is very large, with thousands of employees and multiple sites. Another company is small and was recently acquired by a larger company, but their quality system has not yet been merged. The third company has less than 10 employees. Despite the differences, all 3 companies can simplify their quality systems using 3 strategies.
Consolidate your procedures. 28 procedures are required in ISO 13485:2016 and 25 procedures are required in 21 CFR 820. However, 2 companies have more than 70 procedures and the largest has more than 500. You don’t need a corrective action procedure and a preventive action procedure, when a CAPA procedure will do. You also don’t need a nonconforming materials procedure and a rework procedure. Those 2 procedures can be combined. Design controls requires 3 procedures, but you could easily consolidate that into 1 or 2.
Be and editor--not a writer. Every time a company receives a nonconformity or an FDA 483, the first approach is to add a reminder to a procedure. This seldom is effective. Better training and monitoring quality objectives are more effective. Therefore, delete the ineffective reminders and cut the procedure down to the minimum requirements so every procedure is as simple as it can be. Then implement quality objectives for tasks that are sometimes neglected. Your new lean procedures will be easier to remember too.
Don’t duplicate procedure content in your quality manual. Your manual explains how you meet requirements of each subsection in the standard, but if you have a procedure that meets the requirement--just reference the procedure. This strategy cuts down 28 subsections to a short sentence for each (e.g., This requirement is met by SOP 8.5.2).
Main possibilities from their perspective: 1) agency is taking a different, more cooperative or interactive approach to enforcement activities; 2) Med device co's are becoming more regulation savvy; 3) the Case for Quality Initiative is contributing to the drop
Agree? Disagree? Misses the mark, there are other factors?
Drop in Warning Letters for Medical Devices Raises Interesting Questions About the Industry
In 2017, FDA issued only 44 Warning Letters to medical device establishments. Of those, 11 were related to pre-market issues, which include investigational device exemption violations or lack of
I'm an investor in a medical device start up and our Team is seeking an experienced marketing consultant. The patented device has two major features:
1. Esophageal biopsy and, 2. Therapeutic drug delivery.
We are on track for FDA trial submission in June for the esophageal biopsy feature. The device is a balloon. The design is a single-application geographically oriented, four quadrant, circumferential esophageal biopsy. The balloon’s proprietary pleat system deflates after sampling to preserve cell density. In comparison, the current brush method accesses only a small area, requiring the use of multiple brushes and applications for wider sampling. The therapeutic drug delivery feature is still being tested and we believe it will significantly change the industry.
We have many marketing needs but initially we need assistance from an experienced medical device marketing consultant with development of messaging, product benefits over current methods, and marketing materials.
Referrals and recommendations are much appreciated!
FDA 510(k) applicants should ensure that their submissions meet RTA screening criteria to avoid RTA letters that can delay their US market commercialization plans. Just have a look on the below five key reasons provided to avoid the RTA letter:
𝙁𝙞𝙫𝙚 𝙠𝙚𝙮 𝙧𝙚𝙖𝙨𝙤𝙣𝙨 𝙛𝙤𝙧 𝙧𝙚𝙘𝙚𝙞𝙫𝙞𝙣𝙜 𝙖𝙣 𝙁𝘿𝘼 𝙍𝙏𝘼 𝙡𝙚𝙩𝙩𝙚𝙧
1. Failure to comply with FDA guidance: Applicants should adhere to recommendations listed in the agency’s guidance documents on formatting Traditional, Special and Abbreviated 510(k) submissions. Some device sponsors may not understand how to compile and format their 510(k) submissions.
2. Failure to supply an eCopy: FDA 510(k) applicants must submit an electronic (eCopy) of their 510(k) applications to the agency.
3. Failure to understand the difference between different types of 510(k)s: There are three types of premarket notification submissions: Traditional (most common), Special (less common) and Abbreviated (rare). Some applicants do not understand the differences between these types of 510(k)s and submit the wrong type.
4. Failure to identify FDA guidance applicable to your device: In their submissions, 510(k) applicants should identify FDA guidance documents if applicable to their devices’ specific product code. If such information has not been included in a submission, FDA reviewers will deem your submission lacking.
5. Failure to provide test data applicable to your device: Virtually all 510(k) applications submitted for FDA review must include some type of test data (e.g., electromagnetic compatibility (EMC), electrical safety, sterilization, biocompatibility, shelf-life, mechanical performance, etc.)
"Why don't we see a more widespread use of virtual doctors? We see some here and there, but with the technology already available, why don't we see more?"
I put myself in the physicians shoes.
-Would I ADD computer screen virtual meetings with patients to my existing patient load? Where would I get the time to do that?
-Would I have to cut my existing patient load to add time for virtual meetings? If so, would I charge the same? Can I justify the same charge? Would the quality be the same?
Researchers have told us that over 90% of communication is non-verbal. This is why Webex meetings take longer than face to face meetings. It takes longer to understand something. in face to face encounters we capture feelings, perhaps see expressions that the camera would not catch, hear and feel things the microphone may not hear. We can sense despair, fear, and anxiety, which could lead us to better suited treatment paths.
Will quality of care go down with more virtual doctor visits, or up as some say? Or is it just about cost?
I would like to hear your thoughts.
Application-wise, right now I am looking for a material with similar strength and fatigue properties as titanium that may be easier to use in manufacturing, potentially injection molding.
Click on the following link to register for the webinar:
You will learn how the global technology leader in minimally invasive robotic-assisted surgery, Intuitive Surgical:
• Automated data integration processes, eliminating risk of manual errors
• Centralized label lifecycle management based on a single, compliance-ready platform for easy design, reliable production and cost effective dynamic change management in response to business needs
• Assured data integrity by sharing critical label data from core components of SAP ERP
• Centralized management and distributed production for labels
• Fully automated unattended label production from within SAP ERP
• Had support for changing labeling requirements driven by regulatory, supply chain, local language, postponement strategies and organizational profiles.
Register for this live webinar on 15th March. You can also watch the recording.
The webinar will be presented by Gyan Agarwal, Senior Program Manager, Digital Engagement at Intuitive Surgical and Chris Lentz - VP of SAP Business Development at PRISYM ID.
Please share the registration link with your colleagues http://bit.ly/2orIPKW.
Intuitive Surgical and PRISYM ID: Integrating Labeling with SAP for Label Content Integrity and Control
Date: 15 March | 8:30AM San Francisco/11:30AM New York/3:30PM LondonFor the label designer, creating the layout of a medical device or pharmaceutical label is just part of the story. The content required to populate the label including images, static
does anyone has insights into the interpretation of Article 45 of the MDR (Article 41 in the IVDR). It sais that as part of the market surveillance activities, there is a change that the competent auhorities will review the technical documentation of a product and that this may happen off- or on-site. I think this can be interpreted in two ways - either the CA will review the technical documentation during an audit of the NB or the CA audits the technical documentation during a NB audit of a manufacturer. Do manufacturers need to consider an authority sitting on the table during a NB-surveillance audit? Looking forward to see your thoughts on this.
All the Best