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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: , , , , , , , ,

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: , , , ,

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: , , ,

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: , ,

Opportunities to Work With Doctors and Medical Devices

February 19, 2013 By Leave a Comment

One of the most rewarding aspects of my career has been working with the doctors and nurses who come up with novel medical technologies to help save patient lives. My first real experience of this occurred just a few months into my first job with Cook Medical.

I got to work with Dr. Dietmar Enk, an anesthesiologist from Germany. He had an idea for a medical device to help allow ventilation via high-pressure oxygen. He provided a prototype he had constructed from components and parts found. Like me, Dr. Enk was newer to medical device product development. And we seemed to learn the ropes together. His English was good but the time difference sometimes made communications a little difficult. But before long, I had a design and prototype that Dr. Enk was happy with and proceeded with the next steps to finalize Design Control documentation, work with production to manufacture, and eventually move the Enk Oxygen Flow Modulator to market.

Working with doctors and nurses directly and having opportunities to see devices that I helped design in use has been such a humbling and amazing experience. And I’d like to thank Dr. Enk for helping to establish this foundation for me. He was a great, patient mentor.

I had the opportunity to work with doctors on medical device ideas during the first few years of my career. But then I had a several year hiatus–still working in the medical device industry but not directly with physicians. This changed a few years ago when I started my own business, Creo Quality. Since doing so, I work first-hand with medical device inventors interested in commercializing their products and technologies. It continues to be a rewarding experience.

Filed Under: All, CQ Story, Medical Device - General 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: , , , , ,

CQ Pages Updated

January 28, 2013 By Leave a Comment

Events

Tips for Startups

Medical Device News

Regulatory

Filed Under: All, Medical Device - General

Low-Cost Medical Device Design

January 25, 2013 By Leave a Comment

There appears to be an interesting, albeit still somewhat small, movement happening in the medical device industry. There are a few organizations emerging focusing on simple medical device design to solve real problems in under-served markets. We wrote about Jose Gomez-Marquez and the Little Devices Group finding low-cost solutions leveraging existing products and technologies to solve real medical problems.

I recently discovered another similar group called Shift Labs. Their mission is to make low-cost medical devices to help improve healthcare in low resource settings. I was especially intrigued by the low-cost drip clip device designed and prototyped by the Shift Labs team.  I’m also intrigued by this project because it appears as though they leveraged crowdfunding to fund some of their product development efforts.

And I think the Little Devices Group and Shift Labs are onto something. Not only for medical device product development for low resource markets. But also right here in the United States. With all the recent developments in this country, including increased regulation, medical device taxes, increasing cost of healthcare, and tighter investment funding, I think we will begin to see other organizations emerge and mimic the low-cost device and product development approach. I think we’ll see other inventors and entrepreneurs of medical device technologies leverage crowdfunding models to fund their efforts.

Filed Under: All, Medical Device - General, Product Development - General, start-up, Strategy vs. Tactics Tagged With: , , , , ,
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