FDA 510(k) or CE Marking?

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 (and his colleagues) at Medical Device Academy blog

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!

Using LinkedIn to Expand Medical Device Network

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.

Helping Medical Device Inventor By Paying It Forward

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.

Sometimes Being Brutally Honest Pays Off

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.

Executive Management Must Be Engaged

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.

Morgan County Seeking Jobs

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.

What Comes First: Design Input Requirements or Prototype?

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.

Watching A Train Wreck

“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.

If FDA Knocks, Are You Ready to Answer?

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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Why Does Schedule Mean More Than Scope?

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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Understanding Strategy Is Tough

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.

When Clients Look Fail to Make Decisions

For the past year, I’ve been working for one of those clients that I could write a book about. You know, one of those how-to books, except this would be a how-not-to book.

Without going into too much detail, it’s been a little frustrating. Frustrating because the small team of consultants knows their stuff and has provided solid direction for the client on what to do and how to do it. The problem is the client fails to make a decision either way. But it has been okay; our team moved onto the next issue, identifying issues and potential solutions, hoping the client would eventually make decisions about direction and next steps.

However, decision-making and progress has been really SLOW.

Here we are, a year later, with little real progress to show. Yes, we have uncovered quite a few gaps and issues to address. Yes, we have communicated the ramifications. Yes, we have identified multiple mitigations and paths forward. No, the client has taken no ownership in owning the responsibility to do something about the issues.

I keep hoping that tomorrow will be the day that some decisions are made–any decisions, even ones I wouldn’t entirely agree with. We are just looking for direction. We are just looking for some closure.

Maybe tomorrow . . .

Medical Device Inventors Need to Trust

I had lunch with a friend the other day. We were sharing stories and catching up, mostly about the goings on in Indy’s medical device scene. My friend asked if I had heard from “Tom” lately. Tom previously met with each of us separately to discuss his revolutionary medical device idea. When I met with Tom, I laid out several things for him to focus on and to address in order for him to get to the next step. Tom approached my friend, who is more involved with the funding side of medical device product development. My friend asked Tom several questions, including:

  • Are you willing to give up equity in exchange for funds? Tom’s response: No.
  • Are you willing to give up control and let someone with a proven track record run the business? Tom’s response: No.
  • Do you know how much tooling and development will cost? Tom’s response: No.

Does Tom have a good idea? Maybe. But until he realizes he has to trust others, we may never know. Not to diminish Tom’s expertise, but the idea is easy.  Taking the idea to the next step into product development will be challenging. Frankly, Tom does not have the skill set or experience to do this. Tom has to realize he has to trust others to make it happen. Tom has to realize that to get funding, he will have to give up equity and likely control of his business. If he doesn’t, Tom will only have an idea.

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Get Your Medical Device To End Users ASAP

I’m working with an Indianapolis-based start-up medical device company. We have been working aggressively the past few months to initiate a clinical investigation. No, the product is not ready for production (although the current version does have FDA 510(k) clearance). The product concept is interesting, and I’ll admit, I’m not sure if it is valid.

There’s only one way for us to find out: get this medical device to the end users ASAP. Hopefully you understand there are challenges and regulations to get a medical device ready for actual use, which sometimes can be costly and extremely time consuming. If you don’t have the budget to go the clinical route, there is still a great deal you can learn by engaging end users in concept generation, bench testing, and simulated use studies.

Your goal should be to find out as quickly and inexpensively as possible whether your idea has merit and what features and benefits are important to actual users of your product. Chances are you will be surprised. Chances are what you think is critical may in fact be trivial to users. Chances are the end users will identify surprises and things you haven’t considered.

End user input into your medical device product development also brings validity and credibility to your efforts. And hopefully you realize, this will also increase your chances if and when you need to raise funds.

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