How do I get a Prototype made in Canada?
Jordan Worona • September 1, 2023

How to make a Prototype?

If you are reading this you likely have a product idea in mind, maybe some sketches, drawings, or models. You now want to take the design work to the next step and create a prototype. The prototype can be used for many things, here are a few examples:

  • validating the product idea for yourself (i.e., testing if it works)
  • showing the product idea to potential investors (e.g., giving them something to hold during  your investment pitch)
  • safety testing (e.g., electrical safety)
  • preproduction validation for regulatory submissions for Health Canada and the FDA (e.g., for medical devices)

How much does a Prototype cost?

Depending on the intended use of the prototype, the cost can vary dramatically. Prototypes can range from:

  • Craft-like (e.g., using pipe cleaners, cardboard, and hot glue)
  • Functional yet rough (e.g., using plywood and screws)
  • Non-functional but aesthetically representative of a finished product
  • Preproduction quality (functional and representative of a finished product)



They also vary widely depending on the type of product you are prototyping. For example, prototypes for electromechanical products are generally going to cost more than prototypes for purely mechanical products.


We suggest that before spending a lot of money and time on a prototype, you first perform your due diligence on your product idea. One of the most important due diligences you must perform is to confirm your idea does not infringe on anyone else’s patents. If it doesn’t, then you can continue your product strategy due diligence (market research, etc.) and then file a patent application.


 How do I patent an idea in Canada? 

There are two main patents we care about when it comes to product development:

Design Patents and Utility Patents.

Design Patents are useful in protecting your implementation of an object. Nike might have design patents that cover each one of their shoe designs, and so would Adidas. Usually, these patents have lots of diagrams describing the design aspects that are being patented. If another person copies this patent 90% and only differs from the design aspects specified in the patent, they would not be infringing on the patent. Therefore, design patents are easy to get around by just changing a few inconsequential design characteristics. 

Utility Patents describe the function of a product. I.e., if someone has a utility patent for a shoe it might be described as “An object that wraps around a foot” If Nike has a patent for this – nobody else would be allowed to profit from such an object. It would be a very lucrative patent to have since it would be hard to design a shoe that doesn’t wrap around a foot.


For this reason, utility patents are usually much more valuable than design patents.


Keep these core concepts in mind when searching to see if your product idea is patent protected and when considering patenting your product ideas for yourself.


To learn more about patenting product ideas and searching for patents already issued, we suggest you consult “File a Canadian patent application: Before you start” 


 How do I create a product prototype? 

You have identified that your product idea is new, not patented by someone else, and you have started down the path of patenting it for yourself. Now is the time to start making and testing more serious prototypes.


As described in the introduction, prototype development costs and effort can vary widely. Depending on the intended use of the prototype, you may be able to save a lot of money by doing it yourself with the materials you have around.


Once you start needing to produce prototypes for investors, preproduction validation, or safety testing, you’ll have to get some more rigorous design work in order.


Investor prototypes are usually geared toward showing that the product can work, and that the product can be pretty.


Often early on, you can show these two aspects using two different prototypes, a functional ugly prototype, and a non-functional pretty prototype.


Safety test and preproduction validation prototypes should be representative of what you are intending to sell.


To make these prototypes, you will need to create some design files:

  • CAD files – 3D part files for custom metal work and rapid prototyping of plastic parts.
  • Drawings – most metal shops will require drawings in addition to the CAD files, these drawings call out important dimensions, materials, coatings to use, and other part-specific requirements.
  • Gerbers – electronic circuit board files if you have a custom circuit board in your prototype.
  • Bill of Materials (BOMs) – If you want a manufacturer to build anything out of a bunch of items, you must provide a list of those items in a BOM. You may have many BOMs that describe how to make each one of your assemblies. E.g., one for your custom circuit boards, one for a mechanical sub-assembly, and another for the completed product.
  • Assembly and Test Instructions – If you want someone else to assemble and test your prototype or parts, you will need to communicate how to do so. Assembly and test instructions can be simple to start (a word document listing the steps) and become more detailed as you get closer to production.

 Industrial Prototyping

Next, you will need industrial suppliers for the various parts of your prototype or a turnkey supplier that will make your whole prototype for you. You will send them your design files listed above and they will provide a quote to do the work. Some things to consider:


Building low quantities of parts often have a high unit cost. Prototype costs are therefore not a good indicator of production costs.


Depending on your application, it may be okay to just find anyone with a metal bender, rapid prototyping abilities, or a workshop to make your parts for you.


For higher-risk parts (electronics) or for medical device applications you should properly source reputable vendors. Common certifications to look for are ISO 9001 for general industrial prototyping and ISO 13485 for medical device prototyping. 


When working with reputable suppliers, the “quality” of your parts will depend heavily on your part specifications. For example, if you want a supplier to take sharp edges off your parts, you must tell them to deburr the edges in your drawings. Do not leave anything up to assumptions.


Larger, more reputable suppliers don’t like making small quantities of parts for someone they don’t know. They are often interested in what is in it for them in the long run, so try to paint a picture of your intended production volumes for them. E.g., “we expect to make 100 per month once we get into production”.


If you are still not getting anywhere with part suppliers, they may be too big for you, or you may need to partner with a turnkey prototype manufacturer that will build the whole thing for you. Turnkey manufacturers already have relationships with part suppliers that they can leverage.


 Your Next Steps

Now you’re ready to build your prototype and show how great your idea is! Whether you are designing and building by yourself or working with a Product Development company. The key steps you have just learned about can help you commercialize your product quickly and on budget.  

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When a calibrated torque driver fails an in-house check after it's already been used on a clinical trial build, the question worth investigating isn't whether the tool is broken now. It clearly is. The question is whether the units built before the failure are still within spec, and whether you can defend that conclusion with evidence rather than assumption. A few weeks ago my Director of Quality came to tell me one of our torque drivers had been dropped. We tested it in-house right away and it was reading out of spec. Torque drivers get dropped, you replace them, you move on. The complication was that this particular wrench had been used the week before to build five units for a client's clinical trial. The wrench had a clean recent record. It came back from a full external calibration six months ago, with another six months of useful life ahead of it. About a month before the clinical build we'd spot-checked it on our in-house calibrated torque checker, and it was in spec then too. So when it failed yesterday's test, the obvious story was that the drop had broken it, and the obvious story was probably right. The problem with stopping there is that "probably right" doesn't survive contact with a regulator, and it doesn't really survive contact with a thoughtful client either. We were either going to show that the five clinical units were still good, or we were going to tell the client they weren't. Splitting the difference wasn't an option. Did the drop cause the calibration failure, or did the tool drift earlier?  Honestly, we don't know for certain. The drop is the obvious cause and probably the real one, but we can't rule out earlier drift, and it turns out we don't need to. Whether the drop did it or whether the tool had been creeping out of spec for weeks, the only question with practical consequences is whether the screws on the clinical units were torqued to a value that puts them at risk. So we worked backwards from that. What was the nominal torque setting, how far out was the wrench reading, in which direction, and where in the assembly was it being used. How do you check a torque wrench when your checker doesn't reach the working range? The wrench is an adjustable torque driver set to 5 Nm for a single joint in the build. It was going out for full external calibration regardless — that's not optional after a known impact event — but we wanted a data point quickly. Our in-house checker only goes up to 3.5 Nm, so we set the wrench to 3 Nm and ran it. It read 3.4 Nm, about 13% high. Direction matters as much as magnitude here. A wrench reading high means the operator hits the click later than they should, which means the screws received more torque than spec, not less. That is a meaningfully different failure mode than a wrench reading low. Is over-torque on a screw a risk to the assembly? This was where my Director of Quality and I started disagreeing, which is exactly what's supposed to happen. My read was that over-torque on this joint isn't a loosening risk. The screws are tighter than intended, not looser, and a tighter screw doesn't fall out. Quality pushed back that you can over-torque a screw to the point of stripping the threads, at which point it doesn't matter how high the tool was reading because the screw isn't holding anything. Fair point, and one I had a counter for. A stripped screw doesn't torque. The wrench never reaches the click, the assembler notices the joint isn't behaving the way it usually does, and the unit gets flagged. Our senior techs didn't flag anything on those five builds. Quality still wasn't satisfied. Even short of stripping, sustained over-torque can fatigue a joint and let it back off in service. That one I didn't have a clean answer for. Why a chemical thread-locker resolved the question What got us unstuck was a detail neither of us had on the tip of our tongue. Our manufacturing engineer, who has been close to this project from the start, mentioned that the joint in question also gets Loctite. That changed the picture. The over-torque was bounded at 13% above spec, not double. The screws weren't stripped. And the chemical thread-locker provides retention that doesn't depend on preload at all. Between those three facts the joint is fine, the units are fine, and we can defend that conclusion with evidence instead of assumption. What goes into a Non-Conforming Material Report (NCMR) for an out-of-cal tool? The rest was process. We opened a non-conforming material report on the torque driver with the full timeline, the measurement data, the failure mode reasoning, and the conclusion about the clinical units. Then we told the client. They'll have questions, and they should, that's part of why they hired us, but the rationale holds together and the records are auditable. The broader takeaway I don't think we over-complicated it. The temptation in this kind of situation is to take the convenient explanation, write a short report, and move on, because the convenient explanation is probably right. You don't get credit for being right by accident in a regulated environment. You get credit for being able to show your work. When Ops and Quality disagree, the disagreement is doing useful work, and you should let it run a little longer than feels comfortable before reaching for the answer. The other thing is that whoever is closest to the actual build usually knows something the people running the meeting don't. Neither I nor my Director of Quality remembered the Loctite. The engineer on the floor did, and that detail closed the case. Written by Jordan, Director of Operations at Engineering CPR — a Toronto-based ISO 13485-certified medical device contract manufacturer specializing in high-mix, low-volume elect ro-mechanical assemblies, cleanroom manufacturing, and box builds.
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