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Medical or Aerospace Certification worth it?

Interesting, we do all this but backwards,
All our orders are repeat production, we do larger orders in the hundreds, with very little variation of different parts.
We bought a new Hydmech H14A all material arrives in full bar stock, because of this, I don't wait for 3 days for them to cut it up,
and my material is cheaper because, no cutting, and a lot of the same material I get material cost bulk discount,
my supplier guarantees material by the next day.
So I get material faster, cheaper, and get the job started and finished quicker.

Actually our saw is our favorite machine as far as gave us more efficiency, and saved us the most money, and the crazy thing within that statement is it was $60k.
3 days for 85 different cuts out of different size stock, If I was ordering bar stock it’s guaranteed next day as well and if I was ordering bulk it’s discounted as well. These type of jobs just doesn’t make sense for me to order bar stock to cut out 3 pieces that takes up 18” out of a 144” bar. I’ve done it both ways and compared pricing and always go back to having them cut it.

Most my other work is decent size plate stock, quantity of one or two and I can get that cut next day.

Either way, it’s pretty rare I need any material next day so 3 days doesn’t make a difference, chances are I’m not starting it for 1-2 weeks anyway.

If I was to get into production, ordering bar stock and buying an auto saw would make sense.
 
A "garage" shop would be a guy at his house with all he could fit in a "garage" you can fit like 1 or 2 VMC's max, and its a one man show, check Youtube, there's a bunch of them.
A "small shop" could be at your house barn or large building, or renting/buying an offsite building, the difference would be in scale, larger than a "garage" shop.
I think people are stretching the definition of a "garage" to include things like large barns or buildings.
This would just be your opinion or “2 cents” on the definition of each term.

In my area a detached accessory structure of any size is referred to by many as a shed, so my shop is in a shed. 😂

Also you have to remember if its a 1 man show, you own a "job" not a "business", Sure you do business, yes, but you don't own a business. Why?
because once you are removed, don't work there, retire... there is no business,
you can't sell a job.
This would also be your opinion referring to a 1 man show a “job” and not a “business”, but please reach out to the IRS and let them know they have it wrong, and 1 man shops shouldn’t have to file “business” taxes! I’m sure many would be pleased.

You can totally sell a 1 man shop, why can’t you? If that 1 man shop has customers or equipment that are appealing to another shop you could easily sell it. MultiSource, this is what they do, they buy out machine shops for the customer, in a lot of cases they liquidate the equipment, give an option to the employees to accept employment at another facility and move on.

My mother in law sold her sourcing company she started in the 90’s, it was just her, sourcing jobs from her house via fax machine, sold the business to a machine shop. I thought that would have been a very hard sell.
 
3 days for 85 different cuts out of different size stock, If I was ordering bar stock it’s guaranteed next day as well and if I was ordering bulk it’s discounted as well. These type of jobs just doesn’t make sense for me to order bar stock to cut out 3 pieces that takes up 18” out of a 144” bar. I’ve done it both ways and compared pricing and always go back to having them cut it.

Most my other work is decent size plate stock, quantity of one or two and I can get that cut next day.

Either way, it’s pretty rare I need any material next day so 3 days doesn’t make a difference, chances are I’m not starting it for 1-2 weeks anyway.

If I was to get into production, ordering bar stock and buying an auto saw would make sense.
Yeah, just stating how different shops can be. Not comparing good/bad better/worse efficient/inefficient....just pointing the differences.
 
This would just be your opinion or “2 cents” on the definition of each term.

In my area a detached accessory structure of any size is referred to by many as a shed, so my shop is in a shed. 😂
edit: Just mentioning, because if we lump the differences together, we are just going to have non stop arguing in opinions, if we don't first define the parameters of the subjects we're encapsulating in our opinions.
If I describe the encapsulating word of a "garage shop" as a one man show in a garage with footage able to fit 2 VMC's (a garage),
and the next guy describes a "garage shop" as any business that's a one man show, and that includes 4,000 sq ft barns with 5 automated machines, thats larger than some "small machine shops"
then by not defining the parameters of the encapsulating definition of the word "garage shop" there is just people arguing about nothing!
 
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Yeah, just stating how different shops can be. Not comparing good/bad better/worse efficient/inefficient....just pointing the differences.
I get it, it's one thing I've always found interesting in this trade, no matter the size of the shop, there is no right or wrong way to go about running a business, from the top all the way down to the bottom. Every shop is going to do things different. One way may be more efficient for one shop and not the next. Of course every shop has areas they can improve too.
edit: Just mentioning, because if we lump the differences together, we are just going to have non stop arguing in opinions, if we don't first define the parameters of the subjects we're encapsulating in our opinions.
If I describe the encapsulating word of a "garage shop" as a one man show in a garage with footage able to fit 2 VMC's (a garage),
and the next guy describes a "garage shop" as any business that's a one man show, and that includes 4,000 sq ft barns with 5 automated machines, thats larger than some "small machine shops"
then by not defining the parameters of the encapsulating definition of the word "garage shop" there is just people arguing about nothing!
In all your responses from the OP and by deciding to define the definition of different shops based on size, employees, etc I feel you kind of answered your original question and/or contradicted your original question.

You wanted input on how you can differentiate your shop and "separate our business from the guy in his garage.." You kind of already have, by your definition of course, with having 5 machines and one employee, yea you referred to your son as a helper, so maybe you don't consider him an employee yet. Do you pay him? I assume you do so he's by definition of business, he's an employee. In that same post you said "I currently am a one man show" but your original post as I stated above you want to "separate our business" and again by your own definition, you do not have a business you have a job.

With that being said, again, I would say you already have to an extent separated your shop from "the guy in his garage". And in my opinion I wouldn't invest $800k into a machine and hope you get work for it, that's an expensive hope. Will you get the work, probably but why take the financial risk up front? Unless you have the cash and no worries. I'd start with the certifications, ISO9001, AS9100, get in the door with some customer and see where it takes you, it may open doors to alternate or better opportunities with what equipment you already have and if you start seeing RFQ's for parts that would require a higher end expensive machine, make that decision at that time.
 
For me, the limitation to growth is not my equipment but rather the labor pool in my area. I can't really grow my current business by buying more or different equipment. I could grow by hiring machinists, but I don't think it makes economic sense. I think the future of low volume high mix job shops will be mostly one man operations.

Branching out to injection molding might be a good idea. I think protolabs did it best and is a business to look up to in that field. If you are involved in it personally or with your kid, I would take care with injection molding. Hanging around molten plastic all day will give you cancer and I've worked at companies with mold shops where a lot of the mold shop employees got cancer as they aged. After watching a few of their struggles with chemo and treatment, I lost interest in ever doing injection molding.
 
For me, the limitation to growth is not my equipment but rather the labor pool in my area. I can't really grow my current business by buying more or different equipment. I could grow by hiring machinists, but I don't think it makes economic sense. I think the future of low volume high mix job shops will be mostly one man operations.
I've kind of came to the same conclusion and decided I will always to an extent be limited by my machines, I think every shop is, no matter what you have you will more than likely always max its capability out, so to grow for me is to become more efficient in other areas, set ups and programming, in that order. That was the idea behind the horizontal with 6 station pallet pool, which I didn't actually plan on buying, just couldn't pass the price up. But for me, I can have 6 different pallets that will cover practically all my set up change overs, now I put myself into a position where I'm not moving vises, changing a 3 jaw chuck in a 4th to a vise, and the next week back to a 3 jaw, I have a pallet with a 3 jaw. I also have 3 extra pallet tables if I need additional set ups, I can easily swap a pallet out for an additional set up. I can call up a pallet and my set up is ready to go and I can pre stage work and schedule it. Within set ups, I am planning on pre staging a lot of tools so I can minimize changing tools in holders, they'll all be in a cart ready to go with a tool tag. Then programming comes next, making my CAM software work for me, getting deeper in the Tech Database, fine tuning every operation, I'm starting to use API/Macro's to do numerous tasks in one.
 
If you are involved in it personally or with your kid, I would take care with injection molding. Hanging around molten plastic all day will give you cancer and I've worked at companies with mold shops where a lot of the mold shop employees got cancer as they aged. After watching a few of their struggles with chemo and treatment, I lost interest in ever doing injection molding.

The fumes from plastics are phthalates. Great stuff for plastic. Not so great if you're a living organism with cells that depend on chemical signals for your body to work properly.
 
The fumes from plastics PVC are phthalates. Great stuff for cheap plastic. Not so great if you're a living organism with cells that depend on chemical signals for your body to work properly.
Phthalates are a plasticizer used primarily in flexible PVC. It's the part that makes it flexible. You are correct that they are not good for you.

Lots of different bad stuff in melting plastic: https://www.sentryair.com/blog/indu...ding-recommended-engineering-safety-controls/

Fume and air management are important.

In general, if you are making parts that are going to go into someone, you may require ISO certification depending on how the customer assesses the risk of the component. Most shops I know got their start by making non patient contact parts or prototypes that grow to production. There are lots of parts that don't go in people though.

One trick that can work is to be willing to adopt your customers quality system. You use their procedures, documentation, and are trained in their quality system. Practically, it means you release your procedures in their system. I've used this approach before in early stage medical device companies to move from prototypes to first in human feasibility studies. It is not a long term viable approach in most scenarios though.
 
For whatever it's worth:

I work at a small shop (12 machinists) that has evolved from a lot of standard tooling (e.g. Ejector Blades, pins, sleeves, taperlocks, etc.) to more custom work in molding forms/pins. Tolerances are often .0002 total tolerance, sometimes with surface finish requirements.

  • A great deal of that custom work is for our Medical customers, those molding pins used for injection molding of syringe and other medical devices.
  • We've had to up our game in machines (now have 3 five axis mills) and measuring equipment (Olympus ultrasonic gages to measure wall thicknesses, better roundness and concentricity gages, and a couple of laser mics, in addition to the proven traditional tools such as sine plates, dial indicators and well kept surface plates).
  • So far, we've only needed to be ISO 9001:2015 certified. However, this is based on what our current customers require. We have a different opportunity . . . maybe, the owners are thinking about it and it's not immediate . . . that may require us to be ISO 13485 (medical) certified.

As far as what standards you should be thinking of, I wouldn't think about that right now, per se. That requirement, or not, will come from your prospective customers. If you are scouting a particular set of customers and get the information those companies will require a given standard, then you know what you are going to be required to do.

Best of luck.
 
Fantastic, one of the best posts ever.

Also to note..
-- pallet loading machines at 400k$++ each tend to cost 8k$ per month to pay off.
And they typically need large stocks of materials, tools, racking, storage, inflow, outflow, to run efficiently.

Sure, one guy can run a huge variety of very good parts on a horizontal pallet loader, making excellent margin on even garden-variety parts, given excellent cad/cam and automation skills.
Few people have or can acquire all these skills, and it takes a lot of hours.

And a big setup of jigs, fixtures, pallet stuff, zero-point vices, etc etc.
Easily 100k$ alone.
The same $$ for metrology, if making demanding or inspected parts-

A 1M$ setup for 2 horizontals, etc. is 12.000$ a month ++.
There is noi free money.
The 1 M$ could produce without the machines shop, as well.


A "garage" shop would be a guy at his house with all he could fit in a "garage" you can fit like 1 or 2 VMC's max, and its a one man show, check Youtube, there's a bunch of them.
A "small shop" could be at your house barn or large building, or renting/buying a offsite building, the difference would be in scale, larger than a "garage" shop.
Yes.
A "small shop" could be shit like the ones I've seen. 5 employee's, 4 old machines, no automation....similar,
Yes.
or it could be NO employee's, 1 man show, 2 pallet loading 5 axis, and 2 pallet loading horizontals.
YES !
We also have to consider when talking scale, a single machinist can only setup and run so many machines,

I have found over the years depending on variables an average of 2-3 machines. So without employees you cant scale up past this, UNLESS.
You do everything automated, pallet loaded machines.
 
Fantastic, one of the best posts ever.

Also to note..
-- pallet loading machines at 400k$++ each tend to cost 8k$ per month to pay off.
And they typically need large stocks of materials, tools, racking, storage, inflow, outflow, to run efficiently.

Sure, one guy can run a huge variety of very good parts on a horizontal pallet loader, making excellent margin on even garden-variety parts, given excellent cad/cam and automation skills.
Few people have or can acquire all these skills, and it takes a lot of hours.

And a big setup of jigs, fixtures, pallet stuff, zero-point vices, etc etc.
Easily 100k$ alone.
The same $$ for metrology, if making demanding or inspected parts-

A 1M$ setup for 2 horizontals, etc. is 12.000$ a month ++.
There is noi free money.
The 1 M$ could produce without the machines shop, as well.
Not sure where you are pulling these numbers from, but it hasn't cost me anything close to this to do what I currently have.

Horizontal with 6 station pallet pool
2 Vertical Mills
1 Turning Center

My machines and building don't even exceed $400k
 
For me, the limitation to growth is not my equipment but rather the labor pool in my area. I can't really grow my current business by buying more or different equipment. I could grow by hiring machinists, but I don't think it makes economic sense. I think the future of low volume high mix job shops will be mostly one man operations.

Branching out to injection molding might be a good idea. I think protolabs did it best and is a business to look up to in that field. If you are involved in it personally or with your kid, I would take care with injection molding. Hanging around molten plastic all day will give you cancer and I've worked at companies with mold shops where a lot of the mold shop employees got cancer as they aged. After watching a few of their struggles with chemo and treatment, I lost interest in ever doing injection molding.
This is what happens when shit business owners don't put in ventilation systems, same as machine shops that don't buy mist collectors for their machines, Don't know about you but I'm not a douche business owner,
all my machines have mist collectors with HEPA after filters, and the last mold shop I managed I had them put in ventilation systems like 15"-18" vacuum vents right above the machines critical off gas areas.
Its to big of a hazard to peoples lively hood to me, take care of your fellow man, and he will take care of you.
 
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Not sure where you are pulling these numbers from, but it hasn't cost me anything close to this to do what I currently have.

Horizontal with 6 station pallet pool
2 Vertical Mills
1 Turning Center

My machines and building don't even exceed $400k
Maybe because a lot of machine shop owners have been burned to many times, and will not buy used machines, I wont buy used machines either. just mentioning.
 
Not sure where you are pulling these numbers from, but it hasn't cost me anything close to this to do what I currently have.

Horizontal with 6 station pallet pool
2 Vertical Mills
1 Turning Center

My machines and building don't even exceed $400k
He is definitely correct about the price if talking about new equipment. We get it that you bought your stuff used for less than scrap pricing. I have also seen 8 year old horizontals sell for like 10k at auction. Nobody buys them because they take up a lot of space and are hard to move and are a lot of work to set up.
 
Maybe because a lot of machine shop owners have been burned to many times, and will not buy used machines, I wont buy used machines either. just mentioning.
Understandably if you've been burned. Besides replacing that spindle on my horizontal when I first picked it up, I probably have less than $4k in maintenance/repairs over 5 years on used machines, I also have mechanical break down coverage on all my machines that cost less than $500/year per machine.
 
Understandably if you've been burned. Besides replacing that spindle on my horizontal when I first picked it up, I probably have less than $4k in maintenance/repairs over 5 years on used machines, I also have mechanical break down coverage on all my machines that cost less than $500/year per machine.
Truth is depends on also what you willing to do with your $$$, I make too much profit, and messing around with used possibly broke or worn machines isn't worth.
I actually need to reduce my profits by buying machines, if not I have to give the government 30%+
It's just not worth it usually, unless your a small tight profit deal, managing larger shops I noticed the same thing, they were better off not buying a suspect piece of cheap equipment, and they needed large write offs yearly.
 
He is definitely correct about the price if talking about new equipment. We get it that you bought your stuff used for less than scrap pricing. I have also seen 8 year old horizontals sell for like 10k at auction. Nobody buys them because they take up a lot of space and are hard to move and are a lot of work to set up.
On new equipment yea, I can see that.

Less than scrap pricing 😂

Truth is depends on also what you willing to do with your $$$, I make too much profit, and messing around with used possibly broke or worn machines isn't worth.
I actually need to reduce my profits by buying machines, if not I have to give the government 30%+
It's just not worth it usually, unless your a small tight profit deal, managing larger shops I noticed the same thing, they were better off not buying a suspect piece of cheap equipment, and they needed large write offs yearly.

Horizontal was never a planned purchase but I couldn't pass on a 2013 for $25k, cost, $2500 to get it in place, and $6500 for new spindle. I made 3x that back on one of the first jobs I ran through it.

I always see these post about needing a million $ to start a machine shop, yea I get it, if you are buying all brand new equipment, but it's not NEEDED, you can start for far less than that and be very profitable, even as a one man band, my best year in business so far was 2022 and I cleared $600k by myself with two vertical machines.
 
On new equipment yea, I can see that.

Less than scrap pricing 😂



Horizontal was never a planned purchase but I couldn't pass on a 2013 for $25k, cost, $2500 to get it in place, and $6500 for new spindle. I made 3x that back on one of the first jobs I ran through it.

I always see these post about needing a million $ to start a machine shop, yea I get it, if you are buying all brand new equipment, but it's not NEEDED, you can start for far less than that and be very profitable, even as a one man band, my best year in business so far was 2022 and I cleared $600k by myself with two vertical machines.
But also, starting a business with minimal funds, and buying used machines, is EXTREMELY risky!!!!
 
But also, starting a business with minimal funds, and buying used machines, is EXTREMELY risky!!!!
One could argue it’s just as risky either way starting a business with minimal funds whether you buy used or new. Either route what happens if you don’t have the work to support it and can’t make the payment on that new machine?

No matter which route one is to take they should have some sort of safety net.
 








 
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