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Why Would A Medical Device Company Take FDA 483 Observations Lightly?

May 21, 2013 By Leave a Comment

I wish the tale I’m about to share is hypothetical. It’s not, however.

Several months ago, I was contacted by a small medical device company. The initial conversation led me to believe the company was being somewhat proactive about making improvements to its quality system and internal processes in the spirit of continuous improvement. The company asked me to provide a proposal to revise their QS.

A few weeks went by. The only update provided was the proposal was being reviewed and discussed by the board. Weeks turned into months. No decision.

And then FDA came in for a visit, almost three years to the day from the last FDA inspection. I was asked to participate in the closing meeting. No surprises from FDA. All the 483 observations had been identified by me and others prior to FDA showing up. Despite having a thorough list of issues to address from the FDA inspector, the board was still reluctant to take action.

The initial response of the FDA inspection was drafted by the company within a couple weeks. Commitments were made, including the date for the next follow-up with FDA to be sent about a month later. Despite time ticking and check-ins by me, the company was still sitting idle, doing nothing to address the 483 observations.

Two weeks prior to the next FDA response, the board decided to have a meeting to discuss the observations, among other business issues. I was invited to present my opinions on the matter.

After the board meeting, more indecision. No actions being taken. The date for the FDA response was a couple days away now. I strongly advised that the company still send in an update, even if there was very little to report.

The company chose otherwise. I followed up with them seeking an explanation for why. I again encouraged them to still send a follow-up to FDA, even though it would be late.

Not sure if they ever did.

I don’t understand why a medical device company would take this approach with FDA.

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

Medical Device Product Development Is A Linear Process

May 16, 2013 By Leave a Comment

If you believe this title, you have not worked on many medical device product development projects. But interestingly, FDA design control regulations and ISO 13485 design & development requirements convey the process as a linear progression. And most every product development and design control procedures I’ve read (and written) also lay out medical device product development in a very methodical, step-by-step fashion.

The trouble is no project ever follows a nice linear progression. Sometimes it seems as though everything is happening all at once. Sometimes it seems like manufacturing constraints dominate before the user needs are even defined.

And this is just the way it is.

With each medical device product development project I’m involved with, I grow more and more comfortable in the midst of the chaos. I also consider myself in a very auspicious and unique situation on these projects. I have an innate understanding and comprehension of the rules. And despite the muddy mess of a picture I might have just painted, there are several rules that must be followed. Having someone that knows how to navigate and apply the rules is important (if I do say so myself).

Please don’t misunderstand what I’m trying to convey. Yes, I definitely believe defining the process IS critical. Yes, you need to have a procedure that lays out the project phases and deliverables. And yes, this process should lay things out in a simple, linear fashion. Just don’t be so naive to think your medical device product development project is going to follow that process to the letter. If it does, you are not pushing hard enough. You have to figure out a way to get things done as quickly and thoroughly as possible. The process and the deliverables are reminders of what must be done.

Filed Under: All, Ask CQ, Design Control, Project Management, Project Phases, Strategy vs. Tactics Tagged With: , , , , , ,

Time to Play Design Control Catch Up

May 14, 2013 By Leave a Comment

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.

Filed Under: All, Ask CQ, Design Control, Project Management, Project Phases, start-up Tagged With: , , , , ,

How Hard Is It To Tell Me How Much?

May 7, 2013 By Leave a Comment

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!

Filed Under: All, Ask CQ, Project Management, start-up Tagged With:

Most Project Management Tools Suck

May 6, 2013 By Leave a Comment

I recently read Steve Vinson’s post “I hate MS Project” and kind of have to agree. Here are a couple of my reasons:

  • It’s kind of expensive
  • I’ve never worked on a project where every team member had access to MS Project
  • Saving files as PDFs and other non-MS Project formats is kind of a pain
  • Incompatibility with previous versions of MS Project

A few years ago, I abandoned the use of MS Project as project management tool for CQ. Instead, I have usually resorted to MS Excel. Why? First and foremost, nearly everyone has Excel on their computers. And usually, it’s pretty simple. Templates of project tasks are easy enough to create and use over and over.

I recently learned of Smartsheet and have used it briefly. The price was reasonable so I purchased it for a year. Smartsheet is “in the cloud” and allowing others to view project tasks is pretty simple. It has a lot of good features of MS Project, which I should confess is a good tool. My issues with MS Project are listed above. Take those quirks away, and MS Project would be used by me for every project. It appears as though Smartsheet might have removed most of the quirks. I’ll keep you posted on my experience with it.

Filed Under: All, Project Management Tagged With: , ,

Project Management Requires Zero Complaceny

May 1, 2013 By Leave a Comment

A project manager should never get too comfortable and complacent. The moment you do, your project has more than likely veered off track somewhere. And even if you are completely engaged, a little bit paranoid, and on top of things, your project will more than likely encounter plenty of obstacles.

Don’t let comfort settle in until the job is done. Keep pushing forward. Keep making progress. Focus on the right priorities at the right time. And don’t get complacent. Ever.

Filed Under: All, Ask CQ, Project Management Tagged With: ,

Medical Device Prototyping – A Sometimes Viscous Cycle

April 30, 2013 By Leave a Comment

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.

 

Filed Under: All, Medical Device - General, Product Development - General, start-up Tagged With: , , , , , , , ,

Lack of Communication Leads to Project Death

April 24, 2013 By Leave a Comment

Communication is so critical to medical device product development.

Communicate early. Communicate often.

Filed Under: All, Ask CQ, Product Development - General, Project Management Tagged With: , , ,

But My Project Team Won’t Talk to Me

April 23, 2013 By Leave a Comment

Last week I was told by a project team member that I would receive a certain work product by yesterday. It didn’t happen.

Friday, I was told by a team member that some minor updates were necessary and be ready by the end of the day. It didn’t happen.

Yesterday, I called each individual team member to get status updates on their specific tasks. I got to talk to each person’s voice mail.

I followed up with email messages. No responses.

I spent most of the day in a grumpy / frantic mood. Why was I not getting updates? Why were commitments made and not kept?

Okay, this is not the first project I’ve managed. While the statements listed above are all true tales, none of these are unusual. In fact, each of these scenarios is very common for every project and will most definitely repeat themselves again on this one. Despite my best attempts otherwise.

So I just keep at it. I did get a phone call update around 5:00pm last night from one resource and spoke to a second around 8:00pm. Not the responses I wanted in either case, but at least communication was happening.

Filed Under: All, Project Management Tagged With: , ,

Indiana Life Science Entrepreneur to Present at April INpact

April 19, 2013 By Leave a Comment

Indiana has a rich presence of medical device, pharmaceutical, and other life science companies. There is also a surprising number of startups and entrepreneurs in this space. On April 25, 2013, Catherine Tanner, one of Indiana’s life science entrepreneurs, will share her story with INpact, a medical device networking group. Be sure to RSVP.

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