Joy of 510(k) Clearance

Cinco de Mayo was a good day–for many reasons! One of the reasons is that I received notification from FDA that a 510(k) we submitted for our startup medical device client received clearance. Did I mention “5″ is my number? 510(k) clearance on 5/5–pretty sweet!

The project has been rewarding and challenging, as with most medical device product development projects.

I especially found the FDA 510(k) review process to be a bit more challenging than I had expected. A few rounds of “refuse to accept” followed by a reviewer who seemed to challenge just about everything we provided as supporting evidence. Having gone through this experience with a tough and difficult reviewer is something I do appreciate. Working with him actually made the second submission much more complete and smoother (so far) with FDA.

Receiving a FDA 510(k) clearance letter is no small feat. Especially in today’s medical device regulatory market. So much more to do, however. I’ll not dwell on this too long.

Mixed Emotions About FDA

I’ve shared some recent trials and tribulations on current medical device product development projects and FDA submissions. The saga continues. Last week, I received a round of questions from FDA on a 510(k). Yes, we made it through the RTA phase and into the substantiative review. Some of the questions were familiar themes from this submission, having already fielded FDA questions on the same topics during RTA stage of review. As I read the questions, I was more than a little frustrated and agitated. I felt as though the evidence provided, teleconferences with FDA, and email correspondence suggested that what was provided would meet FDA expectations. I thought wrong. A couple of the topics seemed to be somewhat time consuming to address. Project timeline out the window!

And as I received the FDA questions, I was putting the finishing touches on a complimentary submission. A second submission that had direct ties and linkage to the content of the first. As I took a break from compiling the second submission to read 510(k) questions, I immediately put the breaks on. Based on FDA comments, there was no point in sending the second 510(k) until the questions were answered. Second project timeline be damned too!

Did I say frustrating?

But at the same time, as a potential consumer and recipient of medical device technologies, reading the level of depth and detail of the FDA 510(k) questions was also encouraging. The types of data and information expected is a little bit remarkable and definitely thorough. More thorough than just about any other 510(k) submission I’ve read or been a part of. As a consumer, I felt that FDA is doing the proper due diligence to ensure new devices introduced in the U.S. are as safe and effective as possible.

I immediately shared the list of questions with the medical device startup. It was a Friday, and not exactly the news any of us wanted going into a weekend. But as the startup CEO lamented, FDA establishes the rules for medical device companies. There is little we can do except to react and adjust. And that’s just what we are doing.

Medical Device Perfection – Is It Possible?

Medical device perfection is a matter of perspective. And ensuring your product development team has similar point of view and perspective for your medical device is very important. I think it starts with the vision of the device. It also pertains to what you are trying to achieve and when you are trying to achieve it.

Perfection. Probably not a good choice of words. I’ll try to explain through a short story based on a current medical device product development project.

We are in the midst of a electronic medical device. Without getting into too many specifics, the device is class II. It has a custom designed PCB with embedded firmware (along with a few other electronic components). The electronics are contained within a custom designed enclosure. The device mates with single-use disposable components. We are approaching design verification and gearing up for system testing. But lately, we’ve kind of been chasing our tail (and not catching it) on the design. The device involves measuring pressures. The hardware / firmware resource provided a prototype advertised as ready for testing a few weeks ago. The prototype was delivered to the startup for testing. Within a few hours, the startup put the brakes on stating it was not ready. There was a short list of things to address, and the unit was sent back for tweaks.

A week or so later, the tweaks were made and the unit was given back to the startup. A day later, the startup said it still was not ready.

This happened another time or two until last week. The team sat down face to face to review the prototype. The prototype had all the latest tweaks and adjustments. The startup still had a few issues. The hardware / firmware resource took the device back to make the few minor adjustments. Once completed, I picked it I picked up the device. I walked through it, ensuring the features and functions were addressed. Satisfied, I delivered it to the startup. Within a couple hours, the startup called saying it still was not right. I was stumped.

I dropped everything I was doing and headed to pick it up. I walked through the device again. I felt as though it worked as intended. I decided to bring it home and test it for a few days. I confirmed the device works. Yes, I found a few bugs. But the device works. I let it run for over 2 days. I ran the battery down a couple times. I plugged it in. I changed settings. I communicated this to the project team. We had a meeting earlier today to discuss and review. Prior to the meeting, I hoped we would initiate some performance testing today.

The startup thought otherwise. They listed all the features and reasons the device is not ready. I reiterated that the device works and could be tested further–NOW–to verify performance. It was clear, though, the startup wanted a perfect device before starting testing.

I bit my tongue. During the drive back, I racked my brain. Eventually with my thoughts gathered, I had a chance to chat with the startup CEO. I shared my point of view and opinions. He then stated his: let’s continue moving forward. The near term goal is to prepare a FDA 510(k) submission. To do so we need performance testing. He continued by stating once we make the submission, we have a couple months during FDA review to fine tune and perfect the product. And perfecting the device is critical for this startup; they have no desire to launch an inferior device into the market. I agreed. We need to drive towards a viable device that is safe and effective.

The CEO indicated he relayed this to the other team members. I’m just not sure yet that everyone is on board.

Mad Rush to FDA

Now that the U.S. Federal Government is back in business, will there be a mad rush for medical device companies to send submissions, such as 510(k)s, to FDA? Did the two week shutdown create a backlog at FDA? Have companies been waiting on this day? What about all those submissions that were already in the queue prior to October 1?

I can report that since the shutdown, I have been in communication with FDA on a 510(k) submission. Keep in mind the user fees associated with this were paid prior to shutdown. It’s been encouraging to know that FDA seems to be active reviewing submissions during the past couple weeks.

I can always admit that the shutdown was a little bit of a blessing of sorts too. We have been working on another 510(k) submission and are not quite ready to submit to FDA. Knowing that government shutdown prevented us from providing this submission to FDA was buying me a little time. Now I have no more excuses.

Medical Device Startups Are Like a Craft IPA Beer

Those who know me know I’m a sucker for a good IPA. In my head I’ve been trying to figure out how to correlate my enjoyment for a good IPA and my passion for medical device startups. I’ll confess, I got nothing! Okay, maybe a few points (albeit it is a stretch).

  • Medical device startups are like IPAs. Neither is palatable to the rookie beer drinker.
  • IPAs have a bitter taste. Medical device startups often do too.
  • It’s my opinion that IPAs are highly sophisticated and reserved for the most discriminating of beer drinkers. In the startup world, medical device startups are the same way.
  • Once you get hooked on medical device startups, it’s often difficult working with any other type of company. I’ve learned the same truths about IPAs.

Okay, I could go on. And at the same time I realize comparing a medical device startup to an IPA is a little bit silly. But I’ll say the Black Swan Nugget-Hallertau IPA I’m drinking right now made me write this post. Not really.

Like a medical device startup which has their act together, I have learned to really appreciate the complications of an IPA. Yes, the post is a little in jest. However, IPAs are almost always unique with wonderful hoppiness, strong bitter bite, and an aftertaste that leaves my taste buds anxious for more. Medical device startups are similar.


Tips for Preparing a 510(k) Submission

The past few weeks have been super hectic and crazy busy. I’ve been up to my eyeballs preparing a 510(k) submission for a startup. Good news is that it is sitting on my desk right now and is ready to ship to FDA. The device is relatively simple and straightforward. The submission is too, yet still comes in at ~200 pages.

As I look at the stack of paper sitting on the desk, I begin to wonder if this is how a novelist feels right before sending a manuscript off to be edited. I’m anxious, excited, and a little bit nervous. Regardless, the submission will be boxed up and shipped this week.

And in about 2 – 3 weeks from now, we should get work from FDA whether the 510(k) has been rejected or accepted for additional review.

I realize reflecting on this 510(k) experience is a bit premature. However, I think there are some tips and pointers I can share while the memories are still very fresh.

Create a plan. 

Preparing a 510(k) submission is a project all by itself. Yes, a good plan helps, especially as you work with others to compile all the documents. The milestones are already set and well-defined in the 510(k) checklist. Review the 510(k) requirements with the team to ensure all agree what is and is not applicable to your submission.

Get organized early.

I created folders according to the particular 510(k) sections. As documents were being drafted pertaining to a particular section, they were placed in these folders. I also used Dropbox to share files online with others, again using the same folder structure. And of course, the folders were numbered and named according to the 510(k) checklist.

Establish a schedule.

I created a schedule as to when each item should be completed and drafted. I shared the schedule with the team, along with who had responsibility for each item.

Review in pieces.

Asking your team to review the entire 510(k) submission all at once is a ludicrous idea. Instead, have the team review the entire submission one part at a time. As each section was drafted, I sent it around to the team for review. This allowed the preparation process and review process to happen almost entirely in parallel.

Stay organized.

Yeah, this is tricky–especially as parts and pieces of your submission are in various stages of completion, review, etc. If you’ve drafted a 510(k), you know that much of the content is repeated throughout. If something changes in one section, there are many other sections that require updates as well.

Go to a copy center to print the 510(k) for submission.

I decided it made sense to go to a local FedEx Office location to have the entire submission printed, page numbered, tabulated, and so on. I was fully prepared to spend the entire day there too. Thankfully, because I was so well organized, I was able to hand off the task of printing the 510(k) with a few minimal instructions. And the cost of doing so was very reasonable.

Cross your fingers?

Okay, this is terrible advice. I know my 510(k) submission is well put together and objectively addresses each required element. I believe the substantial equivalence arguments are well structured, clear, and concise. However, we are dealing with the FDA, which can be a huge unknown.

Is Launching A “Me Too” Medical Device Within A Year Realistic?

If you ask an engineer whether or not something can be done, I’ve found that most will provide you with an optimistic response. You usually get an unequivocal “yes, that seems feasible”. And what the engineer fails to provide and you fail to hear is that there is not an infinite amount of money and resources at your disposal to make it happen. But you trek on anyway, believing, or probably better stated wanting to believe what you want to have happen (and likely what your boss expects).

When I was approached by a startup medical device client last winter, I was asked if it would be possible to launch a “me too” medical device within a year. Before answering the question (yes, I’ve been that optimistic engineer), I did give the suggestion a great deal of thought. I also chimed in with quite a few follow-up questions. Satisfied with the answers, I too had mine. Yes, it seemed very probable that we could bring a “me too” medical device to market within a year. And I was sincere.

Now we are about 6 months in. That year target is still within reach, despite all kinds of twists, turns, bumps, obstacles, roadblocks, etc. But the next few weeks will be the telling factor. We have to hit a CRITICAL July milestone to have any hope.

So I’ll push like crazy to make it happen.

8 Lessons Learned from Current Medical Device Product Development Project

The current medical device startup product development project is still in process. However, there have been several lessons learned already with this project. Here are 8:

  1. Finalizing Design Control documentation may lag a little (and it’s okay).
  2. A good project manager maybe should be a control freak.
  3. Trust project team members. Don’t trust project team members.
  4. Go to my network. Expand my network.
  5. A task is not completed until there is clear objective evidence to support it.
  6. Delivering bad news never gets easier but should not be avoided.
  7. When I’m comfortable, I’m being too complacent.
  8. Communicate, communicate, communicate.


On Budget. On Task. On Time.

The other night, I was watching a home improvement show Rehab Addict, when the host, Nicole Curtis, stated: “. . . On budget. On task. On time. . .” I realize home improvements and do it yourself projects have zero to do with medical device product development. However, project management is remarkably similar across industries, genres, project types, etc. As Nicole made the statement, my attention drifted away from her latest remodel to thoughts about current and past medical device projects.

I remember once very early in my career touting that my projects were always on time. And at that time, my employer didn’t really track budgets, so I guess that metric doesn’t really count. But I remember being very proud of being on time with projects. I remember hitting deadlines. Many projects and years later, I’m not sure that those early projects are a good measure of my project management capabilities. Yes, we did bring some good medical devices to market. However, the on time claim was probably a little skewed. That, and the reality is that if you hit your deadlines, you probably aren’t being aggressive enough. And the reality was then the due date was often prescribed to me by my boss ahead of time. Fortunately, my boss either was naive enough or had enough foresight to set a fairly doable date for project completion.

Fast forward to my current project. Like nearly every project I’ve ever had, the due date for this one was also given to me by my “boss”–the entrepreneur behind the idea. The issue in this case is that this is the first time the entrepreneur has ever gone through medical device product development. From the beginning, I have been very critical of the timeline and the budget. I was able to reset the thinking about the budget to a more realistic value. Timeline, while aggressively established by the entrepreneur, continues to be technically possible. Of course nearly every thing has to go the right way the first time.

I think the entrepreneur really knows that launching when he stated will be a difficult and tough assignment to complete. However, he is also the type to push and push to get the most out of a team. And I’m on board. I know the next few weeks are critical to us meeting the overall launch date. But we are on track and the team is for the most part on board making great strides.

Time to Play Design Control Catch Up

I’ve written plenty of design control procedures. I understand FDA design control regulations very well. I’ve trained dozens of engineers and medical device professionals on the “rules” of design control. When to document, how to document, why to document.

And now I’m up to my eyeballs on a startup medical device product development project realizing I have to play catch up. Realizing that we are about to initiate tooling and that the design control documentation needs to get to a similar point in development.

The medical device design control purist will quickly tell you that keeping the design control documentation current and up to date with the state of the project is an absolute must. The medical device pragmatist will tell you to do the real development first and catch up the documentation later. I find myself stuck in between these two schools of thought. A few years ago, I would have been standing at the pulpit of design control advocating the need to keep documentation up to speed and current. Today, I have a very different point of view.

Don’t mishear me. I believe all the intent of design control regulations has been followed on this project. I believe there are documents, emails, notes, action items, etc. that adequately address everything that must be demonstrated with sound documentation and records. The challenge now, though, is to successfully extract this information buried deep in email messages, file folders on computer hard drives, and so on and to ensure it is placed in its proper home in the appropriate design control record.

I feel like now is the time to do so. Not to sound complacent, but I feel like I have time to take a few breaths before the strong push to the finish line. Just better make sure we have everything we need to win this race.

How Hard Is It To Tell Me How Much?

If you ask me how much it will cost to develop a FDA compliant quality system, I can tell you. If you ask me how much it will cost to manage a medical device product development project, I can tell you.

So why is it so difficult for other medical device service providers to provide an estimate? And why does this process take so damn long! Especially when what I’m asking for is more or less already similar to the stuff you already do? It’s confusing.

Are medical device service providers so bad as estimating costs that they have to turn your request for quotation into a mini research project? I don’t get it.

And when you give me the number, stand by it! Don’t come back a few weeks later with an estimate that is 100% higher than your original number. It’s not my fault that you are a bad guesser. Know your business!

Medical Device Prototyping – A Sometimes Viscous Cycle

I’ve talked quite a bit about the importance of prototyping in the past. I’m really appreciating the value of having (or not having) a prototype with the current medical device startup I’m working with. And let me say, that while having a prototype is very useful, having a prototype that is the wrong dimensions may be detrimental. I’ll explain.

This project stalled a couple months ago due to product design concepts. There were a couple of ideas presented on paper along with a 3D prototype that had missed the mark. So, we went back to the drawing board–literally. New thumbnail concepts and ideas were sketched. A few of these were tweaked and refined into 3D images on screen. Progress was being made, albeit much more slowly than I liked.

And then there was a positive turn in momentum, all based on a really smart idea. The contract manufacturer resource, for whom the industrial designer / mechanical engineer works, suggested building a 3D form model to scale in order to give the startup something to hold, versus conceptualizing via looking at computer screen and printed images. It was a great idea. The CM used a chunk of hard wax and machined the basic shape of the device. This was given to the startup, and the result was good. Really good. The wax model was updated a couple times, and before long the shape and size of the device had been determined.

Victory. A small one, but a victory nonetheless. Now the CAD work could focus on the shape. No more thumbnail sketches required. And now, I could hone in on some of the finer details, such as color (more details on this another time). Within a week or so, the crude wax model was turning into detailed, dimensioned design. For the first time in a long time, it felt like this project was moving forward.

It was then time to have another 3D prototype, this time to scale with exact dimensions. The timing of the prototype was discussed last week. It was to be ready Monday. I would review the prototype with the CM and designer and then take to the startup. This 3D prototype, while resembling the wax model, was off a little. And in the days leading up to the prototype build, I reviewed sketches on drawings, showing how everything would go together. It soon hit me that this prototype was bigger than the wax model. I started to realize there could be an issue.

After the meeting with the CM, I took the prototype to meet with the startup. Upon unveiling it, he stated “. . . the butt got big . . .” We couldn’t help but laugh. While the startup can be tough at times, he is nearly always fair. Plus, this is his product. The victory I felt after the wax model experience melted away. It now felt hollow and misguided. We now have to go back to do some overhaul of the design based on the impression left from the wax model. The startup was left with a certain impression about size and features the wax model help establish.

While 3D prototypes are pretty important to medical device product development, realize that they can also be detrimental, or at least damaging. Be sure that you communicate what the prototype is intended to convey. Be sure you are clear about the purpose of the prototypes. Realize that each prototype will leave a lasting impression. Be sure that the impression left is the one you have in mind.


Medical Device Product Development Is Like Going to the Eye Doctor

Have you ever been to the optometrist for an eye exam and been posed with the question which is better? Then the optometrist flips a lens or two while you stare at an eye chart. Sometimes the letters get clearer, other times blurrier.

My latest medical device product development adventure feels sort of like an eye exam. For a few weeks, we have been back and forth and up and down on the design of a medical device. Do you like this one? How about this one?

Some days, it feels like we are getting a step or two closer to ironing out the design. Other days, further away.

While I so wish we would be able to narrow in and define the industrial design of the device, we are making progress on the electronics design and other components. Soon, it will all come together.

Medical Device Startups – Keeping the Balance

Medical device startups need balance. Specifically, keeping quality, regulatory, manufacturing, product development, and business in order and harmony with one another is a challenge and a must.

Which one rules the medical device startup?

Trick question. None of the functional areas rule. The trick is to keep quality, regulatory, manufacturing, product development, and business in balance. And yes, it’s always a trick. And always shifting and requires adjustment. One day quality might have the ball. Another might be regulatory. And yet another, all functions might share it.

As a startup, keeping the balance is a frequent, often daily, challenge. I don’t possess the magic formula. I don’t have all the answers. Helping startups with this balance is a large part of what CQ does.

Don’t Shoot! I’m Just the Messenger.

A current product development project has me in a situation that is not very comfortable. A few weeks ago, the project needed to make a “pivot“. I was given the task of finding options. Meaning, I was tasked with finding product development resources who could assist with industrial design, mechanical engineering, electronics design, firmware, tooling, and manufacturing. As project manager for the startup medical device, this task was definitely within my scope. I tapped into my terrific network to try and figure out a path forward. The startup wanted a pretty quick turnaround for quotes. The startup was okay with having ballpark estimates to make a decision. But they wanted to make a decision as soon as possible; the project had already been delaued a few weeks.

I talked with probably a dozen resources. Some options were full turnkey. Others only addressed a particular functional area. I organized all into a matrix to ensure all areas of concern had been identified and to determine rough overall product development costs. I presented the options to the startup, who in turn asked me to provide and support my recommendations. Fine.

After making a decision, I then had the dubious responsibility of informing all the resource providers of the decisions. For most, this was a difficult message. I had to tell them that the startup chose to work with someone else.

And of course when these sources were told “no”, they wanted to know why. Was it cost? Was it schedule? Was it something else? Most took the decision pretty well–this is how the medical device product development business works. We have all been told that our firm was not selected. Others, though, got defensive and wanted detailed explanations. They wanted to schedule a meeting to better understand and have a chance to revise and so on.

I’ve been managing medical device product development projects for 15 years. I admit that delivering “bad news” is still tough for me. But it comes with the territory, like it or not. My job is to inform and communicate. Sometimes, I am just the messenger.