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matuski

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I don't see a thread on this, so here it is.

I have started a business as of next week distributing pharmaceuticals and medical devices.

My business formed around a handful of my doctor friends basically telling me flat out they would buy certain products from me if Ii could get the license to distribute.  So here I am.  I have a business, I have a storage facility, I have a UPS mailbox, I have insurance, I have a license, I will have inventory and sales by the end of next week.

I also have no idea what I'm doing beyond this.  Questions:

How do you find a good CPA/Lawyer?

Upon inspection I was informed that I need several dozen Policies and Procedures in writing.  Help?  The lady doing my inspection wrote me up laughing to tears at how clueless I was. :bag:

Business plan - I assume writing one for the future would be a good idea, but necessary?  I'm financing this myself.

Inventory tracking/management - I have spreadsheets from past lives I could use, is there an app/software to make this easier?

General advice - Experiences?  Anything you wish you knew starting up?  Best tax/write off advice?

Thank you, I kinda jumped right into this without much thought (I never thought the State would license me to be honest :lmao: )

Matt

 

Edited by matuski

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No need for the bag over your head. My guess is 99% of the self made millionaires in the world who started a business made 200 :bag: mistakes.
They are millionaires because 99% of the people in the world are too afraid to take the risk you took.

 

Good luck.

 

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I'm gonna start rambling for myself as much as anything.

I have 4 docs on board before business began.  They will be able to "lean on" a handful of docs in their referral network.  So 4 accounts growing to 6-12 within 6 months.  I expect early revenue to be tiny, maybe $5-15k per month the first 6 months.  The second half of the year as deductibles are whittled down this will triple/quadruple assuming no new customers.

I have done market research (I asked my 4 docs over beers) on pricing and suppliers.  I will need a pricing strategy.

 

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What kind of inspection are you talking about?  The only policy docs you should need are for your corporation unless there are certain requirements specific to pharmaceuticals.

A business plan would only be required for financing although it is a good idea to have a plan laid out for your own purpose. 

Edited by Megaton

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No need for a formal business plan if you aren’t pursuing outside capital. But, you need to know your B/E, cost of goods, overhead, margin etc like the back of your hand.  Track KPI (key performance indicators).  These will be different for every business.  For mine it’s prospects, # that get converted to warm leads, how many consultations we perform, % of consults that we close into clients, and retention rate.  Yours will be different (maybe average rev/month/clinic or order frequency or some such).

Get a local accountant ASAP. Work with him/her and their team to show you how to start keeping really good records in QuickBooks. It’s an absolute ##### to try to catch up accounting wise if you don’t start right away and stay on top of it.  Because you are selling products you need to know inventory account too I would imagine. 

Make absolutely sure you are doing everything on time re:state and federal regs. Whatever permits, license renewals, etc.  Don’t risk your business by failing to fill out some paperwork on time. 

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14 minutes ago, Megaton said:

What kind of inspection are you talking about?  The only policy docs you should need are for your corporation unless there are certain requirements specific to pharmaceuticals.

A business plan would only be required for financing although it is a good idea to have a plan laid out for your own purpose. 

Storage requirements for pharmaceuticals are pretty demanding.

She came and inspected where I will be keeping my product.  I have to record temperature ranges daily, I have to have a procedure for what happens to the drugs when a natural disaster hits, theft, I need a quarantine procedure setup for recalled/faulty/expired product, written procedure for how product is secured for deliveries when I am not there... on and on and on.

Then all the usual FIFO, inventory records, account records, etc.

 

Edited by matuski

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8 minutes ago, mr roboto said:

Get a local accountant ASAP. Work with him/her and their team to show you how to start keeping really good records in QuickBooks. It’s an absolute ##### to try to catch up accounting wise if you don’t start right away and stay on top of it.  Because you are selling products you need to know inventory account too I would imagine. 

This.  I will have to ask around regarding accountants.  Have always done my own taxes, don't trust the couple I know.

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1 minute ago, matuski said:

Storage requirements for pharmaceuticals is pretty demanding.

She came and inspected where I will be keeping my product.  I have to record temperature ranges daily, I have to have a procedure for what happens to the drugs when a natural disaster hits, theft, I need a quarantine procedure setup for recalled/faulty/expired product... on and on and on.

 

I would think the regulators would have everything you need documented and you would have to follow their guidelines and fill in the specific details.   Should not be hard but you need to dig through and make sure all their boxes are checked.  

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6 minutes ago, matuski said:

This.  I will have to ask around regarding accountants.  Have always done my own taxes, don't trust the couple I know.

I’m talking bookkeeping and planning help as much/more so than simple tax prep. 

How to take salary/draws (which depends on whether you are an LLC, c Corp, filing sub chapter s etc). How to plan for profit at end of year. 

Edited by mr roboto
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7 minutes ago, Megaton said:

I would think the regulators would have everything you need documented and you would have to follow their guidelines and fill in the specific details.   Should not be hard but you need to dig through and make sure all their boxes are checked.  

I doesn't seem hard when I get down to it.. but when I write one out it seems lacking?

Quote

 

Quarantine:

I will keep faulty/recalled/expired product on an isolated rack.

 

FIFO

Quote

Inventory management and valuation will use a "First-In First-Out - FIFO" method.

Haha.. I mean.  It looks ridiculous to me but honestly it is about that simple right now.

Edited by matuski

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2 minutes ago, mr roboto said:

I’m talking bookkeeping and planning help as much/more so than simple tax prep. 

That is the biggest problem with startups, they usually don't have a good grip on all the costs and overhead.  Just see the price they buy it for and their markup and think that is going to be mostly profit.  

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But yes - I have to have these policies and procedures in writing readily available for my 2-3 inspections per year.  I am indeed looking to just "check the boxes" on anything beyond what I need to run the business.

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Just now, matuski said:

I doesn't seem hard when I get down to it.. but when I write one out it seems lacking?

FIFO

Haha.. I mean.  It looks ridiculous to me but honestly it is about that simple right now.

It is, but add some fluff to it to make it seem substantial.   Start with some background on why Quarantine is required and when it kicks in and what the response is (how you take product out of inventory with specific time limits and how you Mark and store then so they can:t be used).  Just fluff it up with BS and they will be impressed. 

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20 minutes ago, Megaton said:

It is, but add some fluff to it to make it seem substantial.   Start with some background on why Quarantine is required and when it kicks in and what the response is (how you take product out of inventory with specific time limits and how you Mark and store then so they can:t be used).  Just fluff it up with BS and they will be impressed. 

I'd be real careful with this.  You need to be prepared to demonstrate that you are actually doing what your procedure says when you get inspected. Fluff = potential complication.  No need for it if they will accept a simple procedure.  So try simple first and let them tell you to add fluff.  Odds are, they won't.

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50 minutes ago, mr roboto said:

I’m talking bookkeeping and planning help as much/more so than simple tax prep. 

How to take salary/draws (which depends on whether you are an LLC, c Corp, filing sub chapter s etc). How to plan for profit at end of year. 

This is great advice.  Finding a good accountant is essential. Find someone who will help get your bookkeeping system set up correctly so that it can grow with the business and also start to do some tax planning. You may need to make estimated tax payments for 2018.

Referrals from people you trust are always the best way to find a professional.  Ask your doctor friends who they use, but be aware that some accountants that handle a lot of doctors may not want to get involved setting up an inventory system for a startup.  Make sure you are comfortable with whoever you choose.

 

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1 hour ago, matuski said:

I don't see a thread on this, so here it is.

I have started a business as of next week distributing pharmaceuticals and medical devices.
Do you have to start off doing both?

My business formed around a handful of my doctor friends basically telling me flat out they would buy certain products from me if Ii could get the license to distribute.  So here I am.  I have a business, I have a storage facility, I have a UPS mailbox, I have insurance, I have a license, I will have inventory and sales by the end of next week.
Sounds like you're off to a good start.

I also have no idea what I'm doing beyond this.  Questions:

How do you find a good CPA/Lawyer?
Maybe you could get in touch with your local SCORE / SBA. They generally have a good network of people, often retired, who can help with many parts of a startup. I didn't retain a lawyer, but my tax accountant used one on my behalf when we decided to file as an S-Corp.

Upon inspection I was informed that I need several dozen Policies and Procedures in writing.  Help?  The lady doing my inspection wrote me up laughing to tears at how clueless I was. :bag:
As a quality guy who has worked in the medical device area I would say that, if you're not going to pay for it, your easiest path, money-wise not work-wise, might include a lot of copy and paste. Go to the FDA.gov site. I don't know specifically what you fall under, but a good start might be to take a look at 21 CFR 821. Google is helpful. Many companies publish their quality manuals and procedures. Your suppliers will also have documentation and you should be able to get copies as their customer, which you can then use to create your own. Then, as said earlier, do what you document and keep records to support audits/inspections.  

Business plan - I assume writing one for the future would be a good idea, but necessary?  I'm financing this myself.
A few years ago I started an LLC and the bank I wanted to open a business account with asked for one. I didn't have one ready, but that didn't prevent me from opening the account. Another area where SCORE / SBA could help.

Inventory tracking/management - I have spreadsheets from past lives I could use, is there an app/software to make this easier?
At least get started with a spreadsheet right away so you don't fall behind. Personally I would create something with MS Access rather than spend what would be needed to buy a canned package. Then again, I like Access, so I'm an Access hammer that sees everything as a nail.

General advice - Experiences?  Anything you wish you knew starting up?  Best tax/write off advice?
Do not fall behind with records! Keep track of everything on your spreadsheet(s) (or whatever you're using) right from the start and make sure your paper records are organized and can be connected to the entries on your spreadsheet. If you do that, once you have a tax accountant, you should be able to catch up on whatever you need tax wise. She/He should keep you on the straight & narrow with your quarterly payments etc.
One thing I did, that you may want to consider, was contract with an employee leasing company for my own services. IIRC this cost me about 10% of payroll and insured my workers comp, unemployment insurance etc. were all correct. Applying for personal loans was easier as I could simply list my employment income, rather than provide business income history. When my LLC business dried up, I had the employee leasing company lay me off.

Thank you, I kinda jumped right into this without much thought (I never thought the State would license me to be honest :lmao: )

Matt

 

Just a couple of thoughts. Bolded above.

Edited by brun
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8 hours ago, matuski said:

Storage requirements for pharmaceuticals are pretty demanding.

 

Can't be that demanding if you just started doing this a few weeks ago.   I've worked for small start-up pharma companies and we had sample storage in our office.  Need refrigerator, locks and record keeping, but didn't seem that bad.  Unfortunately for you, I did all of the sales operations, but didn't touch the supply chain, quality aspects, otherwise I'd offer more advice.

Are you getting license as distributor, manufacturer or pharmacy?  

Sounds like a cool experience and something I'd love to do. 

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1 hour ago, Brony said:

Can't be that demanding if you just started doing this a few weeks ago.   I've worked for small start-up pharma companies and we had sample storage in our office.  Need refrigerator, locks and record keeping, but didn't seem that bad.  Unfortunately for you, I did all of the sales operations, but didn't touch the supply chain, quality aspects, otherwise I'd offer more advice.

Are you getting license as distributor, manufacturer or pharmacy?  

Sounds like a cool experience and something I'd love to do. 

I started on this 3 months ago.  Didn't think it would happen until last week.

It isn't a tough set of protocols, but it is lengthy.  I can't (won't) keep it in my office at home so I ended up going with a storage facility.  Not all of them meet the security and temperature control requirements.  Found a new indoor storage place with units intended for wine storage - temp and humidity controls with records of both kept.  Records of each time the unit is accessed, etc.

The actual need to put the policies and reqs into writing is what I was caught off guard on.  

I have a Wholesale Prescription Drug Distributor license, and a Medical Device Distributor license.

 

Edited by matuski

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You’ll need to come up with a system to keep track of pedigree on all pharmaceuticals.  I assume you will be buying them direct from manufacturer to avoid cost of middleman distributors like cardinal or McKesson.  If you find a good deal on a product, I’d look into perhaps selling it on Matchrx.com which is a peer to peer marketplace for pharmacies.

 

leverage your dr contacts, see if they have any friends in the pharmacy business.  If your dr buddies are the entrepreneurial type, they likely do. Market yourself to them as a secondary or even tertiary wholesaler that can get them a lower price on their brand drugs.  These are their biggest cost, and since the margin is better on generics, the big wholesalers don’t try to be competitive for them.  Also, pharmacy’s usually buy on a rebate program where they are incentivized to have a higher generic %.  They usually get a bigger rebate from their primary wholesaler.  That’s where you come in, if they can shift their brand buying to you for cheaper, it’s a win-win.

Edited by Steed
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3 hours ago, matuski said:

I started on this 3 months ago.  Didn't think it would happen until last week.

It isn't a tough set of protocols, but it is lengthy.  I can't (won't) keep it in my office at home so I ended up going with a storage facility.  Not all of them meet the security and temperature control requirements.  Found a new indoor storage place with units intended for wine storage - temp and humidity controls with records of both kept.  Records of each time the unit is accessed, etc.

The actual need to put the policies and reqs into writing is what I was caught off guard on.  

I have a Wholesale Prescription Drug Distributor license, and a Medical Device Distributor license.

 

Have you applied for state specific wholesale licenses?  Below is Ohio's

https://pharmacy.ohio.gov/Documents/Licensing/WDDD/Apps/Wholesaler Application.pdf

Guessing you know all about drug pedigree requirements.

It seems to me you may have chosen 1 of the legally most difficult business to enter.

 

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19 hours ago, matuski said:

Business plan - I assume writing one for the future would be a good idea, but necessary?  I'm financing this myself.

Inventory tracking/management - I have spreadsheets from past lives I could use, is there an app/software to make this easier?

General advice - Experiences?  Anything you wish you knew starting up?  Best tax/write off advice?

Business plan: In my mind it boils down to value proposition. How do you provide/transfer value to your customers consistently. You need to know your customer segments really well and also have a plan for how you serve them, for service/information and physical products both. There are a number of ways to write a plan, I have used two methods and like them a lot.

One is the Business Model Generation - it uses the Business Model Canvas to help you ask and answer the main questions you should have down if you are to know what you are doing (and why.

The other is the Who, What, How (Why) method by Costas Markides from All the Right Moves. Small description in this article

Inventory tracking/management: Excel works well with a portfolio of few items that move infrequently. Microsoft Dynamics AX should provide you with better control if you have many items and some/all move frequently - and if you at one point will offer your clients the opportunity to order online this will come in right handy

General advice:

Know your competition, use what you know against them. I can recommend the book "Coopetition" for ideas on how to use game theory and change the game in your favour - the examples are a bit dated but it's one of the best books I read when I took my MBA.

Given that you have an inventory and that you will distribute from there: get to know your logistitcs provider really well. Be his best buddy. Have a back up plan for when he fails. Have a plan for reverse logistics. Be 110% that anything you send out is in accordance with the order. On Time, In Full, Invoice Correct (OTIFIC) will be a KEY measurement in your business

Have a plan for giving credit. If you can, limit the credit to your customers to way less that what you get from your suppliers. Cash to Cash (days) is also critical

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9 hours ago, cincredfan said:

Have you applied for state specific wholesale licenses?  Below is Ohio's

https://pharmacy.ohio.gov/Documents/Licensing/WDDD/Apps/Wholesaler Application.pdf

Guessing you know all about drug pedigree requirements.

It seems to me you may have chosen 1 of the legally most difficult business to enter.

 

Yes, Texas.  Received license Friday.

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19 hours ago, matuski said:

 

The actual need to put the policies and reqs into writing is what I was caught off guard on.  

I have a Wholesale Prescription Drug Distributor license, and a Medical Device Distributor license.

 

Good job on the distributor license.  Getting both in 3 months is pretty good, esp when you consider that can take years in some other countries.

RE: policies.  Yeah, having worked in manufacturing, I can appreciate them, but they can also be a little dumb.  For example, you could have a procedure that says that product will remain between 25F to 125F.  That temperature range may not be best for the product, but as long as you document that you will keep the product in that range, any inspector would say you are good to go.  I exaggerate, but it was def more important to say what you plan to do and stick with it than it was to actually do the right thing. 

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Black dot for later. On a plane right now.

One thing - don’t F up early. You are going to get one shot with these guys, especially the ones you don’t know well. Go above and beyond for them, no matter what. Being a new guy, you won’t be getting many second chances.

More later.

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16 hours ago, kutta said:

Black dot for later. On a plane right now.

One thing - don’t F up early. You are going to get one shot with these guys, especially the ones you don’t know well. Go above and beyond for them, no matter what. Being a new guy, you won’t be getting many second chances.

More later.

Yessir.

Bump for Monday crowd.

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On 1/6/2018 at 9:26 AM, matuski said:

I'm gonna start rambling for myself as much as anything.

I have 4 docs on board before business began.  They will be able to "lean on" a handful of docs in their referral network.  So 4 accounts growing to 6-12 within 6 months.  I expect early revenue to be tiny, maybe $5-15k per month the first 6 months.  The second half of the year as deductibles are whittled down this will triple/quadruple assuming no new customers.

I have done market research (I asked my 4 docs over beers) on pricing and suppliers.  I will need a pricing strategy.

 

I am on the pharmacy and have a bit of knowledge on wholesaler side.  Not sure I will know the answer but happy to answer anything if able.

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Can I hijack a bit here?

Wife is starting to make and sell arts and crafts stuff at a local pop up market but may want to get more involved (setting up an ETSY site, etc)

So far she's only made a few hundred bucks, but if she's able to generate a more consistent sales I assume I need to start getting Uncle Sam involved? 

Couple of main questions

1. Should she file as an LLC or something like that?   My concern is some ####### getting a splinter from someone wood craft or something and suing us, just trying to find the best way to protect us there 

2. At what income level would it make sense to start reporting income, paying taxes, finding things to deduct, etc?  I don't expect to get rich or anything, but hopefully she can at least make a couple hundred bucks a month or something 

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On 1/6/2018 at 10:27 AM, Ron Swanson said:

I'd be real careful with this.  You need to be prepared to demonstrate that you are actually doing what your procedure says when you get inspected. Fluff = potential complication.  No need for it if they will accept a simple procedure.  So try simple first and let them tell you to add fluff.  Odds are, they won't.

This. I've written/ reviewed a ton of them. Keep it short and sweet but make sure boxes are checked. I'd create a basic template like this:

1. Purpose- State the purpose of the procedure

2. Scope- This one may be important to you as the requirements of Rx drugs and devices may be different. State which it covers

3. Procedure- Doesn't have to be long but everything you say here you are on the hook for.

4. References- I would reference the CFR or guideline here that the procedure covers. Inspectors like it because even if you aren't doing something 100% perfect, they know you at least read the correct regulation even if your interpretation isn't what they expected.

5- Consider keeping a version history- if an inspector asks you to change something, and then comes back the following year it is good housekeeping to show what changes you made to the document.

This is coming from a larger company perspective but just some thoughts.

 

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On 1/6/2018 at 10:00 AM, matuski said:

I doesn't seem hard when I get down to it.. but when I write one out it seems lacking?

Quarantine:

I will keep faulty/recalled/expired product on an isolated rack.

Haha.. I mean.  It looks ridiculous to me but honestly it is about that simple right now.

Quick procedure:

1- Purpose- The purpose of this SOP is to define how products will be quarantined.

2- Scope- This SOP is limited to fully licensed medical devices

3- Procedure- Any expired products will be labeled with a yellow sticker on a dedicated shelf until properly disposed. Any recalled products will be on a dedicated shelf with a red sticker until disposition is decided.

4- References- CFR1234.89

5- Version 1.0 New Document effective 08JAN2018

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Thanks again to everyone that offered advice starting the year off.

I took it slow this year, not really up and running until June, just sitting on the original customers and product - doting/learning from them. 

Truly the coolest and best thing I have ever done in my life.  So much money out there... all I had to do was go get some of it.  My biggest frustration so far has been the CPA/business planners... I am meeting with my third this week.  I guess businesses like mine are too small to expect decent follow up and follow through?

Regardless -  I had hesitated to do this for years out of fear of failing.  I did fail... several times over for months before I got it set up and running properly.  Looking at it now I wish I had jumped in long ago.  It feels good, it is more fun than scary, it is rewarding in every way.

Edited by matuski
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18 minutes ago, matuski said:

Thanks again to everyone that offered advice starting the year off.

I took it slow this year, not really up and running until June, just sitting on the original customers and product - doting/learning from them. 

Truly the coolest and best thing I have ever done in my life.  So much money out there... all I had to do was go get some of it.  My biggest frustration so far has been the CPA/business planners... I am meeting with my third this week.  I guess businesses like mine are too small to expect decent follow up and follow through?

Regardless -  I had hesitated to do this for years out of fear of failing.  I did fail... several times over for months before I got it set up and running properly.  Looking at it now I wish I had jumped in long ago.  It feels good, it is more fun than scary, it is rewarding in every way.

Good for you. Lots of people want to do something on their own - few ever do.  

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congrats @matuski

not to hijack your thread, but I'll be jumping into the pool as soon as the year turns over. I've been in advertising and design for about 20 years and for the last 8 or so, I've been moonlighting at home doing the same. It started small, with a friend of mine taking on a new job where he controlled the design work, and since then I've added steady clients to where my part-time, side gig was out earning my 9-5.  However, it cost me not going to bed until 2 am almost every night, lots of weekend hours, and sneaking off to Kinkos mid-day for client edits and conference calls. I've finally had enough of that life and my day job turned to crud, so I'll be giving notice after the 1st of the year and jumping in with both feet. 

Nervous, but very excited for more freedom to control my day and keep what I've been doing, just during the bulk of my day, not the end of it. I have so many ideas I need to explore. 

the real gem is that my wife is a teacher and holds all of our family benefits. Without her, IDK if I would be able to do this. 

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1 minute ago, glvsav37 said:

congrats @matuski

not to hijack your thread, but I'll be jumping into the pool as soon as the year turns over. I've been in advertising and design for about 20 years and for the last 8 or so, I've been moonlighting at home doing the same. It started small, with a friend of mine taking on a new job where he controlled the design work, and since then I've added steady clients to where my part-time, side gig was out earning my 9-5.  However, it cost me not going to bed until 2 am almost every night, lots of weekend hours, and sneaking off to Kinkos mid-day for client edits and conference calls. I've finally had enough of that life and my day job turned to crud, so I'll be giving notice after the 1st of the year and jumping in with both feet. 

Nervous, but very excited for more freedom to control my day and keep what I've been doing, just during the bulk of my day, not the end of it. I have so many ideas I need to explore. 

the real gem is that my wife is a teacher and holds all of our family benefits. Without her, IDK if I would be able to do this. 

Very cool.

Yea this is still my side gig.  

Being in sales it does give me the flexibility to keep doing this on the side for now.  My day job pays for the family insurance and benefits right now, so I'll keep that going for the foreseeable future.  I believe I will triple+ my sales in 2019, that will probably start to test my flexibility.  I'll have to make decisions or hire someone at that point.

The long term goal is to be like you and take the plunge... if I can get north of $5m in sales (~$105k since June) I'll probably do so.

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Crazy 2 years.

So much learned, so much to learn.

Feels like I am still getting started.  Anyone else out there found a way to start their own gigs?

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5 minutes ago, matuski said:

Crazy 2 years.

So much learned, so much to learn.

Feels like I am still getting started.  Anyone else out there found a way to start their own gigs?

Just finished my 1st year on my own...what an absolute crazy, crazy ride. Juggling everything, all the time...waking up with night sweats thinking about my bank account. Constantly out networking and meeting anyone who will listen to me. 

On the flip side, I'm now doing things I never expected I would be doing. I started teaching design at my old college 1 day a week, joined my chamber of commerce and was just awarded 'member of the year' last week, and have begun speaking with my first paid speaking gig set for early March. 

Would not trade it for anything right now and am pissed I didn't jump 3 years ago. 

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First inspection since the one to approve my original licensing... this time to renew.

Made same woman approach tears from laughing at my operation.

My 5'x10" storage unit with 2 products on the shelf.  My in/out records kept in manila folders.  My 1 page policies/procedures.  My $4 thermometer stuck to the wall with two-sided tape.  My sans serif printed out and folded up, stuck to a shelf with scotch tape "EXPIRED/DAMAGED" sign. :lmao:

She stopped laughing when she looked at the invoices.  :banned:

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8 hours ago, matuski said:

She stopped laughing when she looked at the invoices.  :banned:

This is EVERYTHING.

The logistics and such can evolve over time. You can hire out for a ton of stuff. But to actually make money on your own? That's something truly special. Because most people simply can't. 

I use a whiteboard and a paper pad for tracking projects. My middle-manager friend teased me about it. But he was sure to add "hey, it works for you, so have at it". Because he knows I make as much as he does, without leaving my house and answering to nobody in particular.  

 

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