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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: , , , , , , ,

Tips for Taking a Medical Device Startup to the Next Step

July 25, 2012 By Leave a Comment

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.

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

Medical Device Companies Should Always Be Ready for FDA

July 23, 2012 By Leave a Comment

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.

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

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

July 20, 2012 By Leave a Comment

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.

Filed Under: All, Ask CQ, 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: , , , , , , , ,

Using LinkedIn to Expand Medical Device Network

July 5, 2012 By Leave a Comment

During the past couple months, CQ has been in the midst of an experiment. No, we have not been mixing chemicals in a lab. No, we haven’t been tinkering with a medical device concept and prototype (at least not directly).

Our experiment has been more in the realm of growing our network and expanding our brand awareness. And I think it has been working. So what did we do?

The main thing that we did is get more engaged on LinkedIn. We found and joined several medical device related groups, including Medical Devices Group and Medical Devices and FDA. We made it a point to visit many of these groups every few days to review the topics being discussed. When we had something to contribute to the discussion, we added our comments. We also decided to post topics for discussion from time to time. Usually, the topics came from our current client engagements and needs. Through our review of the topics being discussed, we started to gauge the topics of interest in the medical device community. We used this information to help us with the content on the CQ blog.

How do I know it’s working?

We have made several new connections on LinkedIn since working on this experiment. We have exchanged emails and in a couple cases had phone conversations with many of these new connections. We have added several of these contacts to our TFMail email marketing list. We have been contacted by a few inventors / entrepreneurs looking for help with their medical device ideas, including the one described in a previous post, which has led to us reconnecting to others in our pre-experiment network and then making more new connections on LinkedIn. You get the point.

Basically, we found several receptive medical device communities through LinkedIn groups and have become active contributors. And we have found that this process is very cyclical and rewarding. We will continue the experiment.

Filed Under: All, Community, Connect, Strategy vs. Tactics Tagged With: , , ,

Helping Medical Device Inventor By Paying It Forward

July 4, 2012 By Leave a Comment

During the past few weeks, I have been helping a person I don’t know and have only met once via a Skype video call get feedback about his medical device concept. The person did not offer me any compensation, nor did I request any payment. I just offered to put some feelers out and see what kind of feedback and responses I could get.

Why? I know I have a top-notch network and am either already connected or easily could be connected with physicians who can and will provide feedback for the inventor. I know that I can help this person understand the medical device product development process just a little better. I know that if the idea isn’t worth pursuing, taking this approach makes the best sense for the inventor–spend as little as possible to find out if the idea is worth taking to the next step. I believe if the idea has merit, this inventor (and maybe others like him) will have an interest in working with Creo Quality.

Yes, it’s definitely a “pay it forward” kind of strategy. Yes, I realize I may never receive any revenue from doing something like this. And that’s okay.

While the feedback is still coming in, I did get one response from an expert in this particular device space. The expert is very interested in helping with a prototype and other business development / research activities. I connected him directly with the inventor.

Filed Under: All, Ask CQ, Catalyst, Connect, Product Development - General, Strategy vs. Tactics Tagged With: , , , , ,

Sometimes Being Brutally Honest Pays Off

June 27, 2012 By Leave a Comment

Last week, I shared a story about a meeting I had with a medical device startup CEO. The topic of discussion was the importance of complying with FDA design controls. I listed this article in the sidebar of the most recent CQ Catalyst newsletter.

This morning, the CEO sent me a message about this post. He was very complimentary and thanked me for writing about our conversation. A few moments ago, he called me. He again thanked me and stated that the way I discussed the topic in the blog was done very well. He appreciated the brutal honesty and the strong statements I made about design control compliance being mandatory for medical device companies. He also appreciated that I didn’t write the post like a sales pitch.

He then said that our conversation and the words in the blog post were compelling enough for him to hire CQ to help ensure their medical device efforts are in compliance with FDA design controls. We should start our efforts with them in a few weeks.

I guess it goes to show some prospects and clients really do appreciate brutal honesty.

Filed Under: All, Design Control, Medical Device - General, start-up, Strategy vs. Tactics Tagged With: , ,

Executive Management Must Be Engaged

June 6, 2012 By Leave a Comment

Being a consultant is very interesting most of the time. We are brought in to help our clients with issues they are struggling with for a variety of reasons. Sometimes we are extra capacity. Other times, we provide strategic guidance. At the end of the day, regardless of the engagement, Creo Quality is there to add value.

From time to time, though, the value we bring seems to get lost. From time to time, we have had client engagements that just didn’t work out the way we had envisioned. I find myself in one of these situations right now.

For much of the past year, I have been a resource to help provide guidance, direction, and expertise for this particular client. And it seems like I spend more time fighting fires than making any real, tangible progress. For months now, I have been very frustrated. It always seems as though there is one difficult obstacle after another to address. From FDA inspections, to facility disasters, to product issues, to ISO audit, to potential recall. It has been a trying several of months with this engagement.

And I must admit, that I knew that this client would be difficult from day one. Plenty of others also warned me. I thought I was going into this situation with eyes wide open, and I think they have been. But there is something about me that you should know. I truly am an optimist. I try to find that proverbial silver lining in every situation, including this engagement.

The team I get to work with is pretty solid. All are hard-working and do the best they can day in and day out. However, there is a wild card involved and has been since the beginning of my time with the client: executive management. In my opinion, the executive management team just isn’t as engaged as they need to be. In spite of this, the company continues to survive. As I have had a chance to work with the team and executive management, I have found myself scratching my head. How does this company continue to survive issue after issue? And lately, I’ve been wondering. How successful could this company be with a solid, engaged executive management team?

I’m trying to learn valuable lessons from this engagement. I’m trying to figure out the formula for success based on the not so stellar example I see in this client. And here are a few of my thoughts for a successful company, regardless if it is a startup or established business:

  • Executive Management must be engaged and have their finger on the pulse of the every day goings on of the business.
  • Executive Management must set a clear vision and establish a realistic strategy.
  • The company’s values and goals must be written down and communicated often throughout the entire organization.
  • A solid team is necessary to execute the tactics supporting the vision and strategy.
  • Setting clear, objective priorities is a must.

Bottom line: A company lacking executive management that is engaged will struggle, regardless of how good the team players are.

Filed Under: All, Strategy vs. Tactics Tagged With: ,

Morgan County Seeking Jobs

January 27, 2012 By Leave a Comment

When I read this story from Inside Indiana Business about Morgan County seeking jobs, my first reaction was a little visceral. Why, you might ask? Creo Quality communicated the need to identify the county’s assets four years ago. We also completed a couple of similar community based projects during 2011.

Now that a few minutes have passed since my initial read of the story, the visceral feelings are gone. Congratulations, Morgan County for getting off the sideline. I believe there are wonderful opportunities here and tremendous assets. A great first step is to identify what these assets are and then determine how to best utilize them.

Filed Under: All, Community, Strategy vs. Tactics Tagged With: , , , ,

What Comes First: Design Input Requirements or Prototype?

October 24, 2011 By Leave a Comment

Okay, this is kind of a trick question. Actually, what should come first the the unmet clinical need. But once you’ve identified the unmet clinical need, what do you do next? Do you define the product’s design inputs? Or do you proceed to building some type of prototype?

I’ve taken both approaches. And I’ve often wondered which is best–which is correct.

I think I now know which approach makes the most sense. Build the prototype first.

Why? A prototype is so much better at communicating than words can ever be. Put a prototype in the hands of end-users, and they can tell you everything that is right about it. More importantly, they can tell you everything that is wrong too.

Capturing and documenting design input requirements becomes so much easier when end-users are able to conceptualize the product, especially if they can hold and manipulate it in their hands.

So go build the prototype. It doesn’t have to be perfect. It doesn’t have to be made using production materials or processes. It has to be good enough to communicate a solution to others.

Then take the information you learn with this prototype and document the design input requirements. And refine the prototype to learn more and more until you have the product design right.

It’s important, though, to not get too stuck in this cycle. It’s easy to do, especially for engineering types. Don’t try to make the perfect product with all the bells and whistles. Know when the product is good enough to address the unmet clinical needs and get it to the market as quickly as possible. Be sure you’ve proven its safety and efficacy, and of course be sure to document all of this along the way.

Filed Under: All, Design Control, Design Input Requirements, Product Development - General, Strategy vs. Tactics Tagged With: , , , , , , , , ,

Watching A Train Wreck

September 27, 2011 By Leave a Comment

“It’s like watching a train wreck”. I’ve heard this expression several times and repeated it myself often, especially since starting consulting several years ago. And it seems like a few client engagements in 2011 have been train wrecks of sorts.

I usually look forward to these types of engagements. Usually these opportunities present quite a bit of “low hanging fruit” to help the company in question make a few tweaks and modifications to drastically improve outcomes. Many times, this type of scenario works out well, allowing us to establish a strong bond and rapport of trust very quickly.

However, there are those occasions where this type of scenario never pans out. We are nearing the end of one of these engagements now. We’ve been working for the client for several months. From day one, we quickly identified several opportunities to improve the situation. We shared our findings and were ready to start making progress. But the culture of the client wasn’t ready to tackle the solutions quite yet. So we moved on to the next set of issues. Same result.

This cycle repeated itself over and over during the course of the engagement. Now as we prepare to wrap up our engagement, I’m reflecting back on this experience to see what lessons I can take away and what milestones we were actually able to achieve. Finding significant milestones is tough. Yes, we did make a few improvements, albeit very minor in the grand scheme of things. But there are a few lessons I’ve learned:

  • Be sure executive management is on board. If not, it will be a bumpy ride.
  • Determine who the go to people are at the company. Just because someone is in a certain role with a certain title doesn’t mean this person has the necessary knowledge and expertise to be an asset. Just as important, there are people “hidden” within the company who possess a wealth of knowledge. These are the people to seek out and find as early as possible.
  • Give the client a “warm fuzzy” by showing progress sooner, even if what has been requested is a huge nebulous cluster. Figure out a way to deliver some work product for near immediate feedback. Don’t just put your head down and chip away at the big, hairy item requested.
  • Sometimes the client doesn’t know what they want, need, or asked for. Figure out what the client knows and doesn’t know. If there is something the client doesn’t know, help educate them. Use objective evidence, such as FDA regulations, as a reference rather than just sharing your own personal experiences and opinions.
  • Find the people who don’t want you there and who are constantly trying to undermine your efforts. These people often feel threatened by your presence. Try to turn them into allies. Try to help them with their needs.
  • Be firm, yet fair. Rather than try to place the nice guy all the time, be objective. Clients deep down do appreciate truth, even if it might sting a little.
I’m sure we’ll have other challenging client engagements in the future. In fact, we may just be at the beginning of another one now. I’m sure I’ll have more insights to share about this experience sometime very soon.
Filed Under: All, Project Management, Strategy vs. Tactics Tagged With: , ,

If FDA Knocks, Are You Ready to Answer?

July 17, 2011 By Leave a Comment

If I look back over the past couple years of business, I notice a common theme from client engagements: address FDA-related non-compliance issues. Sure, maybe this is to be expected since our business focuses on the medical device industry. Regulatory compliance is the name of the game and in our wheelhouse of services and expertise.

But I continue to be a little surprised by some of these engagements and how little the client companies are prepared in case the FDA comes for a visit.

If you are a medical device company (or other company regulated by FDA), you should ALWAYS be prepared for visit from FDA. Technically, FDA is supposed to conduct site inspections of registered companies every couple of years. And if you happen to have product issues, expect the nature of the inspection to be quite a bit more stringent.

What can you do to prepare for a FDA inspection?

  • Conduct internal audits of your processes per Quality System Regulations (which you should be doing any way).
  • Bring in an objective third party at least once a year to thoroughly audit your processes and procedures against FDA regulations.
  • Conduct management reviews annually (and I suggest semi-annually). Be critical of complaint handling, CAPA, supplier management, risk management, document control / record management, and design control processes. Be sure these processes are appropriately linked so that data from one process feeds the others.
  • Be overly conservative in decision-making processes.
  • Consider patient and end-user safety first.
  • Follow your own procedures.

Yes, if your company has adequately defined processes and procedures according to FDA regulations and you follow them, you should always be ready for a FDA inspection.

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

Why Does Schedule Mean More Than Scope?

July 5, 2011 By Leave a Comment

I’m just getting started with a new client medical device product development engagement. The project schedule is a 300+ line item MS Project file with a very firm due date. However, the product requirements have not been fully defined and approved yet. Also, the client mentioned project scope continues to creep. The client said regardless of the scope creep, the due date MUST be met.

I know, this happens ALL the time. Every time, I ask why? How can the project schedule be defined when the project scope is not completely known? How can the project schedule be defined when resources have not been completely determined? When developing a new medical device, there are so many unknowns, not the least of which is regulatory clearances.

I know there is a better way. Hell, everyone involved with medical device product development knows there is a better way. Yet, no one seems to have the ability to try a better way.

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Filed Under: All, Product Development - General, Project Management, Strategy vs. Tactics Tagged With: , , ,

Understanding Strategy Is Tough

July 2, 2011 By Leave a Comment

We recently completed a project for a client. The project was a little time consuming and challenging, like all good projects are. And every step along the way, the client was engaged and challenging us but in a good and constructive way. The project was more strategy based. We evaluated assets and strengths and made some recommendations based on our findings. We provided a strategic vision along with a short list of action items and tactics to help pursue the vision. Not patting us on the back, but we turned in a solid effort for the client. We presented an overview and the results to a small team the client assembled. Lots of discussion, smiles, and head nodding. We signed ourselves up to handle a few of the tactics and offered to assist for the next several weeks, at no additional charge to the client.

We started to complete our actions, informing the client as we did. However, the client’s response suggested they clearly did not understand the several month process and end results we provided. Where was the disconnect?

I think it has a lot to do with strategy. This is yet another example of a client misunderstanding what a strategy is and how to develop an action plan to turn the vision into reality.

Filed Under: All, Strategy vs. Tactics
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