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Medical Device Accelerator in Memphis, TN

January 23, 2013 By Leave a Comment

The medical device industry has several geographic pockets. Memphis, TN is one of these, especially in orthopedics.

I recently read about this medical device accelerator located in Memphis called ZeroTo510. They seem to have all the key pieces for a medical device concept to get off the starting blocks. Part incubator, part educator, part investor, part mentor. The program is geared towards helping medical device inventors and entrepreneurs get to a FDA 510(k) submission, while providing guidance and direction along the way

While I have no idea how successful this program has been, the model is very intriguing. So much so that I wonder if something like this could be piloted in central Indiana.

Filed Under: All, Funding, Indiana Life Sciences, Product Development - General, start-up Tagged With: , , , , , ,

Medical Device Product Development in 12 Months

January 7, 2013 By Leave a Comment

Can it be done? I guess before you answer, it might be helpful for me to share a few more details.

  • Device is pretty clearly a class II with dozens of potential predicates.
  • This is essentially a “me too” product.
  • The project seems to be well-funded.
  • Product development has been outsourced to firms with expertise.

So do you think this medical device can be brought to market in 12 months time?

I believe so. Granted there isn’t much wiggle room in the schedule. And of course, there will be a FDA 510(k) submission involved. But getting this product ready for launch in a year seems feasible.

We had the project kickoff on November 26, 2012 and really got started the first part of December. So far, we have finished the planning phase, including definition of clear, objective design input requirements. The rest of the schedule is laid out. Yes, we all know that medical device product development is full of uncertainties and surprises.

I’ll keep you posted as to our progress along the way.

 

Filed Under: All, Design Control, Product Development - General, Project Phases, start-up Tagged With: , , , , , , , ,

Helping Medical Device Inventors Get Started

October 15, 2012 By Leave a Comment

Do you remember a couple years ago when I put the message out there that Creo Quality was looking to meet “garage inventors”? Ever since, we have been making connections with medical device inventors, entrepreneurs, and startups. It’s been fantastic!

In fact, right now, I am working closely with two very early stage medical device inventors. Both ideas are novel and seem to solve a real problem. In both cases, the inventors seem to be great people who are open to suggestion and are not afraid to admit that there are just things about this process they don’t know.

In both cases, I shared the Building a Business Case questionnaire with the inventor and received the completed responses within a few days. The completed questionnaires are very helpful for a couple reasons–the biggest of which is the fact that the inventor actually took the time to provide responses is an indicator that he is willing to see this thing through. A leap of faith–maybe. But I’ve had plenty of so-called inventors whom I have not heard from since sending the questions.

And for an aspiring medical device inventor who wants a little help and guidance on what to do and when to do it, I’m telling you now you will get some of my time for FREE if you are willing to complete the Buidling the Business Case questionnaire. The links above should guide you to downloading the survey and you can email it to me if you want a little help.

Filed Under: All, Ask CQ, Catalyst, Medical Device - General, start-up Tagged With: , , , , , , , ,

Reprocessing Medical Devices Scares Me

October 12, 2012 By Leave a Comment

I’m investigating an issue for a client on a medical device of theirs which appears to have been reprocessed by a third party vendor. A sales rep recently discovered that one of the company’s products had been reprocessed because it had reached expiration date. The reprocessor took the product and repackaged and re-sterilized it and charged the hospital.

Here are some immediate concerns I had when discovering this:

  • The product was originally sterilized by the original manufacturer (my client) via gamma sterilization. The reprocessor sterilized with ethylene oxide.
  • The reprocessor did not list a new expiration date. A representative from the hospital claims he was told “it’s good forever”.
  • The reprocessed product was listed with the exact same part number as it was from the original manufacturer.
  • The reprocessor did not include the product’s instructions for use.
The customer willingly sent the suspect product back. I had a chance to evaluate it. When I opened the pouches, I removed each component and visually examined. One of the components had a significant curve–one that is not supposed to be there–which could have an impact during its use. And in the event there is an issue during a procedure, there is a good chance the original manufacturer (my client) will receive the complaint.

I realize that FDA allows reprocessors to do their thing, with one significant caveat. The reprocessor is required to receive 510(k) clearance first.

So I checked the 510(k) clearances for this particular reprocessor. They have not received 510(k) clearance to reprocess this product.

I’m completing my investigation and will be making several recommendations to my client.

Frankly, as a potential patient, reprocessed medical devices scare me. Maybe it’s because I know too much about the process for bringing medical devices to market. I mean single-use medical devices are designed and tested prior to reaching hospitals. The packaging, sterilization, shelf-life, performance, and so on have all been proven. For a third party who does not have access to any of this data on the product to come in and repackage, re-sterilize, and suggest that the single-use device is as good as new is just preposterous.

Filed Under: All, Medical Device - General Tagged With: , , , , ,

Check Out Upcoming Medical Device Events

October 9, 2012 By Leave a Comment

The rest of the year is jam packed with a variety of events from medical device investing, to 510(k) workshops, to events focusing on innovation.

Check out the Events Page for a complete listing.

Filed Under: All, Medical Device - General Tagged With: , , , , ,

When Medical Devices Are Used Off-Label

October 8, 2012 By Leave a Comment

What do you do when you find out your medical device is being used slightly differently than you intended? What about when your product is being used on a patient population where you don’t have much data? What about when you learn that the instructions for use and the procedural steps you identified are not being followed?

What do you do? What are you required to do? These are NOT easy questions to answer.

I recently had a client who had to deal with some of these issues. A doctor contacted the company to get a sample device so that he could become more familiar with components, techniques, etc. The doctor, a pediatric surgeon, asked for the product to be sent to his residence. I was asked for my opinion on what to do and how to handle the situation.

Here is what I recommended to my client:

  • Research and review 510(k) submission, paying particular attention to product labeling and indications for use. Even though the patient population for the device has not been specified, the size and length of some of the components might suggest this product is not particularly ideal for pediatric uses.
  • Determine what types of pediatric scenarios and cases where this device could be used.
  • Draft a letter to the physician specifying the product’s indications for use, listing all components–including critical dimensions such as outside diameter and length.
  • Send the requested sample. Be sure the product is not sterile and is labeled accordingly, along with something along the lines of “for evaluation only”.

I take a fairly conservative approach on matters like this. And I advise my clients to do the same. I recommend that they document objective evidence supporting decisions that are made. Sometimes the clients listen; other times they don’t.

If you find yourself in similar types of scenarios, be sure the decisions you make and the actions you take are supported by rationale, objective justifications which are documented.

Filed Under: All, Ask CQ, Medical Device - General Tagged With: , , ,

Reducing Medical Device 510(k) Delays

September 17, 2012 By Leave a Comment

What can you do to reduce FDA medical device 510(k) delays? Aptiv Solutions suggests the following:

  1. Do your homework
  2. Take advantage of pre-submission meetings
  3. Pay your user fee
  4. Ensure high submission quality
  5. Don’t guess
  6. Provide only what is required

The article provides some explanation for each of the tips listed above. Of the tips, I emphasize #1 – Do your homework. Doing the homework for your medical device and the 510(k) submission is critical, especially the importance of establishing sound, meaningful predicate devices. In my experience, the BIGGEST delay in FDA 510(k) review is a direct relationship to the strength of the predicate devices.

Filed Under: All, Medical Device - General Tagged With: , , , ,

Canadian Licence Process for Medical Devices – A Step by Step Example

July 30, 2012 By Leave a Comment

Thanks again to Rob Packard for providing another guest post. Rob is a Regulatory Affairs and Quality Management System expert whose specialty is helping companies with regulatory submission of a Design Dossiers for CE Marking of high-risk Class III medical devices. You can read more of Rob’s work at QC is Dead and RA Review blogs. 

Thank you for reading my previous posting on Creo Quality, “FDA 510(k) or CE Marking?” from July 10th. As an encore performance, I am writing this posting to explain the process for obtaining a Canadian Medical Device License. Why?

Because Canada is easier to obtain approval from than the US FDA or European Notified Bodies.

For my example, I have chosen to invent a client for Jon to help.

Jon just got a call from the makers of Krazy Glue®. They want to start selling their products as medical devices. Fortunately for them, companies have been selling cyanoacrylate (e.g. – Krazy Glue®) as a medical device for years. Therefore, Jon’s client needs to decide if they want to sell the product as: 1) a liquid bandage, 2) a topical adhesive to replace sutures, or 3) a vascular repair device for use inside the body during surgery. Jon’s client indicates that they want to sell cyanoacrylate as a medical device all over the world. Therefore, Jon does a little homework and decides that a “topical adhesive” application will give his client the higher margins of a medical device for prescription use, but it will also avoid the costly pre-market approval (PMA) process at the FDA. Jon also decides to recommend that his client try a pilot launch in Canada first to evaluate their new packaging ideas on a smaller market than the USA or Europe.

My first job in Regulatory Affairs taught me the most valuable lesson of all: “Always go back to the source.” In this case, Jon doesn’t want to rely only this posting for his information on how to get a Medical Device License in Canada. He needs to start with the Regulations. The “helpful links” (http://13485cert.com/helpful-links/) page of my website tells you how to find the Canadian Medical Device Regulations (CMDR), but for those of you that just don’t want to work that hard, here’s the direct link: http://laws-lois.justice.gc.ca/PDF/SOR-98-282.pdf. The Regulations were most recently updated on June 27, 2012. If you want to know what the difference is between the current version and the previous version, I wrote an entire blog posting on just that topic (http://13485cert.com/did-canada-forget-about-document-control/). The posting is 762 words long, but the two-word answer is: “Not much.”

Now that Jon has the single greatest cure for insomnia, he skips ahead to the bottom of page 54. Rule 4 states that “all non-invasive devices that are intended to come into contact with injured skin are classified as Class 2.” This is the applicable rule for this device, but how does Jon know?

Jon identified a competing product for sale in the US and Canada so that he could verify the classification as Class II. In this case, the competing product was “Surgiseal.” Jon checked the establishment listing database at the US FDA, and for Canada Jon reviewed the license information shown below.

Licence No.: 88330

Type: Single Device
Device Class: 2
First Issue Date: 2012-02-27
Licence Name: SURGISEAL TOPICAL SKIN ADHESIVE

 

Device Details
Device Section Identifier Section
First Issue Date Device Name First Issue Date Device Identifier
2012-02-27 SURGISEAL, TOPICAL SKIN ADHESIVE 2012-02-27 SS-035T

 

Now that Jon has verified this is a Class 2 device in Canada, Jon needs to review the Canadian Licensing Process. In the  CMDR, starting on page 16 (Section 32), Jon reviews the process of applying for a Medical Device License. He also reviews the Guidance Document for “How to complete a new medical device license application.” The location of the Health Canada Guidance Document is: http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/md_gd_licapp_im_ld_demhom-eng.php. Fortunately, this is a Class II device and the requirements are primarily to complete the application form and to sign attestations regarding compliance with the safety and effectiveness requirements (Section 10-20 of the CMDR) and compliance with the labeling requirements (Section 21-23 of the CMDR). The application form has a new section requiring information about phthalate content of the device in the application. However, this tissue adhesive would only have phthalates if it was contained in the packaging.

After Jon’s review, he meets with the client to explain the next steps of the process:

1. The client needs to upgrade their existing ISO 9001:2008 Quality Management Certificate to an ISO 13485:2003 Certificate with CMDCAS. “CMDCAS” is the Canadian Medical Device Conformity Assessment System. The Quality System Auditor from the registrar will look for additional requirements specific to the CMDR, but all of these requirements are identified in GD210—another guidance document from Health Canada. This will only require a one-day external audit to upgrade the scope of the current certification.

2. Jon and the client need to revise the labeling to meet the requirements for Sections 21-23 of the CMDR. Since this product will be used by Medial Professionals, rather than an over-the-counter product, the labeling requirements are similar to Europe and the US. The most important thing to do will be to implement the use of appropriate symbols found in ISO 15223:2012—an Internal Standard for Labeling and Symbols.

3. The client will need Jon to conduct an internal audit to the CMDR requirements prior to the certification upgrade audit.

4. Finally, once the new Quality System Certificate is received Jon and the client can complete the application and submit the application with a copy of the new certificate.

In all, Jon estimates that his client can complete this process in less than 60 days. When the client gets an upgrade quotation from their registrar, the earliest date available is in 10 weeks, but their annual surveillance audit is already scheduled for 13 weeks. Therefore, the client decides to combine the two audits to save money on the travel costs and to give themselves a little more time to prepare.

Not all applications are this easy. For higher risk devices (i.e. – Class 3 and 4), summary technical documentation (STED) must be submitted in paper and electronically. Canada provides guidance documents for this, and there is a Global Harmonization Task Force (GHTF) document that explains how to prepare these documents. Depending upon the Classification and complexity of the device being submitted, this documentation can take weeks or months to prepare. The documentation matches the requirements for Technical Files required by Europe for CE Marking and 510(k) submissions required by the US FDA. However, the documentation can be prepared for most devices in less than 6 months—including biocompatibility testing and sterilization validation. This can also be done in parallel with obtaining ISO 13485:2003 certification. The only item that might require longer is if Clinical Studies are required—which is only required for high-risk devices or novel devices that are dissimilar from other devices already on the market.

Filed Under: All, Medical Device - General, Strategy vs. Tactics Tagged With: , , , , , , ,

FDA 510(k) or CE Marking?

July 10, 2012 By Leave a Comment

Today’s guest post comes from Rob Packard. Rob is a Regulatory Affairs and Quality Management System expert whose specialty is helping companies with regulatory submission of a Design Dossiers for CE Marking of high-risk Class III medical devices. You can read more of Rob’s work at QC is Dead and RA Review blogs. 

I’ve read a few business plans that propose to obtain a 510(k), CE Marking and a Canadian Medical Device License all in six months. My first impression is, “Lots of Luck!” Often I will ask how many people are working on this ambitious regulatory project. If the answer in “one”, they haven’t even got a clue. For a low-risk device this MIGHT be possible, but there are “If” qualifiers:

  1. If the device is a Class 2 device in the US requiring a 510(k), and the device is extremely similar to the predicate device, the 510(k) might get approved within 90-120 days.
  2. If the device is a Class IIa device in Europe, an expedited review ($$$) can be as short as 90 days.
  3. If the device is a Class 2 device in Canada, a Medical Device License can be approved in less than 60 days.
  4. If the company has already completed all the verification and validation testing, including any electrical safety and shelf-life testing, a regulatory expert can assemble a submission for all three markets in less than 60 days—assuming the design team has already written most of the documentation.
  5. If the regulatory expert has successfully submitted multiple applications to each of these markets previously, they will have templates to work from and know exactly what each country wants—including formatting.
  6. If the company already has a registered Quality Management System (i.e. – ISO 13485:2003 with CMDCAS), then they won’t need to have a Phase 1 audit, open a bunch of CAPAs, have a Phase 2 audit, and open some more CAPAs.

On rare occasions a motivated team can accomplish the impossible. For example, I started helping a team last year around August 1st. The team was half-way done with their Technical File for CE Marking, already had a 510(k), and they had just finished a pre-assessment audit for ISO 13485. After an obscene amount of work, we achieved CE Marking of their Class IIa device by mid-November (~100 days). CMDCAS and a Canadian Medical Device License application would have killed us, so we postponed that goal for this year.

Why would you want to commit your team to such a ridiculous goal of 3 regulatory approvals in a 6-month period?

The answer is that most companies have the common sense not to. Instead, most companies pick one market and focus on that. Most US-based companies pick the US market and submit a 510(k) first. Why?!

The 510(k) process is harder than CE Marking, new technology takes three years longer on average to get approved in the US than Europe, and the rules change faster than the US FDA publishes guidance documents to explain what they are doing.

Canada is the least rigorous of the three markets I mentioned (If you really want easy, New Zealand only requires registration—there is no “approval” at all for that market.). The Canadian market is 10% of the US Market size, and New Zealand is…well not worth comparing. Europe, however, is a big market.

Most small and mid-sized medical device companies rely upon distributors to sell their devices rather than developing their own direct sales force. What difference does it make if you are selling to a distributor in Austin, TX or Galway, IRE? If your company is going to use distributors, pick the easier regulatory hurdle first and work your way up the ladder of difficultly while your distributors bring in some cash.

Success in any business is about sales, sales and sales.

Before you even start designing a medical device, you should be talking to potential distributors. Distributors and sales people are one of the best sources of product ideas. If you are a CEO/founder hopeful, you are more likely to succeed if your background is sales and marketing. Engineers can invent 100’s of medical devices and mousetraps (MD&M), but it is rare to find an inventor that can sell—let alone explain the difference between the strategic marketing plan and the advertising plan.

My advice is to start with the strategic marketing plan for Canada and then one or two countries in Europe. If you have trouble identifying distributors for your type of device in these markets, then you are not competent as a sales and marketing person. You need to get help!

If you don’t know where to look for help, you might ask your regulatory expert. Regulatory experts have to research the competitor products in order to identify known risks and typical adverse events. Regulatory experts also need to identify the competing products before they can be certain of a regulatory pathway. Authorized representatives are sometimes quite helpful in identifying distributors too.

My final advice is to save the US Market for last!

Filed Under: All, Ask CQ, Medical Device - General, Strategy vs. Tactics Tagged With: , , , , , , , ,

FDA and Other Regulatory News for Medical Device Industry

July 3, 2012 By Leave a Comment

We’ve updated the links on the Regulatory page. Quite a few FDA updates to review.

Filed Under: All, Connect, Medical Device - General Tagged With: , , , , ,

What Are Your Thoughts About the Current FDA 510(k) Process?

June 6, 2012 By Leave a Comment

I recently posted this question on the Medical Devices Group on LinkedIn. The article “FDA Rule Clears Medical Devices Without Human Testing” got me thinking about this topic. I posed a few additional comments about this topic in the discussion on LinkedIn:

  • Do you think human clinical trials should be required for line extensions and product modifications that require 510(k) submission? Why or why not?
  • Do you think conducting human clinicals would really reduce product issues in the field?
  • If FDA were to require human clinicals for all 510(k)s, do you think there would be a reduction in new medical products introduced into the U.S. market?

The few comments posted were insightful, suggesting that U.S. medical device companies are likely to introduce new products and technologies overseas first.

I’ll admit, I was hoping for more dialog and comments on this and decided to post this on the CQ blog. Please chime in.

Filed Under: All, Ask CQ, Medical Device - General Tagged With: , , , ,

February 22, 2012 – IMDMC 510(k) Submission Guidance Workshop

January 23, 2012 By Leave a Comment

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Please join the Indiana Medical Device Manufacturers Council (IMDMC) for our

Analysis of Recent 510(k) Submission Guidances Workshop
on February 22, 2012

Agenda

9:30-10:30 EST Welcome / New 510(k) paradigm Ralph Hall, Faegre Baker Daniels
10:30-11:00 Use of Experts Daniel J. Dillon, MS, RAC (US)
MED Institute
11:00-11:15 Break
11:15-12:15 5 Hot Topics!
NTI
Center Science Council
RUO
Chemical action/definitions
de novo		 Ralph Hall, Faegre Baker Daniels
Gretchen Bowker, Pearl IRB
Scott Thiel, The Anson Group
Brandon Hipsher, DePuy Orthopaedics
Daniel J. Dillon, MED Institute
12:15-1:00 Lunch provided
1:00-2:15 Modifications Scott Thiel, The Anson Group
2:15-2:45 New HDE Guidance Jack Rogers, Beckman Coulter (invited)
2:45-3:15 Appeals Brandon Hipsher, DePuy Orthopaedics
3:15 pm Adjourn


Registration Fees: $125 IMDMC Member / $175 Non-Member

Location: Montage, 8580 Allison Pointe Blvd, Indianapolis, IN 46250

Please register to attend the event now!

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Filed Under: All, Events, Indiana Life Sciences Tagged With: , , , , , ,

New FDA Draft Guidance: When to File 510(k)

August 22, 2011 By Leave a Comment

We’re working with a medical device company now that has several products that received market clearance via 510(k). Many of these products have incurred changes since being launched. The company has done a good job of reviewing FDA 510(k) decision trees to determine whether another submission is required. However, sometimes product changes fall into a gray area where it’s not entirely clear whether a new 510(k) submission is required.

FDA recognizes that these decisions are not always black and white and has drafted a new guidance document for when to file a 510(k). Below are some links about this topic:

Reforming the 510(k) process: the FDA’s latest guidance

FDA Issues Draft Guidance, “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device”

Do You Need New 510(k) Submission? – FDA Clarifies

FDA Provides Draft Guidance for 510(k) Premarket Submission

Filed Under: All, Medical Device - General Tagged With: , , , , , ,

FDA to Hold Public Meeting Regarding IOM Report

August 18, 2011 By Leave a Comment

Did you read about the Institute of Medicine’s findings regarding FDA 510(k) process? FDA has scheduled a public meeting in response to the IOM findings on September 16, 2011. FDA has also set a September 30 deadline for public comments regarding the report.

Filed Under: All, Medical Device - General Tagged With: , , , ,

510(k) Review Times Increase Because of Poor Submissions

August 8, 2011 By Leave a Comment

FDA recently released a report analyzing 510(k) review time. The analysis showed that review times have increased due to the poor quality of data and information provided as part of the 510(k) submission. FDA requests for additional information from submissions steadily increased from 38% in 2001 to 77% in 2010. Requests for additional information obviously increases review time.

CQ has been involved with quite a few 510(k)s during this period of time, ranging from large to early stage start-up medical device companies. Some of the companies we’ve worked with were submitting their very first 510(k), while others were “old pros”. Based on my experiences and anecdotes from my business partner, I definitely agree with the conclusions of this analysis. There were some 510(k)s that probably lacked key data and information. And we received requests for additional information from FDA. The submissions which were more thorough had quicker reviews. Yes, sometimes these also received requests for more information. However, these cases were usually handled via email correspondence and phone calls, all while not stopping the review time clock.

Start-ups seem especially anxious to submit a 510(k) to FDA, usually because this milestone is directly linked to a fund-raising event. I blogged about this some time ago. I think the more meaningful milestone is 510(k) clearance but understand somewhat why there is emphasis on the submission. Regardless, the FDA analysis indicates quality of submission has a direct correlation to review time. Start-ups (and others submitting 510(k)s) take note.

You can read a couple other posts on this topic by clicking the links below:

New FDA study: Insufficient 510(k) submissions causing bulk of 510(k) review delays

FDA 510(k) Reviews Result in More Questions Than Ever

 

Filed Under: All, Medical Device - General, Project Management Tagged With: , , , , , , ,
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