Dozens of U.S. patients may have to undergo surgery to replace their Medtronic heart defibrillators following the discovery of a manufacturing problem that could render the devices unable to provide life-saving electric shocks.
It's pretty amazing these long-existing medical device manufacturers keep releasing products before they're fully (creatively) tested - and the implications are severe: death.
Please feel free to read the article I posted, and tell me what you think.
Medical Device Recalls – Do You See the Pattern…?
Whenever I review the latest entries on the FDA Recall List , I’m still surprised when I see the Reason for Recall information. Especially since several device manufacturers appear on the list – repeatedly. “XYZ Medical” is recalling the “ABC” Product...
The huge advantage of a Special-type submission is that the FDA timeline for decision on your submission is 30 days instead of 90 days. However, you need to make sure that you are making a minor modification to the device. If there are multiple changes, and the changes require multiple functional specialties to review your submission, then your submission will be converted to a Traditional-type of submission and clearance will be delayed.
One strategy that has been used successfully is to submit a series of minor device modifications as a series of Special 510(k) submissions. This is especially useful for software feature additions.
However, most design processes and 510(k) templates that companies use are specific to Traditional-type 510(k) submissions. You need to modify your templates, your submission strategy and your overall design plan for a Special-type submission.
Next Thursday, March 8 @ 1pm EST, I will be hosting a webinar to show people how I modify 510(k) templates for a Special 510(k). I will also explain different strategies for Special 510(k) submissions. Finally, you will learn how to change your approach to design planning for these minor device modifications.
If you are interested in participating in the free webinar, please register on the following webpage: http://medicaldeviceacademy.com/special-510k-submission-webinar/.
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On Thursday, March 8, 2018 @ 1pm – 2pm (EST), Rob Packard is presenting a Special 510k Submission Webinar to explain how your design plan should be different for a Special 510k Submission.
With that, I would like to open up a discussion into this and see what group members, especially senior executives who have successfully navigated these waters, think. More specifically, what are the key components and actions needed to give your new medical device and start-up company the best chances of commercialization success.
If I were trying to establish a relationship with a new supplier, I might spend 15 minutes on introductions--or more. The purpose of a pre-sub meeting is to ask the FDA questions that will help you prepare your submission. You should focus as much time as possible on asking your most important questions.
Names and titles of all attendees can be communicated in advance of the meeting. Five minutes is more than enough for introductions. After introductions, you should only ask the most important questions, and you shouldn’t waste time arguing with the FDA.
The most important question is if your predicate is acceptable. If you select the wrong predicate, your entire submission may be jeopardized, or you may have to repeat comparative testing with a new predicate. The balance of your questions should focus on testing requirements. But not all tests are critical. The critical tests are the tests that take the longest, and the tests that cost the most money. If the test is quick and inexpensive, save those questions for last. You can also ask clarification questions in a supplement to the pre-submission.
You definitely should summarize action items, but this does not require 15 minutes. Typical actions items are: 1) submitting draft meeting minutes, and 2) providing additional data to the FDA in a supplement. The FDA might even be responsible for getting you additional information. Five minutes is probably all you need.
If you want to learn more about 510(k) pre-submission meetings, register for Thursday’s free webinar:
His father askes if I had any ideas - stem cell are the only thought I had or an external body robot that could be strapped on.
I wonder, do you know of any researchers who are in that area of research. If you do, I would appreciate their names so I can help him.
If any group of professionals can, I know they will be in this group who have dedicated their careers to alleviating human and animal suffering.
The FDA released two 510(k) guidance documents in 2016: 1) how to apply ISO 10993-1, and 2) applying human factors engineering. Those two guidance documents resulted in a large number of 510(k) deficiency letters. By 2017, I had completely changed my mind.
A pre-submission meeting should always be requested, even if there is a special controls guidance document. Now I start every new project with a 510(k) pre-submission request. In fact, I had three pre-submission meetings scheduled for the same week in January of this year.
On Thursday, February 22 I’m offering an updated live webinar on 510(k) pre-submissions (Free). Please visit the following webpage to register: http://medicaldeviceacademy.com/510k-pre-submission-webinar/.
In addition, we still have opening for our 2-day, 510(k) workshop in Las Vegas on March 21-22 ($995). To register, please visit the following webpage: http://medicaldeviceacademy.com/las-vegas-510k-workshop/.
Nelson Labs is offering a 1-day seminar the day before the 510(k) workshop on biocompatibility ($499): https://news.nelsonlabs.com/education/events/biocompatibility-testing-for-medical-devices-seminar.
Eisner Safety is also offering a half-day course on electrical safety ($200): https://www.eisnersafety.com/iec-60601-1-basics-workshop-las-vegas-20-mar-2018/.
So if anyone can suggest suitable trade shows it would be greatly appreciated or companies that we should be talking to.
• SWOT “review your QMS to improve or verify compliance.” Back in my day, we called this an internal audit. How is the intent this example different from an internal audit?
• HACCP “an area of improvement in the QMS process then triggers use of a more detailed analysis.” So in the internal audit system, deficiencies and areas of improvement are identified in an audit report. Typically, each item is investigated in an audit response that involves a root cause investigation. Sounds like a “more detailed analysis” to me.
• Project Plan “create a strong project plan for improvement to address identified weaknesses.”Again, most audit response systems I have seen involve a corrective and preventive action plan coupled with effectiveness evaluation. How is a corrective or preventive action plan different from a “strong project plan for improvement”?
I fail to see why the Guide recommends creating a multi-layered risk-based analysis system when existing, long-standing systems within the QMS could be augmented with more risk-based concepts. The last thing small manufacturers need is to reinvent the wheel when existing systems can be utilized to fulfill the intent of the new risk-based approach requirement.
My last point of contention with the example is the number of layers and tools needed to conduct a comprehensive analysis of the QMS. Lets estimate the math.
• 1 SWOT x 5 major subsystems = at least 5 SWOT
• 5 SWOTS x identified 2 areas for improvement per system = 10 HACCP’s
• 10 HACCP’s x identified 3 areas in need of a project plan = 30 project plans
That’s a minimum of 45 new documents to effectively manage. This resource-intense example isn’t practical to small and mid sized manufacturers. And what does modeling a risk of not meeting a regulatory requirement look like? https://wp.me/p6wmF6-eG
Death by Risk-based Approach: The Practical Guide to the ISO 13485:2016 Practical Guide Part 3
This is the third post in the series “The Practical Guide to the ISO 13485:2016 Practical Guide”. (See the first installment and second installment.) This post explores examples and applicat…
In my experience, one unintended consequence is an undercapitalized startup, starved for cash and struggling to achieve milestones with inadequate resources. I own stock in one enterprise that has projected accomplishing its next important big step in six months for the last seven years. With the passage of time, the danger of another new market entrant eating their lunch grows. They could well save on their fare but miss the boat.
Other founders have told me that they loathe raising money, hustling to convince angel investors and or VCs to get attention to make a pitch, and facing serial rejections – even from people who stared at their mobile devices during the presentation. Worse yet, some potential investors do not respond definitively one way or the other. They seemed to endlessly discuss the idea with their partners, or ask for more information, or wait for another investor to move first. No wonder that so many entrepreneurs find the process highly frustrating, even when they are confident that they will eventually succeed at raising the next round.
The balance of risks is a difficult question. Whether it is more dangerous to raise money and risk control and share of the pie, or to shun new money and perhaps slow growth or even invite getting blind-sided by new competitors. Equity-stingy founders may fail to ask the question openly, or exert a genuine effort to answer it honestly, or to revisit the question at appropriate intervals. That kind of mistake could prove fatal.
How in the world can I get past the HR filtering nightmare... and how do I know If I did?
Key take-aways include:
• Justify all requirements or quality system elements deemed not appropriate with a written rationale. While a written justification is not required by the standard or Guide, having the rationale documented will help avoid discussions with an auditor debating the “appropriateness” of a particular requirement.
• Interpret “proportionate to the effects” to be synonymous with applying a risk-based approach.
• Apply a “risk-based approach” or justification to every QMS element.
Note these recommendations are based on my own conclusions after reading the ambiguous information available on risk-based approach. The take-aways are not meant to infer a requirement from the standard or guide but rather reflect my own ideas on implementation.
Take a look at the post and let me know your thoughts on risk-based approach and associated terminology.
Risk-based approach as clear as mud: The Practical Guide to the ISO 13485:2016 Practical Guide Post 2
This is the second post in the series “The Practical Guide to the ISO 13485:2016 Practical Guide.” If you missed the first installment, catch up by reading it here. This post explores how the Pract…
When I see bad numbers staying bad I suspect systemic flaws. So, I am starting a research campaign. I will be calling a select group of 100 industry practitioners to get their take on the problem and the pains it inflicts on them and their organizations.
You can jump ahead of the line and contact me directly to contribute your thoughts. Be prepared to take a quick 5 question problem survey. You can also volunteer for a deeper interview on where the industry should head. Feel free to reply to this post. Also, get more information and be proactive on my website www.menloparkassociates.com. I look forward the conversation we can have.
We are not a manufacturer and there are no local regulation or obligation that sales site shall apply ISO14971 to my knowledge. But, I heard from someone that we should do. Is there anyone that in similar situation?
If sales site should adopt ISO14971, anyone can advise how to? ISO14971 is very much focused on product related risk for its lifecycle and I don't have idea how to apply the standard for commercial process independently.
Any advice or idea sharing will be appreciated!
Eager to know, if there exist vendors/platform to connect multiple health parameters (BP, TP, Glucose, ECG & much more) from monitoring devices of the patient.
This is basically to monitor the patients remotely.
5 Tips for Medical Device Engineers on FDA Design Controls
If you are an engineer in the medical device industry, you probably have a love/hate relationship with the FDA-mandated design controls process. While implementing design controls can feel like a majo
- The practical guide is huge…but it still doesn’t contain all the details industry needs.
- The practical guide does not differentiate between new ISO 13485:2016 and old (2003/2012) requirements
- The Practical Guide’s guidance on the risk-based approach (perhaps one of the most significant changes to the 2016 standard) is limited.
I discuss these points in detail in my latest blog. What were you expecting of the guide? What did you like or dislike? What was helpful to you?
The Practical Guide to the ISO 13485:2016 Practical Guide
Three things to consider before picking up the ISO 13485:2016 Practical Guide Manufacturers everywhere have been waiting a year and a half for additional guidance on the requirements of ISO 13485:2…
Philips Healthcare Trick or Treat
If you have not been scared enough by Halloween, read this consent decree announcement made by the FDA on November 1 to Philips Healthcare concerning quality control issues with their automatic ext…
Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices
How to implement and maintain a risk-based CAPA process while avoiding the most common pitfalls at your medical device company.
1- " shall document a procedure"
2- "shall document procedures"?
Does 1 mean that we need to implement one procedure per subject ( internal audit, control of documents..) and 2 means that we can implement the requirements (example 7.3.9 design changes ) in other procedures ?
Do you know if the FDA can inspect your emails if you used email as a record as a proof of compliance?
If you want to learn more abou the FY 2018 user fees and the strategic implications, the following blog article was posted yesterday:
Applying for small business qualification is best approach to reduce you costs of FDA regulatory submissions. If you have not completed a small business qualification form before, you can learn how to prepare your application for small business qualification by registering for a webinar this Friday, September 8, 2017:
FDA User Fee Increase for FY 2018 – Strategic Implications
This article identifies strategic implications of the FDA user fee increase for FY 2018 that was published by the FDA last week.
Trends in EU regulation of software as medical device
Presentation at the Personal Connected Health Alliance about regulatory trends in EU regulation of software as medical device
New legal obligations and liability under MDR and IVDR
Presentation at the MedTech Summit in Amsterdam on 19 June 2017 on the product liability regime under the MDR and IVDR, its nexus with the EU Product Liability Directive and its impact on other provisions in the MDR / IVDR
The following webpage provides FDA guidance on software documentation required in 510(k) submissions: https://www.fda.gov/RegulatoryInformation/Guidances/ucm089543.htm.
To determine the level of concern, you need to answer 7 questions found in the guidance document. If all 7 questions are negative, then the software is a minor level of concern by default.
It is important to read all questions and answer the questions as if you were the FDA. In many companies, the people performing risk analysis will identify risks of delay in treatment as being insignificant risks. However, the FDA typically scores the potential severity of harm much higher. Therefore, it is important to review any guidance documentation provided for your product classification to see if the FDA has already identified the level of concern for your software. If a guidance exists, but the FDA does not specify the level of concern, I recommend sending an email to the person that is responsible for the guidance at the FDA.
For minor and moderate levels of concern, the guidance indicates that less documentation for software validation needs to be submitted as part of your 510(k) submission.
The guidance DOES NOT say that you need to do less software validation or document less. The FDA allows you to submit less documentation for a 510(k), but you still have to do the same work.
A new, 2-day 510(k) workshop will be hosted in Amsterdam by Factory-CRO and my consulting firm. The dates of the workshop are October 11-12, 2017. For more information, please visit the following webpage: http://medicaldeviceacademy.com/amsterdam-510k-workshop/ .
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?!
The good new is that you have time to write your procedures and train your complaint handling unit properly. Most manufacturers are not upgrading their quality system to ISO 13485:2016 until 2018 or 2019. In addition, the some of the new EU regulations are not truly finalized, because the Eudamed database is not even ready for manufacturers to use yet.
What should be in your procedure?
Your procedure should be detailed enough to enable a person that has not submitted a mandatory problem report before to do so. In addition, you may need detailed instructions for importers or distributors of your device--who may be required to submit adverse event reports.
Well-written procedures typically state that you should review and update your risk management documentation when you are investigating complaints--especially when there is a new adverse event to report. That’s not good enough.
You really need your reporting procedure to reference your risk management process and to provide guidance for what information needs to be reviewed and updated. Ideally your risk management documentation should be aligned with reporting requirements so it is obvious which events require reporting and which events should not require reporting.
If you are interested in learning more about writing a reporting procedure, please review the blog I posted today: http://medicaldeviceacademy.com/blog/. The end of the blog also mentions a new training webinar on Canadian Device Licensing that will be live on Wednesday, May 24.
Our DHF is system based e.g. Cervical plate system including plate, screw and etc. I am wondering whether the design changes require same documentation including design input, output, verification, validation, review and transfer like formal design controls when the change occurrs including screw design changes, some of size addition to previous models without no changes to intended use. In my opinion, the above case indicates that design input is changed so it requires same documentation from input.
I read an article said that.. it is worthy to document DHF when the design plan, design input, design output changes and the risk analysis affected. I'm not clearly understood when I consider those "changes" occurred. Could anybody give me an easy example?
Thanks for reading my posting.
After your IFU is validated, and you obtain regulatory approval for your product, you may still need to make updates to your IFUs as new risks are identified. In order to decide whether you need to update your IFUs you need to gather post-market surveillance data.
Post-market surveillance is not just asking customers if they are satisfied. You need to continue to monitoring adverse event databases, your own complaint database and any service records to determine if there are any new risks and to verify that the risks you identified were accurately estimated with regard to severity and probability of occurrence of harm. In fact, clinical studies and PMS are the only way you can gather data regarding probability of occurrence of harm. When you design your post-market surveillance questions, make sure you include questions specifically targeting the residual risks you identify in your IFU. You should also ask, “What indications do you use this device for. Specifically, please identify the intended diagnosis, treatment and patient populations.” This wording is more effective than asking if a physician is using your product “off label.”
If you want to learn more about using a risk-based approach to developing IFUs, validating IFUs and performing post-market surveillance to monitor the effectiveness of your IFU, then visit my blog posting from earlier today (http://www.medicaldeviceacademy.com/blog) or the following webinar page to register for our webinar on Friday, April 21:
It would be really good to hear from anyone who has taken the plunge and transitioned to only ISO 13485, how did it go? How was the change received both internally and externally by customers and suppliers?
There are four causes for receiving an NSE letter. The first cause is: you failed to verify that the predicate is a legally marketed device. If your predicate was not registered and listed with the FDA (check using this link), then you should have submitted a pre-sub request to determine if the agency has any problem with using the device you chose as a predicate. This is an important question if the manufacturer is no longer in business and the product is no longer for sale.
The second cause is: you failed to evaluate the substantial equivalence of your device’s intended use with the predicate. The FDA typically will work with the company to modify the wording of FDA Form 3881 to ensure the intended use is equivalent or to make sure you provide clinical evidence to address the differences. In my pre-submission requests, I include a comparison document for the intended use to ensure that the FDA is aware of any differences in the intended use.
The third cause is: you failed to convince the FDA that technological differences do not raise different questions of safety and effectiveness. For each difference you must provide a justification for why the difference does not raise different issues or you must provide data to prove it. It is also possible that you were not aware of questions of safety and performance raised by technological differences. To avoid this problem you can submit a detailed device description and draft labeling to the FDA in a pre-sub meeting request.
The fourth cause is: you failed to provide data demonstrating equivalence.
For each difference you should determine an objective method for demonstrating that the difference is equivalent in safety and performance to the predicate. Your test method can be proposed to the FDA in a pre-sub request prior to testing. The FDA sees more than 3,000 companies propose testing methods to demonstrate equivalence each year. They have more experience than you do. Ask them in a pre-sub before you test anything.
In all four root causes identified above, you could benefit greatly from pre-sub meeting. The correction to your NSE letter may not be clear. You should consider requesting a pre-sub meeting as quickly as you can. Most companies choose not to submit a pre-sub meeting request, because they don’t want to wait 75-90 days. However, sometimes pre-sub meetings are scheduled sooner. In addition, 75-90 days is not as costly as receiving a second NSE letter.
If you want to learn more, read the complete article:
If you need help with your 510(k) submission, consider attending the 510(k) training workshop in Chicago on April 18: http://medicaldeviceacademy.com/chicago-510k-workshop/.
Earlier this year I recorded a webinar on the 4th edition of MEDDEV 2.7/1 for clinical evaluations, but the new European Medical Device Regulations requires additional changes to the clinical evaluation process. If you already have CE Marking, you have 3 years to gather the clinical data you need to meet the new requirements. If you don’t you will no longer be able to CE Mark your products--even for Class 1 devices.
If your device is not on the market yet, you need to understand how the new regulations Affect your strategic marketing plan. The EU is no longer the market where medical devices are launched first. Clinical study data is now required for all CE Marked devices. You need clinical data. Learn how to obtain that data from your US customers on May 1st at the CE Marking Workshop in San Diego at 10x: http://medicaldeviceevents.com/.
Despite the lack of design controls for Class 1 devices, manufacturers must still maintain a procedure for design transfer, maintain an approved device master file with all the approved design specifications (i.e., design outputs) and design changes may still require revalidation prior to implementation.
Class 1 devices are simple devices that are already on the market and have a history of clinical safety. Class 2 devices are generally more complex and present a moderate risk. Therefore, changes in the technological characteristics often present a greater risk for Class 2 devices. When you design a Class 1 device, you still have to determine what your design specifications will be, but you don’t need: 1) to review and approve design inputs, 2) a procedure to document your design process, 3) to document formal design reviews, and 4) to create a design plan.
In the 1997 guidance document for design controls, the FDA states that a design transfer procedure should include at least three basic elements. The first of these basic elements (i.e., design and development procedures) is not required for Class 1 devices, because product specifications for most Class 1 devices are simple. The other two requirements are basic principles of document control and configuration management. Therefore, you still need a design transfer procedure for Class 1 devices but you don’t need to include the first element that relies upon design and development procedures.
If you have a Class 1 device, you must still comply with labeling requirements (i.e., 21 CFR 820.120). If your device is sterile, you must still validate and re-validate the process in accordance with 21 CFR 820.75. Class 1 products also require, a device master record (DMR) in accordance with 21 CFR 820.181.
Although you do not technically have to have a DHF for a Class 1 products, the difference between the two categories is the following elements: 1) Design Control Procedure, 2) Design Plan, 3) Approved Design Inputs, and 4) Evidence of at least 1 Design Review.
If you are interested in learning more about design history files (DHF), please read this week’s blog: http://www.medicaldeviceacademy.com/blog/.
Next 510(k) workshop is April 18 in Chicago: http://medicaldeviceacademy.com/chicago-510k-workshop/.
It's a huge change to be got through in 3 years against the backdrop of ISO 13485:2016 and MDSAP transitions going on at the same time.
Are we going to see a reversal of fortunes, as Europe gets more difficult than US FDA?
See http://brandwoodbiomedical.com/almost-there-final-text-of-european-medical-device-regulation-is-published/ for a more detailed look at the changes.
Almost there… Final Text of European Medical Device Regulation is published
The Final text of the long anticipated European Medical Device Regulations has been published. The new regulations include some 123 Articles spit into Ten Chapters and Seventeen Annexes. It’s a weighty read, at some 566 pages compared to the 95...