The last part of this series described one of the most challenging parts for most hardware startups - moving from a functional prototype to a manufacturable product. We left off at the so-called “pre-series,” a set of devices (50–100 in our case, but sometimes thousands for large companies) that are made using as many mass manufacturing techniques as possible. Once that series is complete, there is only one major step left to take — mass manufacturing.

Unfortunately as you may have realized, this is a more complicated part than it initially looks. Manufacturing at scale breaks down into several tasks to complete before shipping to your customers.

1. Analyze Pre-Series and Optimize

Our greatest piece of advice during manufacturing is to learn as much as possible — about the process and from your manufacturing partners. That’s why we're big advocates of keeping it local — when you are close to the people making your product you are bound to learn a lot more.

Creating the pre-series allows you to figure out quickly whether you made the right decision to work with specific manufacturing and supply partners. Since this is your last chance to make changes before you scale the batch, it’s important to be critical of those relationships, get them right this time and avoid expensive switching of partners later on.

During the pre-series the focus should be on:

Finding and correcting errors (incorrect tolerances, wires that are the wrong length, hole offsets, etc)

Optimizing your supply chain (get the right number of suppliers, make sure suppliers are delivering on time, clear up any bad communication, etc.)

Reducing Manual assembly (Figure out what steps you can make faster because if you optimize this, you save a lot of money)

Clarify responsibilities (make sure there is a clear understanding who will be responsible for what role once you start)

Setup a testing routine (setup protocols, checklists, etc.)

Make sure your manufacturing partner tests your device.

2. Tooling and Getting Components

Now you should essentially be ready to hit the button and manufacture your batch. At this point, your device should need no further changes, allowing you to start making the tools.

If you're familiar with manufacturing techniques, making tooling won’t be new to you. Each process is different but for injection moulding, the ‘tool’ is essentially a two-part mold housed in a steel box that allows your manufacturer to inject plastic to create certain parts of your device. The tool must be custom-made to your specifications.

Because the tool is CNC milled directly based on your component and requires an experienced engineer to construct, it’s extremely expensive to produce. Normally tools for injection moulding run anywhere between 5–30K USD depending on the complexity. Additionally, you must account for 6–8 weeks of lead time to make the tool before you can start pumping out pieces for your device.

This is also the point where you get all your components together. A word of caution, components may take up to 4 months to deliver — so order in advance (ideally during your design for manufacturing phase). You must also make sure you use components that have a life cycle of at least two years and are guaranteed to be available.

3. 0-Series

Like the final dress rehearsal, it is now time for the zero-series. This pre-batch is made using all of the actual components, machines and suppliers that you will employ in the final batch — but in a smaller quantity.

There is not much to do for you at this point. If you can, we recommend being present for every step to understand the process and ask questions. It is your responsibility to make sure the quality is right and you produce exactly what you want.

4. Analyze 0-Series and Optimize

As with any final rehearsal there are likely some final adjustments yet to be made and opportunities to optimize. Perhaps the injection moulding temperature needs to be tweaked- finding these minor things is a good way to improve your supply chain.

5. Certification and Testing

After the zero-series, you need to take a small detour into certification and testing. In order to sell a consumer electronic, you must comply with the regulations of the countries in which you want to sell them. Since we have a wireless, low voltage device that we want to use in Europe and North America — so we must obtain the right certifications for this specific case.

In Europe, we need to apply for CE certification, which guarantees that you can’t kill yourself with the device — and if you do, we're not directly liable because it took incredible creativity on your part. Additionally, in North American we will apply for FCC, certifying that our device doesn’t with other wireless communication such as what airplanes use.

There are many other certifications, which ones you need will vary dramatically depending on your market and device (e.g. there are special certifications for medical devices or devices that will touch with food)

Certification isn’t a particularly transparent process. The best way to find out about this is to contact the certification labs directly. There are both big and small certification labs. The larger ones like 7Layers and CETECOM generally cost somewhere between 10–20K, smaller labs for simple certifications will run you about 2–8K.

When you complete your pre-tests, this is the time to make sure you are 90% sure you will pass certification. If they do not pass, you will likely need to redesign your device setting you back 2 months or more.

6. First Main Series

Finally! Now that you have optimized your entire process and have your certifications, you can hit the big red button and start manufacturing.

Again, make sure that you are the one that checks the quality at each step of the way. Make sure that the quality doesn’t shift too much and take testing samples to ensure each device is of highest quality.

To maintain quality throughout the process it is good to create measurable quality standards for everyone — particularly for your manufacturer to understand what is acceptable and what isn’t.

Quality Tests should happen as often as possible including:

When your components arrive at the factory

After manufacturing is completed

After assembly is completed

7. Assembly

We recommend you assemble your product in the same location as your electronics manufacturing. This is because the electronic components are delicate and shouldn’t be shipped around. Likewise, the assembly should also happen in a clean room with under pressure so no dirt enters the device.

You can also choose to do the assembly for the first few thousand devices yourself. This way you get a feeling how to improve this process, how to improve future versions and also get a feeling for the quality.

8. Labeling and Packaging

Once the device is assembled, you need to label it with a few important things. What the device says on it can vary but must common are the following:

Product name

Product information (individual number, batch number, manufacturing date and time - this is useful for tracking if there are problems later on.)

Company name

Certification stickers

Since the requirements for labelling change constantly, it’s best to double check these standards when you manufacture and adhere to them. In some cases it is enough to only where to find the information (instead of displaying on the device directly).

9. Shipping

Shipping is a topic in itself and there is a lot to mess up. That’s why we highly recommend outsourcing this part to companies like Shipwire and Flexport.

And if you can, deliver the devices to your backers in person or add a little thank you note. These people in particular are not only your first customers, they are your first and often most important supporters.

10. Repeat, Repeat, Repeat

Once the device is in the hands of your customers — You made it! You now truly understand the statement ‘Hardware is Hard.’

It is a fantastic feeling to have built a physical product — one that no one can take away from you. Enjoy it! Take time to celebrate your accomplishment before heading back to the drawing board to improve. The shear amount of knowledge you have amassed from delivering that first version will allow you to build something even bigger and better next time.

This is Part 6/8 in the series “Building a Hardware Startup.” Check back for Part 7 about our vision for the future.