Data Quality Is Key to the Success of Medical Wearables
Medical wearables are an emerging technology that allows continuous ambulatory monitoring...
So you have a product idea. It can be quite a challenge to go from idea to product. Here are some tips on navigating through the process of designing your product, finding a manufacturer, and optimizing your relationship with your manufacturer so that you and your customers are happy.
Your idea may not be possible, or it may not be possible to build it at a reasonable price with today’s technology. The first step is to eliminate this risk. Many ideas don’t need this phase, but many do.
Build a simple test of the critical technology. Do it fast at a low cost. Build simple models of cardboard and duct tape, if possible. Do the minimum for a demonstration.
Your goal at this point should be to show how the idea cannot work. It is probably feasible if you fail to prove it cannot work. Very often, the idea changes a lot during feasibility testing. The result of the feasibility phase is either a clear path forward or a decision that the idea cannot work. You don’t want to spend a lot of money if the idea does not work.
One customer had an idea for tire puncture detection. We tested it and found we could detect many punctures, but certain punctures could not reliably be detected. The customer abandoned the idea. Another customer wanted to detect the display on another device. The first feasibility model worked, but it blocked the display too much. The second model worked fine.
If the feasibility phase had been omitted in either of these cases, tens of thousands of dollars might have been wasted.
The second step in the process is to create a prototype. Depending upon the idea and your needs, you may make a fully working prototype ready for production. This purpose is to create an operating version of a solution, which allows you to test how your solution will work and even show the solution to users for feedback.
Sometimes you will need an interim prototype to show to users or to demonstrate to investors. Such an interim prototype may be a “looks-like” model that doesn’t function but looks exactly like the final device. Or, you may make a “works-like” prototype that demonstrates the function of the idea but is not the final size and shape.
A looks-like model can be shown to users to get valuable feedback. A works-like prototype is used when you need a quick demonstration model or don’t have the money to design and build a fully working production-ready device. It is often shown to investors.
Usually, projects require a blend of experts: electronic design, software, and mechanical design. Voler’s senior engineers can design a new product rapidly that works the first time. We know what experts are required and pull them in when needed. We have partners, such as mechanical design firms, who provide the same high quality.
Our customers value working with us for many reasons. We not only help scope and refine the original prototype but also offer many suggestions and ideas for making the product easier to manufacture. We have relationships with several companies that offer prototyping services that are invaluable to new entrepreneurs.
Once you have a prototype, there is testing and tweaking. Now you can give fully working devices to users and get precise feedback. You may discover the design needs changing to fully meet the users’ needs. You will want to do testing to ensure the product is reliable in the environment for which it is designed.
An important part of testing is compliance testing to make sure the device meets the legal requirements, such as radio frequency emissions and safety, or medical device testing to meet FDA or CE requirements.
You will also want to ensure that the design is easily manufactured, called Design for Manufacturability or DfM. For high-volume manufacturing, DfM is critical to keeping costs low and avoiding delays. DfM begins during the design phase and runs right up to the start of manufacturing.
Our partners and we do the work. Parts are checked to confirm they will be available during the life of the product. The design is adjusted to make it easy to test. The design is adjusted for the manufacturing process, which is slightly different for each manufacturer.
You may make half a dozen or more finished prototypes, depending on the testing you are doing and how many people will try them out. Often you will have a prototype manufacturer and different manufacturers for large-volume production. The prototype manufacturer can quickly produce small quantities, while the volume manufacturer is very efficient and can produce large quantities at a low cost.
The best way to locate manufacturers is through referrals. We have close relationships with many, but we also have partners who help with the transfer to manufacturers around the world. One of the first decisions made is to go off-shore or remain on-shore.
Much has been written about on-shore and off-shore manufacturers. Our partners can help you look at the business case for it. Here is a good article:
If it makes sense to use off-shore manufacturing, and you don’t already have experience working with off-shore manufacturers, use an agent in the U.S. who can help guide you through the entire process. Having this knowledgeable middleman can avoid potential setbacks, such as:
Cultural differences often make it difficult to negotiate with off-shore firms. When they say “yes,” they may be saying “yes, I heard,” not “yes, I agree.”
It can be challenging to maintain quality if the manufacturer makes changes to cut his cost without telling you. This often happens. A common problem is the theft of intellectual property. One Chinese manufacturer had no idea that their U.S. client would be unhappy when told they were selling the product locally in China (without paying the client) to increase volume and reduce cost.
One way to make it difficult for manufacturers to steal intellectual property is to have different parts made by different manufacturers while the final assembly is done in the U.S.
Although the agent you are working with should be able to guide you along the way, it is your responsibility to be informed. You are ultimately the responsible party. A good resource is the U.S. Customs and Border Protection. Under “Trade,” click on “Basic Importing and Exporting.”
Once references and the signed NDA are in your possession, it’s time to send your specs to the factory for a quote. When comparing quotes, it’s essential to make sure you are comparing apples to apples. Have the factories quoted the same quantities and quality? Do the quotes include shipping, duties, customs fees, etc., or are you responsible for these?
Be familiar with terms you might see in the quote:
FOB China means the quoted price is for the goods to be delivered to the port in China. You pay for all costs beyond that point. You are responsible for shipping, duties, customs fees, insurance, unloading, etc., from China to the U.S. These additional fees and taxes significantly add to your product’s cost.
If you are buying goods FOB China, you need the services of a customs broker and freight forwarder. A customs broker or customs agent is an individual or firm licensed to enter and clear goods through customs for another individual or firm. A freight forwarder assembles, collects, consolidates shipping, and distributes less than a trailer load (LTL) freight. Talk to companies that handle these responsibilities to better understand what is involved.
FOB L.A. (or other U.S. port) means all shipping, duties, and customs fees are paid as far as Los Angeles (or other U.S. port). You still need to pay to get the goods from the port to their final U.S. destination.
Now that you have selected the factories to work with, it’s time to start production. A limited production run or first article is typical. When you find corrections, take pictures, keep detailed notes, make copies, and send notes back to the factory.
This first article phase is about finding the glitches or surprises that might have been overlooked in the design phase. It is common to start manufacturing in the U.S. and only go off-shore when the production is running smoothly. The higher cost can be offset by shorter time-to-market and lower scrap.
Planning for this transfer from the beginning is important, so the design is ready for off-shore manufacturing.
Supply chain issues have become very important recently. You need to make sure the parts that have been designed into the product will be available for manufacturing. Voler takes steps to help with this.
There are things you should do. Ask for alternate parts in the BOM (bill of materials) to make purchasing easier. Check with the manufacturer about part lead times, especially for key parts. Purchase key parts in advance, if necessary.
At Voler Systems, we reduce the risk of new product design with a proven process that ensures a smooth transfer to manufacturing. Our network of suppliers can help you understand the process and deliver a quality product.
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