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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:

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: ,

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: , , ,

Product Development Happens Because of Teamwork

April 16, 2013 By Leave a Comment

Okay, the title does sound a little cliche. But it really is true.

As you might know based on recent posts, I’m neck deep engaged as project manager for a medical device startup. In the ~5 months since the project was initiated, it has felt like two completely different projects. This can be partially explained because of the transition from one product development phase into another. However, we’ve also had two different teams engaged.

Team 1 was pretty good. Yet we had one set of resources who kept their work close and didn’t share all that often. Plus, they weren’t really hearing what the customer (a.k.a. startup client who writes the checks) was saying. Team 1 was disbanded and new resources had to be found.

Team 2 has been much better. While we still have some of the same design challenges as Team 1, the resources have been very responsive and are listening to the customer. Plus, we are making progress and still have a decent shot at launching the product in 2013, despite being delayed for over 1 month during the team transition.

As project manager for both efforts, Team 2 has been easier to work with. Each team member is starting to get into the groove of what their role is. I have the dubious responsibility to help orchestrate and bring things together at key points during the project.

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

There Is A Plan. I Promise.

April 9, 2013 By Leave a Comment

The last few weeks have been a little stressful and hectic. Yes, I’ve felt the pressure as a project manager for a medical device startup. Our efforts had been stalled for too long yet started to make some real progress a couple weeks ago.

Right now, it feels like chaos. Organized chaos, maybe. There are quite a few components, resources, etc. involved in bringing this medical device closer and closer to market. Each day for the past week or so has been spent identifying the critical pieces–those items which either gate future development and/or are stalled for some reason.

And through all the chaos there is a plan. I’m approaching this a little differently than other medical device product development projects. Overall there will be two products–the main device and an accessory kit. Each product has a few components. And each component seems to have its own intricacies and nuances. Yes, there is a plan. But I’ll be honest, it feels very much like juggling right now.

Fortunately, we have a good team–maybe great if we can pull off the aggressive timeline. The team is committed to getting their parts done as quickly as possible without compromising quality.

Filed Under: All, Ask CQ, Medical Device - General, Planning, Project Management Tagged With: , , ,

Medical Device Product Development Is Like Going to the Eye Doctor

April 4, 2013 By Leave a Comment

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.

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

Medical Device Startups – Keeping the Balance

March 26, 2013 By Leave a Comment

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.

Filed Under: All, Ask CQ, Medical Device - General, Product Development - General, Project Management, start-up Tagged With: , , , ,

New Product Development – Why Start with a Clean Slate?

March 11, 2013 By Leave a Comment

I’m currently providing project management services for a medical device startup. We recently encountered a “roadblock” requiring we find additional resources to move forward. I was able to reconnect with several capable options within my network for possible solutions. Nearly each resource I spoke with wanted to start at the beginning, basically with a clean slate and blank sheet of paper.

The thing is, this medical device project doesn’t need to start with a clean slate. In fact it should NOT for a couple reasons:

  • We’re developing a “me too” device. Yes, there are likely to be a few features and benefits which are unique to this product. But there is a ton of existing products in this space, including a couple identified as benchmarks.
  • The project actually started a few months ago. While we haven’t gotten too far, we have made progress. Let’s leverage and use as much as this progress as possible.
  • We have an aggressive yet realistic timeline to launch this device in 2013.

Thankfully, there were a couple potential resources who get it and want to minimize the research phase and get right into development. They realized and listened to what we were trying to say. We should make a final decision about the next resource(s) later this week. I assure you it will be those who we feel can pick up where we left off and help us get back on schedule as quickly as possible.

There are very few product development scenarios where you start with a clean slate and blank sheet of paper. Beg, borrow, and steal from other products and technologies. It’s very cliche, but don’t reinvent the wheel.

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

When a Startup Says Design Isn’t Important, DO NOT Believe It!

March 7, 2013 By Leave a Comment

On a recent medical device project, I worked with a startup and a couple third party resources on product development. The intended device was basically a “me too” product. Early on, the startup stressed the importance of an aggressive timeline. The actual design–the look and feel–was not formally discussed that often. The startup would sometimes, though, hold up his iPhone and comment about simple, yet elegant the design is. But then the discussion would shift back to technical details. A couple weeks later during a project team meeting, we began discussing detailed requirements and specifications. And again, the startup would casually mention a cool gadget he saw over the weekend, drawing extra attention to its buttons and display.

This sort of thing happened a few times. Sometimes there were emails with sketches. Other times comments like those described above. But for whatever reason, what was heard by the engineering firm was the focus needed to be 100% on the technical details, specifications, and product performance. And this all came to a screeching halt a few weeks later when the engineering firm presented the device concept at a design review. I knew the moment the device image was displayed on the screen during the presentation that the startup did not like what he was seeing. Yet he held his composure and gave me a bit of an earful afterward. I deserved it too. I ASSUMED that the engineering firm heard and understand that design was important. However, they had not.

My advice to you is realize that design is always important. How the product looks, how users will interact, how care givers interface are always aspects that must be considered with any product design.

 

Filed Under: All, Ask CQ, Medical Device - General Tagged With: , , ,

Medical Device Project Management: Crash and Burn? Or Survive then Thrive?

March 5, 2013 By Leave a Comment

I’ll admit this past weekend was a little hectic. A medical device product development project recently stalled. The summary is that the design direction we were pursuing needs to shift and take a new course to be successful. And I’m sure this project–like ALL other medical device product development projects I’ve ever been a part of–will have plenty more course adjustments in the months ahead.

But during the past couple weeks, it became apparent that choices made a couple months ago might not have been the best for the long term efforts of the project. As a project manager, I kicked myself in the ass a little about this. I played the “coulda, woulda, shoulda” game for a few days. Fortunately, I dried my tears and got over the pity party and rolled up my sleeves to take action. The medical device startup is counting on CQ to deliver, now more than ever.

Medical device product development projects always seems to have new twists and turns, resulting in a list of lessons learned. Here are a few from this latest saga:

  • Sometimes a project manager needs to micro-manage product development resources. It is wreckless to assume everyone is always on the same page.
  • Emails are okay. Phone calls are better. Face to face is best. Regardless, limited communication with critical project resources seldom works out well.
  • Remember your brand and reputation are almost always on the line. Clients understand there will be issues to deal with and do not expect everything to be smooth sailing. But a client also NEVER wants to be surprised.
  • As a project manager responsible for coordinating third party resources, ALWAYS insist on pre-screening everything before it is provided to the client.

As I mentioned, this project is about to head in a new direction. And thankfully, I have some fresh project management wounds to remind me of recent past issues and know what to do to mitigate.

This project will NOT crash and burn. We will find a way to survive and thrive!

Filed Under: All, Ask CQ, Medical Device - General, Project Management Tagged With: , , ,

FDA Expects Management to Be Engaged

February 25, 2013 By Leave a Comment

FDA issued several 483 observations relating to Management Responsibility in 2012. Here is a list of some of these 483s as reported by enKap Community. Still think FDA can’t see your Management Review minutes?

The reality is that if during the course of a FDA inspection, all documentation and records could come into the scope of the inspection. If your company’s Management is engaged, and documentation and records are in good order, I would doubt that a FDA inspector would go fishing around too much without a reason to do so. However, if Management is not engaged, a FDA inspection could be a more painful than normal process.

Keep in mind too that today’s FDA inspections are a little more aggressive than from just a few years ago. As noted in a previous post, total number of inspections, 483 observations, and warning letters are higher now than ever. As such, FDA and regulators across the world EXPECT Management to be engaged and part of the overall decision making process, especially as it relates to compliance.

Filed Under: All, Ask CQ, Medical Device - General, Quality System Tagged With: , ,

Medical Device Companies – Get Ready for FDA

February 14, 2013 By Leave a Comment

Are we dealing with a new FDA? I posed this question last summer. In the past couple years, CQ has had quite a few engagements to help medical device companies during FDA inspections and to correct FDA 483 and warning letter observations. Data also supports my anecdotal experience as reported in a recent post on the AssurX blog:

  •  2005: FDA CDRH inspected 2,304.  2011: 3,369. I’m guessing the number was higher still in 2012
  • 2008: CDRH issued 152 warning letters. 2010: 200 issued.
  • 2008: CDRH issued ~4,000 483 observations. 2010: ~5,000.

Sometimes we have a chance to engage prior to a FDA inspection. In these situations, the process is usually a little smoother and calmer and a whole lot less stressful. These are the medical device companies who have enough clairvoyance to realize their shortcomings and are interested in developing an action plan to correct issues. These are the medical device companies who are doing their best to prepare for a visit by FDA.

And other times we don’t get involved until the FDA inspection is over and 483 observations (and sometimes a warning letter) have been issued. There has been a case or two when a medical device company has reacted with a bit of shock and awe after a FDA inspection. Reactions of real surprise. Sorry – but there really shouldn’t be that much of a surprise after a FDA inspection. Okay, the FDA quality system regulations are not entirely black and white. But the QSR is published–has been for quite some time. And a medical device company should have implemented policies and procedures to address the regulations and be active in keeping company procedures current. However, the companies which are suddenly surprised after the inspection did not do a good job of keeping policies and procedures up to date.

Has it been a while since your medical device company has had a FDA inspection? Don’t think FDA will come visit your company? You might be right. I suggest, though, that you get prepared–just in case.

Filed Under: All, Ask CQ, Medical Device - General, Quality System Tagged With: , , , , ,

By The Time I’m 40

February 13, 2013 By Leave a Comment

Yes, I shared in an earlier post that I currently invest time with inventors and entrepreneurs. But by the time I’m 40, I want to be in a position to where I can invest meaningful capital in startups. I have about 2.5 years to achieve this big hairy audacious goal. How am I going to make this happen? My plan is multi-faceted:

  • Continue to invest time in early-stage ventures. Why? The assumption is that a few of these ventures will one day receive funding to pursue product development. Once this happens, CQ should be in a position to continue providing consulting support and be compensated, maybe even with equity opportunities. And maybe, just maybe, one of these funded ventures will have an exit and the resulting equity will have substantial value.
  • Bring UniDoc to market. This is a proprietary CQ software product geared towards helping medical device companies better manage design control and product development documentation and records. We’ve had a couple starts and stops and are at a point where we need to aggressively work towards launching this into the market.
  • Continue to provide consulting services, helping medical device companies with business development, operational efficiency, and project management.
  • Identify and launch other product ideas.
Yes, time is ticking but this is my BHAG. Why? Since starting CQ, I’ve come across several medical device inventors and entrepreneurs whom I think have decent ideas. However, funding, especially locally and during the last few years, has been basically non-existent. I think there are a few very good ideas that are dying due to lack of investment. I’d like to be in a financial position to help make a difference.

 

How?

Invest in them now, providing advice and consulting. Find opportunity or two with equity, resulting in exit.

Also, develop own products, starting with UniDoc.

Filed Under: All, Ask CQ, CQ Story, Funding, start-up, Strategy vs. Tactics, UniDoc Tagged With: , , , , , , , ,
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