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I have made many designs that I would consider "professional grade", but in reality they are still just prototypes. I have used professional board fabs and professional population, but what I haven't had the ability to go through is actually turning that product into a commercial product.

What is needed in order to take the product across this large last step? I can think of obvious things like FCC/CE testing, case design, marketing, distributors, etc. but I am sure there are other things that aren't thought of until going through the process a time or two, as an engineer, what are these things that would come up?

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In my industrial experience, the way things generally go in terms of a design cycle follow this sort of flow (condensed version):

  • Market research/contact with a customer (identification of the what the basics of the product should be)
  • Establishment of a specification (or "spec" as it's often abbreviated)
  • A formal quotation and business agreement between the parties (or between engineering and marketing for a 'standard' product)
  • Initial design / calculation / simulation / debugging
  • Design validation testing, or DVT (you making sure the product meets the spec)
  • Bugfix implementation / regression test
  • Independent DVT (someone else making sure the product meets the spec)
  • Safety and regulatory approvals
  • Design for manufacturability review (DFM)
  • Production release / marketing release

If you have a project that you've developed, and you feel you're ready to market it, you may want to consider some or all of the following points:

  • Write a spec if one doesn't exist. Characterize the typical performance of the product and put this in the spec, as well as any absolute maximums or minimums in terms of 'externals' (volts / amps / degrees) that should be avoided.
  • Make sure that your product meets your spec. Do a formal DVT and make a report of the results. Also, test a quantity of boards against the spec and use statistical analysis (Cp/Cpk) to prove that over tolerances and normal variation, you product can do what you say it can do.
  • Come up with a reduced number of tests to perform per-unit as a manufacturing reliability test. Bad builds, bad parts, new operators, bad equipment can all lead to problems.
  • Make sure that your PCB has in-circuit test pads on as many nets as possible to facilitate in-circuit test (ICT) or manufacturing defect analysis (MDA) - finding problems earlier rather than later is always beneficial.
  • If this product is intended to be high reliability, you may want to perform a life test. Run a quantity of units perpetually until something fails. There are industry standards on life testing (acceleration factors, lot size, etc.) which fall beyond the scope of casual advice.
  • Consider HALT (highly-accelerated reliability testing) as well - testing the product under thermal and mechanical vibration stress can show weaknesses in the design as well as its construction.

Many of these sorts of tests are big bucks. (Tens of thousands of dollars per test). The cheapest things you can do are those that you can do yourself - the spec, the DVT test and statistical analysis, test pads on the PCB, for instance.

You may wish to consult with an experienced manufacturing engineer to figure out what you really need to do, given your budget and the expected revenue of the product.

Good luck!

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This may be somewhat tangential to what you are asking. But it sounds like you are thinking about setting up your own business?

My advice is to forget about government approvals, writing business plans, printed letterheads and all that. Get your prototype into the hands of users, find people that are need your product, that are enthusiastic about it and who is willing to pay you money for it. Until you have something that people are willing to pay you real money for, you don't have a product. Yes, the typical big customer requires approvals, documentation, independent testing, steaks&strippers, etc. etc. etc. You can spend a year or two getting that done, but in the end they won't buy from you anyway. You are a small player. Big Dumb Corporations buy from other Big Dumb Corporations, period.

You have to do the one thing that most engineers hate intensely, and that is getting out of the house and find potential customers. If you don't, your business will go nowhere. Long to-do lists are a trap, a comfortable excuse. Worry about the approvals and all that after you have a product that people are willing to fork over real money for.

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You already covered some of the things needed, but here's my list:

  1. Great Product Design (on the inside).
  2. Great Product Design (on the outside). I'm talking about the parts that the user would care about. The "Look and Feel".
  3. Proper legal and governmental approvals: FCC, CE, RoHS, UL, TUV, ETC.
  4. Proper "environmental" design: ESD, EMI, shock & vibration, temperature,
  5. Great support. This includes the manual, web site resources, and phone/email support.
  6. Reliable manufacturing. Not just electrical here, but chassis, packaging, etc.
  7. Good sales department. Responsive. Much of this can be done online, so a good web site design is an alternative to having a large staff.
  8. International stuff: this includes regulatory, monetary, shipping, etc.

There are thousands or millions of designs that were great products, but failed because of one or more of the other items above. I've also seen companies skimp too much on these things, thinking that they are "just starting" and will "correct it once a revenue stream starts coming in"-- only to find that the revenue never comes in.

It just goes to show you that you need much more than a good product design to be successful.

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In addition to FCC interference testing there's also potentially Underwriters Labs (UL) testing to consider if you think it appropriate. Unfortunately I can't parse the mess of marketing on their website to figure out what a manufacturer is supposed to do. If anyone can parse it maybe we should write a guide.

edit (by stevenvh)
"Underwriters Laboratories, Inc.: A laboratory established by the National Board of Fire Underwriters which tests equipment, materials, and systems that may affect insurance risks, with special attention to fire dangers and other hazards to life." (CRC Press - The Resource Handbook of Electronics, 2001)

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