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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: , , , , ,

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: , ,

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: , , , , ,

Ah, Medical Device Project Management

April 10, 2013 By Leave a Comment

While updating project management activities for a medical device startup and updating blog posts, I decided to reflect back on past posts on the topic. What kind of medicine did I prescribe? And, am I taking any of it or ignoring the advice?

Here are some posts on the topic of medical device project management:

And maybe one of my favorites of my own writing (not to sound too narcissistic) is an oldie “Planning Is Constant”. This project is certainly a testament to that. Each week, sometimes each day, provides news, updates, twists, and turns that must be planned for and then repeated.

Filed Under: All, Medical Device - General, 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 Product Development – Keep It Simple

April 1, 2013 By Leave a Comment

Is it possible for medical device product development to be simple? Remember this post from a couple months ago sharing efforts from Shift Labs and the Little Devices Group? Each of these groups are good examples of trying to keep it simple.

We are involved with a project that on the surface looked to be a keep it simple product development effort. However, today, I would suggest our medical device product development efforts are NOT that simple.

Do you think product development is simple for groups like Shift Labs and Little Devices Group?

Or is it more likely that these groups have committed to developing simple solutions and the product development process is just as trying as what we are going through right now?

Can medical device product development process be simple? I’d like to hear your thoughts.

Filed Under: All, Medical Device - General, Product Development - General, Project Management 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: , , , ,

Don’t Shoot! I’m Just the Messenger.

March 20, 2013 By Leave a Comment

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.

Filed Under: All, Product Development - General, Project Management, start-up Tagged With: , , , ,

INpact – Preparing for FDA Audit

March 18, 2013 By Leave a Comment

There is a great opportunity this Friday (3/22) to hear from Scott Durlacher of Anson Group on preparing for a FDA audit. If you are part of a medical device company, I highly recommend you participate. Having worked with and knowing Scott, he has a ton of experiences and suggestions to assist you in being prepared.

Here is a link to the INpact event page.

Filed Under: All, Events, Indiana Life Sciences, inpact, Medical Device - General Tagged With: , , ,

Medical Device Startups Get to Revenue

March 12, 2013 By Leave a Comment

It’s refreshing to work with a medical device startup with a focus on getting products into the market as quickly as possible to help patients. This same approach will allow this startup to begin generating revenue from the sale of its own products. I say fresh because it is surprising how novel this concept seems to be.

Okay, of course every medical device startup I’ve worked with definitely wanted to get their devices cleared and sold as soon as possible. But this startup seems different.

  • Initial capital equipment will not have lots of bells & whistles and will be similar to other products in this space.
  • Realization that there are quite a few accessories, kits, etc. which could likely enter the market first and serve as a source of revenue to help offset product development expenses.
  • Makes decisions with enough “facts” and without getting too bogged down with minutia.
  • Trusts the resources hired to do the job. When it’s clear there is a mismatch in needs versus capabilities, makes tough decisions about next steps.
  • Focused on the end-goal: get products cleared and ready for sale.

It’s still early. However, I think we are on the cusp of some exciting things with this startup, especially when it comes to the approach and their business model.

Filed Under: All, Indiana Life Sciences, Medical Device - General, Project Management, start-up, Strategy vs. Tactics Tagged With: , , ,
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