Low-Cost Medical Device Design

There appears to be an interesting, albeit still somewhat small, movement happening in the medical device industry. There are a few organizations emerging focusing on simple medical device design to solve real problems in under-served markets. We wrote about Jose Gomez-Marquez and the Little Devices Group finding low-cost solutions leveraging existing products and technologies to solve real medical problems.

I recently discovered another similar group called Shift Labs. Their mission is to make low-cost medical devices to help improve healthcare in low resource settings. I was especially intrigued by the low-cost drip clip device designed and prototyped by the Shift Labs team.  I’m also intrigued by this project because it appears as though they leveraged crowdfunding to fund some of their product development efforts.

And I think the Little Devices Group and Shift Labs are onto something. Not only for medical device product development for low resource markets. But also right here in the United States. With all the recent developments in this country, including increased regulation, medical device taxes, increasing cost of healthcare, and tighter investment funding, I think we will begin to see other organizations emerge and mimic the low-cost device and product development approach. I think we’ll see other inventors and entrepreneurs of medical device technologies leverage crowdfunding models to fund their efforts.

Reward Depends on the Magnitude of Risk

Did you hear about the Powerball lottery jackpot? It’s up over $500 million or something crazy like that. Did I buy a ticket? Yeah, I did–on a whim. Will I reap a huge reward based on my minuscule risk? Well, the odds are not in my favor.

But there is a part of me that believes very much that I have the winning ticket in my possession. Why is that?

And what about other get rich quick schemes. Do you remember how glamorous flipping houses was a few years ago? So many people got sucked into that truly believing they could gobble up a house or two at rock bottom prices, invest a little, and turn around and sell it for mega profit.

Others think that taking a pill will magically transform their overweight and out of shape body into a rock hard, sculpted, ripped muscle machine.

My experience tells me otherwise for all of these things. The reward received is directly proportional to the risk taken. Let me bring this topic a little closer to my world and work.

Earlier this week I had a meeting to kick off a new project. The project will be a medical device product development project and require FDA submission, company formation, etc. The stuff I absolutely enjoy. The stuff that triggered me starting my own business over 6 years ago. I met a friend for lunch after the kickoff meeting. I told her about the project. Yet, she didn’t see or hear the excitement from me that she expected. I seemed cautious, worried, concerned.

Her assessment was spot on. I did feel cautious, worried, concerned. Why?

The project is a very sizeable and is an excellent match with my skillset and expertise. But there is pressure. Pressure to perform. Pressure to hit a target completion date. Yes, I perform very well under pressure. Yes, there is risk with the project. What if there are issues during design and development? What if FDA has questions? What if things happen that we didn’t predict? What if we miss the target date? And I know that all of these things are VERY likely to come to pass. I also know I’ve been through this many times before and will know how to navigate through.

The reward of this project will be commensurate with the risk, as any project should be. It will take hard work to make this a success. Once successful, this project will lead to other exciting opportunities.

When Is the Best Time for Management Review?

Is there an ideal time of year for conducting Management Review? Does it make sense for this to be part of the year-end activities? Or will cramming it into December lose meaning and purpose?

My opinion is that having a Management Review towards the end of the year makes good sense–especially in helping the management team plan and prepare for the next year. My vote would be to have one sometime around Christmas. In my experience, things are usually less hectic for medical device companies during then.

I will be helping three clients conduct Management Reviews in December. Each of these clients has a different take and point of view with respect to Management Review. Let me summarize:

  • Client A – The December Management Review will be the 3rd one for 2012. They are very good about having at least one Management Review annually. However, sometimes the concept of Management Review is used too frequently. In my opinion, the time between Management Reviews is just too short. There are limited resources and their ability to make significant progress on QS and related issues between reviews is difficult. Plus, the team already meets weekly in a change review board to discuss complaints, CAPAs, ECOs, etc. I think this client uses Management Review too frequently. Twice year should be more than sufficient for them.
  • Client B – Currently addressing deficiencies identified in a FDA Warning Letter. They’ve been in business since the late 1970s. I venture to guess that they’ve never had a Management Review. And as we’ve worked through the deficiencies, I’m not sure they see the vision and benefit of this or any other QMS related activity. We are having a Management Review because we have to.
  • Client C – Hired CQ as a proactive measure, realizing their practices might not be in complete alignment with QS regulations. They want to be better and have asked me to provide guidance and direction to help them with compliance related initiatives. While they too have never held a Management Review, they realize the purpose of this and want to begin this practice this year.

Okay, three different “flavors” and approaches to conducting Management Review. And my advice to you is to incorporate Management Review as part of normal business. Just doing it to check it off the list really defeats the purpose.

Build A Cushion Before Making Leap Into Entrepreneurship

A couple weeks ago I participated in a panel discussion at a startup event at Rose-Hulman. The event was organized by student entrepreneurs known as Rise! The panel I participated on was “barriers to entry”. And I’ll admit that prior to the event, I thought about barriers to entry much differently than the way the discussion went. Many of the questions were about barriers to starting a business.

The audience at this event was largely students. Yet, there were a few in attendance who reminded me of myself from a career standpoint 6 – 7 years ago. 30-somethings who have had plenty of the corporate world and have a flavor for entrepreneurship. However, because of the career path and choices to date, making a leap into entrepreneurship presents a large risk–large for the spouses and kids involved.

I shared some of my thoughts about safe(er) ways to enter into entrepreneurship, ways to help insulate spouses and families from risks. The biggest thing I offered was to start a venture during nights and weekends while maintaining the current day job. All revenue generating from the side project should be stocked away and become a cushion for one day in the future. This was the path that I was able to choose before going completely on my own. It took five months of building a cushion before making the leap. And fortunately, my family did not notice a difference in our way of life when I made the switch.

I just finished reading an article on Forbes.com “What Would You Do If You Got Fired Tomorrow?” which caused me to think about this topic a little more. As I told the audience at the Rose startup event, I credit getting fired as a catalyst for me starting my own business. But at the time of being fired, I was in no way as prepared as I should have been. And this article provides a few very good tips I wish I would have considered all those years ago.

You may think you have a stable and secure job. And you might be right. But sometimes, you just don’t know. When you find yourself most comfortable and complacent is when you are the most vulnerable.

I also think the Forbes article is very good for anyone considering entrepreneurship and starting a business.


New Medical Devices Need A Regulatory Strategy

I’m working with a physician inventor on a new medical device idea. It’s early yet I have been focused on the regulatory strategy for this product. Initially, the inventor identified a few potential competitive / predicate devices to compare to. The predicates are all pretty complicated gadgets containing both electrical and mechanical parts and are FDA class II.

But as I’ve learned more about his idea, I’ve realized his concept is much simpler than predicates and does not include electronics. I might have found a legitimate and probably even more likely path for his product which will be class I.

Why will this matter? If we can proceed as a class I, I anticipate the following to be true (versus class II):

  • Shorter timeline to market.
  • Less capital required.
  • No FDA submission.
  • Ability to test clinically sooner.

It’s my opinion that all new medical devices should have a regulatory strategy. The strategy should thoroughly explore all viable options and include markets other than just the U.S. Sometimes when you dig a little below the surface, you may be able to find applicable regulatory codes that the inventor did not know about initially. And in the end, the ability to get a product launched in the market and generating revenue as quickly as possible for its intended use is ideal.

Good Read for Aspiring Entrepreneurs

Over the weekend, I came across 21Times, a resource that claims to help inspire entrepreneurs to turn side projects into businesses. I decided to go ahead and sign up–what the heck.

If the first email from 21Times is any indicator, I’m glad I signed up. The article shared is from Spencer Fry title “How to Bootstrap”. Now I don’t know who Mr. Fry is or how much success he has had. But I found his blog post interesting and thought you might get a few insights from it as well.

Topics covered include:

  • Idea Generating
  • Team Building
  • Off Hours
  • Consult on the Side
  • There’s No Need to Rush
  • Building Organically
  • Making That First Dollar
  • When Investors Come a Calling

Medical Device Entrepreneurs Need to Start at the Beginning

But where is this? I guess because of the years of experience I have with medical device product development, I often times take the process too much for granted. This became a little evident to me the other day while talking with a medical device inventor / entrepreneur.

The inventor is an ER doctor who developed an idea for a novel solution to a problem he has had to treat a few times. I had the opportunity to hear the doctor speak at an event a couple weeks ago. He was very humble and apologized several times for being out of his element. But the doctor spoke very well, almost eloquently, about the issue. The audience was on the edge of their seats, listening intently. When it was time for Q&A, nearly half the audience threw their hand up to ask a question. I think the question and answer session lasted as long, maybe even longer than the presentation.

A few days afterward, I had a chance to connect with the inventor via email. He humbly admitted again that he was out of his element and wanted to know if I would be interested in talking to him. Of course. We had that first, semi in-depth conversation a couple days ago. I provided a high-level overview of medical device product development. And the doctor was very hungry for knowledge on this topic. He understood that we needed to start at the beginning and asked question after question to understand what this means and where the beginning actually begins.

It was actually very refreshing for me. Not always, but many times when working with inventors / entrepreneurs, they are more concerned about the end rather than starting at the beginning. Within the next couple weeks, I expect to have a face to face meeting with the doctor. He asked if we could use this time to review medical device product development process and discuss FDA Design Control regulations.

Pre-Market Notification Process for Medical Devices – A 510(k) Step by Step Example

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 (and his colleagues) at Medical Device Academy blog

Thank you for reading my previous posting on Creo Quality, “CE Marking Process for Medical Devices – A Step by Step Example” from August 14th. This third posting in the series explains the process for obtaining US FDA Clearance for medium-risk Medical Devices.

For our example, we will be using the same hypothetical client for Jon to help.

Jon’s client called to say that they are now ready to tackle the US market. As with the Canadian and European markets, the US FDA considers cyanoacrylate a medical device when it is used as a topical adhesive. Jon’s first step is to determine the device classification. Jon’s client was considering asking the FDA to identify the classification of topical adhesives using the 513(g) submission process, but Jon had a free solution. Jon showed them my blog from September 11th (http://wp.me/p19REq-8E)—which conveniently used another topical adhesive as an example.

The information provided in my earlier blog identifies topical adhesives as a Class 2 device with the three-letter product code “MPN”. This product classification also gives Jon’s client additional options that are not available to all companies that are trying to achieve 510(k) clearance for the first time. Most new products can only achieve initial 510(k) clearance from the US FDA by submitting a “traditional” 510(k). This process is supposed to take 90 days—assuming there are no significant questions about the submission and there are no backlogs with the reviewer.

For some products, there are recognized consensus standards (i.e. – ISO Standards) that define the performance requirements for a medical device or a Special Controls document published by the FDA that identifies which performance Standards the FDA requires for a specific product classification. In the case of topical adhesives, the FDA has published a Special Controls document. When there is a Special Controls guidance document available, the company may submit an “Abbreviated 510(k)” instead of a Traditional 510(k). An Abbreviated 510(k) contains summaries of all the testing results required in the Special Controls document or in an ISO Standard recognized by the US FDA. Since all the required performance testing presented in an Abbreviated 510(k) is in accordance with a previously accepted standard, the FDA reviewer only has to verify that the performance testing identified in the Special Controls document or the ISO Standard has been completed and acceptance criteria have been met. Therefore, the reviewer needs less time and clearance can be achieved in 60 days—instead of 90 days.

In addition to Special Controls documents, the FDA also has guidance documents for other things, such as: “Format for Traditional and Abbreviated 510(k)s.” By following this document verbatim, Jon can avoid a lot of time-consuming questions from a reviewer that is having trouble finding the information they are looking for. If a section of the suggested format is not applicable, Jon knows that he should still include this section. However, he should indicate the reason why this section is not applicable in a brief paragraph (i.e. – a one page section).

As Jon reads through the Special Controls Guidance document, he realizes that a specific format for Abbreviated 510(k)’s is described for topical adhesives. Therefore, Jon modifies his normal template to match the FDA format for topical adhesive Abbreviated 510(k)’s. As Jon reads further, he realizes that there will be some additional testing required that his client may not have anticipated.

In the Special Controls document, there are several risks and recommended mitigation measures identified:


The risks of adverse tissue reaction, chemical burns, and infection have all been addressed by biocompatibility testing and sterility testing. Jon’s client also performed animal testing to identify any problems in a simulated use environment. However, the client did not perform any testing to specifically address unintentional bonding, wound dehiscence, applicator malfunction or delayed polymerization. Some of these questions were asked and answered during the CE Marking application process, but the client did not have formal protocols and test reports to address these risks.

Another difference between testing that Jon’s client performed in the past and the US FDA’s requirements for a 510(k) submission is the concept of a predicate device. Jon’s client needs to select a similar topical adhesive that received a 510(k). Ideally, a recent 510(k) should be selected because “old” technology may no longer be considered acceptable from a safety standpoint. In the case of topical adhesives, the applicator is one of the primary differences between legacy products and more recent 510(k) products. The most recent version of Surgiseal™ (see picture below) is an example of a new applicator for a monomeric, 2-octyl cyanoacrylate similar to the product Jon’s client is selling in Canada and Europe.

Jon’s client has a similar applicator design to the pictures above, and therefore Surgiseal is selected as the predicate device for this hypothetical 510(k) submission. For all the testing protocols that need to be created for this 510(k) submission, comparative testing is performed with a sample of Surgiseal and a sample of product made by Jon’s client. In each of these protocols, the acceptance criteria is performance “not worse than Surgiseal”.

In addition to completing the testing required for the 510(k) submission, Jon’s client also needs to add procedures to their Quality System to address unique US FDA requirements. Jon’s client already has a training procedure, but the data analysis procedure does not address the requirement for statistical techniques in 21 CFR 820.250. There are also requirements for maintaining a device master record (21 CFR 820.181), medical device reporting (21 CFR 803) and corrections/removals (21 CFR 806).

Jon’s client completed all of the required testing protocols comparing their new product with Surgiseal™ within 10 weeks. During this same period, Jon helped them to update their procedures to meet the FDA’s specific requirements that are not included in Canadian or European legislation or the ISO 13485 Standard. Finally, Jon’s client was ready to pay their fee for the 510(k) submission and submit the 510(k) for review. The FDA reviewer requested copies of a few of the reports that were summarized in the submission: biocompatibility testing reports, sterilization validation reports, and a usability report that was created to address human factors concerns related applicator malfunction and use errors. Each of these reports were provided by email within 24 hours of the request. The reviewer had no further questions, and the 510(k) clearance letter was issued within 55 days of initial receipt.

After receipt of the 510(k) clearance letter, Jon’s client registered with the FDA as a device manufacturer and specifications developer and began selling in the USA.

What Is the Real Purpose of Medical Device Management Review?

Conducting Management Reviews is required form medical device companies per FDA 820.20 quality system regulations. Specifically:

Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer’s established quality policy and objectives. The dates and results of quality system reviews shall be documented.

And if you think about it, a periodic review of a company’s systems, processes, procedures, etc. does make very good business sense.

However, most medical device companies seem to treat Management Review as a checkbox activity that must be done because the regulations say so. And in some cases, I’ve witnessed Management Reviews as the time when executive management pays attention to the business. To me, this doesn’t work. In my opinion, executive management should always have their finger on the pulse of their business.

I’ve also rarely witnessed when Management Reviews actually effectively evaluate the suitability and effectiveness of a company’s quality system. Yes, the results of the various QS processes are reviewed and discussed, but executive management seems to be out of touch with QS efficiency.

I’ve also witnessed executive management using Management Reviews to assert their authority and dictate new initiatives that seem to be more of a whim than driven for overall streamlining and improvement.

Okay, I guess I just told you several things that Management Review should not be. So what should it be?

Management Review should critically and methodically evaluate quality data and objectives. To me, it starts with the overall vision and strategy of the company. So if the company lacks vision and strategy, then this must first be defined. With a strategy in place, quality plan and objectives can be defined to align with the overall vision and strategy. Management Review assesses whether these objectives are appropriate. Management Review is a time when course adjustments can be discussed in order to stay in alignment with the vision.

Make Sure There Is “Pain”

A couple months ago, I got connected to an inventor who has an idea for a new medical device. His inspiration came from literal pain and suffering from a procedure he had to endure as a patient.

Last night, my best friend told me about an idea she has for a new software application. Her inspiration came from figurative pain entering data into her computer.

Both ideas have merit. Both ideas are novel. Most importantly, both ideas were inspired by “pain”.

And I think this is VERY important for any product development endeavor. Your idea maybe the coolest thing ever. But if it does not solve a real problem and reduce / eliminate pain of some kind, then you are probably wasting your time.

CE Marking Process for Medical Devices – A Step by Step Example

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 (and his colleagues) at Medical Device Academy blog

Thank you for reading my previous posting on Creo Quality, “Canadian Licence Process for Medical Devices – A Step by Step Example” from July 30th. This second posting in the series explains the process for obtaining CE Marking approval for a Medical Device.

For our example, we will be using the same hypothetical client for Jon to help.

Jon’s client called to ask if he could help them expand into the European market. As with the Canadian Market, Europe also considers cyanoacrylate a medical device when it is used as a topical adhesive. Jon’s first step is to determine the device classification as per Annex IX in the Medical Device Directive (93/42/EEC as modified by 2007/47/EC). Instead of relying solely upon the Directive, Jon also uses guidance documents published on the Europa website–specifically MEDDEV 2.4/1 rev 9 (the following link explains the European MEDDEV guidance documents – http://wp.me/p2DThn-1r).

Jon identifies three potential device classifications: 1) Class 1 as per Rule 4 (a non-invasive device which comes into contact with injured skin, if the device is intended to be used as a mechanical barrier, for compression or for absorption of exudates); 2) Class 2a as per Rule 7 (a surgically invasive device intended for short-term use [i.e. - < 30 days] are in Class 2a; and 3) Class 2b as per Rule 8 (an implantable device). These three applications match the three possible applications that Jon identified when he was reviewing Canadian Device licenses.

If this device were not required to be “sterile”, then a Class 1 device could use the Annex VII route of conformity (i.e. – self-declaration). However, even generic bandages are sold as sterile devices. Therefore, whether the device is a sterile Class 1 device or a Class 2a device, obtaining CE Marking approval will still require a Notified Body’s review and approval. The most common route would be the Annex V route of conformity. If Jon’s client were to launch their product as a “glue” for internal use, then the device would require an Annex II.3 Full Quality System Certificate or the combination of an Annex V Certificate and a Type Examination Certificate (i.e. – Annex III).


The previous paragraph was hard to understand, but the source of this jargon is Article 11 of the Medical Device Directive. This one section is best practices in European legalese. If you want to make something almost unintelligible, copy Article 11. If you want to understand this stuff, a flow chart of the various routes to conformity is as good as it gets (still hard to understand, but fewer words).

What you need to know…

Jon’s client only has one product family and they are currently selling the product in Canada for external use by healthcare professionals—not as an implant. Therefore, the device is a Class 2a device requiring an Annex V certificate. Jon’s client will need to do the following:

1)      Select a Notified Body

2)      Submit a Technical File for review and approval

Fortunately, Jon’s client already obtained an ISO 13485:2003 certificate with CMDCAS from their current registrar as part of the Canadian Licensing process. Therefore, the changes required for the Quality System consist of adding a few work instructions to meet European-specific requirements, such as vigilance reporting, creating a technical file and performing clinical evaluations. Jon’s client also needs to add the European Requirements as an applicable regulatory requirement in the Quality Manual.

The bigger challenge is assembly of a Technical File for submission. Since the product is already on the market in Canada, all of the technical requirements have been met. The documentation of these requirements now needs to be converted into a format acceptable to a Notified Body. There are three recommended strategies:

  1. What ever the Notified Body prefers. Some of the Notified Bodies have a checklist of requirements for a Technical File. If such a checklist exists, the client should organize the Technical File in exactly the same order.
  2. The GHTF STED format (GHTF/SG1/N011:2008). The Global Harmonization Task Force (www.ghtf.org) published this guidance document in an effort to standardize the format for submission of regulatory submissions. This is the format required for Class 3 and 4 Canadian medical device license applications.
  3. The NB-MED recommended format (NB-MED 2.5.1/rec 5). This document was created by the “Big 5” Notified Bodies. It provides a template in a two-part format for submissions. This is the format I use most often for auditing files and for creating new files.

Jon’s client chose option 3 for organizing their Technical File, because they have full reports for each of the verification and validation tests that were performed, but creating summaries for each report would take longer than assembling a Technical File with copies of each of these full reports.

In all, Jon estimates that his client can complete their preparations in about 60 days. Therefore, Jon suggested that the client obtain a quotation from their registrar for an Annex V Certificate. In addition, Jon suggested hiring a consultant to help them with preparation of a Clinical Evaluation. Prior to 2010, Clinical Evaluations were only required for high-risk devices. As part of the new MDD, clinical evaluations are now required for all devices. Since the use of and risks associated with cyanoacrylates is well characterized in published literature, Jon’s client may use a literature search method for preparing a Clinical Evaluation as per MEDDEV 2.7/1 rev 3.

The company hired an authorized representative to handle European registration, receive customer complaints and to act as a liaison with the Competent Authority in the event of an adverse event. An Authorized Representative Agreement was signed, and the Authorized Representative recommended a few corrections to procedures they reviewed as part of entering the contract with a new client.

The company also hired a regulatory consultant that was able to complete a literature search and write a Clinical Evaluation within 4 weeks. The complete Technical File was assembled and submitted to the Notified Body electronically with 7 weeks of starting the project. The Notified Body’s first round of questions were received within 6 weeks. Jon and the client prepared responses to the questions in a week and submitted them to the Notified Body. Fortunately, the responses were thorough and the Technical File was well-organized from the start. The Notified completed their final review and recommended the product for CE Marking within 3 more weeks. The Notified Body conducted two panel reviews to verify the technical, regulatory and risk aspects of the submission. Finally, the Annex V certificate was received 12 weeks after initial submission of the Technical File.

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

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 (and his colleagues) at Medical Device Academy blog

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


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.

Tips for Taking a Medical Device Startup to the Next Step

We told you a couple weeks ago that CQ UniDoc was to be featured during the Innovation Showcase. It was a good opportunity and learning experience.

Prior to the event, we had taken some baby steps towards commercializing the product. Since the event, I have been thinking about the overall business strategy for UniDoc. And I need to spend more time on this.

In the meantime, I thought I’d share some tips that I read about things a startup should do to get to the next level. I shared some tips from a few articles: From Contest to Company: 6 Tips for Taking a Startup to the Next Level, 5 Sure Signs a Startup Firm Will Succeed, and 12 Rules for Building Your First Profitable Startup. While the tips provided are not unique to medical device startups, they certainly apply.

  • Baby steps matter – Don’t be afraid to take baby steps and fail quickly
  • Has validated customers - A successful startup scales its growth on the basis of proven, steady and paying customers.
  • Sell something - If your company isn’t selling something, you have a project, not a product.
  • Replace part of your customer’s workflow with a better solution – Look at your prospective customers’ current business processes and identify steps or tasks of theirs that can be simplified, automated, or eliminated.
  • Don’t Plan for Exits or VC Money - Focus on selling your product for a profit.

Reading these articles has provided some food for thought for me regarding UniDoc. I hope these help you too.

Medical Device Companies Should Always Be Ready for FDA

Within the past year or so, I’ve had several clients go through FDA inspections. While this experience can be very stressful for a company, it shouldn’t ever come as a surprise. If a company is registered with FDA, they should expect a visit every few years. The trouble is that many medical device companies have never had a FDA inspection. And sometimes this can lure a company into a false sense of security.

CQ has had a couple clients hire us recently to be more proactive regarding their quality system and preparations for a potential visit from FDA. We applaud these companies for their approach. While the clients have had some gaps and issues to address, they had enough vision and foresight to realize it was necessary to bring a fresh set of eyes with FDA quality system experience in to review their practices.

Interestingly, one of these clients was called a couple weeks ago by FDA. Guess what? FDA was informing this client that they would be visiting for a QSIT inspection. Although the company had not fully implemented the things CQ identified, the company did have a plan in place and has been actively working on addressing identified issues. This did not prevent them from receiving some 483 observations but might have saved them from receiving a warning letter.

The advice we provide medical device prospects and clients is that they should proactively and objectively evaluate their quality system from time to time to ensure that their practices and procedures are up to speed and in compliance. Medical device companies should always be ready for a FDA inspection too.

Why Do Small Medical Device Companies Overburden Themselves with Wordy Procedures?

During the past few months, CQ has been working with a number of small medical device companies. While the products these companies produce are vastly different, they all have similarities in their culture and day-to-day business practices. And of these commonalities, the one that is most glaring to me pertains to the Quality System.

First, I should qualify that I prefer a descriptive meaningful picture instead of pages and pages of words.

Apparently, though–at least from my recent experiences, small medical device companies prefer lots of wordy procedures. In my opinion, my small medical device clients are overburdening themselves because of their QS. Yes, I know they need to address the FDA / ISO QS requirements. However, I’m kind of confused why they chose to waste so many words on paper to do so.

I suspect the reason is pretty simple. Many of the procedures I’ve been reviewing are more or less a regurgitation of FDA and ISO terminology. The company puts their “unique” spin on things, adding their lexicon and specific terminology. And while their procedures may in fact be in compliance with the regulations, I know there is a huge disconnect. I know they are NOT in compliance because they don’t always follow the words written in their procedures.

I know there is a better way to document QS procedures–especially for the small medical device company. My simple advice is this: map the processes and create a pretty, easy to follow flow chart.