Medical Device Prototypes Can Mislead

Once upon a time, I was a huge proponent of prototyping medical devices as soon as possible. Today, I’m a little more hesitant. Don’t mishear me–prototypes of your medical device can certainly be extremely valuable. However, I think it is VERY important to be clear about what you hope to learn from the prototype. Equally important, it is VERY important to understand what the prototype can not do. In other words, know what decisions can be made based on the type of prototype you have.

Let me expand a little.

Several months ago, we were initiating a medical device design and development project. We had some product designs sketched and started to narrow the list down to just a few concepts. Once narrowed, the design resource offered to “grow” some 3D prototypes. Within a few days, we had 3D concepts in our hands to better evaluate some of the design ideas we had been discussing a viewing on screen. Having the prototypes in hand was helpful. We were able to better evaluate features and aspects of the product design. We were able to play around with component interfaces and get a feel for how the user would interact with the device. We made a few tweaks but soon, we decided to proceed with cutting steel for injection mold tooling.

Tooling was to take ~10 weeks. We made progress on other parts of the product design while we patiently waited for those first articles. When the tooling was completed, first articles were provided soon after. We were all anxious to evaluate these parts. When we did, the design presented to us via concept sketches and 3D prototypes did not seem to translate into injection molded parts. What happened? Why not? The design resource offered that the prototypes might not have been an ideal representation of the injection mold parts. They also stated that they could make a few minor modifications to fix some of the design concerns. Another round of prototypes and another round of discussions.

Why was this round of 3D prototypes any different? I guess we trusted that the designers would make the design right.

Several more weeks were necessary to modify the tools. And eventually another round of first articles. Which once again, failed to hit the mark we needed with the product design. Frustrated began to mount. And I kind of scratched my head. What went wrong? Why were the prototypes so bad at representing the product design?

Then it hit me. Medical device prototypes are not the end all be all. Prototypes have limitations. You have to understand what the 3D prototype can and can not do for your design efforts. I learned that SLA-type of prototypes is not a real approximation of what you might expect from injection mold tooling.

When you get prototypes for your next project, take a few moments to truly understand what these prototypes can tell you. What exactly can you learn? More importantly, do not fall into the trap that a 3D prototype can answer all your design questions. It’s a tough trap to avoid. The proliferation of 3D CAD tools and easy access to affordable 3D printers has allowed the rapid proliferation of prototypes. Sometimes we have a tendency to make 3D prototypes just because we can and it’s cool. Rather, we should be striving for effective prototyping.

I was once told that if a picture is worth a thousand words, then a prototype is worth a thousand pictures. No truer words have ever been said. But if you do not fully understand what the prototype can teach you about your product, it doesn’t matter if the prototype is worth one million pictures.

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.


Failing Fast & Cheap During Product Development

Several weeks ago, I suggested in a YouTube video that I was considering developing a new device for handling unruly nose hair. I spent less than $10 to come up with a couple “proof of concept” prototypes. A few weeks later, someone who watched the video created an animation of a 3D concept for a nose hair trimming device (I still haven’t met this person even via email, but I thank them for their interest). The other day while shopping for a few household items, I visited the personal grooming aisle. There are quite a few gadgets available claiming to be the best nose hair trimmers on the market. And maybe one actually is. I don’t plan to purchase each one by one to find out. But at the same time, noticing how many products are currently available has me a little concerned about the ability to penetrate the market.

The other day, I learned that people sometimes have nose hair removed via hot wax. And yes, there are plenty of YouTube videos on this as well. I decided to do a little research into this and found a local spa who is willing to rip my nose hairs out later today. Yes, I plan to have a video of this experience too.

Why am I sharing all this? Despite being a little bit of a cheesy example, I am actually traveling slowly down the path of medical device product development. It started with an idea and since, I’ve been in discovery mode–learning some about the market, competitors, etc. I have limited my expenses while trying to make progress. And depending on how the spa session goes later today, I might just kill the concept altogether.

This is an important point for product development of any kind. If you are going to fail, do it fast. Do it cheap. Then move on to the next idea. Product development is a process. There is (or at least should be) a method to the madness.


Helping Medical Device Inventor By Paying It Forward

During the past few weeks, I have been helping a person I don’t know and have only met once via a Skype video call get feedback about his medical device concept. The person did not offer me any compensation, nor did I request any payment. I just offered to put some feelers out and see what kind of feedback and responses I could get.

Why? I know I have a top-notch network and am either already connected or easily could be connected with physicians who can and will provide feedback for the inventor. I know that I can help this person understand the medical device product development process just a little better. I know that if the idea isn’t worth pursuing, taking this approach makes the best sense for the inventor–spend as little as possible to find out if the idea is worth taking to the next step. I believe if the idea has merit, this inventor (and maybe others like him) will have an interest in working with Creo Quality.

Yes, it’s definitely a “pay it forward” kind of strategy. Yes, I realize I may never receive any revenue from doing something like this. And that’s okay.

While the feedback is still coming in, I did get one response from an expert in this particular device space. The expert is very interested in helping with a prototype and other business development / research activities. I connected him directly with the inventor.

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.

Medical Device Prototyping: An Interview with Larry O’Cull, Priio

I recently conducted an interview with Larry O’Cull, President of Priio on the topic of medical device prototyping.



Creo Quality: Tell us a little about Priio. Give us the 30-second pitch.

Larry O’Cull: Priio does ‘whole solution’ product development, whether it’s creating new products or fixing current problems. We generate products from basic concept to anywhere along the ideation-to-creation process using industrial design, software development, and mechanical and electrical engineering (often small medical or electronic devices with interactive intelligence).

Our ‘special sauce’ is a keen understanding of human factors engineering – because we believe product function should be obvious to the user as well as pleasing in design.

CQ: When is the right time to build a prototype?

LO: It depends on your goals, and where you are on the development timeline. If you need a “proof-of-concept” model, a little clay and duct tape might be enough to tell you whether or not an idea is feasible. If you’re seeking late stage funding, a fully realized “looks-like, feels-like” prototype can be a great tool for gathering user data and market feedback.

CQ: What types of prototypes are there?

LO: There are several type of prototypes, including:

  • Proof-of-concept Model – a crudely formulated model (also known as the “Quick and Dirty”)
  • Form Model  - a prototype that “Looks Like” the end product; not interactive or functional
  • Functional Model – a prototype that “Works Like” the end product; used to prove usefulness
  • Interactive Functional Model – a computer-based interactive device, such as a diagnostic meter, a web-site, an app, etc.
  • Clinical-Use or Field-Use Model – a pre-production product that is ready to go into the field for human-interaction study and product use validation. (This models may be handy in regulatory testing for agencies such as UL, CE, FCC, TUV, FDA, FAA, etc.)

CQ: Describe a few of the preferred prototyping methods used by Priio?

LO: Some of Priio’s everyday methods for realizing mechanical components include:

  • 3D printed models from either a fused-deposition-modeling machine (FLM) or stereolithography assembly machine (SLA)
  • Urethane-foam models hand-shaped or milled on a CNC machine
  • Cast-urethane molded models

We often create electronic devices with software on board, so we’ve been known to hack up/bodge together manufacturer-supplied demonstration boards and sample softwares in order to get something working fast. We may also build and test a user interface for a hand-held instrument on a PC before before we even begin to create the instrument itself.

We find CAD simulation tools are also an effective way to prototype – we can simulate some circuits or “twist” a mechanical part in-silico (on the computer) before we ever create a “real” printed circuit board or mechanical component.

CQ: Describe Priio’s typical medical device client? What stage are they usually at?

LO: Our medical device clients range from startups to large experienced companies, with products ranging from invasive diagnostic instruments to pharma-storage environments used on aircraft.

In the case of startups, it’s generally early stage. Having proven some feasibility in the lab, a scientist, bio-engineer, etc. will now seek to commercialise the idea.

In the case of some of more experienced clients, they may already have market presence but are seeking to bring on something new or update a current product.

CQ: Priio develops products for multiple industries. What special circumstances and considerations that Priio must consider for medical device prototypes?

LO: The design process at Priio is generally the same regardless of market, although medical devices typically require extra documentation and due diligence. Occasionally other industries require levels of due diligence compatible with the FDA, such as those which manufacture devices that must intrinsically-safe, explosion-proof, or concerned with safety..

The FDA seems pretty consistent about safety and patient and end-user needs. They have established a “minimum code” (IEC-60601) to use when constructing a device or product, mechanically and electrically. This guidance code is usually required even at the prototype stage – because if the device is even potentially unsafe you cannot use it for collecting field-trial data.

CQ: What do you view is the biggest obstacle for medical device entrepreneurs / inventors?

LO: The biggest obstacle for nearly every entrepreneur is funding. With the current economic climate (particularly in Indiana) there seems to be much more late-stage than early stage funding available.

Medical device entrepreneurs have an added disadvantage of regulatory agency requirements (FDA 510K) that increase costs – easily doubling or tripling cost of development over other market segments.

CQ: When clients approach you, have they proven the science behind their ideas or do they expect Priio to do this work?

LO: Some of our clients would like us to help them prove their science, but for the most part they come with basics already established.

We do find, however, that re-proving the science is common. Once a concept is realized to commercial form, a validation process (usually a field study) is necessary. This is a good path because it uncovers any potential anomalies.

CQ: Do you have any medical device product development case studies you are able to share, including images?

LO: Therametric Technologies, Inc. (TTI) came to Priio asking for a wireless, battery powered, hand-held device which dentists could use to get diagnostic photographs of individual teeth.
Expediency was important for testing this product because the expense of dental research is often prohibitive to marketing innovations.  With this in mind, Priio devised an alternative: an ergonomic hand-held device which accomplished the required task but without wireless connectivity and battery operation, instead using USB as the power source and data connection to the analysis computer. The solution was cost effective and quick to develop and produce “looks like/works like” models that could be used for testing.

Medical Device Prototypes

I recently shared a video on YouTube about the importance of building the business case. Sometimes as part of this important step and certainly soon after, the need for a prototype becomes crucial. I know we have written quite a bit over the years on the topic of prototyping but didn’t realize how long it has been since we visited this important topic. Here are a few of the posts from the past on prototyping:

3 Ways to Ensure Design Project Success

What Come First: Design Input Requirements of Prototype?

Tips For Start-Ups (from Upstarts!)

Get Your Prototype in the Hands of Users ASAP

What if the Start-Up Has No Money?

Re-reading these posts reminded me that prototyping is VERY important to medical device product development. Over the next few weeks, we will be spending more time addressing this topic.

Improving Your Chances for Success

I found an interesting article about medical device product development that talks about the lack of success that many companies seem to have in taking their product from start to finish.

Although introducing a successful new medical device has never been easy, it seems like it’s been especially difficult in the last few years. According to a 2010 survey from McKinsey Global, only 39% of 2240 executives feel confident in their companies’ ability to do so. And the cost of failure isn’t exactly cheap—a launch delay or failure can cost millions of dollars. It’s no surprise then that many firms would like to improve in this regard.

Mr. Buntz suggests that while companies spend a lot of time developing product prototypes, perhaps they should also spend time developing sales model prototypes.

To deal with this problem, companies can adopt a custom, highly focused, modular sales model prototype prior to full-scale launch that is designed to rapidly validate the market and business opportunity. Similar to product prototyping, this technique enables a company to identify the viability of a product at minimal cost. A sales prototype enables a company to answer three fundamental questions: Will the product quickly fail after it is introduced? Will the profit margins be sufficient to justify placing the product into a core sales channel? And is the product worth taking to full scale?

Another recommendation to improve the chances of success when launching a new product is to employ outsourcing, when it is useful. Schimelfenig advises companies to look for a partner with a business model that shares risk and shared reward. This ensures that interests are aligned. An experienced sales partner can help deploy customized strategies to accelerate revenue by developing a sales channel for the specific needs of company and product. Things to look for when sourcing a business partner include solid sales support, tight operational infrastructure, and a successful track record building custom sales models.

I believe that if you combine these suggestions, along with our ideas from Building The Business Case and Creo Quality’s medical device product development expertise, you will greatly increase your chances of success in launching a new product.

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Sally Centrifuge – 2010 Favorite Medical Device Story

My favorite medical device story from 2010 was about Rice University students turning a salad spinner into a centrifuge for about $30.  The students call the product “Sally Centrifuge”.


The students’ assignment was to build a tool that could help diagnose anemia without the use of electricity. I think their result is really innovative and practical. It’s a solution that potentially could be manufactured inexpensively for use in third world countries.

The Sally Centrifuge parts list:

  • one salad spinner
  • some hair combs
  • yogurt container
  • plastic lids
  • glue gun

I like this story for two reasons:

  1. The students figured out how to build a functioning prototype quickly and easily with readily available parts / components.
  2. The product solution solves an unmet need that appears to have market potential.

Here are a several links about the Sally Centrifuge:


Rice University

Discover Magazine

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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.

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reBlog from Prototype Processes (from February meeting)

I found this fascinating quote today:

The February INpact presentation on “Prototype Processes” featured several INpact members and their prototyping capabilities: Catalyst PDG, Indesign, Gale Force Software, Online Resources, and, Prototype Processes (from February meeting), Mar 2010

You should read the whole article.

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reBlog from I Want A Prototype!

I found this fascinating quote today:

Thanks to Ryan Wolfinbarger of Catalyst PDG and Larry O’Cull of Priio for the chocolate chip cookies and for presenting “I Want A Prototype!” during the January INpact meeting. Here is some of the information they, I Want A Prototype!

You should read the whole article.

January 15, 2010 – Medical Device Prototype (INpact)

What: INpact Monthly Meeting
When: January 15, 2009 from 11:00 – 1:00
Where: Bingham-McHale (2700 Market Tower, 10 W. Market Street, Indy)
Register by January 13, 2009

During January’s meeting, our topic will focus on prototyping. Details are forthcoming.

Continue sharing INpact with others in the medical device community. If you know of entrepreneurs and early-stage medical device companies, invite them to attend.

If you are not a member but are interested, please submit an inquiry for the advisory board to review.

Not interested in being a member? You can still attend for the cost of $20.

Make checks out to INpact, Inc.

Mark you calendars for INpact events in 2010. Here are confirmed dates through June:

  • January 15
  • February 19
  • March 19
  • April 16
  • May 21
  • June 18
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Medical Startup Ideas – What do I do first?

Small businesses are important to economic growth and have an incredible impact on economic growth. So, let’s say you are a small business and you have a medical device idea. What should you do first and where should you spend your money when building your idea?

Before you do anything, you need to prove that there is a market for your product or idea. Will people use / buy your product? At this stage, we recommend limiting the amount of dollars spent by determining your market through market research. Do not rush to build a prototype.

Yes, prototypes have value, but you must be sure that there is a need for the product and that the pricing to manufacture the product and sell it is such that your product price is justifiable and people will buy it.

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3 Ways to Ensure Design Project Success

Yesterday I received my daily Harvard Business Review Management Tip and thought it was especially practical for Creo Quality blog readers…

Based on Target’s approach four years ago to their eventually successful, user-friendly pill bottle design, HBR has suggested the following three tips to ensure success:

  1. Prototype early so everyone involved in the project can see and rally around it.
  2. Prepare for a long ride and a lot of persistence.
  3. Involve the people who matter most as early and often as possible.

These tips are important to consider when developing medical devices too. We’ve talked about critical things a medical device start-up should do in previous posts and will continue to do so. In my opinion, prototyping is critical.

Read the full post and join the discussion.