“The students really did an amazing job of taking very simple, low-cost materials and creating a device their research shows correlates nicely with hematocrit levels in the blood,” said Maria Oden, professor in the practice of engineering education and director of Rice’s Oshman Engineering Design Kitchen (OEDK). She was the team’s co-adviser with Richards-Kortum. “Many of the patients seen in developing world clinics are anemic, and it’s a severe health problem. Being able to diagnose it with no power, with a device that’s extremely lightweight, is very valuable,” she said.

Not exactly a replacement for the Ultracrit, but an innovative solution considering the manual actuation and low device cost. Nicely done.

The article on the Sally Centrifuge. The radio broadcast (mp3).

What is that “everything else”?

It includes marketing, legal, manufacturing, operations, quality assurance, sales, distribution, customer service, and more.  And if it’s a regulated medical device, then there are also regulatory and reimbursement issues that are critical to the ability to sell a product and that directly affect price points.  Most of these issues need to be addressed prior to or at the same time as the technology development.

At this point of a presentation, I know I’ve lost most of the technical inventors in the audience, because when you say words like “marketing”, “legal” and “regulatory” to technology types, they often hear “wah, wah, wah”.   So I won’t go on any longer.  Just know that if you are undertaking this kind of development, you need to manage far more than just developing technology, and your plan and your team should be ready to address all of these factors.

The traditional way to make a product cheaper has always been subtraction – in essence, minimizing the size and complexity of a device without sacrificing its performance.  Size and complexity reductions can drive down costs on materials, packaging, and shipping, while also favoring higher-throughput production and the use of disposable parts – an increasingly important consideration in biomedical applications.  With that said, the simpler and smaller approach is not without limitations, and these limitations are being tested now by “hugely small” applications.

In the case of micro-electromechanical systems (MEMS), microfluidic chips, nano-sensing technology, and numerous other scale-intensive fields, reduced size is actually a profound contributor to increased complexity.  And while these innovative fields show tremendous promise for the future, they currently pose costly manufacturing hurdles as a consequence.  The cost of prototyping and manufacturing micro-parts should be carefully weighed when considering whether or not to pursue an otherwise-avoidable micro-approach.  As of now, these costs can quickly consume the benefits of implementing questionable technology since this often requires several iterations of low-volume custom components.  Lab-on-a-chip devices are a good example prone to this paradoxical limbo.  Even a relatively straightforward microfluidic component can require robust interfaces and innovative prototyping and assembly processes to ensure proper functionality.  Before long, the microfluidic system isn’t so “micro” anymore – in size or cost.

So what can designers and our manufacturing comrades do to advance the cost effectiveness of these emerging technologies?  For starters, let’s abandon subtraction and opt for addition;  additional measures to define and achieve design tolerances, additional manufacturing techniques for creating repeatable micron and sub-micron parts, additional design features for ease of alignment during assembly, additional quality assurance measures to assess as-built dimensions, and – most importantly – additional communication between manufacturers and designers for continued success on the field of dreams we now find ourselves playing.

In The Innovator’s Prescription, Clayton Christensen discusses how disruptive solutions are the evolutions that take the status quo to the next level. They may or may not be technical leaps, but they are new business models that take Blue-Chip titans by surprise, knocking them from #1 and leaving them trying to catch up. Think Canon taking printing business from Xerox by moving it from the giant mega-machine to the desktop. Christensen’s book specifically addresses the business models of health-care, but many of the concepts can be easily transported to other industries.

Here are two examples of the DIY mentality creating some disruptive, and hopefully game-changing, solutions to common problems.

Michelle Khine is an Assistant Professor at UC Irvine working on microfluidics and nanotechnologies. As part of their research, she and her team developed a technique to create microfluidic chips quickly and cheaply using Shrinky Dinks®, an oven, and a printer. Although she was just trying to get her lab up and running quickly, she ended up creating a breakthrough technology that resulted in her being named one of MIT’s TR35, an award given to top innovators under 35 years old. Yes, the toys of childhood are now the research tools of the future. So, if your boss asks you why you have Rock ‘Em Sock ‘Em Robots on your desk, you can point to this.

Technology Review 2009 – A children’s toy inspires a cheap, easy production method for high-tech diagnostic chips

Chemistry students at Harvard University devised a $2 device to separate plasma from blood using an egg-beater and a few other parts. The resulting plasma is more than sufficient to detect diseases such as Hepatitis B and cystercosis. While not quite ready for the major laboratories, the device would be useful to doctors in remote locations without the financial resources to send blood off to a lab for testing.

$2 egg-beater could save lives in developing countries

Photo credit: Malancha Gupta

When you’re trying to solve a problem, it’s easy to just attack it with a bunch of ideas and hope something sticks. This might even work, but which idea was the real winner? Even if the solutions are expensive, you might not care if you’re just solving a one-time problem, but if you’re struggling with something longer term, it’s going to be helpful to track it down.

I don’t know exactly when my body decided high school sports were a distant memory, but for about 6 months, I’ve been struggling with shin splints and knee pain from the overuse and strain of regularly running on pavement. I’d also recently bought new shoes, just because of wear, and I had greatly increased my mileage for a half-marathon in March. There was a lot going on in a short period of time. My running left me in pain, and I wanted some fast relief while still being able to continue my training for an October marathon.

Complication and cost

Solving a problem with a shotgun approach can lead to a complicated result and a poor understanding of all the factors involved. If you’re designing something for production, you wouldn’t want to pay for implementation that you don’t need. It gets expensive, and when something else goes wrong later, things could get messy. The best approach is to take the time to understand all of the factors by isolating the variables, analyzing the theory, and testing, testing, testing.

In the case of my legs, I gave each solution a couple of weeks before declaring them failures, and I restarted from the control conditions. I purchased new shoes, added orthotic insoles, moved my foot-strike forward to the ball of my foot, reduced my stride length, worked on muscle strength, and started running on trails to lessen the impact. By isolating the solutions, I learned that my foot-strike change actually hurt my knees over long distances, that I need stability shoes but not $30 insoles, and that trail running both requires and improves general strength in my legs. In the future, I’ll get to save $30 on insoles and hundreds of dollars in physical therapy, and hopefully I’ll finish that marathon in the Fall.

It’s never too late

Even if you’ve been struggling with a problem for a while (especially so), it’s never too late to sit back and reset. Analyze all of your assumptions, isolate the variables as much as possible, and brainstorm some new theories. If this is a new process, don’t be afraid to waste a little time. If you’ve been struggling for a while, what’s the harm in taking a little longer when it’s in the right direction?

1. Use Resources Efficiently

Getting a full time, highly trained engineer to do everything in the product development process may move the project along faster, but it can be more expensive. Instead of paying an engineer to perform every task, such as testing a prototype or drafting a report, maybe a lab technician or college intern can run specific parts of the test and write up the final report under the engineer’s supervision. What they cost in inefficiency they often make up for in reduced overhead.

2. Plan Ahead

Nothing wastes time and money more than having to do things over. There’s certainly plenty of iteration required in product development, but making mistakes by rushing or failing to prepare for likely problems should be avoided by taking the time to plan ahead.

3. Mind Your Perspective

While working on a project, it’s easy to get caught up in the details. At least once a week, step back to look at the big picture. Consider what you (and others) are working on and where it lays on the path between the design specification and the finished product. Is your team working efficiently? Are you spending time on minutia too early in the project? Adding (and rebuilding) the draft angles and fillets required for injection-molding are often unnecessary when using most rapid prototyping techniques.

4. Look Off-The-Shelf

Using commercial off-the-shelf parts (COTS) is a great way to reduce the schedule and cut development costs. Designing products takes time, so if someone has already spent the time and money to build a sub-system, try to take advantage. Look for at least one more supplier so you have options if they raise the price, discontinue the product, or don’t meet expectations as a vendor. Sole-source products should be avoided as much as possible, but you can spare yourself some pain by purchasing stock well ahead of time or negotiating a contract with the supplier. Of course, don’t squeeze a square peg in a round hole just to save a buck, either. If you can’t find anything to meet the requirements, and changing the requirements is out of the question, it’s time to design it yourself.

5. Conserve Energy

We have a responsibility to be environmentally conscious, but efforts to that effect can also make financial sense. Reducing the power requirements for your product can decrease the size, weight, and cost of your power supply. It can also increase the battery life for a product used in the field. Choosing the same materials or components within a product or across product lines makes recycling easier, but it also means you can save money by purchasing raw materials in higher quantities.

Keep your pipeline moving. Photo credit: Steve Knight

You can save money and continue working with a smaller budget by implementing stage gates early in the product pipeline to examine risk – technical risk, market risk, manufacturing risk, regulatory risk, supply chain risk, etc. A well managed pipeline has procedures in place to identify areas of risk and evaluate them. The process of assessing and addressing risk is an excellent, cost effective means of advancing the product pipeline in lean times.

• Technical risk is assessed with basic proof of concept prototypes and technology research that address specific aspects of the product that are considered high risk.
• Market risk is assessed with targeted market studies, limited voice of the customer (VOC) interviews, and other information gathering efforts focused on reducing risk. For medical products, preliminary research to understand the reimbursement environment for the product may be of particular importance.
• Regulatory risk can be minimized through careful planning of the submittal process and preliminary discussions with regulatory personnel. For products that will be launched into regulated environments (medical, nuclear, etc), regulatory acceptance of the product is critical to product success.
• Supply chain risk is assessed through detailed conversations with manufacturing vendors and suppliers. Risk may be significantly minimized by reducing the number of “single-point failures” required for a product such as a sole-sourced component or highly-specialized service. Trusted vendors often prove to be invaluable resources later in the NPD process and should be involved as early as possible.

The risk assessment phase of NPD is absolutely critical to maintaining the health of the new product pipeline and preventing unpleasant surprises late in the game when a product is almost ready for release. By attacking and reducing risk early, unfeasible projects are eliminated earlier in the pipeline and feasible projects become easier to forecast. It is also a relatively inexpensive phase, as compared to the balance of the development process. In weak economic times, focusing on this early phase can filter multiple concepts, preparing them for the more costly process of advancing them down the pipeline when the economy improves.