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Launching an OTC Drug

A detailed account of a Fastlane process...

real_rbl

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This is my first execution thread. I'm a software engineer by trade and have spent the past five years working on a variety of different side projects, startups, hustles, etc. on the side without much success. The common denominator between all of them I recently discovered is not moving quickly enough to put the product in front of the customer. Seriously, I've probably put thousands of man hours into a variety of codebases that never saw the light of day. It was all code I loved learning & writing (machine learning projects) but not a dime was earned -- in fact, I probably lost a few hundred in server costs over the years.

Since this thread is public, I'll be keeping the details of the drug (name, website, etc) secret until I'm far enough along. I'll speak generally about the process in this thread -- the process is all that matters, not the events.

I recently came across this idea a couple weeks ago after suffering an ailment and have never truly been satisfied with the existing OTC products. I've often had to combine other supplements, vitamins, drugs, etc. to become fully healed. Call it fate, but my mind shifted back to reading the millionaire fastlane 5 years ago. What can I produce to better serve my need? Is this even possible to pull off? I know absolutely nothing about drug manufacturing. Who the F*ck am I? My consumer/producer balance has been out of whack for too goddamn long. I immediately reread TMF . The book is like a red pill -- once you think like a producer, you can never go back to the normal life of consumption.

PROGRESS
1. COMPETITIVE ANALYSIS.
There are other competitors out there that offer products similar to what I plan to offer. One competitor has a retail presence in one of the major drug stores (I've used their product). The other is newer to the scene (past two years) and primarily online sales based. The rest of the competitors (5-6 or so) are primarily online sales driven. All of the competitors have weak social presence (10k instagram followers on the primary competitor, 5k on the next).

My plan to enter market is to target a specific niche of the market that would use this OTC. I plan to tailor my branding around this niche, do outreach on instagram where my target niche resides, and build a network and name around these people & use that to snowball to the larger market. Given none of the competitors have a strong social following, I believe this is my "edge".

Furthermore, my second edge is product offering. I'll be offering a unique cocktail of ingredients in the OTC drug that none of the competitors offer. I will combine the drugs/vitamins/etc I take to best solve the ailment. Secondly, I plan on offering a different deliverable -- chewable tablet instead of the traditional pill. These are my two differentiators on the product side.

2. DOMAIN. I've decided on a name that is two syllables, not trademarked in the drug industry, and has potential branding around the playfulness of it. I was able to procure the domain getXXX.com where XXX is the name of the company. I plan on naming the first OTC drug product XXX and future products that support the main product XXX ____ where ____ is another name. I think it's important to highlight #1 two syllables is important and #2 you don't need to start out with XXX.com. It's pretty much impossible these days.

3. LOGO. I'm outsourcing the logo design work to fiverr. The logo design is important to me because it will be key in differentiating myself from a branding perspective. Since this is a OTC drug that will solve ailments, I'm looking for calming colors like grey, blue, etc. This is still in progress right now so I don't have much more to share.

4. WEBSITE. Even though I'm a full stack developer and capable of building my own site, this is a DISTRACTION. This is something I would've normally done and the reason why I have nothing to show after 5 years of development. Instead, I'll use shopify and customize the theme on my own. Just pay the damn $29 a month to start and prove the concept before wasting 200 hours on a useless site.

IN PROGRESS
1. MANUFACTURERS.
I've built up a list of FDA approved manufacturers capable of producing OTC chewable tablets. I'm currently in the process of contacting them now to source a reputable manufactuer to produce my product. My plan is to get a 100 tablet sample.

2. TEST CLIENTS. I'll also need to source test clients which will be hard because I can't just make them sick with the ailment. I still need to think up a plan on this.

I also plan on spinning up a complimentary execution thread in the INSIDERS forum to get more tailored feedback on branding &messaging.
 
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Roli

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This is my first execution thread. I'm a software engineer by trade and have spent the past five years working on a variety of different side projects, startups, hustles, etc. on the side without much success. The common denominator between all of them I recently discovered is not moving quickly enough to put the product in front of the customer. Seriously, I've probably put thousands of man hours into a variety of codebases that never saw the light of day. It was all code I loved learning & writing (machine learning projects) but not a dime was earned -- in fact, I probably lost a few hundred in server costs over the years.

Since this thread is public, I'll be keeping the details of the drug (name, website, etc) secret until I'm far enough along. I'll speak generally about the process in this thread -- the process is all that matters, not the events.

I recently came across this idea a couple weeks ago after suffering an ailment and have never truly been satisfied with the existing OTC products. I've often had to combine other supplements, vitamins, drugs, etc. to become fully healed. Call it fate, but my mind shifted back to reading the millionaire fastlane 5 years ago. What can I produce to better serve my need? Is this even possible to pull off? I know absolutely nothing about drug manufacturing. Who the F*ck am I? My consumer/producer balance has been out of whack for too goddamn long. I immediately reread TMF . The book is like a red pill -- once you think like a producer, you can never go back to the normal life of consumption.

PROGRESS
1. COMPETITIVE ANALYSIS.
There are other competitors out there that offer products similar to what I plan to offer. One competitor has a retail presence in one of the major drug stores (I've used their product). The other is newer to the scene (past two years) and primarily online sales based. The rest of the competitors (5-6 or so) are primarily online sales driven. All of the competitors have weak social presence (10k instagram followers on the primary competitor, 5k on the next).

My plan to enter market is to target a specific niche of the market that would use this OTC. I plan to tailor my branding around this niche, do outreach on instagram where my target niche resides, and build a network and name around these people & use that to snowball to the larger market. Given none of the competitors have a strong social following, I believe this is my "edge".

Furthermore, my second edge is product offering. I'll be offering a unique cocktail of ingredients in the OTC drug that none of the competitors offer. I will combine the drugs/vitamins/etc I take to best solve the ailment. Secondly, I plan on offering a different deliverable -- chewable tablet instead of the traditional pill. These are my two differentiators on the product side.

2. DOMAIN. I've decided on a name that is two syllables, not trademarked in the drug industry, and has potential branding around the playfulness of it. I was able to procure the domain getXXX.com where XXX is the name of the company. I plan on naming the first OTC drug product XXX and future products that support the main product XXX ____ where ____ is another name. I think it's important to highlight #1 two syllables is important and #2 you don't need to start out with XXX.com. It's pretty much impossible these days.

3. LOGO. I'm outsourcing the logo design work to fiverr. The logo design is important to me because it will be key in differentiating myself from a branding perspective. Since this is a OTC drug that will solve ailments, I'm looking for calming colors like grey, blue, etc. This is still in progress right now so I don't have much more to share.

4. WEBSITE. Even though I'm a full stack developer and capable of building my own site, this is a DISTRACTION. This is something I would've normally done and the reason why I have nothing to show after 5 years of development. Instead, I'll use shopify and customize the theme on my own. Just pay the damn $29 a month to start and prove the concept before wasting 200 hours on a useless site.

IN PROGRESS
1. MANUFACTURERS.
I've built up a list of FDA approved manufacturers capable of producing OTC chewable tablets. I'm currently in the process of contacting them now to source a reputable manufactuer to produce my product. My plan is to get a 100 tablet sample.

2. TEST CLIENTS. I'll also need to source test clients which will be hard because I can't just make them sick with the ailment. I still need to think up a plan on this.

I also plan on spinning up a complimentary execution thread in the INSIDERS forum to get more tailored feedback on branding &messaging.

I dunno man, you may have a great idea, but throwing away five years and all that experience seems a bit hasty...

I bet your problem wasn't not getting it in front of customers fast enough, I bet it was just a lack of marketing and sales execution. This is often the case for software geniuses like yourself, great at the build and design, not so great at selling...

Anyway, you sound like you've thought this one through... A quick piece of advice on client sourcing:

You need to run some ads and set up a simple landing page, if you get good responses you'll know that it's worth pursuing. Check out @Andy Black's threads on Google adwords, essentially you need to buy some data and find out if there are enough people searching your niche, and what terms they're using.

I get you're chomping at the bit and raring to go, however you need to take a step back and really plan this out client acquisition-wise, it will take you a fraction of the time it would to even sketch out the requirements for a new piece of software, and it's well worth it.

There's nothing worse than sitting on loads of product that you can't sell, and never bothered to properly check out if you could (trust me, I know!).

Interested to take a look at some of your software products though :)
 

RahKnee

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I hope for your sake you are talking about a nutritional supplement. If you're talking about an actual medicine, then you either have a cease and desist from the FDA in your future or a long, grueling, and expensive new drug application.
 
D

Deleted50669

Guest
This is my first execution thread. I'm a software engineer by trade and have spent the past five years working on a variety of different side projects, startups, hustles, etc. on the side without much success. The common denominator between all of them I recently discovered is not moving quickly enough to put the product in front of the customer. Seriously, I've probably put thousands of man hours into a variety of codebases that never saw the light of day. It was all code I loved learning & writing (machine learning projects) but not a dime was earned -- in fact, I probably lost a few hundred in server costs over the years.

Since this thread is public, I'll be keeping the details of the drug (name, website, etc) secret until I'm far enough along. I'll speak generally about the process in this thread -- the process is all that matters, not the events.

I recently came across this idea a couple weeks ago after suffering an ailment and have never truly been satisfied with the existing OTC products. I've often had to combine other supplements, vitamins, drugs, etc. to become fully healed. Call it fate, but my mind shifted back to reading the millionaire fastlane 5 years ago. What can I produce to better serve my need? Is this even possible to pull off? I know absolutely nothing about drug manufacturing. Who the F*ck am I? My consumer/producer balance has been out of whack for too goddamn long. I immediately reread TMF . The book is like a red pill -- once you think like a producer, you can never go back to the normal life of consumption.

PROGRESS
1. COMPETITIVE ANALYSIS.
There are other competitors out there that offer products similar to what I plan to offer. One competitor has a retail presence in one of the major drug stores (I've used their product). The other is newer to the scene (past two years) and primarily online sales based. The rest of the competitors (5-6 or so) are primarily online sales driven. All of the competitors have weak social presence (10k instagram followers on the primary competitor, 5k on the next).

My plan to enter market is to target a specific niche of the market that would use this OTC. I plan to tailor my branding around this niche, do outreach on instagram where my target niche resides, and build a network and name around these people & use that to snowball to the larger market. Given none of the competitors have a strong social following, I believe this is my "edge".

Furthermore, my second edge is product offering. I'll be offering a unique cocktail of ingredients in the OTC drug that none of the competitors offer. I will combine the drugs/vitamins/etc I take to best solve the ailment. Secondly, I plan on offering a different deliverable -- chewable tablet instead of the traditional pill. These are my two differentiators on the product side.

2. DOMAIN. I've decided on a name that is two syllables, not trademarked in the drug industry, and has potential branding around the playfulness of it. I was able to procure the domain getXXX.com where XXX is the name of the company. I plan on naming the first OTC drug product XXX and future products that support the main product XXX ____ where ____ is another name. I think it's important to highlight #1 two syllables is important and #2 you don't need to start out with XXX.com. It's pretty much impossible these days.

3. LOGO. I'm outsourcing the logo design work to fiverr. The logo design is important to me because it will be key in differentiating myself from a branding perspective. Since this is a OTC drug that will solve ailments, I'm looking for calming colors like grey, blue, etc. This is still in progress right now so I don't have much more to share.

4. WEBSITE. Even though I'm a full stack developer and capable of building my own site, this is a DISTRACTION. This is something I would've normally done and the reason why I have nothing to show after 5 years of development. Instead, I'll use shopify and customize the theme on my own. Just pay the damn $29 a month to start and prove the concept before wasting 200 hours on a useless site.

IN PROGRESS
1. MANUFACTURERS.
I've built up a list of FDA approved manufacturers capable of producing OTC chewable tablets. I'm currently in the process of contacting them now to source a reputable manufactuer to produce my product. My plan is to get a 100 tablet sample.

2. TEST CLIENTS. I'll also need to source test clients which will be hard because I can't just make them sick with the ailment. I still need to think up a plan on this.

I also plan on spinning up a complimentary execution thread in the INSIDERS forum to get more tailored feedback on branding &messaging.
Guessing you've worked mostly in python or R?
 
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real_rbl

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Mar 5, 2019
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I bet your problem wasn't not getting it in front of customers fast enough, I bet it was just a lack of marketing and sales execution. This is often the case for software geniuses like yourself, great at the build and design, not so great at selling...

You're spot on. I won't be making that mistake going forward. I am still working on procuring samples but plan to immediately get in front of users. I have several friends that also suffer from this ailment and I know they are chomping at the bit for what I'm working on since they've used a similar concoction.

Interested to take a look at some of your software products though :)

I haven't given up on my software I've produced over the few years. It's been a long journey of mastering python, nodejs, bootstrapping pages, etc. I'll be posting an execution thread in the INSIDERS on my SaaS I'm about a week away from getting to the point where I can demo to clients.

I hope for your sake you are talking about a nutritional supplement. If you're talking about an actual medicine, then you either have a cease and desist from the FDA in your future or a long, grueling, and expensive new drug application.

It will be an OTC (over the counter) drug containing ingredients already approved by the FDA for OTC use. I'm not making a new drug profile.

Guessing you've worked mostly in python or R?

Python is my go to nowadays but I started with java & c++. I love python bootstrapping plus it is insanely powerful for the data science work I do.
 
D

Deleted50669

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You're spot on. I won't be making that mistake going forward. I am still working on procuring samples but plan to immediately get in front of users. I have several friends that also suffer from this ailment and I know they are chomping at the bit for what I'm working on since they've used a similar concoction.



I haven't given up on my software I've produced over the few years. It's been a long journey of mastering python, nodejs, bootstrapping pages, etc. I'll be posting an execution thread in the INSIDERS on my SaaS I'm about a week away from getting to the point where I can demo to clients.



It will be an OTC (over the counter) drug containing ingredients already approved by the FDA for OTC use. I'm not making a new drug profile.



Python is my go to nowadays but I started with java & c++. I love python bootstrapping plus it is insanely powerful for the data science work I do.
Respect to anyone who's ever worked with C++.
 

AF77

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You're spot on. I won't be making that mistake going forward. I am still working on procuring samples but plan to immediately get in front of users. I have several friends that also suffer from this ailment and I know they are chomping at the bit for what I'm working on since they've used a similar concoction.



I haven't given up on my software I've produced over the few years. It's been a long journey of mastering python, nodejs, bootstrapping pages, etc. I'll be posting an execution thread in the INSIDERS on my SaaS I'm about a week away from getting to the point where I can demo to clients.



It will be an OTC (over the counter) drug containing ingredients already approved by the FDA for OTC use. I'm not making a new drug profile.



Python is my go to nowadays but I started with java & c++. I love python bootstrapping plus it is insanely powerful for the data science work I do.



I don’t want to put your idea on blast, because I’m impressed by your “do it” attitude, but taking an OTC drug that’s approved and throwing vitamins at it is going to be a lot of money to get on shelves.

You take 200mg ibuprofen, add 400mg Vitamin C, 10IU D, and 5mg Zinc to it, and market it for Flu recovery. That’s per (large) pill, and you recommend 2-3 for an Adult.


That’s going to be a lot of time and money before you can sell it.
 
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Last edited:
D

Deleted50669

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I don’t want to put your idea on blast, because I’m impressed by your “do it” attitude, but taking an OTC drug that’s approved and throwing vitamins at it is going to be a lot of money to get on shelves.

You take 100mg ibuprofen, add 400mg Vitamin C, 10IU D, and 5mg Zinc to it, and market it for Flu recovery.

That’s going to be a lot of time and money before you can sell it.
How would you even calculate the costs of making that happen?
 

AF77

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Last edited:

real_rbl

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And get ready to fight patent attorneys because of the patents around pretty much every otc combination you can think of.

This second Point is the more important of the two, because he can probably get the okay through an existing monograph.

Yes I'm using existing monographs and adding in my own vitamins. It's definitely not an easy process but hence the barrier of entry is high, which also adds to my defensive moat assuming I can get a product made. I think I'll make an update post every Monday on the current status of the drug development & manufacturing.
 
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Azure

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From what I know(close family friend was the founder of the largest generic pharma company in Canada) you have a massive mountain in front of you.

@Scot

Seems right up your alley.
 

Scot

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Thanks for the tag @Azure

I’m not too familiar with the OTC side, only really for prescription side.

But others have mentioned you’re going to have a lot of uphill battle with the FDA and patent office.

The one thing that not many have mentioned is that when the words FDA come into play, so do massive amounts of capital.

Costs to Bring a Drug to Market

So, bringing a new prescription drug costs anywhere between $600M and $3B. A lot of that is study costs, but a very significant portion is navigating the mess that is FDA Bureaucracy.

My $.02 is unless you get VC firm to cut you a $10M check, I’d steer clear of anything OTC drug related and see if this can be considered a supplement.

Making health claims and ingredients aren’t subject to FDA oversight. If you make ANY health claim (which you’d need you do to market at all) you better have clinical data showing that, or the FDA will own you.

A+ for ambition but aside from starting a rocket ship startup, you picked one of the more difficult industries to break into with a serious bankroll and team to back you up.
 

real_rbl

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I appreciate all the feedback thus far. I still think I can make this work and once my product becomes revealed I think it'll be a little more clear on why. I'm not afraid to fail on this one and I'll be sure to take the appropriate legal steps to protect myself as well. If anyone has OTC manufacturing and/or packaging knowledge, especially when it comes to combination of monographs, I'd love to chat.
 
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