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.

 

Nose Hair Trimmer Medical Device 3D Concept

A few days ago, I was pleasantly surprised to receive a message in my YouTube inbox from someone who watched my Medical Device – Proof of Concept video. Surprised because InnovativeMedTech, someone I’ve never met or corresponded with, shared a short video demonstrating a 3D concept of a nose hair trimmer.

I hope to have a chance to connect with InnovativeMedTech (I don’t even know the person’s name) soon to discuss this and other medical device concepts.

Medical Device Proof of Concept Prototype

I have a problem and decided to “create” a proof of concept prototype.

Sometimes a “prototype” can be inexpensive and easy to assemble. With the proof of concept prototype described in the video, I was able to purchase a couple items for a few bucks in order to help explain my idea and demonstrate a possible solution. If there is interest and a market opportunity, I will have other more functional prototypes.

INpact Virtual Approach to Daraza Project

Daraza process January 2007 – December 2008:

Daraza launches the process be developing the FluoreCam proof-of-concept prototype.

January – April 2009:

Daraza has a functional prototype in hand and recruits Priio to develop additional features to make device more usable. Lebanon-based Online Resources, Inc. assisted Priio in this.

April – October 2009:

Daraza works with RND Group, Inc. to develop the software application for FluoreCam.

October – November 2009:

Daraza brings in Creo Quality, LLC to do the FDA submission work on the project.

April 2010:

Daraza received FDA approval and set launch for device for October 2010. The device will be marketed to dentists for about $5000.

Enhanced by Zemanta