Good idea or bad?

[Woodsman81]

I am super green and don't know if I am on the right track or not so hopefully you guys can help me out.

The idea: I recently had knee surgery. I was offered to rent an iceless cold therapy machine for after the surgery for $275 for two weeks. The first thing I did was come home and do some research to see if anyone made one for a reasonable price to purchase instead of renting. The only one I could find was on sale for $500 down from $700 and it did hot and cold.

After a little more research I found out that you can buy an ice maker that goes on your counter for just over $100 and an ice cold therapy machine for just over $100. So my uneducated guess is that I could produce this for between $100 to $200 and sell it for $300.

So what I've done so far is had a 3D model made. I was going to use this model on a landing page with a buy now button for product testing to see how many clicks I got, but it seems expensive to have someone build that. Maybe that was my first fail.

The problem: You may need to ice a lot longer than 2 weeks so renting the machine could get expensive.

The solution: Produce and sell a machine that is close to the same price as renting one then you can use it as long as you need.

The market: People that just had knee or shoulder surgery.

Business model: 1. Sell them off of a website possibly Amazon in the future.
2. Have a flyer for the doctor's office to hand out to their patients. That is what the other company does.

Fast lane model: Be a producer not a consumer.

Execution challenges: I don't think this is me to product ( please correct me if I'm wrong) just picking one off the internet and having someone produce it a different color is going to be a challenge.

Here are some questions I have. I am a very one-step-at-a-time type person.

1. What is the best way to product test this idea, or is it better to get a small batch produced and see if they sell?

2. How would you go about getting something like this produced. Do you need a prototype first or is there a company that can just create it off a description?

Any advice you have would be greatly appreciated. Even if it is dream crushing drop the idea and go back to the drawing board.

 

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[MHP368]

"1. What is the best way to product test this idea, or is it better to get a small batch produced and see if they sell?"

produce, no idea. Test? lookup "skilled nursing facility" local to you, most will have a "long term care" unit (nursing home as commonly understood) as well as a "skilled nursing" unit - thats folks who just had hip surgery or knee replacements who are temporarily living at the facility, they'll have physical therapists and certified physicial therapy assistants on staff, those are the gatekeepers. You want them to agree to test your device on patients who come in with recent knee surgeries.

Also, just throwing this out but maybe it could be a modified "knee cpm machine" with the icing integrated? , don't want to make you lose focus but - that occurred to me reading your post (it would also simplify production as you'd just be modifying an existing product someones already engineered and designed)

 

[Woodsman81]

Sorry not to actually test the product once it's produced but too see if there is a market for the product before it is produced.

 

[MHP368]

Sorry not to actually test the product once it's produced but too see if there is a market for the product before it is produced.

Maybe a little smooth talk / social engineering to see if you can figure out from the surgeon how many of his patients go home vs go inpatient? Do that for a few different doctors and extrapolate out

You already have a relationship woth the doc hence me suggesting that route , I doubt the company renting the devices will give you numbers

 

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[Rawseed]

Sorry not to actually test the product once it's produced but too see if there is a market for the product before it is produced.

I'd list the possibilities, but you already read Unscripted . @MJ DeMarco discusses this in Chapter 40. It's the third P.

 

[Woodsman81]

Maybe a little smooth talk / social engineering to see if you can figure out from the surgeon how many of his patients go home vs go inpatient? Do that for a few different doctors and extrapolate out

You already have a relationship woth the doc hence me suggesting that route , I doubt the company renting the devices will give you numbers

Thanks I will give this a try. I can tell you that the day I had surgery he was doing five knee surgeries not sure how many shoulders. He does two days of surgery a week.

 

[Woodsman81]

I'd list the possibilities, but you already read Unscripted . @MJ DeMarco discusses this in Chapter 40. It's the third P.

Thanks I will relisten to the chapter. In the meantime how would you go about validating this idea?

 

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[Rawseed]

Thanks I will relisten to the chapter. In the meantime how would you go about validating this idea?

I'm far from being an expert at validating, but I'd consider driving traffic to a landing page. You could use a free site builder like: Launchrock - The Fastest Way to Acquire Customers

On the landing page have great copy and the price you'd like to charge.

The traffic could come from Adwords, or forums where your customers would be, or using the flyer strategy you were planning to use with the doctor's offices.

When people click, tell them that you've sold out. That's not necessarily a lie because you actually don't have any to sell.

 

[Woodsman81]

That is why I had the 3D model made, but after talking to a local web designer who was going to charge $500 to build this, and did not think I would get results. I thought it would be best to post here first and see if that is my best course of action, or if there was a better way to validate this idea.

I would not try the flyers at the doctor's office until I actually have product to sell, or at the very least a prototype, and being honest and saying I would not have product to sell until xx/xx/xxxx.

Thanks I will check out launch Rock.

 

[JSM]

I used one at physical therapy after I dislocated my knee and I loved it. It would be great to have one for when my knee bugs me. I just did some research on one and it is a class 2 medical device. There are a few posts on here about getting the FDA to approve medical devices but I don’t remember the thread. I would research that. It also says that it has to be prescribed by a physician.

 

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[MHP368]

I used one at physical therapy after I dislocated my knee and I loved it. It would be great to have one for when my knee bugs me. I just did some research on one and it is a class 2 medical device. There are a few posts on here about getting the FDA to approve medical devices but I don’t remember the thread. I would research that. It also says that it has to be prescribed by a physician.

It might meet equivalence threshold then , obviously talk to a lawyer first woodsman but...

"...devices of moderate risk, Class II, live in a grey area involving the 510k process. For 510k Class II devices, there is no need for clinical studies as long as the manufacturer can demonstrate ‘substantial equivalence’ to already approved devices. Over time, if product B is almost equivalent to gold standard product A, then product C can be approved if it is nearly equivalent to newly approved Product B creating a chain of equivalence making it difficult to say how far “equivalence” has been stretched..."

Doesn't help with your immediate validation concern but don't get discouraged by legal hurdles!

 

[ruzara5]

2. How would you go about getting something like this produced. Do you need a prototype first or is there a company that can just create it off a description?

Yes. Prototype 'a1' or something accordingly. This is being basically illustrated as a medical device or basic aid device. The initial impression is that this will be hot or cold for soothing pain related to knee and shoulder surgeries and the like. Check the forum. There are others in different posts developing 'devices'. It could be designed locally or regional. Possibly from a offshore venture once a proven source is solid. Get to doing some research. If you have a market and you get some solid verification. Get the 'value statement' for the product. Then get more details going on this concept idea. Potential for impact is evident.

 

[Woodsman81]

Thank you guys I am learning allot.

I used one at physical therapy after I dislocated my knee and I loved it. It would be great to have one for when my knee bugs me. I just did some research on one and it is a class 2 medical device. There are a few posts on here about getting the FDA to approve medical devices but I don’t remember the thread. I would research that. It also says that it has to be prescribed by a physician.

That is exactly why I think purchasing one is better than renting one. I purchased one with no proof of having a prescription. I am assuming by them saying that that it is a way to remove any liability they may have.

It might meet equivalence threshold then , obviously talk to a lawyer first woodsman but...

"...devices of moderate risk, Class II, live in a grey area involving the 510k process. For 510k Class II devices, there is no need for clinical studies as long as the manufacturer can demonstrate ‘substantial equivalence’ to already approved devices. Over time, if product B is almost equivalent to gold standard product A, then product C can be approved if it is nearly equivalent to newly approved Product B creating a chain of equivalence making it difficult to say how far “equivalence” has been stretched..."

Doesn't help with your immediate validation concern but don't get discouraged by legal hurdles!

Do you have experience doing this? It kind of does help with the validation it explains why there isn't ten of these on the market already.

Yes. Prototype 'a1' or something accordingly. This is being basically illustrated as a medical device or basic aid device. The initial impression is that this will be hot or cold for soothing pain related to knee and shoulder surgeries and the like. Check the forum. There are others in different posts developing 'devices'. It could be designed locally or regional. Possibly from a offshore venture once a proven source is solid. Get to doing some research. If you have a market and you get some solid verification. Get the 'value statement' for the product. Then get more details going on this concept idea. Potential for impact is evident.

I made a pretty big assumption on the cost of producing this. Is there a way to go about getting an estimate for a prototype and an estimate for production cost at the same time?
I obviously want to build a quality product but I feel that the price point is the key value.

 

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[Hyrum]

Why not just buy a few and rent them out for a more affordable rate? Even if you could get them made at a cheap enough rate to price them more affordably, what are the patients going to do once the 2 weeks are up? Just keep an expensive piece of medical equipment around - some might, but how many won't? Re-sell it (and thus compete with you)?

Also, what is the potential market for this device? 10,000 per year? 1,000 per year? Is there any money in producing them once you pay for manufacturing, certifications, and distribution?

I'm sure medical devices can be lucrative if you have something unique. But to me, this sounds like a "me too" type product because there doesn't seem to be any major innovation besides price.

 

[Woodsman81]

Why not just buy a few and rent them out for a more affordable rate? Even if you could get them made at a cheap enough rate to price them more affordably, what are the patients going to do once the 2 weeks are up? Just keep an expensive piece of medical equipment around - some might, but how many won't? Re-sell it (and thus compete with you)?

Also, what is the potential market for this device? 10,000 per year? 1,000 per year? Is there any money in producing them once you pay for manufacturing, certifications, and distribution?

I'm sure medical devices can be lucrative if you have something unique. But to me, this sounds like a "me too" type product because there doesn't seem to be any major innovation besides price.

It's been 7 weeks since my surgery and I'm still using mine (that requires ice) . There's two on the market now ones $3,500 and the other ones on sale for $500. I would have gladly purchased one for 300 vs renting one knowing I would use it longer than 2 weeks.
As far as if there is there any money to be made after manufacturing and distributing. That is the next step I am working on figuring out.
Do you have any suggestions on the best was to figure that out?

 

[Hyrum]

Here are a couple for $150

AirCast CryoCuff Medium Knee with gravity feed cooler

IceMan Classic Cold Therapy Unit

Here's another for $495

ThermaZone Continuous Thermal Therapy Device

Is this kind of what you were looking for? They appear to be common enough you might get by with checking Alibaba for a private label opportunity, kind of like this:

Compact Home Care Cold Therapy Used For Reduce Swelling - Buy Cold Therapy,Home Care,Reduce Swelling Product on Alibaba.com

 

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[Woodsman81]

No those require ice, but yes those are all knockoffs of the game ready that is a $2,500 machine. So I am trying to make a knock off of the nice recovery machine.
The problem with ice is that you have to refill it about twice a day.
So your ice machine in your freezer won't keep up. Trying to do anything on crutches or with one arm is extremely difficult. So filling up the ice machine getting ice from the store and so on are no easy tasks.

 

[JSM]

No those require ice, but yes those are all knockoffs of the game ready that is a $2,500 machine. So I am trying to make a knock off of the nice recovery machine.
The problem with ice is that you have to refill it about twice a day.
So your ice machine in your freezer won't keep up. Trying to do anything on crutches or with one arm is extremely difficult. So filling up the ice machine getting ice from the store and so on are no easy tasks.

I haven’t seen one that doesn’t require ice. I used the game ready when I was recovering and I was only on it for 15 minutes. I don’t think having one on all day would be good

 

[MHP368]

Do you have experience doing this? It kind of does help with the validation it explains why there isn't ten of these on the market already.

No , I had an ejuice company so I have a vague understanding of federal compliance shenanigans and i'm a nurse so i'm familiar with the devices, but i've never tried to bring anything to market.

 

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[Woodsman81]

I haven’t seen one that doesn’t require ice. I used the game ready when I was recovering and I was only on it for 15 minutes. I don’t think having one on all day would be good

Verbally I was told to ice as much as I could stand. My release instructions say to ice 5 to 6 times a day for 30 minutes.

 

[MJ DeMarco]

I like the idea, I actually own one of these machines.

I had no idea that they rented them for god-awful fees, not to mention how expensive they are when in fact, they're glorified coolers.

Kinda reminds me of renting AV equipment from a hotel -- at the cost of the rental, I could have bought an entire system.

 

[Woodsman81]

1. Prototype ( how much should this cost?).
2. Validation.
3. FDA approval.
4. Manufacturing.

Are these the steps I should be taking?
Is there a way to get a rough estimate on the cost of manufacturing without a prototype?

 

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[Niptuck MD]

Also, what is the potential market for this device? 10,000 per year? 1,000 per year? Is there any money in producing them once you pay for manufacturing, certifications, and distribution?

I'm sure medical devices can be lucrative if you have something unique. But to me, this sounds like a "me too" type product because there doesn't seem to be any major innovation besides price.

Not gonna lie, i scrolled down this feed just for @Hyrum response lol. He would def. know haha.

But yea, as far as testing and what not does that involve a lot more regulation when doing initial testing/cases of the potential unit? The manufacturing costs are one thing but the fees and medical costs for testing/patenting etc is probably a never ending ordeal

 

[Hyrum]

1. Prototype ( how much should this cost?).
2. Validation.
3. FDA approval.
4. Manufacturing.

Are these the steps I should be taking?
Is there a way to get a rough estimate on the cost of manufacturing without a prototype?

I would honestly put "Validation" as your first step. There's no point in creating a prototype if no one is going to buy it. It does sound like this is something that has benefited a few people on this thread, so it might be worth investigating further. Especially:
- The machines that use ice water run a couple hundred dollars, so you would want to find out if people are willing to pay a couple hundred dollars extra to get an iceless version. Or what people would be willing to pay to purchase. If people would pay up to $600 instead of renting, then you could be cutting out a lot of profit.
- Patentability. Do you have something that can be patented? Does Game Ready have a patent that they could use against you?
- Size of market. How many people will want to purchase vs rent? It looks like the rental cost is roughly 10% of the purchase price.
- What is your USP? Price? Portability? Quality? Accessibility?

2. Prototype. I imagine if you hit the ball out of the park on your very first try you could keep prototyping costs under $1000. I wouldn't bet on that happening, however. I would probably budget between $10k - $30k to get you to a manufacture ready model. This product basically consists of 4 parts, the sleeve, the coolant, a pump, and the refrigeration unit. Here are some random thoughts about what I would do in creating a prototype.
- Make sure the sleeve has antimicrobial properties
- What coolant are you using? Water? Glycol based? Proprietary, either your own or something like Fluorinert? How much will you need per unit (volume)? How much will it cost?
- Closed system vs open system. Closed is preferred, but how will it interface with the refrigeration unit? What coolants are compatible with a closed system? (hint: water expands when its cooled. Will it expand too much?).
- How cold will it get? Is there the potential for it to get too cold and cause frostbite?
- What size refrigeration unit do you need? How is it powered? How much does it weigh? How much will it cost?
- How powerful of a pump do you need? What is the optimal rate of flow?
- How will it be powered?

I would start by just getting the components and playing around with them in a Coleman cooler until I get the layout right. Then I would get something 3D printed. No point in paying for an expensive print job until I have an idea of where everything goes.

3. FDA Approval. If you do it completely by yourself, I think the filing fees are only a few thousand dollars. It is highly recommended to get professional help with this. This is around $30k to start. This device should not need to undergo medical testing as it is similar to an already existing device (search "510(k) Pre-Market Notification" for more details). If you're planning on patenting it, this would be where you would do it (add an additional $10k).

4. At this point you should have a pretty good idea on how the thing fits together, so finding a manufacturer or three is pretty trivial. You would most likely have one place manufacturer to refrigeration unit / pump, one place manufacture the sleeve, and one place manufacture the case (and potentially assemble it).

Hope this helps a little.

 

[Woodsman81]

It does help Thank you. I am actually going for a reasonable price version of the nice recovery system instead of the game ready.
NICE Recovery Systems

My biggest concern right now is how much it will cost to manufacture. If it cost $300 to manufacture then it is not worth pursuing. If I can get it manufactured for around 150 then I think I would be doing all right.

If it goes into the $500 and $600 range this one is already one being made.
ThermaZone Continuous Thermal Therapy Device

 

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[Woodsman81]

Thank you for all the help but I think I'm going to drop this idea with the whole FDA approval it is expensive that adds crowdfunding and will not allow me to hit the price point I was hoping for with this product .Getting something to Market is going to be hard enough for me without crowdfunding and FDA approval.